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PG — Annual Report 2024
Apr 24, 2026
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Annual Report
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Polaris
Novel Drugs For Cancer
Stock Code: 6550
Polaris Group
2024
Annual Report
Notice to readers
This English translation is provided for reference only. In case of any discrepancies, the original Chinese version shall prevail.
Printed on March 23, 2025
Information website: http://mops.twse.com.tw
Official Website: http://www.polarispharma.com
I. Company Spokesperson:
| Spokesperson | : | Hsu, Jaan-Pyng | Title | : Chief Executive Officer, Chairman |
| --- | --- | --- | --- | --- |
| Telephone | : | (886)2-2656-2727 | Email | : [email protected] |
| Deputy Spokesperson | : | Position to be filled | Title | : IR/PR |
| Telephone | : | (886)2-2656-2727 | Email | : [email protected] |
II. Addresses and Telephone Numbers of Headquarters, Branch and Plant:
-
Headquarters
Name : Polaris Group
Address : P.O. Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands
Telephone : (886) 2-2656-2727 -
Head Office and Subsidiaries
Name : Polaris Group-Taipei Office
Address : Rm., 7F., No. 298, Ruiguang Rd., Neihu Dist., Taipei City 11491, Taiwan (R.O.C.)
Telephone : (886) 2-2656-2727
Name : Polaris Pharmaceuticals, Inc.
Address : 10675 Sorrento Valley Road, Suite 200, San Diego, CA92121, USA
Telephone : (1) 858-452-6688
Name : DesigneRx Europe Limited
Address : 90 High Holborn, London, WC1V 6XX
Telephone :
Name : Polaris Pharmaceuticals Australia Pty Ltd
Address : 58 Gipps Street, Collingwood VIC3066, Australia
Telephone :
Name : Polaris Pharmaceuticals Ireland Limited
Address : 88 Harcourt Street, Dublin 2, Ireland
Telephone :
Name : Polaris Pharmaceuticals (Taiwan), Inc.
Address : Rm., 7F., No. 298, Ruiguang Rd., Neihu Dist., Taipei City 11491, Taiwan (R.O.C.)
Telephone : (886) 2-2656-2727
Name : DesigneRx Pharmaceuticals, Inc
Address : 4941 Allison Parkway, Suite B, Vacaville, CA95688, USA
Telephone : (1) 707-451-0441
Name : TDW HK Limited
Address : 6/F Alexandra HSE 18 Chater Road, Central, Hong Kong
Telephone : (886) 2-2656-2727
Name : DesigneRx Pharmaceuticals (Shanghai) Inc.
Address : 3rd Floor, Building 1, No. 400 Fangchun Road, Shanghai Free Trade Zone, China
Telephone : (86) 28-8795-7676
Name : DesigneRx Pharmaceuticals (Chengdu) Inc.
Address : No. 198, Tiansheng Road, High-tech West District, Chengdu, China
Telephone : (86) 28-8795-7676
Name : Lin Yang Biopharma, Ltd.
Address : The Grand Pavilion Commercial Centre, Oleander Way, 802 West Bay Road, P.O. Box 32052, Grand Cayman, KY1-1208, Cayman Islands
Telephone :
Name : Genovior Biotech Corporation
Address : 4 F., No. 50-8, Keyan Rd., Zhunan Township, Miaoli County 350401, Taiwan (R.O.C.)
Telephone : (886) 37-580280
Name : Nanotein Technologies, Inc.
Address : 2950 SAN PABLO AVE BERKELEY, CA 94702, USA
Telephone : (1) 866 828-2355
Name : Northern Biopharmaceutical Co., Ltd. (Fujian)
Address : Room 204, No. 255, Jiaojie, Jieshan Village, Jieshan Town, Quangang District, Quanzhou City, Fujian Province, China
Telephone :
Polaris Group Annual Report Catalog
I. Letter to Shareholders...1
II. Company Profile
- Date of Establishment and Group Profile...8
- Group Structure...8
- Risks...8
III. Corporate Governance Report...9
- Information on Directors, Supervisors, President, Vice President, Assistant Directors, Heads of Departments and Branches...9
- Remuneration for Directors, Supervisors, President and Vice President for the Most Recent Year...18
- Corporate Governance...25
- Information on Accountants' Fees...58
- Information on Change of Accountant...58
- The Chairman of the Board of Directors, the President, and the Manager in Charge of Financial or Accounting Matters of the Company, Who Have Worked in the Firm of the Certified Public Accountant or Its Affiliates within the Last Year...59
- Changes in the Shareholding of Directors, Supervisors, Managers and Shareholders Holding More Than 10% of the Shares and Pledges of Shares in the Most Recent Year and up to the Date of Publication of the Annual Report...60
- Information on the Top Ten Shareholders Who Are Related to Each Other or Are Related to Each Other as Spouses or Relatives within Second Generation...61
- Number of Shares Held by the Company, Its Directors, Supervisors, Managers and Businesses Directly or Indirectly Controlled by the Company in the Same Business to Which the Company Invests, and Combined to Calculate the Consolidated Shareholding Percentage...62
IV. Capital Raising...64
- Capital and Shares...64
- Corporate Bonds...73
- Preferred Shares...73
- Overseas Depositary Receipts...73
- Employee Stock Options...74
- New Shares with Restricted Employee Rights...78
- Issuance of New Shares through Merger, Acquisition or Transfer of Shares of Other Companies...78
- Implementation of Capital Utilization Plan...78
V. Operation Overview...82
1. Business Contents...82
2. Market and Production Overview...96
3. Information on Employees...100
4. Information on Environmental Protection Expenditure...100
5. Labor Relations...101
6. Infocomm Security Management...102
7. Important Contracts...103
VI. Review and Analysis of Financial Condition and Financial Performance and Risk Matters...105
1. Financial Status...105
2. Financial Performance...106
3. Cash Flow...107
4. The Impact of Major Capital Expenditures on Financial Business in the Most Recent Year...108
5. Reinvestment Policy in the Most Recent Year, the Main Reasons for Its Profit or Loss, Improvement Plan and Investment Plan for the Next Year...108
6. Analysis and Evaluation of Risks and Management...109
7. Other Important Matters...116
VII. Special Notes...117
1. Information about Affiliate Enterprises...117
2. Private Placement of Securities...121
3. Other Supplementary Information Required...122
4. Explanation of the Major Differences with My Country's Provisions on the Protection of Shareholders' Rights and Interests...122
5. In the Most Recent Year and as of the Date of Publication of the Annual Report, Any Event that has a Material Impact on the Equity of Shareholders or the Price of Securities as Specified in Paragraph 2, Item 3, Article 36 of the Securities Exchange Act has Occurred...130
1
I. Letter to Shareholders
Dear esteemed shareholders, ladies and gentlemen:
We'd like to express our gratitude for shareholders for your support and trust throughout the first year of listing of Polaris Group. Recalling 2024, Polaris Pharmaceuticals evolved from a company focused on new drug development to successfully expanding into the fields of multiple peptide drugs, APIs, generic drugs, and CDMO through the acquisition of Genovior Biotech; these two highly promising product lines will become the dual engines for Polaris Group's future growth, driving the continuous expansion of the overall business.
Under the drive of the dual-engine growth model, in 2024 we repositioned the mission directions of each subsidiary, moving away from the past R&D-centric business model and shifting towards a development strategy focused on commercial production and profit pursuit.
Looking ahead, our objectives are not only to accelerate the commercialization of ADI-PEG 20 under the premise of meeting clinical needs and further establish a leading position in the metabolic anti-cancer field; at the same time, we will continue to develop GLP-1 products such as Semaglutide and Tirzepatide, actively expand the global market, continuously enhance competitiveness, and establish our leadership in the peptide field.
Below is a report of our achievements for 2024.
I. FY 2024 Operating Results
(I) 2024 Business Plan Implementation Results
1. Clinical Trials of ADI-PEG 20
The Clinical Trials in progress are as follows:
| Cancer Type | Stage | Lead Cancer Center | Intervention/Treatment |
|---|---|---|---|
| Soft Tissue Sarcoma | Phase III | University of Washington | ADI-PEG 20 |
| + Gemcitabine | |||
| + Docetaxel | |||
| Cerebral cancer | Phase II/III | Linkou Chang Gung Memorial Hospital | |
| Taiwan/Global Coalition for adaptive Research | ADI-PEG 20 | ||
| + Temozolomide | |||
| + Radiotherapy | |||
| Hepatic cell Carcinoma | Phase II/III (Note) | Linkou Chang Gung Memorial Hospital, Taiwan | Monotherapy |
| Acute Myeloid Leukemia | Phase I | MD Anderson Cancer Center Houston, Texas, United States | ADI-PEG 20 |
| + Venetoclax | |||
| + Azacitidine | |||
| NASH | Phase II | Linkou Chang Gung Memorial Hospital, Taiwan | Monotherapy |
Note: This is the clinical trial for NDA submission.
- CDMO Pharmaceutical Contract Development and Manufacturing Services
The Company completed the merger of the subsidiary Polaris Biopharmaceuticals, Inc. and the sub-subsidiary Genovior Biotech in July 2024.
In the past, CDMO services were the primary revenue source for Genovior Biotech. However, compared to the explosive potential of new drugs, self-produced polypeptides, and anti-cancer products in the commercial market, the growth potential of the CDMO business is relatively limited. Therefore, in future resource allocation, the Company will prioritize the research, development, and mass production of its own new drugs, polypeptides, and anti-cancer products to ensure a more competitive market position and long-term development.
(II) Budget Implementation
The Company only sets an internal budget plan in 2024 and does not disclose financial forecast data to the public. The overall budget spending situation generally conforms to the plan set by the Company.
(III) Financial Income and Expenditure and Profitability Analysis
The increase in revenue and operating costs compared to 2023 was primarily due to the Company's acquisition of Genovior Biotech Corporation in December 2023, with the company's financial statements consolidated into our company. Revenue and operating costs were primarily attributable to Genovior Biotech Corporation's CDMO foundry business. Operating expenses increased by 38.7% compared to 2023, mainly due to the acquisition of Genovior Biotech, which raised overall expenses, as well as the significant increase in related facility costs in response to the Group's drug license application and expansion in staffing for future mass production. Additionally, multiple Phase III clinical trials were launched in 2024, leading to an increase in clinical expenses. Non-operating income decreased by 64.7%, mainly due to the Company's lower cash levels in 2024, resulting in reduced interest income.
Unit: NTD1,000
| Items | The year 2024 | Domestic sales | Difference | % |
|---|---|---|---|---|
| Operating Income | 107,000 | 7,481 | 99,519 | 1,330.3 |
| Operating costs | (183,923) | (10,546) | (173,377) | (1,644.0) |
| Operating gross profit | (76,923) | (3,065) | (73,858) | (2,409.7) |
| Operating expenses | (2,557,962) | (1,852,657) | (705,305) | (38.7) |
| Operating profit or loss | (2,634,885) | (1,855,722) | (779,163) | (41.99) |
| Non-operating incomes and expenses | 89,342 | 363,579 | (274,237) | (75.4) |
| Net profit or loss before tax | (2,545,543) | (1,492,143) | (1,053,400) | (70.6) |
(IV) R&D Status
For details, please refer to the "2024 Business Plan Implementation Results" hereinabove.
3
II. 2024 Business Plan Outline
(I) Operating Strategy
-
The Company has submitted a rolling application for mesothelioma drug license to the FDA and plans to complete the submission of all related information on the drug license by 2025. At the same time, we will actively seek Priority Review qualification from the FDA to accelerate the review process, aiming to bring the Product to market sooner.
-
Strategically plan clinical trials to obtain global drug licenses as soon as possible to benefit cancer patients worldwide.
-
Continue to explore the relationship between ADI-PEG 20 and biomarkers, maximize the therapeutic benefit of patients through biomarker testing, so as to achieve the ultimate goals of precision medicine, increase the penetration rate of ADI-PEG 20 in various cancer markets, and ultimately expand the market size.
-
Combining the expertise of Polaris Group and Genovior Biotech Corporation, we will expand our product line to include peptide related apis, difficult generics, and Class 505b2 drugs to better meet the needs of different patients.
-
Find and co-development or regional licensing with strategic alliance partners to secure working capital and spread risks.
-
Practically carry out relevant clinical trials on metabolic disease indications, such as severe fatty liver and diabetes, to make ADI-PEG20 the first choice for combination of metabolic therapy and various cancer drugs, so that more patients can benefit.
(II) Expected Sales and Its Basis and Important Production&Sales Policies
The Company's self-developed products are still in the clinical trial stage and have not yet been marketed. At present, the main business income comes from contracting CDMO services. Management sets the Company's operation goals and strategies every year, and then the R&D, manufacturing, and clinical teams in the U.S. and Taiwan propose various R&D and CDMO projects accordingly. The R&D/foundry projects are approved for execution after evaluating feasibility, marketing and financial status.
III. The Company's Future Development Strategy
(I) Clinical Trials for NDA Submission
As a widely effective new cancer drug, ADI-PEG20 has been successfully used in clinical trials of various indications by many international medical centers before. Therefore, ADI-PEG20 has always been highly expected by the international medical community in the field of metabolic therapy for cancer. Therefore, ADI-PEG20 has been highly expected by the international medical community in the field of metabolic therapy for cancer. Now that it's unblinded, the Company will soon obtain the first first-line drug certificate in mesothelioma, which will be a prelude to the widespread application of this drug in cancer metabolic therapy. The primary goal of the future development strategy is to obtain more definite clinical efficacy data in the shortest possible time in order to enhance the value of the Company and make metabolic therapy the main treatment method for cancer. In the future, the Group will focus its resources on accelerating phase II/III clinical trials for hepatocellular carcinoma and soft tissue sarcoma. In addition, the Company has also initiated Phase II Glioblastoma and joined the GBM AGILE platform for Phase II/III Glioblastoma trials, as well as phase I clinical trials for Acute Myeloid Leukemia. At the same time, clinical trials for metabolic related diseases such as NASH will be conducted. These trials are described as follows:
- Soft Tissue Sarcoma
The Phase III clinical trial program received FDA approval for IND and completed its first patient admission for ADI-PEG 20 combined with Gemcitabine and Docetaxel for leiomyosarcoma. The trial was randomized and double-blind, with multiple countries and centers involving. The main evaluation index was Progression Free Survival and the secondary evaluation index was Overall Survival.
- Hepatic Cell Carcinoma
In order to accelerate the clinical trial, the Company changed the enrollment condition to screening by arginine concentration. Hepatic cell carcinoma was treated with ADI-PEG 20, the new metabolic therapy. The trial was randomized and double-blind, with multiple countries and centers involving. The main evaluation index was Progression Free Survival and the secondary evaluation index was Overall Survival. In addition to patient enrollment at seven medical centers in Taiwan, approval has been obtained from the Vietnam Ministry of Health (MOH) for the trial, and a memorandum of understanding has been signed with the Vietnam National Cancer Hospital, with patient enrollment expected to commence.
4
- Cerebral Cancer
This clinical trial was conducted with ADI-PEG20 combined with radiotherapy and Temozolomide in the treatment of Glioblastoma, GBM. This case was originally a Phase I clinical trial, and after completing this stage, the evaluable subjects were enrolled. The Phase II clinical trial has been continued, with a change to a control placebo group, randomized allocation, and double-blind trial. It is expected that the scale of the trial will be expanded, and the number of cases collected globally will be 100. The main evaluation indicator was the Overall Survival, and the trial physician would observe the Progression-free survival. This experiment was led by Taiwan Linkou Chang Gung Memorial Hospital and collaborated with five renowned medical centers in Korea. Patient enrollment is expected to be completed by mid-year.
At the same time, the Company joined GBM AGILE, a new clinical trial platform approved by the FDA, which allows simultaneous evaluation of multiple new drugs for cerebral cancer and sharing of patients in control group. And the platform has signed contracts with major international hospitals in order to quickly recruit patients. In August 2023, the ADI-PEG 20 group being trialled on the GBM AGILE platform will enroll patients with newly diagnosed and relapsing GBM. Dr. Nicholas Blondin, assistant professor of clinical neurology at Yale School of Medicine, and Dr. Macarena de la Fuente, associate professor of neuro-oncology and director of neuro-oncology at the Sylvester Comprehensive Cancer Center, University of Miami, will serve as the lead trial program hosts for ADI-PEG 20.
- Acute Myeloid Leukemia
This is a Phase 1 clinical trial of ADI-PEG 20 in combination with Venetoclax and Azacitidine in patients with acute myeloid leukemia, led by MD Anderson Cancer Center. In addition to evaluating the safety and tolerability of ADI-PEG 20 in combination with Venetoclax and Azacitidine, the efficacy of this combination in the RP2D (recommended phase 2 dose) arm will also be explored.
(II) Contract Development and Manufacturing Organization (CDMO)
In addition to the production of ADI-PEG 20, DRX USA, the Group's subsidiary in Northern California, also has a very mature technology that uses E. coli as a production platform. Since officially providing Drug Development and Production (CDMO) services in November 2019, we have received positive feedback. With the success of the Phase III clinical trial for mesothelioma, DRX USA is gradually transitioning to a commercial operation model and actively promoting related preparations, including three batch validation production, GMP inspection preparation, and drug license registration application to meet the regulatory requirements for drug market launch.
In addition, the Group established Subsidiary DRX Chengdu in Chengdu, originally as a support center for new product development and research for the Northern California plant. With the completion of phased tasks, the Company has been planning since the beginning of this year to upgrade DRX Chengdu from a research and development unit to a GMP-compliant production pharmaceutical plant. This is expected to bring stable revenue to the Group in the future.
5
(III) Polypeptide Product Development and Process Optimization
The Company will strengthen research and innovation in the polypeptide product line at Genovior Biotech Corporation, with a special focus on the development of multiple polypeptide products and process optimization to improve production efficiency and product quality. The following are the Company's main plans for polypeptide product development and process optimization. These trials are described as follows:
- Semaglutide
Semaglutide, a drug used to treat diabetes, is a hormone that is a receptor agonist for GLP-1 (glucagon-like peptide-1), an analogue of the insulin hormone that stimulates insulin production and lowers blood sugar levels. In addition, Semaglutide is also used for weight management in obesity, as it can promote appetite reduction and contribute to weight loss. In addition, Semaglutide is expected to continue to expand with the progress of clinical trials of the original company, including the treatment of renal failure in diabetes patients and other related indications. The Company is committed to further optimizing Semaglutide products, including the development of generic drug products from active pharmaceutical ingredients (APIs), injections, and oral formulations. Moreover, the Company also expanded the market size of its products through the development of Class505b2 new drugs to meet the needs of patients and improve therapeutic effectiveness.
The Semaglutide API 200kg production line is scheduled to be completed in 2025. In the aspect of commercial development, the Company is currently focusing on the expansion of the new market (emergingmarket). As the supply of Semaglutide products falls short of demand, the company also plans to cooperate with new market countries to enter major new market countries through joint venture, co-development or technology transfer, etc.
- Teriparatide
As a peptide substance used in the treatment of osteoporosis, Teriparatide has a significant effect on enhancing bone mineral density and reducing the risk of fracture. The company is committed to improving the production efficiency and quality of Teriparatide to ensure that patients have access to safe and effective treatments. In 2025, we will continue to develop Teriparatide preparations, drug inspection registration, and marketing planning.
With these efforts, the Company expects to enhance its influence in the biopharmaceutical industry and lay a solid foundation for future development. This is also the Company's commitment to the field of medical science and technology, that is, providing more advanced and more effective treatment solutions while pursuing excellent quality and a high degree of market competitiveness.
6
7
IV. The Impact of External Competition, Regulations and the General Business Environment
The Company is committed to the comprehensive vertical integration and development of cancer, and equipped with all-round research and development capacities. With its unique mechanism of action, ADI-PEG 20 has shown initial efficacy and safety in multiple cancer trials, and its applicability in combination with a variety of other treatments is expected to be highly competitive in the future market. ADI-PEG 20 will face less homogeneous drug competition in the short term after obtaining the drug license.
In terms of laws and regulations, the Company has experts who have deep understanding of the drug management system of countries and have been paying close attention to the latest trends of laws and regulations to ensure the stable operating environment of the Company. The Company's senior management has profound experience in new drug research and development as well as company operation, always conducting market management and analysis of market movements in a sensitive manner, so as to ensure that the company can immediately adapt to the environment, reduce environmental pollution and maintain a high level of competitive edge.
We will strive to achieve the Company's outstanding achievements in the field of cancer management with a sense of commitment and humility, and create the maximum value for all stakeholders.
Chairman: Hsu, Jaan-Pyng
CEO: Hsu, Jaan-Pyng
Accounting Supervisor: Yi-Ming Kao
8
II. Company Profile
I. Date of Establishment and Group Profile
Polaris Group (hereinafter referred to as the “Company” or “Polaris”) was incorporated in the British Cayman Islands on February 9, 2006 with a par value of NT$10 per share. The Company and its subsidiaries include Polaris Pharmaceuticals, Inc., Polaris Group Korea Limited, DesigneRx Europe Limited, Polaris Pharmaceuticals Australia Pty Ltd, Polaris Pharmaceuticals Ireland Limited, Polaris Pharmaceuticals (Taiwan), Inc., DesigneRx Pharmaceuticals, Inc., TDW HK Limited, DesigneRx Pharmaceuticals (Shanghai) Inc., DesigneRx Pharmaceuticals (Chengdu) Inc., Polaris Biopharmaceuticals, Inc. and Nanotein Technologies, Inc., collectively referred to as the “Group”. The Group’s principal business activities are the manufacturing and sale of new drugs, biotechnology services, commissioned development and production related services and drug testing. The Group’s core research is the novel cancer target drug ADI-PEG 20, which is currently undergoing human clinical trials for various cancers worldwide.
II. Group Structure
Please refer to VII of this Annual Report under “Special Notes”.
III. Risks
Please refer to VI “Review and Analysis of Financial Condition and Financial Performance and Risks” in this Annual Report for details of the general economic and political and economic environment in the countries of incorporation and the main operating countries, foreign exchange control, rent and taxation and related laws and regulations, recognition of the validity of civil verdicts by the courts in the ROC, and other risks
March 23, 2025
III. Corporate Governance Report
I. Information on Directors, Supervisors, President, Vice President, Assistant Directors, Heads of Departments and Branches
(I) Information on Directors and Supervisors (the Company does not have a supervisor)
- Name, Gender, Age, Nationality or place of incorporation, Experiences, Shareholdings and Nature
9
| Title | Nationality or place of incorporation | Name | Gender Age | Election (appointment) Date | Term | Initial Election when elected | Shareholdings Now | Hold Number of shares | Sposse, minor children now Shareholdings | Shareholdings in the name of others | Experiences | Currently holds positions in the Company and other companies | Other supervisors or directors with a spouse or relationship within the second degree | Note |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chairman (Note4) | Taiwan | Chen, Hung-Wen | Male 64 years old | 2023.06.12 | 3 | 2014.11.24 | 34,700 | 0.005 | 1,034,700 | 0.001 | — | — | — | — |
| • Taiwan Semiconductor Manufacturing Co., Ltd. | ||||||||||||||
| • Taixin Semiconductor Co., Ltd. | • Director of PPL, DEX USA, DEX Chengdu, DEX Shanghai, PPTW, LYB and Genovior Biotech | |||||||||||||
| • Chairman of the Board of Gentek Technology Co., Ltd. | ||||||||||||||
| • Chairman of the Board of Browan Communications Incorporation | ||||||||||||||
| • Chairman of the Board of Speedlink Communications Co., Ltd. | ||||||||||||||
| • Director of G-Technology Investment Co., Ltd. | ||||||||||||||
| • Director of Witek Investment Investment Co., Ltd. | ||||||||||||||
| • Director of Ampak International Holding Ltd. | ||||||||||||||
| • Director of Primax Communication(B.V.I.) | ||||||||||||||
| • Inc. Director of Billionaire Microelectronics Co., Ltd. --- | None | None | None | None | ||||||||||
| Director (Note5, Note6) | Samsa | Digital Capital Inc. | — | 2023.06.12 | 3 | 2020.02.25 | 290,000,000 | 37.641 | 290,000,000 | 37.641 | — | — | — | — |
| Title | Nationality or place of incorporation | Name | Gender Age | Election (appointment) Date | Term | Initial Election when elected | Shareholdings Now | Hold Number of shares | Sponse, minor children now Shareholdings | Shareholdings in the name of others | Experiences | Currently holds positions in the Company and other companies | Other supervisors or directors with a spouse or relationship within the second degree | Note | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | Title | Name | Relation | ||||||||||
| Directors | Taiwan | Representative: Hua, Jaan-Pyng | Male 67 years old | 2024.01.02 | Note 1 | 2024.01.02 | — | — | 1,000,000 | 0.001 | 2,000 | 0.000 | — | — | • PhD in Chemical Engineering, Massachusetts Institute of Technology, USA | |||||
| • Chairman/President of Savior Lifetee Corporation | ||||||||||||||||||||
| • VP of RD, ScinoPharm Taiwan | ||||||||||||||||||||
| • Manager of Pharmaceutical Department of Sinon Corporation | ||||||||||||||||||||
| • Senior Engineer, Production technology Department of Merck & Co., USA | • CEO of the Company | |||||||||||||||||||
| • Director of PBI, PPTW, LYB | ||||||||||||||||||||
| • Chairman and President of Genovior Biotech | ||||||||||||||||||||
| • Director of Fujian Genohope Biotech Ltd. | None | None | None | None | ||||||||||||||||
| Taiwan | Chen, Shyan Tser | Male 75 years old | 2023.06.12 | 3 | 2020.02.25 | 4,950,000 | 0.642 | 4,950,000 | 0.642 | 3,802,000 | 0.51 | — | — | Department of Chemistry, National Tsing Hua Universit | • Director of PPI, DRX USA, PPTW, PBI, Genovior Biotech | |||||
| • Supervisor of DRX Shanghai | ||||||||||||||||||||
| • Chairman of the Board of GlobalSat WorldCom Corporation | ||||||||||||||||||||
| • Director of Songhai Technology Co., Ltd. --- | None | None | None | None | ||||||||||||||||
| Indirectors | Cayman Islands | Mai Investment Co., Ltd | — | 2023.06.12 | 3 | 2023.06.12 | 40,527,138 | 5.260 | 40,527,138 | 5.260 | — | — | — | — | — | — | None | None | None | None |
| United States/Republic of China | Representative: Tsai, Kao-Chung | Male 64 years old | 2023.06.12 | Note 2 | 2025.03.13 | — | — | — | — | — | — | — | — | Vice Chairman of Hung Kuan Electronic Industry Co., Ltd. | Director of Polaris Group | None | None | None | None | |
| Independent Director | Taiwan | Way, Tzong Der | Male 53 years old | 2023.06.12 | 3 | 2020.02.25 | — | — | — | — | — | — | — | — | Ph.D. in Chemistry and Molecular Biology, National Taiwan University | Professor and Dean of the Department of Biotechnology, Academy of Technology, Pharmacy and Food Science, China Medical University | None | None | None | None |
| Independent | Taiwan | Chao, Ying- | Male | 2023.06.12 | 3 | 2021.08.23 | — | — | — | — | — | — | — | — | • Master of | • Consultant of | None | None | None | None |
| Title | Nationality or place of incorporation | Name | Gender Age | Election (appointment) Date | Term | Initial Election when elected | Shareholdings Now | Hold Number of shares | Spouse, minor children now Shareholdings | Shareholdings in the name of others | Experiences | Currently holds positions in the Company and other companies | Other supervisors or directors with a spouse or relationship within the second degree | Note |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | Title | Name | Relation | ||||
| Director | Chen | 65 years old | ||||||||||||
| Independent Director | Taiwan | Wen, Kuo-Lan | Female 59 years old | 2024.5.3 | Note 3 | 2024.5.3 | — | — | — | — | — | — | — | — |
Note 1: The legal representative of Digital Capital Inc., was originally the director, Patrick Y. Yang. On January 2, 2024, Digital Capital Inc. reassigned its representative Hsu, Jaan-Pyng, who took effect on January 2, 2024 and served until June 11, 2026.
Note 2: The corporate director representative of Mai Investment Co., Ltd was originally Lin, Wei-Yuan. On March 13, 2025, Digital Capital Inc. reassigned its representative to Tsai, Kao-Chung, effective March 13, 2025, and serving until June 11, 2026.
Note 3: Independent Director Wen, Kuo-Lan assumed office after the by-election of Independent Directors at the 2024 General Meeting of Shareholders, effective May 3, 2025, with a term ending on June 11, 2026.
Note 4: On April 8, 2024, Mr. Hung-Wen Chen resigned from his position as Chairman of the Company and continues to serve on the Board as a Director.
Note 5: The corporate director, Digital Capital Inc. (Representative: Hsu, Jaan-Pyng), was elected as Chairman of the Board by resolution of the Company's Board of Directors on April 8, 2025, and assumed office on the same day.
Note 6: When the Chairman of the Board also serves as the President or another executive officer, or when they are spouses or within the second degree of kinship, the Company shall disclose the reasons, rationality, necessity, and corresponding measures. For related assessments, please refer to page 17, “(II) Information on Directors, Supervisors, President, Vice President, Assistant Directors, Heads of Departments and Branches.”
13
2. Substantial Corporate Shareholders
March 23, 2025
| Name of the Corporate Shareholder | Substantial Corporate Shareholders |
|---|---|
| Digital Capital Inc. | Chen, Shyan Tser 25%、Chen Chang, Fang Hsin 25%、Chen, Yi Ting 25%、Chen, Yi Chun 25% |
| Mai Investment Co., Ltd. | Digital Mobile Venture Ltd. 100% |
3. Principal shareholders of legal entities whose principal shareholders are legal entities.
| Name of the Legal Entity | Substantial Corporate Shareholders |
|---|---|
| Digital Mobile Venture Ltd. 100% | Chen, Shyan Tser 25%、Chen Chang, Fang Hsin 25%、Chen, Yi Ting 25%、Chen, Yi Chun 25% |
4. Directors' Professional Knowledge and Independence
(1) Disclosure of Directors' Professional Qualifications and Independence of Independent Directors
| Name | Professional Qualifications and Experience | Independence | Number of Other Public Companies Currently Acting as Independent Director |
|---|---|---|---|
| Chen, Hung-Wen | 1. Experience in business or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10. | ||
| 2. None of the circumstances described in Article 30 of the Company Act | Non-independent director. | 0 | |
| Chen, Shyan Tser | 1. Experience in business or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10. | ||
| 2. None of the circumstances described in Article 30 of the Company Act | Non-independent director. | 0 | |
| Hsu, Jaan-Pyng | 1. Experience in business or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10. | ||
| 2. None of the circumstances described in Article 30 of the Company Act | Non-independent director. | 0 | |
| Tsai, Kao-Chung | 1. Experience in business or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10. | ||
| 2. None of the circumstances described in Article 30 of the Company Act | Non-independent director. | 0 |
| Conditions
Name | Professional Qualifications and Experience | Independence | Number of Other Public Companies Currently Acting as Independent Director |
| --- | --- | --- | --- |
| Way, Tzong Der | 1. Member of the Audit Committee who is at least a lecturer from a public or private college or university with a degree in business, law, finance, accounting or a related discipline required for corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10.
2. None of the circumstances described in Article 30 of the Company Act | 1. No relative within the scope of the Company or its affiliates is a director, supervisor or employee of the Company or its affiliates.
2. None of the Company's shares are held by the individual, his/her spouse, or a relative within the second degree of consanguinity (or in the name of another person).
3. Not a director, supervisor, or employee of the company with which the Company has a specific relationship.
4. No remuneration for business, legal, financial, or accounting services provided by the Company or its affiliates in the last two years. | 1 |
| Chao, Ying-Chen | 1. Audit Committee Members with experience in business or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10.
2. None of the circumstances described in Article 30 of the Company Act | 1. No relative within the scope of the Company or its affiliates is a director, supervisor or employee of the Company or its affiliates.
2. None of the Company's shares are held by the individual, his/her spouse, or a relative within the second degree of consanguinity (or in the name of another person).
3. Not a director, supervisor, or employee of the company with which the Company has a specific relationship.
4. No remuneration for business, legal, financial, or accounting services provided by the Company or its affiliates in the last two years. | 0 |
| Wen, Kuo-Lan | 1. Audit Committee Members with experience in business or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10.
2. None of the circumstances described in Article 30 of the Company Act | 1. No relative within the scope of the Company or its affiliates is a director, supervisor or employee of the Company or its affiliates.
2. None of the Company's shares are held by the individual, his/her spouse, or a relative within the second degree of consanguinity (or in the name of another person).
3. Not a director, supervisor, or employee of the company with which the Company has a specific relationship.
4. No remuneration for business, legal, financial, or accounting services provided by the Company or its affiliates in the last two years. | 1 |
(2) Board Diversity and Independence
A. Board Diversity:
Policy on Diversity of Board Members
In accordance with Article 20, Item 1 of the Company's Code of Corporate Governance Practices, the composition of the Board of Directors of Directors should consider diversity and formulate appropriate diversity policies with respect to its operations, business model and development needs, including but not limited to basic qualifications and values (gender, age, nationality, culture and ethnicity, etc.) and professional knowledge and skills (such as legal, accounting, industrial, financial, marketing or technology, etc.).
Implementation of Policy on Diversity of Board Members, Specific Management Objectives and Achievements
The Company's Board of Directors shall instruct the Company's strategy, supervise the management, and be responsible to the Company and its shareholders. The practices and arrangements of the Company's corporate governance system shall ensure that the Board of Directors of Directors shall exercise its authority in accordance with the law, the provisions of the Articles of Incorporation, or the resolutions of the shareholders' meeting. The Company's directors possess the knowledge, skills, education, and industrial decision-making and management abilities necessary for the execution of their business. The Company continues to arrange diversified training programs for its board members to enhance their decision-making quality and supervisory ability, and to strengthen the functions of the Board of Directors of directors. In addition, the Company also emphasizes gender equality in the composition of the Board of Directors. The Company currently includes one female director, but females do not yet constitute one-third of the directors. In the next election of directors, the Company will consider the diversity of gender ratio as one of the factors in the nomination and selection of directors, actively increasing the number of female director seats to achieve diversity and gender balance in the Board of Directors.
15
The Company's current Board of Directors consists of seven directors, including three independent directors, three corporate directors and one natural person director, and the abilities of each director based on their academic experience and the relevant implementation are as follows:
| Title | Name | Gender | Age | Nationality | Biotechnology industry professional background | Business, finance and accounting experience | Coordinated planning management and leadership experience | National certification of lecturer qualification or professional technology in tertiary institutions |
|---|---|---|---|---|---|---|---|---|
| Chairman | Hsu, Jaan-Pyng | Male | 60~69 | Republic of China, R.O.C. or Taiwan | ✓ | ✓ | ✓ | |
| Director | Chen, Hung-Wen | Male | 60~69 | Republic of China, R.O.C. or Taiwan | ✓ | ✓ | ||
| Director | Tsai, Kao-Chung | Male | 60~69 | Republic of China, R.O.C. or Taiwan | ✓ | ✓ | ||
| Director | Chen, Shyan Tser | Male | 70~79 | Republic of China, R.O.C. or Taiwan | ✓ | ✓ | ||
| Independent Director | Way, Tzong Der | Male | 50~59 | Republic of China, R.O.C. or Taiwan | ✓ | ✓ | ✓ | |
| Independent Director | Chao, Ying-Chen | Male | 60~69 | Republic of China, R.O.C. or Taiwan | ✓ | ✓ | ||
| Independent Director | Wen, Kuo-Lan | Female | 50~59 | Republic of China, R.O.C. or Taiwan | ✓ | ✓ | ✓ |
Note 1: The Company has 1 Director with employee status, accounting for 14.3%
Note 2: There are 3 Independent Directors, accounting for 42.9%, whose tenure doesn't exceed 9 years.
Note 3: There are 2 Directors aged between 50 and 59, 4 aged between 60 and 69 and 1 aged between 70 and 79.
Note 4: There are 3 Directors with Biotechnology Industry Professional Background, accounting for 42.9%.
Note 5: There is 1 Director with professional teaching position and professional certification, accounting for 14.3%
Note 6: There are 6 Directors with a background in business, finance and accounting experience, accounting for 85.7%.
Note 7: There are 6 male Directors and 1 female Director.
B. Independence of the Board of Directors
The Board of Directors of Directors is composed of six directors with professional backgrounds and extensive experience, whose role is to enhance the long-term corporate value of the Company and to protect the interests of shareholders and stakeholders through sound corporate governance, integrity and ethical values. Of the seven Directors, the Directors are nominated by candidates and are selected by the Shareholders' Meeting from a list of candidates for Director (including Independent Director). Of the six Directors, the Directors are nominated by candidates and are selected by the Shareholders' Meeting from a list of candidates for Director (including Independent Director), and the Directors have delegated the authority to establish a Compensation Committee and an Audit Committee to assist the Directors in carrying out their responsibilities.
The Board of Directors of Directors is not subject to the provisions of Article 26-3, Paragraphs 3 and 4 of the Securities and Exchange Act, and there is no spouse or consanguineous relationship between the Directors.
(II) Information on Directors, Supervisors, President, Vice President, Assistant Directors, Heads of Departments and Branches
March 23, 2025
| Title | Nationality | Name | Gender | Election (appointment) date | Shareholdings | Spouse, minor children shareholdings | Shareholdings in the name of others | Experiences | Currently engaged in other company duties | Manager with spouse or second degree of consanguinity | Note | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | Title | Name | Relation | ||||||||
| CEO (Note1) | Republic of China, R.O.C. or Taiwan | Hsu, Jaan-Pyng | Male | 2023.12 | — | — | 2,000 | 0.000% | — | — | PhD in Chemical Engineering, Massachusetts Institute of Technology, USA | |||||
| Chairman/President of Savior LifeteC Corporation | ||||||||||||||||
| VP of RD, ScinoPharm Taiwan | Representative of Digital Capital Inc. Director of Fujian Genohope Biotech Ltd. | None | None | None | None | |||||||||||
| Executive Vice President | United States | John Bomalaski | Male | 2007.01 | — | — | — | — | — | — | MD, USA St. Louis University | |||||
| Registered Physician in Internal Medicine and Rheumatology, USA | ||||||||||||||||
| Founder of USA Phoenix Pharmacologics | None | None | None | None | None | |||||||||||
| Chief Financial Officer | ||||||||||||||||
| Corporate Governance Supervisor | Republic of China, R.O.C. or Taiwan | Yi-Ming Kao | Male | 2025.03 | — | — | — | — | — | — | Master in Finance and Real Estate, London School of Economics and Political Science | |||||
| Bachelor of Finance, National Taiwan University | ||||||||||||||||
| CFA (Chartered Financial Analyst) | ||||||||||||||||
| Director of the Finance Department at AVerMedia Technologies | ||||||||||||||||
| Managing Director of Dogin Capital | ||||||||||||||||
| APWC (Asia Pacific Wire & Cable Ltd.) Chief Financial Officer | None | None | None | None | None | |||||||||||
| CSO | United States | Chien-Hsing Chang | Male | 2023.06 | — | — | — | — | — | — | PhD in Chemistry, Johns Hopkins University | |||||
| Vice President of Research and Development at IMMUNOMEDICS | None | None | None | None | None | |||||||||||
| CISO | Republic of China, R.O.C. or Taiwan | Kevin Wu | Male | 2023.12 | — | — | — | — | — | — | Master of Law, Soochow University | |||||
| Master/PhD, Institute of Life Sciences, National Tsing Hua University | ||||||||||||||||
| Associate Director, Business Law firm, Deloitte & Touche | None | None | None | None | None | |||||||||||
| Audit Director | Republic of China, R.O.C. or Taiwan | Yang Wei-yao | Male | 2024.10 | — | — | — | — | — | — | BS, Department of Accounting, Tunghai University | |||||
| Manager, Risk Advisory, Deloitte & Touche | ||||||||||||||||
| Associate, Audit Services, Deloitte & Touche | None | None | None | None | None | |||||||||||
| Vice President of Production | United States | Chris Huxsoll | Male | 2005.02 | — | — | — | — | — | — | Ph.D. in Physiology, University of California, Davis | |||||
| Researcher at Hygienia Biotech, USA California, 15 years of experience in pharmaceutical quality control | None | None | None | None | None | |||||||||||
| Vice President of Clinical Affairs | United States | Amanda Johnston | Female | 2010.10 | 140,000 | 0.02% | — | — | — | — | PhD in Pharmacy, University of London, UK | |||||
| Senior investigator and clinical team leader at Agouron Pharmaceuticals, Warner-Lambert and Pfizer | None | None | None | None | None |
Note 1: The Chairman of the Board also serves as the President of the Company. This arrangement has been adopted to enhance decision-making efficiency and resource integration. Its rationality and necessity have been carefully evaluated, and the Company will increase the number of independent directors within the period prescribed by law
II. Remuneration for Directors, Supervisors, President and Vice President
(I) Remuneration for Directors, Supervisors, CEO and Vice Presidents for the Most Recent Year (2024)
- Remuneration for Directors and Independent Directors
Unit: NTD1,000
| Title | Name | Director remuneration (Note 1) | Total amount of A, B, C and D and percentage of net income after tax | Relevant remuneration received by directors who are also employees | Ratio of the Sum of Items A, B, C, D, E, F, and G to Net Profit after Tax (%) | Remuneration from Investee companies other than subsidiaries or from the parent company |
|---|---|---|---|---|---|---|
| Remuneration (A) | Retirement pension (B) | Director's remuneration (C) | Business execution fee (D) | Salaries, bonus, and allowance (E) (Note 2) | Retirement Pension (F) | Employee compensation (G) |
| The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company |
| Chairman | Digital Capital Inc. Representative: Hsu, Jaan-Pyng (Note 3) | 325 | 325 | — | — | — |
| Director | Chen, Hung-Wen | 3,600 | 3,600 | — | — | — |
| Director | Mai Investment Co., Ltd. Representative: Wayne Lin | 1,200 | 1,200 | — | — | — |
| Tsai, Kao-Chung (Note 1) | 371 | 371 | — | — | — | — |
| Director | Chen, Shyan Tser | 1,200 | 1,200 | — | — | — |
| Independent Director | Way, Tzong Der | 1,500 | 1,500 | — | — | — |
| Independent Director | Chao, Ying-Chen | 1,500 | 1,500 | — | — | — |
| Independent Director | Wen, Kuo-Lan | 494 | 494 | — | — | — |
-
Please explain the payment policies, systems, standards, and structures for remuneration of Independent Directors and explain the connection between factors (such as duties, risks, and time invested) and the amount of remuneration paid: According to the Articles of Incorporation of the Company, the remuneration of directors shall be submitted to the Board of Directors for resolution after being agreed by the Remuneration Committee based on the value of their participation and contribution to the operation of the Company with reference to the common standards within the industry. The Company shall set a different salary and compensation for the Independent Director than the average Director. In addition, in accordance with the rules on the scope of duties of the independent directors of the Company, the remuneration of the independent directors of the Company shall be fixed in the Articles of Incorporation of the Company or in accordance with the resolution of the shareholders' meeting, and may be subject to reasonable remuneration different from that of ordinary directors. The Company currently pays the Independent Director a monthly compensation of NTD100,000 and NTD5,000 for travel expenses for each Director meeting, taking into account domestic and international industry standards.
-
In addition to the above table, the remuneration received by the Company's Director for services rendered to all companies reported in the financial statements (such as serving as a consultant to non-employees) in the most recent year: None
Note 2: The corporate director representative of Mai Investment Co., Ltd was originally Lin, Wei-Yuan. On March 13, 2025, Digital Capital Inc. reassigned its representative to Tsai, Kao-Chung, effective March 13, 2025, and serving until June 11, 2026.
Note 3: The total amount of remuneration not actually received by directors and employees shall include the amount of expenses recognized by IFRS 2 -- Share-based Payment for stock warrants granted by the Company to employees in accordance with the standards for annual returns recorded by the Company.
19
Remuneration Table
| Pay each Director remuneration level of The Company | Name of Director | |||
|---|---|---|---|---|
| First four remuneration totals (A+B+C+D) | First seven remuneration totals (A+B+C+D+E+F+G) (Note 1) | |||
| The Company | All companies reported in the financial statements H | The Company | All companies reported in the financial statements I | |
| Less than NTD1,000,000 | Chen, Hung-Wen, Chen, Shyan Tser, Wayne Lin, Way, Tzong Der, Chao, Ying-Cheng, Tai, Jang Huei, Patrick Y. Yang | Chen, Hung-Wen, Chen, Shyan Tser, Wayne Lin, Way, Tzong Der, Chao, Ying-Cheng, Tai, Jang Huei, Patrick Y. Yang | Chen, Shyan Tser, Wayne Lin, Way, Tzong Der, Chao, Ying-Cheng, Tai, Jang Huei, Patrick Y. Yang | Chen, Shyan Tser, Wayne Lin, Way, Tzong Der, Chao, Ying-Cheng, Tai, Jang Huei, Patrick Y. Yang |
| NTD1,000,000 (inclusive) to NTD2,000,000 (exclusive) | — | — | — | — |
| NTD2,000,000 (inclusive) to NTD3,500,000 (exclusive) | — | — | — | — |
| NTD3,500,000 (inclusive) to NTD5,000,000 (exclusive) | — | — | Chen, Hung-Wen | Chen, Hung-Wen |
| NTD5,000,000 (inclusive) to NTD10,000,000 (exclusive) | — | — | — | — |
| NTD10,000,000 (inclusive) to NTD15,000,000 (exclusive) | — | — | — | — |
| NTD15,000,000 (inclusive) to NTD30,000,000 (exclusive) | — | — | — | — |
| NTD30,000,000 (inclusive) to NTD50,000,000 (exclusive) | — | — | — | — |
| NTD50,000,000 (inclusive) to NTD100,000,000 (exclusive) | — | — | — | — |
| More than NTD100,000,000 | — | — | — | — |
| Total | 7 people | 7 people | 7 people | 7 people |
Note 1: The corporate director representative of Mai Investment Co., Ltd was originally Lin, Wei-Yuan. On March 13, 2025, Digital Capital Inc. reassigned its representative to Tsai, Kao-Chung, effective March 13, 2025, and serving until June 11, 2026.
- Supervisor's Remuneration
The Audit Committee was established within the Company, so it's not applicable.
3. Remuneration for the President and Vice President
Unit: NTD1,000
| Title | Name | Compensation (A) | Retirement pension (B) | Bonuses and special expenses, etc. (C) | Employee Compensation Amount (D) | Total amount of A, B, C and D and percentage of net income after tax (%) | Remuneration from investee companies other than subsidiaries or from the parent company | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | |||||
| Cash | Stock | Cash | Stock | |||||||||||
| CEO | Hsu, Jaan-Pyng | 325 | 325 | — | — | — | — | — | — | — | — | 325 (0.02) | 130 (0.02) | — |
| Executive Vice President | John Bomalaski | — | 9,300 | — | — | — | 3,954 | — | — | — | — | — | 13,254 (0.83) | — |
| COO | You, Huei-Yuan (Note 2) | 5,800 | 5,800 | 108 | 108 | 6,237 | 6,237 | — | — | — | — | 12,145 (0.76) | 12,145 (0.76) | — |
| CSO | Chien-Hsing Chang | — | 6,000 | — | — | — | 4,041 | — | — | — | — | — | 10,041 (0.63) | |
| Chief Financial Officer/Corporate Governance Supervisor | Kay Huang (Note 3) | 1,430 | 2,790 | 45 | 45 | 1,704 | 4,089 | — | — | — | — | 3,179 (0.20) | 6,924 (0.43) | — |
| Chief Financial Officer/Corporate Governance Supervisor | Rui-Bin Wu (Note 4) | |||||||||||||
| Chief Financial Officer/Corporate Governance Supervisor | Yan, Feng-Kui (Note 5) |
| Title | Name | Compensation (A) | Retirement pension (B) | Bonuses and special expenses, etc. (C) | Employee Compensation Amount (D) | Total amount of A, B, C and D and percentage of net income after tax (%) | Remuneration from investee companies other than subsidiaries or from the parent company | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | |||||
| Cash | Stock | Cash | Stock | |||||||||||
| Chief Financial Officer/Corporate Governance Supervisor | Yi-Ming Kao | |||||||||||||
| CISO | Kevin Wu | 367 | 367 | 18 | 18 | 15 | 15 | — | — | — | — | 400 (0.03) | 400 (0.03) | — |
| Vice President of Production | Chris Huxsoll | — | 6,900 | — | — | — | 3,081 | — | — | — | — | — | 9,981 (0.63) | — |
| Vice President of Clinical Affairs | Amanda Johnston | — | 9,504 | — | — | — | 2,991 | — | — | — | — | — | 12.495 (0.78) | — |
| Vice President of Research and Development | Richard Showalter (Note 6) | — | 6,637 | — | — | — | 2,921 | — | — | — | — | — | 9,558 (0.60) | — |
Note 1: The actual total amount of bonuses and special payments received by the managers was zero. However, the amount of bonuses and special payments was calculated in accordance with the Guidelines Governing the Recordation of Financial Reports by Public Companies, plus the amount of fees recognized on the basis of IFRS 2 for employee stock options.
Note 2: The Company canceled the position of COO on July 23, 2024, and Mr. You, Huei-Yuan stepped down.
Note 3: Ms. Kay Huang stepped down as Chief Financial Officer, Corporate Governance Supervisor on June 25, 2024, and was replaced by Mr. Wu, Jui-Pin.
Note 4: Mr. Wu, Jui-Pin stepped down as Chief Financial Officer, Corporate Governance Supervisor on September 20, 2024, and was replaced by Mr. Yen, Fong-Kuei.
Note 5: Mr. Yen, Fong-Kuei stepped down as Chief Financial Officer, Corporate Governance Supervisor on September 20, 2024, and was replaced by Mr. Yi-Ming Kao.
Note 6: Richard Showalter (Note 6) stepped down as Vice President of Research and Development on January 16, 2024.
4. Remuneration of the Top 5 Executives of TWSE/TPEx-listed Companies
Unit: NTD1,000
| Title | Name | Compensation (A) | Retirement pension (B) | Bonuses and special expenses, etc. (C) | Employee Compensation Amount (D) | Total amount of A, B, C and D and percentage of net income after tax (%) | Remuneration from investee companies other than subsidiaries or from the parent company | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | The Company | All companies reported in the financial statements | |||||
| Cash | Stock | Cash | Stock | |||||||||||
| Executive Vice President | John Bomalaski | — | 9,300 | — | — | — | 3,954 | — | — | — | — | — | 13,254 (0.83) | — |
| COO | You, Huei-Yuan (Note 2) | 5,800 | 5,800 | 108 | 108 | 6,237 | 6,237 | — | — | — | — | 12,145 (0.76) | 12,145 (0.76) | — |
| CSO | Chien-Hsing Chang | — | 6,000 | — | — | — | 4,041 | — | — | — | — | — | 10,041 (0.63) | |
| Vice President of Production | Chris Huxsoll | — | 6,900 | — | — | — | 3,081 | — | — | — | — | — | 9,981 (0.63) | — |
| Vice President of Clinical Affairs | Amanda Johnston | — | 9,504 | — | — | — | 2,991 | — | — | — | — | — | 12,495 (0.78) | — |
Note 1: The actual total amount of bonuses and special payments received by the managers was zero. However, the amount of bonuses and special payments was calculated in accordance with the Guidelines Governing the Recordation of Financial Reports by Public Companies, plus the amount of fees recognized on the basis of IFRS 2 for employee stock options.
Note 2: The Company canceled the position of COO on July 23, 2024, and Mr. You, Huei-Yuan stepped down.
- Name of the Manager Who Distributed Employee Compensation and the Distribution: The Company Did Not Distribute Employee Compensation.
(II) Provide a comparative analysis of the total compensation paid to The Company's directors, supervisors, general managers and vice presidents as a percentage of net income after tax for the most recent two years for The Company and all consolidated companies, and describe the policies, criteria and mix of compensation payments, the procedures for determining compensation, and the relationship to operating results and future risks.
- An analysis of the total compensation paid to the Company's directors, presidents and vice presidents as a percentage of net income after income taxes for individual or separate financial statements of the Company and all consolidated reporting companies
| Items | 2023 | 2024 | ||
|---|---|---|---|---|
| Total remuneration as a percentage of net income after tax (%) | Total remuneration as a percentage of net income after tax (%) | |||
| The Company | All companies in the consolidated report | The Company | All companies in the consolidated report | |
| Director | (0.52) | (0.52) | (0.56) | (0.76) |
| President and Vice President | (1.24) | (5.06) | (1.01) | (4.71) |
Note: The total amount of remuneration not actually received by the Director and the Manager includes the amount of fees recognized in accordance with the IFRS 2 share-based payment to employees for stock options granted by the Company, as regulated by the Guidelines on Recordable Events in Public Company Annual Reports.
- Policies, standards and composition of compensation payments, procedures for determining compensation, and correlation with operating performance and future risks
The Company has a Compensation Committee that sets and regularly reviews the annual and long-term performance evaluation and compensation of the Directors and the Managers. The Company has a Compensation Committee that sets and regularly reviews the policies, systems, standards and structures for the annual and long-term performance evaluation and compensation of directors and managers, and the source of director compensation is based on Article 117 of the Company's Articles of Incorporation regarding the distribution of earnings. In addition, the Company has established a remuneration plan for Directors, which specifies the salaries of Independent Directors and the travel expenses for Directors to attend Directors' meetings. As for the remuneration of the President and Vice President, it is considered in accordance with the approved principles of the Company's ranking, and the bonus payment is appropriately adjusted considering the operating performance and future risks.
24
III. Corporate Governance
(I) Information on the Operation of the Director's Meeting
As of the printing date of the annual report for fiscal year 2024 to 2025, the Board of Directors meeting was held 16 times (A), and the Director attended the meeting as follows:
| Title | Name | Actual number of attendance (B) | Attendance by proxy | Actual attendance (attendance) rate (%) [B/A] | Note |
|---|---|---|---|---|---|
| Chairman | Digital Capital Inc. Representative: Hsu, Jaan-Pyng | 16 | 0 | 100% | |
| Director | Chen, Hung-Wen | 16 | 0 | 100% | |
| Director | Chen, Shyan Tser | 16 | 0 | 100% | |
| Director | Mai Investment Co., Ltd Representative: Wayne Lin | 11 | 0 | 78.6% | Note 1 |
| Director | Mai Investment Co., Ltd Representative: Tsai, Kao-Chung | 2 | 0 | 100% | Note 1 |
| Independent Director | Wen, Kuo-Lan | 11 | 0 | 91.7% | Note 2 |
| Independent Director | Way, Tzong Der | 16 | 0 | 100% | |
| Independent Director | Chao, Ying-Chen | 16 | 0 | 100% | |
| Note: The general election of directors was held at the shareholders' meeting on June 12, 2023. | |||||
| (1) Reappointed, Tsai, Kao-Chung was reassigned on March 13, 2025. Wayne Lin should attend 14 times and Hsu, Jaan-Pyng should attend 2 times. | |||||
| (2) New entrants should attend 12 times. | |||||
| Other matters to be noted: | |||||
| 1. If the operation of the Director meeting is one of the following, the date of the Director meeting, the period, the content of the motion, all Independent Director's opinions and the Company's handling of Independent Director's opinions shall be described. | |||||
| (1) Matters set forth in Article 14-3 of the Securities and Exchange Act: | |||||
| Date/Term | Motions | All Independent Director's comments and the Company's handling of Independent Director's comments | |||
| 2024/01/19 (The first time in 2024) | 1. Proposal of Subsidiary Polaris Biopharmaceuticals, Inc.'s Intention to Purchase Zhunan Plant. | ||||
| 2. Proposal of Subsidiary Polaris Biopharmaceuticals, Inc.'s Intention to Purchase Zhunan Plant. | |||||
| 3. Release the Ban on Directors from Participating in Competitive Business. | All Independent Director approved | ||||
| 2024/02/20 (The second time in 2024) | 1. Proposal of Cash Increase to Subsidiary Polaris Biopharmaceuticals, Inc. | All Independent Director approved |
25
| | 2024/03/12
(The third time in 2024) | 1. Amendments to the Company's Rules of Procedures of the Board of Directors
2. Proposal to Change CPAs Handling Financial Report in Response to the Internal Shift of PwC Taiwan | All Independent Director approved |
| --- | --- | --- | --- |
| | 2024/04/26
(The fourth time in 2024) | 1. Proposal of Loan Extension for Subsidiary's PPI Fund Lending to Australian Subsidiary
2. The Company's application for a transaction limit with Citibank Taiwan
3. Proposal of DRX (Chengdu)'s application for bank financing limit
4. Funding loaned to Subsidiary DRX Chengdu
5. Funding loaned to Subsidiary Polaris Biopharmaceuticals, Inc.
6. Funding loaned to Subsidiary Genovior Biotech.
7. Amend the operational regulations related to financial transactions between related parties.
8. Capital increase for subsidiary TDW HK Limited. | All Independent Director approved |
| | 2024/05/14
(The fifth time in 2024) | 1. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group | All Independent Director approved |
| | 2024/06/25
(The sixth time in 2024) | 1. The Company's Employee Stock Warrant Issuing List for The Year 2024 Case
2. Funding loaned to Subsidiary DRX Chengdu
3. Funding loaned to Subsidiary Polaris Biopharmaceuticals, Inc.
4. Proposal of changing CFO | All Independent Director approved |
| | 2024/07/23
(The seventh time in 2024) | 1. The Company and its subsidiary, DesigneRx Pharmaceuticals (Chengdu) Inc., plan to apply for a transaction limit with Citibank.
2. Supplementary Amendment for the Merger of Subsidiary Polaris Biopharmaceuticals, Inc. and Sub-subsidiary Genovior Biotech. | All Independent Director approved |
| | 2024/08/22
(The eighth time in 2024) | 1. Accounting Supervisor Ratification Case
2. Proposal for the 2024 Q2 Consolidated Financial Statements.
3. Handle the case of issuing new shares for a cash capital increase in The year 2024.
4. The investment plan of the subsidiary DesigneRx Pharmaceuticals (Chengdu) Inc. in a peptide intermediate production base.
5. Independence Evaluation and Compensation of the Company's CPA. | All Independent Director approved |
| | 2024/09/20
(The ninth time in 2024) | 1. Proposal of changing financial supervisor and accounting supervisor | All Independent Director approved |
| | 2024/10/29
(The tenth time in 2024) | 1. Amend the case of issuing new shares for a cash capital increase in The year 2024.
2. The Company's Allocation Plan for the Issuance of New Shares in a Cash Capital Increase for Employees in The Year 2024.
3. The appointment of the Head of Audit of the Company.
4. Propose capital increase for USA subsidiary DRX USA.
5. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group | The Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group was postponed for discussion, and all remaining motions were approved as per the proposal by all Independent Directors. |
| | 2024/11/11
(The eleventh time in 2024) | 1. Proposal for the 2024 Q3 Consolidated Financial Statements. | All Independent Director approved |
| | 2024/12/24
(The twelfth time in 2024) | 1. Proposal of Cash Increase to Subsidiary Genovior Biotech. | All Independent Director approved |
27
| 2. Proposal for capital increase for subsidiary TDW HK Limited. | ||
|---|---|---|
| 2025/01/23 | ||
| (The first time in 2025) | 1. The subsidiary, Northern Biopharmaceutical Co., Ltd. (Fujian), is planning a financing case with Digital Mobile Venture Ltd. | |
| 2. The cash capital increase plan for the funding loaned to the subsidiary DesigneRx Pharmaceuticals (Chengdu) Inc. by The Company. | All Independent Director approved | |
| 2025/02/20 | ||
| (The second time in 2025) | 1. Proposal for capital increase for subsidiary TDW HK Limited. | |
| 2. The Company proposes to serve as a joint guarantor for a NTD 15 million bank loan under the Subsidiary Genovior Biotech Corporation. | All Independent Director approved | |
| 2024/3/17 | ||
| (The third time in 2025) | 1. Proposal of changing financial supervisor and accounting supervisor | |
| 2. Proposal of changing Corporate Governance Supervisor | All Independent Director approved | |
| 2025/3/24 | ||
| (The fourth time in 2025) | None | None |
(2) In addition to the preceding items, other matters resolved by the Independent Director's meeting in which the Director opposes or reserves his or her opinion and has a record or written statement: None.
- The Director shall state the name of the Director, the content of the motion, the reasons for recusal, and the circumstances of participation in the vote.
| The date of Board Meeting | Motions | Director recusal and reasons for interest recusal | Voting participation |
|---|---|---|---|
| 2025/1/23 | The subsidiary, Northern Biopharmaceutical Co., Ltd. (Fujian), is planning a financing case with Digital Mobile Venture Ltd. | Director Chen, Shyan Tser has a personal interest in the case. | Director Chen, Shyan Tser recused himself from this board meeting due to his personal interest involved in the discussion of the motion; The case was approved by the other Directors present. |
- Implementation of Self (or peer) Evaluation:
Implementation of the Board of Directors's evaluation
| Evaluation Period | Executed once a year |
|---|---|
| Evaluation Period | January 1, 2024 to December 31, 2024 |
| Scope of Evaluation | Board of Directors, individual Directors and functional committees |
| Evaluation Method | Internal self-evaluation by Board of Directors, self-evaluation by board members |
| Evaluation Contents | 1. Board of Directors performance evaluation: |
| Participation in the operation of the company, improvement of the quality of Board of Directors' decisions, composition and structure of the Board of Directors of Directors, selection and continuing education of Directors, internal control. |
- Performance evaluation of individual Director members:
Mastery of company goals and tasks, knowledge of Director's responsibilities, |
28
| | participation in company operations, internal relationship management and communication, Director's professionalism and continuing education, and internal control.
3. Functional committee performance evaluation:
Involvement in company operations, awareness of functional committee responsibilities, improvement of functional committee decision quality, composition and selection of functional committee members, internal control |
| --- | --- |
| Evaluation Result | 1. Board of Directors performance evaluation: Excellent
2. Performance evaluation of individual Director members: Excellent
3. Performance evaluation of functional committees: Excellent
The Board of Directors of Directors' self-assessment and the Director members' self-assessment overall results are excellent, and on March 17, 2025, the Board of Directors of Directors reported the internal self-assessment results for the year 202IV. |
- Assessment of the current and most recent Board of Directors' objectives (eg, establishment of an audit committee, enhancement of information transparency, etc.) and their implementation
(1) Objectives of the Board of Directors of Directors
To implement corporate governance, improve supervision functions and strengthen management functions, the Company shall, in accordance with Article 14-4 of the Securities Exchange Act, form an Audit Committee composed of all independent directors to strengthen the functions of the Board of Directors of directors. The Company regularly arranges for directors to participate in professional development courses so that directors can maintain their core values and professional advantages and capabilities.
(2) Performance Evaluation
The Company has established an Audit Committee and a Compensation Committee to assist the Board of Directors in carrying out its duties. The Company will post important resolutions on the MOPS in real time after the Board of Directors meeting after the listing of the Company to protect shareholders' rights and interests. The Company has designated dedicated personnel to be responsible for the collection and disclosure of corporate information, and established a spokesman system to ensure that all major information is disclosed in a timely manner for shareholders and interested parties to refer to the Company's financial information.
(II) Information on the Operation of the Audit Committee
The Audit Committee met 15 times (A) from 2024 to 2025 as of the printing date of the annual report, and the Independent Directors attended the meetings as follows:
| Title | Name | Actual number of attendance (B) | Attendance by proxy | Actual attendance rate (%) (B/A) | Note |
|---|---|---|---|---|---|
| Independent Director | Way, Tzong Der | 15 | 0 | 100% | |
| Independent Director | Wen, Kuo-Lan | 10 | 0 | 90.9% | Note 1 |
| Independent Director | Chao, Ying-Chen | 15 | 0 | 100% | |
| Note: The general election of directors was held at the shareholders' meeting on June 12, 2023. (1) New entrants should attend 11 times. Other matters to be noted: I. If the Audit Committee operates in one of the following circumstances, it should state the date, period, content of the motion, results of the Audit Committee's resolution, and the Company's handling of the Audit Committee's opinion. (I) Matters set forth in Article 14-5 of the Securities and Exchange Act: | |||||
| Audit Committee date /term | Motions | Results of Audit Committee resolutions and the Company's handling of Audit Committee Opinions | |||
| 2024/01/19 (The first time in 2024) | 1. Proposal of Subsidiary Polaris Biopharmaceuticals, Inc.'s Intention to Purchase Zhunan Plant. 2. Proposal of Cash Increase to Subsidiary Genovior Biotech. 3. Release the Ban on Directors from Participating in Competitive Business. | Approved by the Audit Committee as written | |||
| 2024/02/20 (The second time in 2024) | 1. Proposal of Cash Increase to Subsidiary Polaris Biopharmaceuticals, Inc. | Approved by the Audit Committee as written | |||
| 2024/03/12 (The third time in 2024) | 1. Adoption of "Statement on Internal Control System" for year 2023 proposal 2. The recognition of the 2023 Annual Report of Operations and Financial Statements 3. Proposal of 2023 Deficit Compensation 4. Amendments to the Company's Rules of Procedures of the Board of Directors 5. Proposal to Change CPAs Handling Financial Report in Response to the Internal Shift of PwC Taiwan | Approved by the Audit Committee as written | |||
| 2024/04/26 (The fourth time in 2024) | 1. Bank financing of Subsidiary Polaris Biopharmaceuticals, Inc. 2. The Company's application for a transaction limit with Citibank Taiwan 3. Proposal of DRX (Chengdu)'s application for bank financing limit 4. Funding loaned to Subsidiary DRX Chengdu 5. Funding loaned to Subsidiary Polaris Biopharmaceuticals, Inc. 6. Funding loaned to Subsidiary Genovior Biotech. | Approved by the Audit Committee as written |
| | 7. Amend the operational regulations related to financial transactions between related parties.
8. Capital increase for subsidiary TDW HK Limited. | |
| --- | --- | --- |
| 2024/05/14
(The fifth time in 2024) | 1. Proposal for the 2024 Q1 Consolidated Financial Statements.
2. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group | Approved by the Audit Committee as written |
| 2024/06/25
(The sixth time in 2024) | 1. The Company's Employee Stock Warrant Issuing List for The Year 2024 Case
2. Proposal of DRX (Chengdu)'s application for bank financing limit, funding loaned to AAA Company
3. Funding loaned to Subsidiary Polaris Biopharmaceuticals, Inc.
4. Merger of Subsidiary Polaris Biopharmaceuticals, Inc. and Sub-subsidiary Genovior Biotech.
5. Proposal of Cash Increase by Subsidiary Polaris Biopharmaceuticals, Inc. to Genovior Biotech.
6. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group
7. Proposal of changing CFO
8. Proposal of changing Corporate Governance Supervisor | Approved by the Audit Committee as written |
| 2024/07/23
(The seventh time in 2024) | 1. The Company and its subsidiary, DesigneRx Pharmaceuticals (Chengdu) Inc., plan to apply for a transaction limit with Citibank.
2. Supplementary Amendment for the Merger of Subsidiary Polaris Biopharmaceuticals, Inc. and Sub-subsidiary Genovior Biotech. | Approved by the Audit Committee as written |
| 2024/08/22
(The eighth time in 2024) | 1. Accounting Supervisor Ratification Case
2. Proposal for the 2024 Q2 Consolidated Financial Statements.
3. Handle the case of issuing new shares for a cash capital increase in The year 2024.
4. The investment plan of the subsidiary DesigneRx Pharmaceuticals (Chengdu) Inc. in a peptide intermediate production base.
5. Independence Evaluation and Compensation of the Company's CPA. | Approved by the Audit Committee as written |
| 2024/09/20
(The ninth time in 2024) | 1. Proposal of changing financial supervisor and accounting supervisor | Approved by the Audit Committee as written |
| 2024/10/29
(The tenth time in 2024) | 1. Amend the case of issuing new shares for a cash capital increase in The year 2024.
2. The Company's Allocation Plan for the Issuance of New Shares in a Cash Capital Increase for Employees in The Year 2024.
3. The appointment of the Head of Audit of the Company.
4. Propose capital increase for USA subsidiary DRX USA.
5. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group | Approved by the Audit Committee as written |
| 2024/11/11
(The eleventh time in 2024) | 1. Proposal for the 2024 Q3 Consolidated Financial Statements. | Approved by the Audit Committee as written |
31
| 2024/12/24
(The twelfth time in 2024) | 1. Proposal of Cash Increase to Subsidiary
Genovior Biotech.
2. Proposal for capital increase for
subsidiary TDW HK Limited. | Approved by the Audit Committee as
written |
| --- | --- | --- |
| 2025/01/23
(The first time in 2025) | 1. The subsidiary, Northern
Biopharmaceutical Co., Ltd. (Fujian), is
planning a financing case with Digital
Mobile Venture Ltd.
2. The cash capital increase plan for the
funding loaned to the subsidiary
DesigneRx Pharmaceuticals (Chengdu)
Inc. by The Company. | Approved by the Audit Committee as
written |
| 2025/02/20
(The second time in 2025) | 1. Proposal for capital increase for
subsidiary TDW HK Limited.
2. The Company proposes to serve as a
joint guarantor for a NTD 15 million
bank loan under the Subsidiary Genovior
Biotech Corporation.
3. Plan to handle the case of issuing new
shares for a cash capital increase in the
year 2025.
4. Case of Issuing Employee Stock Option
Certificates | Approved by the Audit Committee as
written |
| 2024/3/17
(The third time in 2025) | 1. Proposal of changing financial supervisor
and accounting supervisor
2. Proposal of changing Corporate
Governance Supervisor
3. Adoption of "Statement on Internal
Control System" for year 2024 proposal
4. Proposal of 2024 Business Report and
Consolidated Financial Statements
5. Proposal of 2024 Deficit Compensation | Approved by the Audit Committee as
written |
(II) Except for the preceding matters, other matters not approved by the Audit Committee and approved by two-thirds or more of all Directors: None.
II. Where the Independent Director recuses from the implementation of the interest motion, the Independent Director's name, the content of the motion, the reasons for the recusal, and the participation in voting shall be stated:
| Date | Motions | Director recusal and reasons for interest recusal | Voting participation |
|---|---|---|---|
| None | None | None | None |
III. Communication between the Independent Director and the internal auditor and the accountant (including the major issues, methods and results of communication regarding the Company's financial and business status).
(I) The Internal Audit Supervisor of the Company regularly communicates with the members of the Audit Committee about the results of the audit report and the status of tracking the implementation of the report. In case of any special circumstances, the Internal Audit Supervisor shall immediately inform the members of the Audit Committee. This is not the case in the year 2024; The Company's Audit Committee is in good communication with the head of internal audit.
(II) CPAs of the Company regularly participates in the Audit Committee and communicates with the Audit Committee on matters related to the examination or review of financial statements. According to the provisions of external laws, CPAs should immediately report the significant matters found to the members of the Audit Committee. The Company's Audit Committee is in good communication with CPAs.
(III) The operation of corporate governance and the differences between it and the code of practice on governance of TWSE/TPEx-listed companies and the reasons thereof
| Assessment items | Operations | Differences from the Code of Corporate Governance Practices of TWSE/TPEx-listed companies and the reasons for such differences | |||
|---|---|---|---|---|---|
| Yes | No | Abstract | |||
| 1. | Has the company formulated and disclosed the Code of Corporate Governance Practices in accordance with the "Code of Corporate Governance Practices for TWSE/TPEx-listed Companies"? | ✓ | The Company has established a "Code of Practice on Corporate Governance" adopted by the Board of Directors of Directors and disclosed on the Company's website, and all governance practices will be operated in accordance with the Code of Practice on Corporate Governance. | No significant difference. | |
| 2. | Shareholding structure and shareholders' rights(1) Has the Company established internal procedures to deal with shareholders' proposals, questions, disputes and litigation matters, and implemented them in accordance with the procedures? | ✓ | (1) In addition to the protection of shareholders' rights and interests as stipulated in the Company's Articles of Incorporation and internal rules, the Company has set up a dedicated unit to handle matters relating to the Company's relations with investors, in order to properly handle shareholders' proposals, doubts and disputes. | No significant difference. | |
| (2) Does the Company have a list of the major shareholders and the ultimate controllers of the major shareholders who actually control the Company? | ✓ | (2) The Company has a dedicated person and appointed a shareholder affairs organization to handle and report on the Company's affairs, which is disclosed on the public information website. The Company also keeps track of the shareholdings of directors, managers and shareholders holding more than 10% of the shares, and requests the assistance of a stock agency to provide an updated register of major shareholders. | No significant difference. | ||
| (3) Has the Company established and implemented a risk control and firewall mechanism with its affiliates? | ✓ | (3) The Company has established the "Regulations Governing Related Parties' Transactions", "Regulations Governing the Supervision of Subsidiaries", "Regulations Governing the Lending of Funds to Others" and "Procedures for Endorsement and Guarantee" to prevent the occurrence of financial malpractice that may have a knock-on effect on related companies. | No significant difference. | ||
| (4) Has the Company established internal regulations to prohibit insiders from trading marketable securities using undisclosed information? | ✓ | (4) The Company has established the "Regulations Governing the Processing of Internal Important Information and the Prevention of Insider Trading" and has informed its employees, managers and directors of the regulations to reduce the risk of insider trading. | No significant difference. | ||
| 3. | Compositional Responsibilities of the Board of Directors of Directors(1) Has the Board of Directors of Directors established a diversity policy, specific management objectives and implemented them? | ✓ | (1) The composition of the directors of the Company considers diversity, except that the directors who are also managers of the Company should not be more than one third of the directors, and the Company has formulated an appropriate diversity policy for the operation, business type and development needs of the Company. The directors and independent directors of the Company have experience in biotechnology, financial accounting, business management and industry. The Board of Directors of Directors is diversely composed of with excellent competencies. Implementation of diversity of Board directors in 2024: The Company has 7 directors, 2 of whom are aged between 50 and 59, 4 of whom are aged between 60 and 69 and 1 of whom is aged between 70 and 79. | No significant difference. |
| Assessment items | Operations | Differences from the Code of Corporate Governance Practices of TWSE/TPEx-listed companies and the reasons for such differences | ||
|---|---|---|---|---|
| Yes | No | Abstract | ||
| There is one director with employee status, accounting for 14.3%; Three independent directors accounted for 42.9%, and the tenure of independent directors did not exceed 9 years; There is one female member.The diversity of its membership is shown in the following aspects:(1) Biotechnology industry background: Directors Hsu, Jaan-Pyng, Way, Tzong Der, Wen, Kuo-Lan;(2) Working experience in business and accounting&financing: Directors Chen, Hung-Wen, Hsu, Jaan-Pyng, Wayne Lin, Chen, Shyan Tser, Chao, Ying-Cheng, Directors Chen, Hung-Wen, Hsu, Jaan-Pyng, Wayne Lin, Chen, Shyan Tser, Chao, Ying-Chen, Wen, Kuo-Lan;(3) Working experience in planning management and leadership: Directors Chen, Hung-Wen, Hsu, Jaan-Pyng, Wayne Lin, Chen, Shyan Tser, Way, Tzong Der, Chao, Ying-Chen, Wen, Kuo-Lan;(4) Lecturer or professional qualification certificate from a college or university: Lecturer or professional qualification certificate from a college or university: Director Way, Tzong Der For details on Board diversity, please refer to page 14 of this annual report. | ||||
| (2) Does the Company voluntarily establish various functional committees other than the Compensation Committee and Audit Committee in accordance with the law? | ✓ | (2) The Company has not established any functional committees other than the Salary and Compensation and Audit Committees in accordance with the law, and will establish other functional committees in the future in accordance with the law and actual needs. | Establish according to future demand. | |
| (3) Has the Company established the Board of Directors of Directors' performance evaluation method and its evaluation method, and conducts performance evaluation annually and regularly, and submits the results of performance evaluation to the Board of Directors of Directors and uses them as reference for individual Director's salary and compensation and nomination for reappointment? | ✓ | (3) In order to implement corporate governance, improve the functions of the Board of Directors of Directors of the Company, and establish performance targets to enhance the operation efficiency of the Board of Directors of Directors, the Company has formulated the "Regulations Governing the Board of Directors Performance Evaluation" and has conducted performance evaluation regularly in accordance with the provisions. The internal performance evaluation of the Board of Directors of Directors in 2024 has been submitted to the Board of Directors of Directors on March 17, 2025. | No significant difference. | |
| (4) Does the Company regularly evaluate the independence of the certified public accountants? | ✓ | (4) The Audit Committee of the Company regularly evaluates the independence and suitability of the accountants annually and reports the evaluation results to the Board of Directors. On August 22, 2024, the Board of Directors of Directors and Audit Committee evaluated the independence and competence of the certified public accountant:1. Accountant's declaration of independence.2. Audit and non-audit services provided by accountants are subject to prior approval by the Audit Committee to ensure that non-audit services do not affect the audit results. | No significant difference. |
| Assessment items | Operations | Differences from the Code of Corporate Governance Practices of TWSE/TPEx-listed companies and the reasons for such differences |
|---|---|---|
| Yes | No | Abstract |
| 4. Does the TWSE-TPXs-listed company have a suitable and appropriate number of corporate governance personnel and designate a corporate governance officer to be responsible for corporate governance-related matters? (including but not limited to providing information necessary for Directors and supervisors to carry out their business, assisting Directors and supervisors to comply with laws and regulations, handling matters related to Board of Directors and Shareholders' Meetings in accordance with the law, preparing The Company has established the Board of Directors of Directors and Shareholders' Meeting minutes.) | ✓ | |
| Date | Course Name | Hours |
| 2024/10/30 | Discussion on Audit Practices for Annual Operation Plan and Budget Preparation | 6 |
| 5. Has the Company established communication channels with stakeholders (including but not limited to shareholders, employees, customers and suppliers) and set up a stakeholder area on the Company's website, and appropriately respond to important CSR issues of concern to stakeholders? | ✓ | |
| 6. Does the Company appoint a professional stock agent to handle the affairs of the Shareholders' Meeting? | ✓ | |
| 7. Information Disclosure(1) Has the Company set up a website to disclose financial and corporate governance information?(2) Does the Company adopt other methods of information disclosure (such as setting up an English website, appointing a dedicated person to collect and disclose company information, implementing a | ✓ |
| Assessment items | Operations | Differences from the Code of Corporate Governance Practices of TWSE/TPEx-listed companies and the reasons for such differences | ||
|---|---|---|---|---|
| Yes | No | Abstract | ||
| spokesperson system, and presenting the Company's website during the legal representative briefing process)?(3) Does the Company publish and file its annual financial report within two months after the end of the fiscal year, and publish and file its financial report for the first, second and third quarters and its operating situation for each month before the prescribed time limit? | ✓ | (3) The Company shall announce and declare the annual financial report, the first, second and third quarter financial report and the operating situation of each month within the prescribed time limit. | No significant difference. | |
| 8. Whether the Company has other important information that can help to understand the operation of corporate governance (including but not limited to employees' rights and interests, employee care, investor relations, supplier relations, rights of interested parties, further study of directors and supervisors, implementation of risk management policies and risk measurement standards, implementation of customer policies, liability insurance purchased by the Company for directors and supervisors, etc.) ? | ✓ | 1. Employees' rights and interests: In order to motivate employees and strengthen their motivation, the Company has established an employee stock option plan.2. Employee care: The Company and its major operating entities have established employee welfare systems in accordance with the laws and regulations of each country to protect the rights and interests of employees.3. Investor relations: The Company and its major operating entities have established employee welfare systems in accordance with the laws and regulations of each country to protect the rights and interests of employees.4. Supplier relations: The Company has clear agreements with suppliers and clinical trial partner hospitals to regulate the rights and obligations of each other.5. Rights of interested parties: The Company's Articles of Incorporation clearly regulate the Director's execution and recusal of interested parties' motions.6. Continuing study of directors: All the directors of the company have professional backgrounds, and all of them have studied securities laws and regulations, corporate governance and other courses in accordance with the "Rules for Promoting Continuing Education for Directors and Supervisors of Listed and OTC Companies", and have complied with the training hours. For continuing study, please refer to page 40.7. Implementation of risk management policies and risk measurement standards, implementation of customer policies: The Company formulates various internal rules and regulations according to law, and carries out various risk management and assessment.8. Liability of directors and supervisors: The Company has insured the directors against liability. | No significant difference. | |
| 9. Please provide information on the results of the corporate governance assessment released by the Corporate Governance Center of the Taiwan Stock Exchange Corporation in the most recent year, as well as the priorities and measures for improvement for those companies that have not yet improved.As of the date of publication of the Annual Report, the results of the 2024 Corporate Governance Review have not been released. |
Continuing Study of Directors in 2024:
| Title | Name | Date | Organizer | Course name | Hours of further education |
|---|---|---|---|---|---|
| Director | Chen, Hung-Wen | 2024/11/05 | Corporate Governance Association | Legal Planning and Design for Business Succession | 3 |
| 2024/11/08 | Corporate Governance Association | Insider Trading Prevention and Countermeasures | 3 | ||
| Director | Chen, Shyan Tser | 2024/11/05 | Corporate Governance Association | Legal Planning and Design for Business Succession | 3 |
| 2024/11/08 | Corporate Governance Association | Insider Trading Prevention and Countermeasures | 3 | ||
| Representative of Corporate Director | Wayne Lin | 2024/11/05 | Corporate Governance Association | Legal Planning and Design for Business Succession | 3 |
| 2024/11/08 | Corporate Governance Association | Insider Trading Prevention and Countermeasures | 3 | ||
| Independent Director | Chao, Ying-Chen | 2024/11/05 | Corporate Governance Association | Legal Planning and Design for Business Succession | 3 |
| 2024/11/08 | Corporate Governance Association | Insider Trading Prevention and Countermeasures | 3 | ||
| Independent Director | Way, Tzong Der | 2024/11/05 | Corporate Governance Association | Legal Planning and Design for Business Succession | 3 |
| 2024/11/08 | Corporate Governance Association | Insider Trading Prevention and Countermeasures | 3 | ||
| Independent Director | Wen, Kuo-Lan | 2024/11/05 | Corporate Governance Association | Legal Planning and Design for Business Succession | 3 |
| 2024/11/08 | Corporate Governance Association | Insider Trading Prevention and Countermeasures | 3 |
(IV) If the Company Has a Compensation Committee, It Shall Disclose Its Composition, Duties and Operation.
- Information on Members of the Compensation Committee
| Identify | Conditions Name | Professional qualifications and experience | Independence | Number of other public companies where he/she is also a member of the compensation committee |
|---|---|---|---|---|
| Independent Director | Way, Tzong Der | 1. Member of the Audit Committee who is at least a lecturer from a public or private college or university with a degree in business, law, finance, accounting or a related discipline required for corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10. | ||
| 2. None of the circumstances described in Article 30 of the Company Act | ||||
| 3. Years of experience: 0~3 years | Refer to pages 8~10 for Director and Supervisor information. | 0 | ||
| Independent Director (Convener) | Chao, Ying-Chen | 1. Experience in business, law, finance, accounting or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10. | ||
| 2. None of the circumstances described in Article 30 of the Company Act | ||||
| 3. Years of experience: 0~3 years | Refer to pages 8~10 for Director and Supervisor information. | 0 | ||
| Remuneration Committee Members | Wen, Kuo-Lan | 1. Experience in business, law, finance, accounting or corporate business. For professional qualifications and experience, please refer to the main qualifications of directors and supervisors on pages 8~10. | ||
| 2. None of the circumstances described in Article 30 of the Company Act | ||||
| 3. Years of experience: 0~3 years | Refer to pages 8~10 for Director and Supervisor information. | 0 |
37
- Information on the Operation of the Compensation Committee
(1) There are three members of the Compensation Committee in the Company.
(2) The term of office of current members: from June 12, 2023 to June 11, 2026. As of the date of publication of the Annual Report 2024 to 2025, the Remuneration Committee has met 4 times (A) with the following attendance:
| Title | Name | Actual number of attendance (B) | Attendance by proxy | Actual attendance rate (%)(B/A) | Note |
|---|---|---|---|---|---|
| Members | Way, Tzong Der | 4 | 0 | 100% | |
| Convener | Chao, Ying-Chen | 4 | 0 | 100% | |
| Members | Wen, Kuo-Lan | 3 | 0 | 100% | (Note 1) |
| Note 1: Compensation Committee Member Wen, Kuo-Lan was appointed as Compensation Committee Member at the Board of Directors meeting on May 14, The year 2024 and should attend 3 times. | |||||
| Other matters to be noted: | |||||
| 1. If the Board of Directors of Directors does not adopt or amend the recommendation of the Compensation Committee, the Board of Directors of Directors shall state the date, period, content of the motion, the result of the Board of Directors of Directors' resolution and the Company's treatment of the recommendation of the Compensation Committee (if the Board of Directors of Directors' approved compensation is superior to the recommendation of the Compensation Committee, the Board of Directors of Directors shall state the date, period, content of the motion, the result of the Board of Directors of Directors' resolution and the Company's treatment of the recommendation of the Compensation Committee): None. | |||||
| 2. If any Members of the Compensation Committee oppose or reserve their opinions on the resolutions of the Compensation Committee and there are records or written statements, the date of the Compensation Committee, the period, the content of the motion, all Members' comments, and the handling of Members' comments shall be stated: None. |
- Reasons for Discussion and Results of Decisions of the Compensation Committee
| Date/Term | Motions | All Members' Comments and the Company's Handling of Members' Comments |
|---|---|---|
| 2024/03/12 | ||
| (The first time in 2024) | 1. Discussion on Undistributable Compensation for Directors and Employees for Year 2023 | All attending members approved the proposal |
| 2024/06/25 | ||
| (The second time in 2024) | 1. The Company's Employee Stock Warrant Issuing List for Year 2024 | |
| 2. Proposal for Adjustment of COO's Compensation | All attending members approved the proposal | |
| 2024/10/29 | ||
| (The third time in 2024) | 1. The Company's Allocation Plan for the Issuance of New Shares in a Cash Capital Increase for Employees in The Year 2024. | All attending members approved the proposal |
| 2025/03/17 | ||
| (The first time in 2025) | 1. Discussion on Undistributable Compensation for Directors and Employees for Year 2024 | |
| 2. Proposal for CFO's Compensation | All attending members approved the proposal |
(V) Implementation of Sustainable Development and Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences |
|---|---|---|
| Yes | No | Abstract |
| 1. Does the Company have a governance structure to promote sustainable development and a dedicated (and part-time) unit to promote sustainable development that is handled by senior management authorized by the Board of Directors of Directors and supervised by the Board of Directors of Directors? | ✓ | |
| 2. Does the company conduct risk assessments on environmental, social and corporate governance issues related to its operations in accordance with the principle of materiality, and has it formulated relevant risk management policies or strategies? | ✓ | |
| 2. The Company conducts analysis based on the material principle of the Sustainability report and communicates with internal and external stakeholders. The Company also reviews domestic and international research reports, integrates data reference of various departments and subsidiaries and international sustainability norms and standards (GRI standards,SASB,TCFD), and formulates risk management policies for effective identification, measurement, evaluation, supervision and control, and takes specific action plans to reduce the impact of related risks. | ||
| 3. Based on the assessment, relevant risk management strategies are formulated as follows: | No significant difference | |
| Significant issues | Risk assessment items | The Company's countermeasures and strategies |
| Corporate Governance | Law compliance | • Set up a legal compliance department to deal with the business of compliance, and update the latest legal developments in various countries in a timely manner |
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences |
|---|---|---|
| Yes | No | Abstract |
| • Establish internal controls for integrity management in accordance with the Company's business strategy of integrity and ethical values, in line with the legal system | ||
| • Plan the internal organization, establishment and management, and set up a mutual supervision and balance mechanism for business activities with high risk of dishonest behavior within the business scope | ||
| • Promote and coordinate integrity policy advocacy training | ||
| • A whistleblowing system shall be established and supervised jointly by interested parties | ||
| Corporate Governance | Information security | • Clearly define the functions and responsibilities of the information department, and control the development and modification permissions of the system and programs |
| • Program and data access control files and devices are subject to rigorous security control | ||
| • Systematically divide business information accessible to R&D and clinical staff | ||
| • Improve the internal control of information security and strengthen the division of responsibilities between the |
40
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences |
|---|---|---|
| Yes | No | Abstract |
| • Conduct risk assessment for information and network security, install network security equipment, firewalls and security software in computer systems to reduce information security concerns | ||
| Product aspect | Innovative management | • Sign joint research and development agreements with research institutions to expand drug indications |
| • Set up a dedicated unit to manage the distribution and validity of patent rights | ||
| • Sign confidentiality agreements with practitioners to ensure that business secrets are properly protected, de-identify research and development information, and strictly control accessible personnel | ||
| Product aspect | Customer health and safety/drug safety/clinical trials | • Develop a series of procedures to select external commissioned research organization (CROs) to commission clinical trials, experimental research and development or drug development consulting services according to the needs of each clinical trial |
| • Comply with cGMP pharmaceutical factory specifications | ||
| • Establish a drug safety monitoring system | ||
| • Establish a quality management system | ||
| • Personnel are qualified and properly trained and supervised by a third party independent body | ||
| Product aspect | Fraudulent medicine | • After the drug is launched, the drug will be sold to medical institutions through a proprietary channel to ensure that the sales process is fully |
41
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences | ||||
|---|---|---|---|---|---|---|
| Yes | No | Abstract | ||||
| tracked | ||||||
| Product aspect | Drug access | • Improve drug manufacturing in the new drug development phase to reduce research and development costs | ||||
| • Actively expand drug indications in the clinical development stage. and apply for mercy therapy to treat patients with rare diseases | ||||||
| • Vertically integrate industrial chain in the production and manufacturing stage, and strictly check in each stage | ||||||
| • In the future, a dedicated sales channel will be set up after the drug is launched to stabilize market supply | ||||||
| • Plan short -, medium - and long-term drug license application programs around the world during the drug license application phase to expand equal access to health care for patients worldwide | ||||||
| • Planning for off-label use in the drug acquisition phase allows physicians to deliver ADI-PEG 20 to appropriate patients based on their professional judgment to achieve precision medicine | ||||||
| Social Aspect | Talent attraction and retention | • Sign industry-university cooperation with schools to recruit professional talents | ||||
| • Provide excellent compensation and benefits | ||||||
| • Formulate Training Management Procedures to construct staff education and training | ||||||
| • Provide multiple appealing channels such as announcements, appeal forms, senior officer's mailboxes, holding management meetings, etc., to promote two-way communication between employers and employees |
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| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences | ||||
|---|---|---|---|---|---|---|
| Yes | No | Abstract | ||||
| Social Aspect | OHS | • Introduce an occupational safety and health management system and implement multiple management mechanisms, such as hazard identification and risk assessment, workplace safety and accident prevention mechanisms, and contractor safety management • Regular health checks for all employees • Provide SOP training on workplace safety management for new employees upon entry | ||||
| 3. Environmental Issues (1) Has the company established an appropriate environmental management system in accordance with its industrial characteristics? | ✓ | The Company has relevant regulations for quality management, safety and health, and environmental protection, and complies with the inspection standards of relevant authorities. | No significant difference | |||
| (2) Is the Company committed to improving energy efficiency and using recycled materials with low impact on the environment? | ✓ | 1. In response to the global climate change issue, the Company attaches importance to energy management, responds to the government's promotion of environmental protection and energy-saving policies, and implements energy-saving and carbon reduction measures to improve energy efficiency and reduce greenhouse gas emissions. In order to make the best use of various resources, the Company promotes and implements electronic form system, resource waste classification, recycling and reduction activities, and implements the use of recycled paper, and improves the utilization efficiency of various resources. 2. Because the biotechnology industry is characterized by high technology and low pollution, it is less likely to use materials that have impact on environmental load. | No significant difference | |||
| (3) Does the Company assess the potential risks and opportunities of climate change for the company now and in the future, and take relevant measures in response? | ✓ | 1. The Company is in the new drug research and development industry and is actively facing the impact of climate change. The company assesses climate risks and opportunities in accordance with the recommendations of the TCFD Guidelines and reports climate management progress to the Chairman by the ESG Project Group. 2. Based on the degree of impact and likelihood of occurrence of the risks, the company identified two major climate-related risks as "increase in raw material costs" and "increase in average temperature", and therefore prioritized the development of response strategies and mitigation and adaptation actions. | No significant difference | |||
| (4) Has the Company compiled statistics on greenhouse gas | ✓ | 1. The Company is a new drug research and development industry, not a highly energy intensive industry, and does not set or use facilities that produce a large amount of greenhouse gases. In order to achieve | No significant difference | |||
| social and economic impact | and environmental impact | and environmental protection | ||||
| 4. Environmental Issues (2) Has the company established an appropriate environmental management system in accordance with its industrial characteristics? | ✓ | The company has the following recommendations: 1. The company is the new drug research and development industry and is actively facing the impact of climate change. The company assesses climate risks and opportunities in accordance with the recommendations of the TCFD Guidelines and reports climate management progress to the Chairman by the ESG Project Group. 2. Based on the degree of impact and likelihood of occurrence of the risks, the company identified two major climate-related risks as "increase in raw material costs" and "increase in average temperature", and therefore prioritized the development of response strategies and mitigation and adaptation actions. | No significant difference |
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences |
|---|---|---|
| Yes | No | Abstract |
| emissions, water consumption and total weight of waste in the past two years, and formulated policies for greenhouse gas reduction, water use reduction or other waste management? | ||
| 4. Social Issues (1) Has the Company established relevant management policies and procedures in accordance with relevant laws and regulations and international human rights conventions? | ✓ | |
| Human right issues | Objectives | |
| Non-disorientation | Recruitment content is non-discriminatory Disputes over work environment | Recruitment content is non-discriminatory No disputes over work environment |
| Sexual harassment | Sexual harassment in workplace | Sexual harassment workplace: 0 |
| Young worker | No child labor of minimum employment age is employed Young workers are not engaged in dangerous or harmful work | Employment of workers (under 15 years old): 0 Young worker (under 18 years of age) In dangerous positions: 0 |
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences | ||||
|---|---|---|---|---|---|---|
| Yes | No | Abstract | ||||
| Notice of changes to operating activities | The notice period for termination of the contract of employment under Article 12 or 13 of the Code of Conduct of Employee is as follows: | |||||
| 1. For those who have been working for three months to less than one year, notice shall be given ten days before. | ||||||
| 2. For those who have been working for more than one year and less than three years, notice shall be given before 20 days. | ||||||
| 3. For those who continue to work for more than three years, notice shall be given 30 days in advance. | Give notice to the employee within the prescribed time for termination of the contract of employment | |||||
| 4. Multiple communication channels | ||||||
| Pay attention to the ideas and opinions of every employee, and continuously improve the communication and coordination system within the Company. The Company establishes channels for regular communication and dialogue between employees, so that employees have the right to obtain information and express their opinions on the Company's operation and management activities and decisions through appeal forms, high-rise mailboxes, etc. The Company also respects the right of employee representatives to negotiate on working conditions, and provides employees with the necessary information and hardware facilities to facilitate consultation and cooperation between employers, employees and employee representatives. | ||||||
| (2) Has the Company established and implemented reasonable employee welfare measures (including salary, vacation and other benefits) and appropriately reflected business performance or results in employee compensation? | ☑ | The Company will make reference to the compensation system according to the industrial characteristics, market conditions and future development, and provide appropriate rewards to employees with contributions according to the achievement of operational objectives and the results of employee performance appraisal. Employees are encouraged to create operational performance and long-term value together with the Company through incentive mechanisms such as stock options. The Company's promotion of employee welfare and workplace diversity and equality measures are disclosed in the Sustainability Report and the Company's website. | ||||
| Employee welfare measures, including compensation, leave and other benefits, and appropriately include business performance in employee compensation: | No significant difference |
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences | ||
|---|---|---|---|---|
| Yes | No | Abstract | ||
| 1. Remuneration Committee: responsible for the policy, system, standard and structure of remuneration. | ||||
| 2. Performance evaluation and management: Perform performance evaluation every year, and use the evaluation results as the basis for promotion, salary adjustment, bonus and remuneration. Perform performance evaluation every year, and use the evaluation results as the basis for promotion, salary adjustment, bonus and remuneration. | ||||
| (3) Does the Company provide a safe and healthy working environment for employees and implement safety and health education for employees on a regular basis? | ☑ | 1. The Company is committed to improving the safety and health of employees at work. Each operating point has established an occupational safety and health management system according to the relevant local laws and regulations, and regularly inspects and maintains the safety and health of the working environment to reduce the harm of the working environment to the safety and health of employees. No occupational accidents occurred in 2023. Personnel entering the laboratory should wear laboratory clothes and shoes to avoid chemical or microbial operation, so as to maintain the work safety of operators. Conduct regular staff health check, care for staff health. | ||
| 2. Personnel who are exposed to noise, dust or chemical poisons are required to be equipped with protective measures and receive relevant training. | ||||
| 3. No occupational accidents occurred in the year 2024. | ||||
| 4. No fire incidents occurred in the year 2024. | ||||
| (4) Has the Company established an effective career development training program for employees? | ☑ | The Company will, depending on the individual's situation, encourage continuing study and establish effective career ability development training. Every employee has access to the training resources provided by the company since joining the company through systematic training planning, such as new staff training, on-the-job training, professional training. to help employees of different positions and ranks to deepen their professional fields and improve management functions. |
The Company's current training program is divided into three categories:
1. Pre-job education and training: All new employees will be instructed with company history, organization overview, corporate cultures and core values, welfare policies and get familiar with personnel of each division.
2. Professional course training: For professional pre-job education and training, the employing department shall formulate an individual training plan for employees according to the expertise and work needs of new employees, and provide courses that meet the needs of employees to strengthen their professional knowledge and skills. Professional pre-job education and training are formulated by the employing department according to the expertise and work needs of new employees, creating an individualized training plan for employees. This provides courses that meet the needs of employees to enhance their professional knowledge and skills. | No significant difference |
| Items | Operations | Differences with the Code of Practice for Sustainable Development of TWSE/TPEx-Listed Companies and the Reasons for Such Differences | ||
|---|---|---|---|---|
| Yes | No | Abstract | ||
| 3. On-the-job training: In addition to providing expatriate opportunities for qualified employees, employees are also encouraged to participate in professional training, lectures or further study courses organized by training institutions at home and abroad. | ||||
| (5) Does the Company comply with relevant laws and regulations and international standards regarding customer health and safety, customer privacy, marketing and labeling of products and services, and has it established relevant policies and grievance procedures to protect the rights of consumers or customers? | ☑ | The Company's products are still in the research and development stage and have not yet been sold. The Company follows clinical trial, drug manufacturing regulations and relevant international standards with high specifications and rigorous standards for drug safety/clinical trials to ensure the health and safety of subjects and users; in addition, a special area for stakeholders is set up on the website to provide channels for questions, complaints or suggestions, and properly handle and respond to the principle of good faith to protect the rights and interests of stakeholders. | No significant difference | |
| (6) Has the Company established a supplier management policy that requires suppliers to comply with relevant regulations on environmental protection, occupational safety and health, or labor human rights, and the status of implementation? | ☑ | The Company follows current Good Manufacturing Practice (current Good Manufacturing Practice; cGMP) to develop Supplier Quality Control and Monitoring Procedures. From raw materials to testing, cleaning services, and even the logistics operators who transport raw materials to the company, any supplier involved in the Company's industrial chain is subject to this quality control process, in order to jointly establish a quality and stable long-term cooperation relationship. The Company will pay attention to this in the future contract with major suppliers and will gradually promote the handling | Plan to gradually promote in the future. |
Implementation of Climate-Related Information
| Items | Implementation |
|---|---|
| 1. Explain the oversight and governance of climate-related risks and opportunities by the Board of Directors and management. | The Company's Board of Directors regularly reviews significant risks at the group level, including operational risks at the subsidiary level that may arise from climate policies, extreme weather, or the transition to a low-carbon economy. Management is responsible for integrating the group's climate-related risk identification, response, and management mechanisms, and reporting to the Board of Directors. |
| 2. Explain how the identified climate risks and opportunities affect the company's business, strategy, and financials. (Short-term, medium-term, long-term). | The Company, focusing on new drug research and development, is currently in the research and clinical stages with no large-scale production activities. In the short term, greenhouse gas emissions are extremely low, and the direct impact of climate change on operations and finance is limited. In the mid to long term, as drugs enter the commercialization stage, areas such as manufacturing, supply chain, and regulatory compliance may face carbon management requirements, changes in climate policies, and pressures of a low-carbon economy, which could impact strategies related to cost, risk management, and partner selection. The company will continue to evaluate the potential impact of climate risks on the transformation of R&D outcomes, investment decisions, and financial structure as a reference for strategic adjustments. |
| 3. Describe the impact of extreme climate events and transition actions on financials. | The Company has never experienced operational disruptions or significant losses due to extreme climate events; currently, the financial impact of extreme climate events on the Company is extremely low. However, with global policies gradually moving towards a low-carbon economy, if future regulations such as carbon pricing and sustainable financial norms extend to R&D enterprises, they may indirectly impact funding costs. The company has |
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| initially established relevant risk identification mechanisms and incorporated them as references in long-term strategies and resource allocation. | |
|---|---|
| 4. Explain how the identification, assessment, and management process of climate risks are integrated into the overall risk management system. | The Company has included climate change as one of the risk identification items and incorporated it into the overall risk management framework for supervision and management. |
| The management conducts an annual risk assessment of the internal and external operating environment of the group, including aspects such as regulatory changes, industry trends, difficulty in obtaining capital, and reputational risk. Appropriate response strategies are proposed based on the operational progress of the subsidiaries. | |
| In the future, if entering the production or commercialization stage, a more detailed carbon risk assessment mechanism will be gradually introduced and integrated with the internal control system to establish a forward-looking and resilient climate management mechanism. | |
| 5. If scenario analysis is used to assess resilience to climate change risks, the scenarios, parameters, assumptions, analysis factors, and major financial impacts used should be explained. | The Company has not yet conducted a comprehensive climate scenario analysis, primarily because it has not yet entered the large-scale production and supply stage following drug approval, resulting in very low overall carbon emissions and climate risk exposure. |
| The timeline and location for future entry into mass production will refer to international standards for climate scenario construction and assess the resilience to potential changes in operating costs, financing conditions, and law compliance under different emission scenarios. | |
| 6. If there is a transition plan to manage climate-related risks, explain the content of the plan, as well as the metrics and objectives used to identify and manage physical and transition risks. | The Company has not yet implemented a comprehensive climate risk transition plan, but has begun exploring feasible future carbon management and green R&D strategies. These include prioritizing energy-saving technology platforms and principles for selecting sustainable suppliers to enhance climate resilience in future mass production stages. Relevant objectives and management methods will be progressively developed in line with the Company's operational development stages. |
| 7. If internal carbon pricing is used as a planning tool, the basis for price determination shall be explained. | The Company has not yet implemented an internal carbon pricing system and plans to gradually promote it in the future. |
| 8. If climate-related objectives are set, the activities covered, the scope of greenhouse gas emissions, the planning period, and the annual progress should be explained; if carbon offsets or renewable energy certificates (RECs) are used to achieve the relevant objectives, the source and amount of carbon offsets or the amount of RECs should be explained. | As the Company has no physical production and logistics operations, greenhouse gas emissions are extremely low. Therefore, no specific carbon reduction objectives have been established, and there is no need to use carbon offsets or renewable energy certificates (RECs). The Company has planned to gradually establish measurable and verifiable environmental performance indicators to facilitate future greenhouse gas disclosure and reduction objectives design. |
| 9. Greenhouse gas inventory and assurance status, along with reduction objectives, strategies, and specific action plans. | The Company recognizes that greenhouse gas management has become one of the global sustainability standards in the pharmaceutical industry. In the future, it will plan to implement phased inventory operations based on the progress of its operations and regulatory trends, and formulate corresponding reduction strategies according to different areas and operational scales, enhancing the overall ESG responsiveness of the group. |
Greenhouse gas inventory and assurance status for the past two years of the Company
| Detail the greenhouse gas emissions for the last two years (tons of CO2e), intensity (tons of CO2e/million), and the data coverage scope. |
|---|
| As the ultimate parent company, Polaris Group itself has no physical operating facilities and therefore does not emit greenhouse gases. |
(VI) Fulfillment of the Code of Conduct for Integrity Management and Differences from the Code of Conduct for Integrity Management of TWSE/TPEx-Listed Companies and the Reasons
| Assessment items | Operations | Differences from the Code of Conduct for Integrity Management of TWSE/TPEx-listed Companies and the reasons | ||
|---|---|---|---|---|
| Yes | No | Abstract | ||
| 1. Formulation of policies and programs for integrity management | ||||
| (1) Has the Company formulated an integrity management policy approved by the Board of Directors of Directors, and has the policy and practices of integrity management been clearly stated in the Articles of Incorporation and external documents, as well as the commitment of the Board of Directors of Directors and the senior management to actively implement the management policy? | ☑ | The Company has formulated the "Code of Conduct for Integrity Management", "Operating Procedures and Guidelines for Integrity Management" and "Code of Ethical Conduct" to govern the Company's policy on ethical practices. It also specifies that employees, managers and directors do know and comply with the provisions of the laws and regulations and do enforce them. The directors, managers and employees shall comply with the relevant laws and regulations of the Company Act and the Securities Exchange Act, and implement the principle of integrity management. | No significant difference. | |
| (2) Has the Company set up a mechanism to assess the risk of dishonest conduct, regularly analyze and evaluate the business activities within the scope of business that have a higher risk of dishonest conduct, and accordingly, formulate a plan to prevent dishonest conduct, and at least cover the preventive measures for the conducts mentioned in Item 2 of Article 7 of the "Code of Conduct for Integrity Management of Listed Companies"? | ☑ | The Company has formulated the "Code of Conduct for Integrity Management", "Operating Procedures and Guidelines for Integrity Management", which specifies the plan to prevent dishonest conduct, and evaluates the business activities with high risk of dishonest conduct within the business scope, and specifies that illegal political donations are not provided, bribery and acceptance of bribes are strictly prohibited, and relevant preventive measures are strengthened. | No significant difference. | |
| (3) Does the Company specify the operating procedures, guidelines for conduct, disciplinary and grievance systems for non-compliance in the plan to prevent dishonest conduct, and implement them, and regularly review and revise the aforementioned plan? | ☑ | The Company has formulated the "Code of Conduct for Integrity Management", "Operating Procedures and Guidelines for Integrity Management", which clearly defines the program to prevent dishonest behavior, including operating procedures and conduct guidelines, reward as well as punishment system and appeal system, and implement it and review and revise it regularly. | No significant difference. | |
| 2. Implementation of integrity management | ||||
| (1) Does the Company evaluate the integrity records of its customers and specify the terms of integrity behavior in the contracts signed between the Company and its customers? | ☑ | The Company has a high degree of self-discipline and has never engaged in business activities that are unlawful or for any other purpose; it evaluates the integrity records of its customers before dealing with them. | No significant difference. | |
| (2) Has the Company established a dedicated unit under the Board of Directors of Directors to promote ethical corporate management and report to the Board of Directors of Directors on a regular basis (at least once a year) on its ethical management policies and plans to prevent dishonest practices and monitor their implementation? | ☑ | The Company has established a part-time unit (Department of Finance and Administrative Management designated) under the Board of Directors of Directors for integrity management and prevention. | No significant difference. |
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| Assessment items | Operations | Differences from the Code of Conduct for Integrity Management of TWSE/TPEx-listed Companies and the reasons | ||
|---|---|---|---|---|
| Yes | No | Abstract | ||
| (3) Does the Company have a conflict-of-interest prevention policy, provide appropriate channels of representation, and implement them? | ✓ | The Company has established the "Code of Conduct for Integrity Management", "Operating Procedures and Guidelines for Integrity Management", and set up a special area for stakeholders on the Company's website and provide channels for employees and external complaints. | No significant difference. | |
| (4) Has the Company established an effective accounting system and internal control system for the implementation of integrity management, and has the internal audit unit prepared an audit plan based on the assessment of the risk of dishonest acts, and checked the compliance of the plan to prevent dishonest acts or appoint an accountant to perform the audit? | ✓ | In order to ensure the implementation of integrity management, the Company has established an effective internal control system and accounting system, and the internal audit unit has formulated an internal audit plan, according to which various audits are carried out, and submitted the audit results and subsequent improvement plans to the Board of Directors of Directors and management to implement the audit results. | No significant difference. | |
| (5) Does the Company regularly conduct internal and external education and training on integrity management? | ✓ | The Company places emphasis on the implementation of the principle of integrity by all employees in its daily operations, and holds meetings from time to time to promote the principle. | No significant difference. | |
| 3. Operation of the Company's whistleblower system(1) Has the Company established a specific whistleblower and reward system, established a convenient whistleblower channel, and assigned appropriate staff to handle whistleblowers? | ✓ | The company has a whistleblowing system, including whistleblowing matters and reward system, and has a whistleblowing mailbox and whistleblowing hotline. The acceptance unit for the subject of the prosecution is the audit room. | No significant difference. | |
| (2) Has the Company established standard operating procedures for the investigation of whistleblowing matters, follow-up measures to be taken after the completion of the investigation and the relevant confidentiality mechanism? | ✓ | After the Audit Office accepts the complaint, the person involved in the case shall report it to the chairman or independent director, and the complaint involving a director or senior supervisor shall be reported to the Audit Committee for investigation. The company keeps the identity of the whistleblower and the contents of the whistleblower confidential, and allows the whistleblower to report anonymously. After the investigation is completed, the files are classified as confidential files and encrypted protection. | No significant difference. | |
| (3) Does the Company take measures to protect whistleblowers from improper treatment as a result of whistleblowing? | ✓ | The Company's whistleblower system has established relevant provisions for the protection of whistleblowers, and the identity of whistleblowers and the contents of whistleblowers are kept confidential to ensure that whistleblowers are not improperly handled due to the whistleblowers. | No significant difference. | |
| 4. Enhance Information DisclosureDoes the Company disclose the content and effectiveness of its Code of Conduct for Integrity Management on its website and MOPS? | ✓ | The Company has formulated various integrity management systems and implemented the disclosure of relevant information on its website to provide the public with access at any time | No significant difference. | |
| 5. If the Company has its own Code of Conduct for Integrity Management in accordance with the "Code of Conduct for Integrity Management of Listed Companies", please describe the difference between its operation and the code: The Company has formulated a Code of Conduct for Integrity Management. At present, the internal operations of the Company continue to be handled in accordance with the provisions of the Code, and there is no material difference from the content of the Code. |
| Assessment items | Operations | Differences from the Code of Conduct for Integrity Management of TWSE/TPEx-listed Companies and the reasons | ||
|---|---|---|---|---|
| Yes | No | Abstract | ||
| 6. Other important information that is helpful to understand the Company's integrity management: In addition to the Company's Code of Conduct for Integrity Management, the Company has other internal regulations (e.g., prevention of insider trading). In addition, the Company arranges directors to participate in corporate governance courses and periodically promotes integrity management policies to employees. |
(VII) Other important information that may enhance the understanding of the operation of corporate governance may also be disclosed.
Please refer to The Company's website at http://www.polarispharma.com/investors/
(VIII) Implementation Status of Internal Control System
- Statement of Internal Control
Polaris Group
Statement of Internal Control System
Date: March 17, 2025
The Company's internal control system for fiscal year 2024 is based on the results of its self-assessment. We hereby state as follows:
-
The Company acknowledges that it is the responsibility of the Board of Directors of Directors and the Manager to establish, implement and maintain a system of internal control, and that the Company has established such a system. The Company has established such a system to provide reasonable assurance of the effectiveness and efficiency of operations (including profitability, performance and safeguarding of assets), reliability of reporting, timeliness, transparency and compliance with relevant regulations and compliance with relevant laws and regulations.
-
No matter how well designed, an effective internal control system can only provide reasonable assurance of the achievement of the above three objectives; moreover, the effectiveness of the internal control system may change due to changes in circumstances and conditions. The Company's internal control system has a self-monitoring mechanism and the Company will take corrective action once deficiencies are identified.
-
The Company determines the effectiveness of the design and implementation of the internal control system in accordance with the criteria for determining the effectiveness of the internal control system set forth in the "Guidelines Governing the Establishment of Internal Control Systems by Public Companies" (the "Guidelines"). The judgment items of the internal control system adopted in the "Guidelines" are divided into five components based on the management control process: control environment, risk assessment, control operations, information and communication, and monitoring operations. Each component includes a number of items. Please refer to the "Guidelines" for the aforementioned items.
-
The Company has adopted the above internal control system judgment items to evaluate the effectiveness of the design and implementation of the internal control system.
-
The Company found the following matters after the evaluation: Due to the immediacy of business needs, the Company signed a loan contract (nature of the loan is shareholder to subsidiary loan) on December 26, 2024, and completed the receipt of funds on December 31, 2024. This loan transaction could not be submitted to the Board of Directors for deliberation in advance due to time constraints. However, to ensure compliance with the Company's financial and business-related operational regulations concerning related parties, it was submitted to the Board of Directors for deliberation on January 23, 2025. The reasonableness of the financing conditions was also included in the Board's agenda for discussion and approval.
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-
Based on the evaluation results in the preceding paragraph, the Company believes that the internal control system (including supervision and management of subsidiaries) of the Company as of December 31, 2012, including the degree of understanding the effectiveness and efficiency goals of operations, the reliability, timeliness, transparency of reporting, and compliance with relevant regulations and laws, is effective in its design and implementation, and can reasonably ensure the achievement of the above goals.
-
This statement will be the main content of The Company's annual report and public statement, and will be made public. If any of the above-mentioned contents are disclosed in a false or concealed manner, the Company will be subject to legal liability under Article 20, Article 32, Article 171 and Article 174 of the Securities and Exchange Act.
-
This statement has been approved by the Board of Directors of the Company on March 17, 2025 and among the seven directors present, none of them held any opposing views, and the rest of them agreed to the contents of this statement.
Polaris Group

Chairman: Chen, Hung-Wen

CEO: Hsu, Jaan-Pyng

(IX) Significant Resolutions of the Shareholders' Meeting and the Board of Directors of Directors for the Most Recent Year and up to the Date of Printing of the Annual Report
- The dates of the Shareholders' Meetings and the important resolutions of the shareholders present are as follows:
| Date | Meeting | Matters for resolution | Implementation |
|---|---|---|---|
| May 3, 2024 | Regular Shareholders' Meeting | 1. The recognition of the 2023 Annual Report of Operations and Financial Statements | |
| 2. The recognition of the loss of 2023 | |||
| 3. Proposed to the by-election of one independent director. | |||
| 4. Release the restriction on New Independent Directors from Participating in Competitive Business. | Resolution passed. | ||
| Resolution passed. | |||
| Resolution passed. | |||
| Resolution passed. |
- Board of Directors Dates and Resolutions:
| The date of Board Meeting | Important resolutions |
|---|---|
| January 19, 2024 | 1. Proposal of Subsidiary Polaris Biopharmaceuticals, Inc.'s Intention to Purchase Zhunan Plant. |
| 2. Proposal of appointment of secretary to the Board of Directors | |
| 3. Updated the Group's Budget for year 2024 | |
| 4. Proposal of Cash Increase to Subsidiary Genovior Biotech. | |
| 5. Proposal of by-election of independent director | |
| 6. Release the restriction on New Independent Directors from Participating in Competitive Business. | |
| 7. Proposed to handle matters related to the convening of the 2024 General Shareholders' Meeting | |
| February 20, 2024 | 1. Proposal of Cash Increase to Subsidiary Polaris Biopharmaceuticals, Inc. |
| March 12, 2024 | 1. Recognition of 2023 Statement on Internal Control System |
| 2. The recognition of the 2023 Annual Report of Operations and Financial Statements | |
| 3. Proposal of 2023 Deficit Compensation | |
| 4. List of independent director candidates nominated by the Board of Directors of Directors | |
| 5. Adoption of Power of Attorney to Exercise Proxy Rights through Shareholders' Regular Meetings | |
| 6. Amendments to the Company's Rules of Procedures of the Board of Directors | |
| 7. Amendments to the Company's "Articles of Incorporation of Audit Committee" | |
| 8. Amendments to the Company's "Articles of Incorporation of Compensation Committee" | |
| 9. Proposal to Change CPAs Handling Financial Report in Response to the Internal Shift of PwC Taiwan | |
| Proposal to Change CPAs Handling Financial Report in Response to the Internal Shift of PwC Taiwan |
| The date of Board Meeting | Important resolutions |
|---|---|
| April 26, 2024 | 1. Proposal of Loan Extension for Subsidiary's PPI Fund Lending to Australian Subsidiary 2. The Company's application for a transaction limit with Citibank Taiwan 3. Proposal of DRX (Chengdu)'s application for bank financing limit 4. Funding loaned to Subsidiary DRX Chengdu 5. Funding loaned to Subsidiary Polaris Biopharmaceuticals, Inc. 6. Funding loaned to Subsidiary Genovior Biotech. 7. Amend the operational regulations related to financial transactions between related parties. 8. Capital increase for subsidiary TDW HK Limited. |
| May 14, 2024 | 1. Proposal for the 2024 Q1 Consolidated Financial Statements. 2. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group 3. Proposal to reappoint the Director of the Subsidiary 4. Proposal for the Appointment of Members of the Compensation Committee |
| June 25, 2024 | 1. Proposal to reappoint the Director of the Subsidiary 2. The Company's Employee Stock Warrant Issuing List for Year 2024 3. Funding loaned to Subsidiary DRX Chengdu 4. Funding loaned to Subsidiary Polaris Biopharmaceuticals, Inc. 5. Merger of Subsidiary Polaris Biopharmaceuticals, Inc. and Sub-subsidiary Genovior Biotech. 6. Proposal of Cash Increase by Subsidiary Polaris Biopharmaceuticals, Inc. to Genovior Biotech. 7. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group 8. Proposal for Adjustment of COO's Compensation 9. Proposal of changing CFO 10. Proposal to change spokesman 11. Proposal of changing Corporate Governance Supervisor 12. The case of appointing Langzhi Biomedical Co., Ltd. to offer shares in the securities market Authorized signatory |
| July 23, 2024 | 1. Proposal to cancel the position of COO 2. Appointment of Corporate Governance Supervisor Proposal 3. The Company and its subsidiary, DesigneRx Pharmaceuticals (Chengdu) Inc., plan to apply for a transaction limit with Citibank. 4. Supplementary Amendment for the Merger of Subsidiary Polaris Biopharmaceuticals, Inc. and Sub-subsidiary Genovior Biotech. |
| August 22, 2024 | 1. Accounting Supervisor Ratification Case 2. Proposal for the 2024 Q2 Consolidated Financial Statements. 3. Handle the case of issuing new shares for a cash capital increase in The year 2024. 4. The investment plan of the subsidiary DesigneRx Pharmaceuticals (Chengdu) Inc. in a peptide intermediate production base. 5. Independence Evaluation and Compensation of the Company's CPA. 6. Draft the 2023 Sustainability Report 7. Update the proposal of sound operation planning 8. Proposal to reappoint the Director of the Subsidiary |
| The date of Board Meeting | Important resolutions |
|---|---|
| September 20, 2024 | 1. Proposal of changing financial supervisor and accounting supervisor2. Proposal of changing Corporate Governance Supervisor3. Proposal to change acting spokesman and secretary to the Board of Directors |
| October 29, 2024 | 1. Amend the case of issuing new shares for a cash capital increase in The year 2024.2. The Company's Allocation Plan for the Issuance of New Shares in a Cash Capital Increase for Employees in The Year 2024.3. The appointment of the Head of Audit of the Company.4. Propose capital increase for USA subsidiary DRX USA.5. Proposal of Adjustment of Approval Authority between the Parent Company and Subsidiaries in the Group |
| November 11, 2024 | 1. Proposal for the 2024 Q3 Consolidated Financial Statements.2. Preparation of the Group's Audit Plan for 20253. Preparation of the Group's Sustainable Information Management Proposal4. The Company's Second Employee Stock Warrant Issuing List for The Year 2024 |
| December 24, 2024 | 1. Preparation of the Group's Budget for 20252. Proposal of Cash Increase to Subsidiary Genovior Biotech.3. Proposal for capital increase for subsidiary TDW HK Limited.4. The subsidiary Genovior Biotech Corporation plans to establish in Zhunan. Phase II plant project proposal5. The subsidiary Genovior Biotech Corporation plans to seek bank financing.6. Updated the Company's Audit Plan for 2025. |
| January 23, 2025 | 1. The subsidiary, Northern Biopharmaceutical Co., Ltd. (Fujian), is planning a financing case with Digital Mobile Venture Ltd.Digital Mobile Venture Ltd. financing case2. The cash capital increase plan for the funding loaned to the subsidiary DesigneRx Pharmaceuticals (Chengdu) Inc. by The Company. |
| February 20, 2025 | 1. Cancel the cash capital increase plan for the funding loaned to the subsidiary DesigneRx Pharmaceuticals (Chengdu) Inc. by The Company.2. Proposal for capital increase for subsidiary TDW HK Limited.3. The Company proposes to serve as a joint guarantor for a NTD 15 million bank loan under the Subsidiary Genovior Biotech Corporation.4. Plan to handle the case of issuing new shares for a cash capital increase in the year 2025.5. Proposed to handle matters related to the convening of the 2025 General Shareholders' Meeting6. Amendments to the Company's Articles of Incorporation based on the Shareholders' Meeting's special resolution7. Case of Issuing Employee Stock Option Certificates |
| March 12, 2024 | 1. Proposal of changing financial supervisor and accounting supervisor2. Proposal for CFO's Compensation3. Proposal of changing Corporate Governance Supervisor4. Adoption of "Statement on Internal Control System" for year 2024 proposal5. Proposal of 2024 Business Report and Consolidated Financial Statements6. Proposal of 2024 Deficit Compensation |
| March 12, 2024 | 1. Adoption of Power of Attorney to Exercise Proxy Rights through Shareholders' Regular Meetings |
(X) The main contents of the most recent year and as of the date of publication of the annual report, if the Director or supervisor has different opinions on important resolutions passed by the Board of Directors of Directors and there are records or written statements: None.
IV. Information on Accountants' Fees
Amount Unit: NTD1,000
| Name of accounting firm | Name of CPAs | Audit period | Audit fee | Non- audit fee | Total | Note | |
|---|---|---|---|---|---|---|---|
| PwC Taiwan | Liao Rongling | 2024.01.01~2024.12.31 | 3,656 | 780 | 4,436 | CPA for the financial statements | |
| Alan Chien |
(I) If the non-audit fees paid to the certified public accountant, the certified public accountant's firm and its affiliates amount to more than one-fourth of the audit fees, the amount of audit and non-audit fees and the content of non -audit services should be disclosed:
The non-audit fees mainly include NTD780,000 for expert review services.
(II) If the audit fee paid in the year of change of accounting firm is less than the audit fee in the year before the change, the amount of audit fee before and after the change and the reasons for the change should be disclosed: None.
(III) If the audit fee is reduced by 10% or more from the previous year, the amount, percentage and reasons for the reduction shall be disclosed: None.
V. Information on Change of Accountant
(I) Regarding the former accountant
| Date of change | Adopted by the Board of Directors on March 12, 2024 | |||
|---|---|---|---|---|
| Reason | In line with PwC’s partner rotation effective from the first quarter of 2024. | |||
| Explanation if the appointer or accountant terminates/declines the engagement | The party Situation | Accountant | Appointer | |
| Voluntarily terminate the engagement | N/A | N/A | ||
| Decline to continue the engagement | N/A | N/A | ||
| Opinions other than unqualified opinions and the reasons therefor, as stated in audit reports issued within the most recent two years | N/A | |||
| Whether there were | Yes | Accounting principles or practices |
| any disagreements with the issuer | Disclosure in the financial statements | ||
|---|---|---|---|
| Scope or procedures of the audit | |||
| Other matters | |||
| No | ✓ | ||
| Explanation | |||
| Other disclosure matters (those required to be disclosed under Article 10, Paragraph 6, Items 1(4) to 1(7) of these Regulations) | N/A |
(II) Regarding the succeeding accountant
| Name of the accounting firm | PwC Taiwan |
|---|---|
| Name of CPAs | Liao Rongling Alan Chien |
| Date of engagement | Adopted by the Board of Directors on March 12, 2024 |
| Consultations prior to engagement on accounting treatment/principles for specific transactions and possible audit opinions, and the results thereof | N/A |
| Written opinion(s) of the successor CPA regarding matters of disagreement with the former CPA | N/A |
(III) The former CPA's written response to the matters under Article 10, Paragraph 6, Subparagraph 1 and Subparagraph 2, Item 3 of these Regulations : None.
VI. The Chairman of the Board of Directors, the General Manager, and the Manager in Charge of Financial or Accounting Matters of the Company, Who Have Worked in the Firm of the Certified Public Accountant or Its Affiliates within the Last Year: None.
VII. Changes in the Shareholding of Directors, Supervisors, Managers and Shareholders Holding More Than 10% of the Shares and Pledges of Shares in the Most Recent Year and up to the Date of Publication of the Annual Report
(I) Changes In Shareholdings of Directors, Supervisors, Managers and Major Shareholders
Unit: Shares
| Title | Name | 2024 | 2025 As of March 23 | ||
|---|---|---|---|---|---|
| Holding Number of shares increase (decrease) number | Pledge Number of shares increase (decrease) number | Holding Number of shares increase (decrease) number | Pledge Number of shares increase (decrease) number | ||
| Chairman | Chen, Hung-Wen Digital Capital Inc. Representative: Hsu, Jaan-Pyng | — | — | — | — |
| Director | Chen, Shyan Tser | — | — | — | — |
| Director | Chen, Hung-Wen | 1,000,000 | — | — | — |
| Director | Mai Investment Co., Ltd Representative: Tsai, Kao-Chung (Note 1) Wayne Lin (Note 1) | — | — | — | — |
| Independent Director | Way, Tzong Der | — | — | — | — |
| Independent Director | Chao, Ying-Chen | — | — | — | — |
| Independent Director | Wen, Kuo-Lan | — | — | — | — |
| Manager | Hsu, Jaan-Pyng | 1,000,000 | — | — | — |
| Manager | John Bomalaski | — | — | — | — |
| Manager | You, Huei-Yuan (Note 2) | (5,000) | — | — | — |
| Manager | Chien-Hsing Chang | — | — | — | — |
| Manager | Kevin Wu | — | — | — | — |
| Manager | Kay Huang (Note 3) | (132,000) | — | — | — |
| Manager | Rui-Bin Wu (Note 4) | — | — | — | — |
| Manager | Yan, Feng-Kui (Note 5) | — | — | — | — |
| Manager | Yi-Ming Kao (Note 6) | — | — | — | — |
Note 1: On March 13, 2025, the corporate director Mai Investment Co., Ltd reassigned its representative to Tsai, Kao-Chung, with Wayne Lin stepping down.
Note 2: The Company canceled the position of COO on July 23, 2024, and Mr. You, Huei-Yuan stepped down.
Note 3: Resigned on June 25, 2024, and was replaced by Mr. Wu, Jui-Pin.
Note 4: Resigned on September 20, 2024, and was replaced by Mr. Yen, Fong-Kuei.
Note 5: Resigned on January 24, 2025, and was replaced by Yi-Ming Kao.
Note 6: Assumed office on March 17, 2025.
(II) Information on the transfer of shares to related parties: None.
(III) Information on pledges of shares to related parties: None.
VIII. Information on the Top Ten Shareholders Who Are Related to Each Other or Are Related to Each Other as Spouses or Relatives within Second Generation:
Shareholding information as of March 23, 2025; Unit: Shares; %
| Name | Shareholdings held by me | Spouse, minor children shareholdings | Bominal total of shareholdings using others' names | The names or names and relationships of the top ten shareholders who are related to each other or who are related to each other as spouses or second degree relatives, etc. | Note | ||||
|---|---|---|---|---|---|---|---|---|---|
| Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | Name | Relation | ||
| Digital Capital Inc. | 290,000,000 | 37.64 | — | — | — | — | Mai Investment Co., Ltd., Digital Mobile Venture Ltd. | Same ultimate beneficiary | — |
| Representative: Hsu, Jaan-Pyng | 1,000,000 | 0.13 | 2,000 | 0.00 | — | — | — | — | — |
| Digital Mobile Venture Ltd. | 61,729,295 | 8.01 | — | — | — | — | Mai Investment Co., Ltd., Digital Capital Inc. | Same ultimate beneficiary | |
| Representative: Chen, Shyan Tser | 4,950,000 | 0.67 | 3,802,000 | 0.49 | — | — | — | — | — |
| Mai Investment Co., Ltd. | 40,527,138 | 5.45 | — | — | — | — | Digital Capital Inc., Digital Mobile Venture Ltd | Same ultimate beneficiary | — |
| Representative: Tsai, Kao-Chung | — | — | — | — | — | — | — | — | — |
| G-Technology Investment Co., Ltd. | 26,467,465 | 3.44 | — | — | — | — | Gemtek Technology Co., Ltd. | Same shareholder and representative | — |
| Representative: Chen, Hung-Wen | 34,700 | 0.00 | — | — | — | — | — | — | — |
| Cathay United Bank entrusted with the custody of the investment account of Lineage Tech Co., Ltd. | 14,800,669 | 1.39 | — | — | — | — | — | — | — |
| Chen, Yi-Chun | 10,739,761 | 1.39 | — | — | — | — | Chen, Yi-Ting | The shareholders are the same ultimate beneficiary/ relatives of these three companies. | — |
| Chen, Yi-Ting | 10,633,094 | 1.38 | — | — | — | — | Chen, Yi-Chun | The shareholders are the same ultimate beneficiary/ relatives of these three companies. | — |
IX. Number of Shares Held by the Company, Its Directors, Supervisors, Managers and Businesses Directly or Indirectly Controlled by the Company in the Same Business to Which the Company Invests, and Combined to Calculate the Consolidated Shareholding Percentage
| Name | Shareholdings held by me | Spouse, minor children shareholdings | Bominal total of shareholdings using others' names | The names or names and relationships of the top ten shareholders who are related to each other or who are related to each other as spouses or second degree relatives, etc. | Note | ||||
|---|---|---|---|---|---|---|---|---|---|
| Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | Name | Relation | ||
| Masterpiece Enterprise Co., Ltd. | 10,000,000 | 1.30 | — | — | — | — | — | — | — |
| Representative: King Regent Management Limited | — | — | — | — | — | — | Gemtek Technology Co., Ltd., G-Technology Investment Co., Ltd. | Same shareholder and representative | — |
| Capital World Investment Corporation | 9,340,456 | 1.09 | — | — | — | — | Gemtek Technology Co., Ltd., G-Technology Investment Co., Ltd. | The shareholders are the spouses of the representatives of these two companies. | — |
| Representative: Lu, Hsiao-Ju | — | — | — | — | — | — | — | — | — |
| Gemtek Technology Co., Ltd. | 7,784,542 | 1.01 | — | — | — | — | G-Technology Investment Co., Ltd. | Same representative | — |
| Representative: Chen, Hung-Wen | 34,700 | 0.00 | — | — | — | — | — | — | — |
Unit: Shares; %
| Reinvestment business | The Company investment | Director, manager and investment in directly or indirectly controlled business | Comprehensive investment | |||
|---|---|---|---|---|---|---|
| Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | |
| Polaris Pharmaceuticals, Inc. | 23,000 | 100 | — | — | 23,000 | 100 |
| DesigneRx Europe Limited | 1 | 100 | — | — | 1 | 100 |
| Polaris Pharmaceuticals Australia Pty Ltd. | 100 | 100 | — | — | 100 | 100 |
| Polaris Pharmaceuticals Ireland Limited | 100 | 100 | — | — | 100 | 100 |
| Polaris Pharmaceuticals, Inc. | 43,800,000 | 100 | — | — | 43,800,000 | 100 |
| DesigneRx Pharmaceuticals, Inc. | 136,979,257 | 100 | — | — | 136,979,257 | 100 |
| Reinvestment business | The Company investment | Director, manager and investment in directly or indirectly controlled business | Comprehensive investment | |||
|---|---|---|---|---|---|---|
| Number of shares | Shareholding % | Number of shares | Shareholding % | Number of shares | Shareholding % | |
| TDW HK Limited | 88,750,001 | 100 | — | — | 88,750,001 | 100 |
| DesigneRx Pharmaceuticals (Shanghai) Inc. | (Note 1) | 100 | — | — | (Note 1) | 100 |
| DesigneRx Pharmaceuticals (Chengdu) Inc. | (Note 1) | 100 | — | — | (Note 1) | 100 |
| Nanotein Technologies, Inc. | 6,347,330 | 54.89 | — | — | 6,347,330 | 54.89 |
| Polaris Biopharmaceuticals, Inc. | 125,000,000 | 100 | — | — | 125,000,000 | 100 |
| Lin Yang Biopharma, Ltd. | 168,138,001 | 100 | — | — | 168,138,001 | 100 |
| Genovior Biotech Corporation | 79,806,000 | 65.05 | 122,681,000 | 100 | 122,681,000 | 100 |
| Northern Biopharmaceutical Co., Ltd. (Fujian) | — | — | (Note 1) | 100 | (Note 1) | 100 |
Note 1: There is no number of shares given that it's a limited company.
IV. Capital Raising
I. Capital and Shares
(I) Source of Capital
March 23, 2025, Unit: NTD1,000; Foreign Currency; USD; Shares
| Year and month | Issue price (USD) | Authorized share capital | Paid-in capital | Note | ||||
|---|---|---|---|---|---|---|---|---|
| Number of shares (Stock) | Amount (USD) | Number of shares (Stock) | Amount (USD) | Source of equity (USD) | Offset by property other than cash | Others | ||
| March 2011 | 0.35 | 500,000,000 | 5,000 | 252,185,594 | 2,521,856 | Cash capital increase of $2,000,000 | None | — |
| May 2011 | 0.315 | 500,000,000 | 5,000 | 265,542,770 | 2,655,428 | Debt to stock conversion of $4,207,510 | None | — |
| May 2011 | 0.35 | 500,000,000 | 5,000 | 277,377,134 | 2,773,771 | Debt to stock conversion of $4,142,027 | None | — |
| May 2011 | 0.45 | 500,000,000 | 5,000 | 279,599,357 | 2,795,994 | Cash capital increase of $1,000,000 | None | — |
| February 2012 | 0.35 | 500,000,000 | 5,000 | 285,313,641 | 2,853,136 | Cash capital increase of $2,000,000 | None | — |
| September 2012 | 0.50 | 600,000,000 | 6,000 | 306,533,641 | 3,065,336 | Cash capital increase of $10,610,000 | None | — |
| January 2013 | 0.60 | 600,000,000 | 6,000 | 356,457,529 | 3,564,575 | Cash capital increase of $29,954,333 | None | — |
| February 2014 | 0.75 | 600,000,000 | 6,000 | 356,817,529 | 3,568,175 | Conversion of stock warrants $270,000 | None | — |
| May 2014 | 0.50 | 600,000,000 | 6,000 | 356,852,529 | 3,568,525 | Conversion of stock options $17,500 | None | — |
| May 2014 | 0.60 | 600,000,000 | 6,000 | 356,877,662 | 3,568,777 | Conversion of stock options $15,080 | None | — |
| June 2015 | 0.47 | 600,000,000 | 6,000 | 421,076,250 | 4,210,763 | Conversion of preferred shares to common shares (Note 1) | None | — |
| September 2015 | 1.50 | 600,000,000 | 6,000 | 428,212,261 | 4,282,123 | Cash capital increase of $10,704,000 | None | — |
64
| Year and month | Issue price (USD) | Authorized share capital | Paid-in capital | Note | ||||
|---|---|---|---|---|---|---|---|---|
| Number of shares (Stock) | Amount (USD) | Number of shares (Stock) | Amount (USD) | Source of equity (USD) | Offset by property other than cash | Others | ||
| October 2015 | — | 600,000,000 | 6,000 | 517,873,234 | 5,178,732 | Exchange 1 share of TDWG stock for 1.13 shares of Polaris Pharmaceuticals stock, issuing 89,660,973 new shares | None | — |
| Change of denomination from USD0.01 to USD10 per share and exchange of new shares | ||||||||
| Year and month | Issue price (NTD) | Authorized Share Capital | Paid-in capital | Note | ||||
| Number of shares (Stock) | Amount (1,000 dollars) | Number of shares (Stock) | Amount (1,000 dollars) | Source of equity capital (1,000 dollars) | Offset by property other than cash | Others | ||
| October 2015 | — | 240,000,000 | 2,400,000 | 207,149,255 | 2,071,493 | Change of capitalization currency and 2.5 share consolidation | None | — |
| November 2015 | — | 240,000,000 | 2,400,000 | 206,630,589 | 2,066,306 | Share buyback $5,187,000 | None | — |
| July 2017 | 18.00 | 320,000,000 | 3,200,000 | 246,630,589 | 2,466,306 | Cash capital increase of $400,000,000 | None | (Note 2) |
| August 2017 | 33.60 | 320,000,000 | 3,200,000 | 255,630,589 | 2,556,306 | Private placement of common stock Cash capital increase of $90,000,000 | None | — |
| September 2017 | USD 0.875~1.25 | 320,000,000 | 3,200,000 | 255,924,589 | 2,559,246 | Exercise of employee stock options $2,940,000 | None | — |
| October 2017 | USD 0.875~1.25 | 320,000,000 | 3,200,000 | 256,305,089 | 2,563,051 | Exercise of employee stock options $3,805,000 | None | — |
| October 2017 | 63.00 | 320,000,000 | 3,200,000 | 265,555,089 | 2,655,551 | Private placement of common stock Cash capital increase of $92,500,000 | None | — |
| November 2017 | $0.875 | 320,000,000 | 3,200,000 | 265,612,589 | 2,656,126 | Exercise of employee stock options $575,000 | None | — |
| January 2018 | USD 1.25~1.925 | 320,000,000 | 3,200,000 | 265,659,255 | 2,656,593 | Exercise of employee stock options $467,000 | None | — |
| March 2018 | USD 0.875 | 320,000,000 | 3,200,000 | 265,689,255 | 2,656,893 | Exercise of employee stock options $300,000 | None | — |
| April 2018 | USD 0.875~1.25 | 320,000,000 | 3,200,000 | 265,727,825 | 2,657,278 | Exercise of employee stock options $385,000 | None | — |
| Year and month | Issue price (NTD) | Authorized Share Capital | Paid-in capital | Note | ||||
|---|---|---|---|---|---|---|---|---|
| Number of shares (Stock) | Amount (1,000 dollars) | Number of shares (Stock) | Amount (1,000 dollars) | Source of equity capital (1,000 dollars) | Offset by property other than cash | Others | ||
| September 2018 | 30.00 | 420,000,000 | 4,200,000 | 285,727,825 | 2,857,278 | Cash capital increase of $200,000,000 | None | (Note 3) |
| September 2018 | USD 0.875 | 420,000,000 | 4,200,000 | 285,756,396 | 2,857,564 | Exercise of employee stock options $286,000 | None | — |
| October 2018 | USD 0.875 | 420,000,000 | 4,200,000 | 285,796,396 | 2,857,964 | Exercise of employee stock options $400,000 | None | — |
| November 2018 | USD 0.875 | 420,000,000 | 4,200,000 | 285,836,396 | 2,858,364 | Exercise of employee stock options $400,000 | None | — |
| March 2019 | 21.83 | 420,000,000 | 4,200,000 | 292,901,396 | 2,929,014 | Private placement of common stock Cash capital increase of $70,650,000 | None | — |
| July 2019 | 12.00 | 720,000,000 | 7,200,000 | 352,901,396 | 3,529,014 | Cash capital increase of $600,000,000 | None | (Note 4) |
| December 2019 | 10.00 | 720,000,000 | 7,200,000 | 652,901,396 | 6,529,014 | Private placement of common stock Cash capital increase of $3,000,000 | None | — |
| March 2021 | USD 1.25 | 720,000,000 | 7,200,000 | 652,915,396 | 6,529,154 | Exercise of employee stock options $140,000 | None | |
| April 2021 | USD 0.875~1.68 | 720,000,000 | 7,200,000 | 653,374,110 | 6,533,741 | Exercise of employee stock options $4,587,000 | None | |
| June 2021 | USD 0.875~1.25 | 720,000,000 | 7,200,000 | 654,612,109 | 6,546,121 | Exercise of employee stock options $12,380,000 | None | |
| July 2021 | USD 0.875~1.25 | 720,000,000 | 7,200,000 | 654,751,109 | 6,547,511 | Exercise of employee stock options $1,390,000 | None | |
| August 2021 | USD 1.25 | 720,000,000 | 7,200,000 | 654,761,109 | 6,547,611 | Exercise of employee stock options $100,000 | None | |
| August 2021 | 80 | 1,000,000,000 | 10,000,000 | 718,761,109 | 7,187,611 | Cash capital increase of $640,000,000 | None | (Note 5) |
| October 2021 | USD 0.875 | 1,000,000,000 | 10,000,000 | 718,825,109 | 7,188,251 | Exercise of employee stock options $640,000 | None | |
| November 2021 | USD 1.25~1.68 | 1,000,000,000 | 10,000,000 | 718,835,109 | 7,188,351 | Exercise of employee stock options $100,000 | None | |
| December 2021 | USD 0.33 | 1,000,000,000 | 10,000,000 | 718,845,109 | 7,188,451 | Exercise of employee stock options $100,000 | None | |
| January 2022 | USD 0.33~1.25 | 1,000,000,000 | 10,000,000 | 719,368,681 | 7,193,687 | Exercise of employee stock options $5,236,000 | None |
| Year and month | Issue price (NTD) | Authorized Share Capital | Paid-in capital | Note | ||||
|---|---|---|---|---|---|---|---|---|
| Number of shares (Stock) | Amount (1,000 dollars) | Number of shares (Stock) | Amount (1,000 dollars) | Source of equity capital (1,000 dollars) | Offset by property other than cash | Others | ||
| February 2022 | USD 0.33~2.0575 | 1,000,000,000 | 10,000,000 | 719,641,681 | 7,196,417 | Exercise of employee stock options $2,730,000 | None | |
| March 2022 | USD 0.33~3.30 | 1,000,000,000 | 10,000,000 | 720,047,945 | 7,200,480 | Exercise of employee stock options $4,063,000 | None | |
| April 2022 | USD 0.47~2.0575 | 1,000,000,000 | 10,000,000 | 720,944,893 | 7,209,449 | Exercise of employee stock options $8,969,000 | None | |
| June 2022 | USD 0.33~2.0575 | 1,000,000,000 | 10,000,000 | 721,037,823 | 7,210,378 | Exercise of employee stock options $929,000 | None | |
| June 2022 | 84.57 | 1,000,000,000 | 10,000,000 | 741,037,823 | 7,410,378 | Cash capital increase of $200,000,000 | None | (Note 6) |
| July 2022 | USD 0.33~1.5 | 1,000,000,000 | 10,000,000 | 741,451,866 | 7,414,519 | Exercise of employee stock options $4,141,000 | None | |
| August 2022 | USD 0.33~1.68 | 1,000,000,000 | 10,000,000 | 741,604,297 | 7,416,043 | Exercise of employee stock options $1,524,000 | None | |
| September 2022 | USD 0.47~3.3 | 1,000,000,000 | 10,000,000 | 741,746,313 | 7,417,463 | Exercise of employee stock options $1,420,000 | None | |
| October 2022 | USD 1.68~2.0575 | 1,000,000,000 | 10,000,000 | 741,804,313 | 7,418,043 | Exercise of employee stock options $580,000 | None | |
| November 2022 | USD 0.33~0.47 | 1,000,000,000 | 10,000,000 | 741,967,691 | 7,419,677 | Exercise of employee stock options $1,634,000 | None | |
| December 2022 | USD 0.33~1.68 | 1,000,000,000 | 10,000,000 | 742,048,378 | 7,420,484 | Exercise of employee stock options $807,000 | None | |
| January 2023 | USD 0.47 | 1,000,000,000 | 10,000,000 | 742,050,378 | 7,420,504 | Exercise of employee stock options $20,000 | None | |
| February 2023 | USD 0.33~2.0575 | 1,000,000,000 | 10,000,000 | 742,206,378 | 7,422,064 | Exercise of employee stock options $1,560,000 | None | |
| March 2023 | USD 0.33~2.0575 | 1,000,000,000 | 10,000,000 | 742,897,253 | 7,428,973 | Exercise of employee stock options $6,909,000 | None | |
| April 2023 | USD 0.33~2.0575 | 1,000,000,000 | 10,000,000 | 743,000,460 | 7,430,005 | Exercise of employee stock options $1,032,000 | None | |
| June 2023 | USD 0.33~2.0575 | 1,000,000,000 | 10,000,000 | 743,076,606 | 7,430,766 | Exercise of employee stock options $761,000 | None |
| Year and month | Issue price (NTD) | Authorized Share Capital | Paid-in capital | Note | ||||
|---|---|---|---|---|---|---|---|---|
| Number of shares (Stock) | Amount (1,000 dollars) | Number of shares (Stock) | Amount (1,000 dollars) | Source of equity capital (1,000 dollars) | Offset by property other than cash | Others | ||
| July 2023 | USD 0.33~2.4 | 1,000,000,000 | 10,000,000 | 743,423,606 | 7,434,236 | Exercise of employee stock options $347,000 | None | |
| August 2023 | USD 0.33~0.47 | 1,000,000,000 | 10,000,000 | 743,425,064 | 7,434,251 | Exercise of employee stock options $15,000 | None | |
| September 2023 | USD 0.47~1.5 | 1,000,000,000 | 10,000,000 | 743,463,314 | 7,434,633 | Exercise of employee stock options $383,000 | None | |
| October 2023 | USD 0.33~0.47 | 1,000,000,000 | 10,000,000 | 743,745,936 | 7,437,460 | Exercise of employee stock options $2,826,000 | None | |
| November 2023 | USD 0.33~2.4 | 1,000,000,000 | 10,000,000 | 743,759,153 | 7,437,592 | Exercise of employee stock options $132,000 | None | |
| January 2024 | USD 0.47~1.68 | 1,000,000,000 | 10,000,000 | 743,859,153 | 7,438,592 | Exercise of employee stock options $1,000,000 | None | |
| February 2024 | USD 0.33~1.68 | 1,000,000,000 | 10,000,000 | 744,324,732 | 7,443,247 | Exercise of employee stock options $4,656,000 | None | |
| March 2024 | USD 0.47 | 1,000,000,000 | 10,000,000 | 744,420,732 | 7,444,207 | Exercise of employee stock options $960,000 | None | |
| May 2024 | USD 0.33~1.68 | 1,000,000,000 | 10,000,000 | 745,142,092 | 7,451,421 | Exercise of employee stock options $7,214,000 | None | |
| June 2024 | USD 0.35~1.68 | 1,000,000,000 | 10,000,000 | 745,677,829 | 7,456,778 | Exercise of employee stock options $5,357,000 | None | |
| July 2024 | USD 0.33~2.0575 | 1,000,000,000 | 10,000,000 | 746,100,479 | 7,461,004 | Exercise of employee stock options $4,226,000 | None | |
| August 2024 | USD 0.47 | 1,000,000,000 | 10,000,000 | 746,132,479 | 7,461,325 | Exercise of employee stock options $320,000 | None | |
| September 2024 | USD 0.33~1.68 | 1,000,000,000 | 10,000,000 | 746,195,438 | 7,461,954 | Exercise of employee stock options $1,824,000 | None |
| Year and month | Issue price (NTD) | Authorized Share Capital | Paid-in capital | Note | ||||
|---|---|---|---|---|---|---|---|---|
| Number of shares (Stock) | Amount (1,000 dollars) | Number of shares (Stock) | Amount (1,000 dollars) | Source of equity capital (1,000 dollars) | Offset by property other than cash | Others | ||
| October 2024 | USD 0.47 | 1,000,000,000 | 10,000,000 | 746,206,272 | 7,462,063 | Exercise of employee stock options $158,000 | None | |
| December 2024 | NTD 10 | 1,000,000,000 | 10,000,000 | 770,206,272 | 7,702,063 | Cash capital increase $240,000,000 | None | (Note 6) |
| December 2024 | USD 0.47 | 1,000,000,000 | 10,000,000 | 770,251,272 | 7,702,513 | Exercise of employee stock options $694,000 | None | |
| January 2025 | USD 0.47~ 1.68 | 1,000,000,000 | 10,000,000 | 770,287,272 | 7,702,873 | Exercise of employee stock options $794,000 | None | |
| February 2025 | USD 0.47 | 1,000,000,000 | 10,000,000 | 770,320,272 | 7,703,203 | Exercise of employee stock options $509,000 | None | |
| March 2025 | USD 0.33~ 0.47 | 1,000,000,000 | 10,000,000 | 770,433,022 | 7,704,330 | Exercise of employee stock options $1,395,000 | None |
Note 1: Convertible preferred shares were issued in February 2012 at a total price of USD 30,000,000 and fully converted to common shares in June 2015.
Note 2: Cash capital increase approval date: June 6, 2017; Approval No. 1060021095.
Note 3: Approval date of cash capital increase: August 3, 2018; Approval No. 1070327709.
Note 4: Approval date of cash capital increase: May 7, 2019; Approval No. 1080313697.
Note 5: Approval date of cash capital increase: June 15, 2021; Approval No. 1100346636.
Note 6: Approval date of cash capital increase: April 18, 2022; Approval No. 1111701116.
Shareholding information as of March 23, 2025
| Type of shares | Authorized share capital (Shares) | Note | ||
|---|---|---|---|---|
| Outstanding | Unissued | Total | ||
| Registered Common Shares | 770,251,272 | |||
| (Including private placement of 307,065,000) | 229,748,728 | 1,000,000,000 |
(II) List of Major Shareholders
The names, amounts and percentages of the top ten shareholders with at least 5% or more of the shares are listed below.
Shareholding information as of March 23, 2025
| Shares
List of major shareholders name | Number of shares held
(Shares) | Shareholding % |
| --- | --- | --- |
| Digital Capital Inc. | 290,000,000 | 37.65 |
| Digital Mobile Venture Ltd. | 61,729,295 | 8.01 |
| Mai Investment Co., Ltd. | 40,527,138 | 5.26 |
| G-Technology Investment Co., Ltd. | 26,467,465 | 3.44 |
| Cathay United Bank entrusted with the custody of the investment account of Lineage Tech Co., Ltd. | 14,800,669 | 1.92 |
| Chen, Yi-Chun | 10,739,761 | 1.39 |
| Chen, Yi-Ting | 10,633,094 | 1.38 |
| Masterpiece Enterprise Co., Ltd. | 10,000,000 | 1.30 |
| Capital World Investment Corporation | 8,414,456 | 1.09 |
| Gemtek Technology Co., Ltd. | 7,784,542 | 1.01 |
(III) Dividend Policy and Implementation Status
- Dividend policy as stated in the Company's Articles of Incorporation
The Company shall set aside at least 1% of the Company's annual profit as employee bonus and not more than 3% of the Company's annual profit as director compensation, provided that the Company shall reserve the amount of compensation in advance if there is an accumulated deficit.
Employee bonuses may be paid in cash or in stock to employees of the Company's subsidiaries who meet certain criteria established by the Board of Directors of Directors.
The Company may distribute earnings in accordance with a plan of distribution prepared by the Board of Directors of Directors and approved by the shareholders by ordinary resolution. The Board of Directors of Directors shall distribute or appropriate in the following order: (i) final tax contributions; (ii) to cover losses; (iii) a further 10% of the statutory surplus reserve; Except when the legal surplus reserve has reached the total capital of the Company; (iv) The Company may set aside special surplus reserves as required by the listing Act or the competent authority.
Subject to the aforesaid, the Board of Directors may distribute any remaining profits for the relevant financial year plus all accumulative and undistributed profits from previous years ("Distributable Profit") in the following manner upon approval by the Shareholders. The Company's business belongs to a capital intensive industry and is in a growing stage. As the Company may have capital requirements for further capital expenditures in the next few years, when making the proposal of dividends distribution, the Board of Directors may take into consideration financial, business and operational factors for proposing a dividend/bonus distribution plan in accordance with the Law and the Applicable Listing Rules. The total amount of dividends to be paid to shareholders shall not be less than 10% of the current year's distributable earnings, and the percentage of cash dividends to be distributed shall not be less than 10% of the current year's total dividends to shareholders.
- Proposed Dividend Distribution at the Shareholders' Meeting
The Company will not distribute dividends this year due to negative retained surplus on the books.
(IV) Impact of the proposed stock dividend on the Company's operating results and earnings per share: There was no stock dividend distribution for the year.
71
(V) Compensation for Employee, Director and Supervisor
- The percentage or scope of compensation for employees, directors and supervisors as stated in the Company's Articles of Incorporation
The Company shall set aside at least 1% of the Company's annual profit as employee bonus and not more than 3% of the Company's annual profit as director compensation, provided that the Company shall reserve the amount of compensation in advance if there is an accumulated deficit. Employee bonuses may be paid in cash or in stock to employees of the Company's subsidiaries who meet certain criteria established by the Board of Directors of Directors.
The Company may distribute earnings in accordance with a plan of distribution prepared by the Board of Directors of Directors and approved by the shareholders by ordinary resolution. The Board of Directors of Directors shall distribute or appropriate in the following order: (i) final tax contributions; (ii) to cover losses; (iii) a further 10% of the statutory surplus reserve; Except when the legal surplus reserve has reached the total capital of the Company; (iv) The Company may set aside special surplus reserves as required by the listing Act or the competent authority.
Subject to the aforesaid, the Board of Directors may distribute any remaining profits for the relevant financial year plus all accumulative and undistributed profits from previous years ("Distributable Profit") in the following manner upon approval by the Shareholders. The Company's business belongs to a capital intensive industry and is in a growing stage. As the Company may have capital requirements for further capital expenditures in the next few years, when making the proposal of dividends distribution, the Board of Directors may take into consideration financial, business and operational factors for proposing a dividend/bonus distribution plan in accordance with the Law and the Applicable Listing Rules. The total amount of dividends to be paid to shareholders shall not be less than 10% of the current year's distributable earnings, and the percentage of cash dividends to be distributed shall not be less than 10% of the current year's total dividends to shareholders.
- The basis for estimating the amount of compensation for employees, directors and supervisors, the basis for calculating the number of shares for employee compensation distributed by stock, and the accounting treatment if the actual amount of distribution differs from the estimated amount.
The Company has accumulated losses in the accounts for the year 2024, which have not been assessed or distributed for the compensation of employees, directors and supervisors.
72
- The Board of Directors of Directors approved the distribution of compensation:
(1) The amount of compensation to employees, directors and supervisors is distributed in cash or stock. If the amount of compensation is different from the amount estimated in the year in which the expense is recognized, the amount of the difference, the reason for the difference and the treatment of the difference should be disclosed: Not applicable.
(2) The proportion of employee compensation distributed in stock to the total amount of net profit after tax and employee compensation for the period: not applicable.
- The Shareholders' Meeting reported the distribution of compensation and the results:
The Company still has losses accumulated in its books for fiscal year 2024, so it is not applicable.
- The actual distribution of compensation to employees, directors and supervisors in the previous year (including the number of shares distributed, the amount and share price), the difference between the distribution and the recognition of compensation to employees, directors and supervisors, and the number of differences, the reasons for the differences and the treatment of the differences: Not applicable.
(VI) The Company's repurchase of The Company's shares: The Company has not repurchased shares of the Company in the most recent year and as at the date of publication of the Annual Report.
II. Corporate Bonds
(I) Outstanding bonds in process: None.
(II) Convertible bonds: None.
III. Preferred Share: None.
IV. Overseas Depositary Receipts: None.
73
V. Employee Stock Options
(I) Stock options that have not yet expired
March 23, 2025
| Type of Employee Stock Option Certificate | Polaris Group 2011Annual Stock Option Plan | Polaris Group 2011Annual Stock Option Plan | Polaris Group 2011Annual Stock Option Plan | Polaris Group 2011Annual Stock Option Plan |
|---|---|---|---|---|
| Declaration Effective Date | Not applicable. | Not applicable. | Not applicable. | Not applicable. |
| Issue Date | April 15, 2015 | July 7, 2015 | October 30, 2015 | November 17, 2015 |
| Period of Existence | 10 years | |||
| Number of units issued (1 share / 1 unit) | 519,999 (Among them, 399,999 shares have expired) | 128,000 (Among them, 128,000 shares have expired) | 312,000 (Among them, 312,000 shares have expired) | 3,128,000 (Among them, 1,994,750 shares have expired) |
| Number of units can be issued | — | — | — | — |
| Number of shares issued as a percentage of the total number of shares issued | 0.07% | 0.02% | 0.04% | 0.41% |
| Subscription period | 9 years | |||
| Performance method | Issuance of new shares | |||
| Restricted period and ratio (%) | 25% for 1 year and the remaining 75% for the next 36 months, 1/36th per month | |||
| Number of shares exercised | — | — | — | 64,829 |
| Executed subscription amount | — | — | — | USD213,936 |
| Number of shares not executed | 120,000 | — | — | 1,118,421 |
| Subscription price per share for unexecuted stock options | USD2.5 | USD2.5 | USD2.5 | USD3.3 |
| Number of shares outstanding as a percentage of the total number of shares issued (%) | 0.02% | 0.00% | 0.00% | 0.15% |
| Effect on shareholders' equity | No significant impact. | No significant impact. | No significant impact. | No significant impact. |
74
March 23, 2025
| Type of Employee Stock Option Certificate | The First Employee Stock Option Certificate in 2017 | The First Employee Stock Option Certificate in 2017 | The First Employee Stock Option Certificate in 2019 | The Second Employee Stock Option Certificate in 2019 | The First Employee Stock Option Certificate in 2021 | The Second Employee Stock Option Certificate in 2021 |
|---|---|---|---|---|---|---|
| Declaration Effective Date | December 04, 2017 | December 04, 2017 | November 19, 2019 | November 19, 2019 | May 14, 2021 | May 14, 2021 |
| Issue Date | January 03, 2018 | May 31, 2018 | November 20, 2019 | April 01, 2020 | June 24, 2021 | December 13, 2021 |
| Period of Existence | 10 years | |||||
| Number of units issued (1 share / 1 unit) | 6,111,000 (Among them, 3,690,450 shares have expired) | 210,000 (Among them, 60,000 shares have expired) | 1,788,000 | 4,697,000 (Among them, 718,147 shares have expired) | 818,000 (Among them, 93,833 shares have expired) | 640,000 (Among them, 120,000 shares have expired) |
| Number of units can be issued | - | - | - | - | - | - |
| Number of shares issued as a percentage of the total number of shares issued | 0.79% | 0.03% | 0.24% | 0.61% | 0.11% | 0.08% |
| Subscription period | 8 years | |||||
| Performance method | Issuance of new shares | |||||
| Restricted period and ratio (%) | 50% for 2 years and the remaining 50% for the next 48 months, 1/48th per month | |||||
| Number of shares exercised | 1,112,550 | 10,000 | 1,760,500 | 3,277,040 | 21,167 | - |
| Executed subscription amount | USD1,869,084 | USD16,800 | USD580,965 | USD1,540,209 | USD50,589 | - |
| Number of shares not executed | 1,308,000 | 140,000 | 27,500 | 701,813 | 703,000 | 520,000 |
| Subscription price per share for unexecuted stock options | NTD 50.87 | NTD 51.02 | NTD 10.05 | NTD 14.26 | NTD 67.27 | NTD 71.26 |
| Number of shares outstanding as a percentage of the total number of shares issued (%) | 0.17% | 0.02% | 0.00% | 0.09% | 0.09% | 0.07% |
| Effect on shareholders' equity | No significant impact. | No significant impact. | No significant impact. | No significant impact. | No significant impact. | No significant impact. |
March 23, 2025
| Type of Employee Stock Option Certificate | The Third Employee Stock Option Certificate in 2021 | The First Employee Stock Option Certificate in 2022 | The Second Employee Stock Option Certificate in 2022 | The Third Employee Stock Option Certificate in 2022 |
|---|---|---|---|---|
| Declaration Effective Date | May 14, 2021 | December 06, 2022 | December 06, 2022 | December 06, 2022 |
| Issue Date | May 10, 2022 | December 14, 2022 | June 20, 2023 | December 21, 2023 |
| Period of Existence | 10 years | |||
| Number of units issued (1 share / 1 unit) | 570,000 (Expired 120,000 shares) | 7,262,500 (Expired 1,250,000 shares) | 1,450,000 (Expired 250,000 shares) | 2,820,000 (Expired 365,000 shares) |
| Number of units can be issued | - | 4,467,500 | ||
| Number of shares issued as a percentage of the total number of shares issued | 0.07% | 0.94% | 0.19% | 0.37% |
| Subscription period | 8 | |||
| Performance method | Issuance of new shares |
| Restricted period and ratio (%) | 50% for 2 years and the remaining 50% for the next 48 months, 1/48th per month | |||
|---|---|---|---|---|
| Number of shares exercised | — | — | — | — |
| Executed subscription amount | — | — | — | — |
| Number of shares not executed | 450,000 | 6,012,500 | 1,200,000 | 2,455,000 |
| Subscription price per share for unexecuted stock options | NTD 123.71 | NTD 101.50 | NTD 83.9 | NTD 70.70 |
| Number of shares outstanding as a percentage of the total number of shares issued (%) | 0.06% | 0.78% | 0.16% | 0.32% |
| Effect on shareholders' equity | No significant impact. | No significant impact. | No significant impact. | No significant impact. |
| Type of Employee Stock Option Certificate | The Fourth Employee Stock Option Certificate in 2022 | The Fifth Employee Stock Option Certificate in 2022 | ||
| --- | --- | --- | ||
| Declaration Effective Date | December 06, 2022 | December 06, 2022 | ||
| Issue Date | July 01, 2024 | November 14, 2024 | ||
| Period of Existence | 10 years | |||
| Number of units issued (1 share / 1 unit) | 2,570,000 (Expired 0 shares) | 1,880,000 (Expired 0 shares) | ||
| Number of units can be issued | 0 | |||
| Number of shares issued as a percentage of the total number of shares issued | 0.33% | 0.24% | ||
| Subscription period | 8 years | |||
| Performance method | Issuance of new shares | |||
| Restricted period and ratio (%) | 50% for 2 years and the remaining 50% for the next 48 months, 1/48th per month | |||
| Number of shares exercised | — | — | ||
| Executed subscription amount | — | — | ||
| Number of shares not executed | 2,100,000 | 1,880,000 | ||
| Subscription price per share for unexecuted stock options | NTD 75.10 | NTD 51.20 | ||
| Number of shares outstanding as a percentage of the total number of shares issued (%) | 0.27% | 0.24% | ||
| Effect on shareholders' equity | No significant impact. | No significant impact. |
Note: TDW Group, a subsidiary of The Company, originally had the 2013 Annual Stock Option Plan, which was originally subject to the common shares issued by TDW Group. In September 2015, the company acquired the outstanding shares other than TDW Group shares held by the Board of Directors of Directors through equity exchange. As a result, TDW Group, through a Director's resolution, adjusted the performance of its 2013 Annual Stock Option Plan by converting one share of TDW Group common stock into 1.13 shares of The Company common stock at the same proportional exercise price. The exercise price will be adjusted in the same proportion.
(II) Name, Acquisition and Subscription of the Top Ten Employees Who Have Acquired Employee Stock Options and the Number of Shares Authorized by the Stock Options as of the Publication Date of the Annual Report
- Managers who obtained employee stock options
March 23, 2025
| Title | Name | Number of share subscribed (1,000 shares) | Ratio of the number of subscribed shares to the total number of issued shares | Executed | Not Executed | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of share subscribed (1,000 shares) | Subscription price | Subscription amount (1,000 dollars) | The ratio of the number of shares recognized to the total number of issued shares | Number of share subscribed (1,000 shares) | Subscription price | Subscription amount (1,000 dollars) | The ratio of the number of shares recognized to the total number of issued shares | |||||
| Manager | CEO | Hsu, Jaen-Pyng | 3,683 | 0.48% | 1,120 | USD0.33–1.5 | USD606 | 0.15% | 1,900 | USD0.33–3.32 | USD4,510 | 0.25% |
| Executive Vice President | John Bomalaski | |||||||||||
| COO (Note 1) | You, Huei-Yuan | |||||||||||
| Chief Financial Officer | Yan, Feng-Kai | |||||||||||
| CSO | Chien-Hsing Chang | |||||||||||
| CISO | Kevin Wu |
Note 1: The Company canceled the position of COO on July 23, 2024, and Mr. You, Huei-Yuan stepped down.
- Obtaining stock warrant certificates can be recognized as the top ten employees of number of shares
March 23, 2025
| Title | Name | Number of share subscribed (1,000 shares) | Ratio of the number of subscribed shares to the total number of issued shares | Executed | Not Executed | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of share subscribed (1,000 shares) | Subscription price | Subscription amount (1,000 dollars) | The ratio of the number of shares recognized to the total number of issued shares | Number of share subscribed (1,000 shares) | Subscription price | Subscription amount (1,000 dollars) | The ratio of the number of shares recognized to the total number of issued shares | |||||
| Employee | Science Consultant (PPI) (PPI) | Chen, Tsao-Chen | 6,222 | 0.81% | 3,018 | USD 0.33–3.30 | USD2,027 | 0.39% | 1,864 | USD 0.33–3.32 | USD4,826 | 0.24% |
| Vice president of Clinical Division (PPI) (PPI) | Amanda Johnston | |||||||||||
| Vice president of Production Division (DRX USA) (DRX USA) | Chris Huxsoll | |||||||||||
| Consultant of Production Department (DRX USA) (DRX USA) | Liang Xia | |||||||||||
| Vice President of Finance (DRX USA) (DRX USA) | Bishoram Guragai | |||||||||||
| Director of Clinical Department (TDW TW) (TDW TW) | Liu, Hui-Fen | |||||||||||
| Senior Clinical Project Manager/Clinical Statistics | Kao, Chi-Ling | |||||||||||
| Manager of Production Department (DRX USA) (DRX USA) | Christopher Starr | |||||||||||
| Senior Clinical Project Manager | Huang Yulun | |||||||||||
| Accounting Manager | Hsu, Shu-Yen |
VI. New Shares with Restricted Employee Rights:
(I) For new shares with restricted employee rights that have not fully met the acquired conditions, the transaction status as of the date of publication of the annual report and the impact on shareholders' rights and interests shall be disclosed: None.
(II) The managers who have obtained new shares with restricted employee rights and the names of the top ten employees who have obtained number of shares until the date of publication of the annual report: None.
VII. Issuance of New Shares through Merger, Acquisition or Transfer of Shares of Other Companies: None.
VIII. Implementation of the Fund Utilization Plan:
As of the quarter before the publication date of the annual report, the plan content and execution status of the previous issuance or private placement of securities that have not been completed or have been completed within the last three years and the plan benefits have not yet materialized:
The Company’s previous plans for fundraising and issuance of securities have all been completed and executed in accordance with the intended use of proceeds, with no instances of execution progress falling short of the original targets.
Exceptions are as follows: the cash capital increase through the issuance of common shares for participation in an overseas depository receipt program, which had been approved by the Financial Supervisory Commission (FSC) under Letter No. 1120347292 dated July 11, 2023, but was subsequently terminated upon the Company’s application due to greater-than-expected stock price volatility, and formally revoked by the FSC under Letter No. 1120362241 dated November 16, 2023; and the cash capital increase through the issuance of common shares for fiscal year 2024, approved by the FSC on October 17, 2024, which remains within its execution period.
An assessment of the execution status of the 2024 cash capital increase plan is provided as follows:
(I) Approval Date and Reference Number by the Competent Authority: Approved by the Financial Supervisory Commission (FSC) under Letter No. 1130358020 dated October 17, 2024.
(II) Total Amount of Funds Required for This Plan: NT$2,053,762 thousand.
(III) Source of Funds:
-
Issuance of 24,000 thousand new common shares through cash capital increase, with a par value of NT$10 per share and an issue price of NT$49 per share, raising a total amount of NT$1,176,000 thousand.
-
Of the funds required for this plan, NT$853,762 thousand will be financed through the Company’s own funds and bank loans.
78
(IV) Project Items and Estimated Schedule of Funds Utilization :
Unit: NT$ thousand
| Project Items | Required Funds | Source of Funds | Planned Schedule of Funds Utilization | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 2024 Q1–Q3 | 2024 年 第 4 季 | 2025 | |||||||
| Q1 | Q2 | Q3 | Q4 | ||||||
| Expansion of the Zhunan New Plant (Note 1) | 300,000 | This Offering | - | 30,000 | 50,000 | 80,000 | 100,000 | 40,000 | |
| Acquisition of Equipment (Notes 1 and 2) | Zhunan New Plant | 440,000 | This Offering | - | 110,000 | 120,000 | 70,000 | 30,000 | 110,000 |
| Chengdu Plant | 303,180 | - | 45,180 | 64,500 | 64,500 | 64,500 | 64,500 | ||
| Subtotal | 743,180 | - | 155,180 | 184,500 | 134,500 | 94,500 | 174,500 | ||
| Zhunan New Plant | 460,447 | Own Funds and Bank Loans | 352,822 | 107,625 | - | - | - | - | |
| Chengdu Plant | 393,315 | 375,366 | 17,949 | - | - | - | - | ||
| Subtotal | 853,762 | 728,188 | 125,574 | - | - | - | - | ||
| Reinforcement of Operating Capital | 132,820 | This Offering | - | 132,820 | - | - | - | - | |
| Total | 2,029,762 | 728,188 | 443,574 | 234,500 | 214,500 | 194,500 | 214,500 | ||
| Overview of Expected Benefits | (1) Plant Expansion and Equipment Acquisition In view of the growth potential of peptide products, the Company plans to expand its Zhunan New Plant by constructing additional facilities, including an injectable production line and a GLP-1 peptide active pharmaceutical ingredient (API) production line. In addition, the Company intends to expand the Chengdu Plant in Mainland China with the addition of a GLP-1 peptide API production line. Production and sales of peptide drugs at both the Zhunan New Plant and the Chengdu Plant are expected to begin generating operating profit in 2027, with operating income projected to grow year by year thereafter. The payback period is estimated to be approximately four years. (2) Reinforcement of Working Capital Under this fundraising plan, the Company intends to allocate NT$132,820 thousand to strengthen the working capital of its subsidiaries in Taiwan and the United States. The Group’s oncology drug ADI-PEG 20 has been submitted to the U.S. FDA for Biologics License Application (BLA) review. In addition, the subsidiary LinkYan Biotech is developing multiple difficult-to-replicate peptide drugs, and the Group’s CDMO business continues to expand. Accordingly, the Company will inject funds to support the ongoing development and daily operating needs of its subsidiaries in Taiwan and the U.S. Based on the Company’s current average bank borrowing rate of approximately 2.5%, it is estimated that NT$277 thousand in interest expense will be saved in 2024, and NT$3,321 thousand will be saved annually thereafter. | ||||||||
| --- | --- |
Note 1: Location of Zhunan Plant Expansion: No. 27, Kexue Road, Zhunan Township, Miaoli County (Zhunan New Plant of subsidiary LinkYan Biotech).
Note 2: Planned Locations for Equipment Installation: Zhunan Plant of subsidiary LinkYan Biotech (No. 27, Kexue Road, Zhunan Township, Miaoli County) and Chengdu Plant of subsidiary DRX.
(V) Implementation Status :
Unit: NT$ thousands; %
| Project Item | Implementation Status | Q1 2025 | Cumulative up to Q1 2025 | Reasons for Ahead/Behind Schedule and Improvement Plan | ||
|---|---|---|---|---|---|---|
| Expansion of Zhunan New Plant | Amount Utilized | Planned | 50,000 | Planned | 80,000 | As the Hsinchu Science Park Administration only approved the issuance of the building permit in January 2025, the Company subsequently entered into a construction contract with the contractor in February 2025 for the Phase II plant project in the Zhunan Park. As a result, the schedule was deferred, with groundbreaking expected in April 2025. |
| Actual | - | Actual | - | |||
| Implementation Progress (%) | Planned | 100.00% | Planned | 26.67% | ||
| Actual | 0% | Actual | 0% | |||
| Acquisition of Equipment - Zhunan New Plant | Amount Utilized | Planned | 120,000 | Planned | 230,000 | As prior approval of the investment application from the Science Park Administration was required, the Company obtained the approval letter in January 2025. Accordingly, the capital injection into Lin-Yang Biotech was completed in January 2025, after which the related equipment and construction payments were made. As a result, the acquisition schedule was deferred; however, following the capital injection, the Lin-Yang plant commenced payment for the relevant equipment in accordance with the plan. |
| Actual | 134,786 | Actual | 134,786 | |||
| Implementation Progress (%) | Planned | 100.00% | Planned | 52.27% | ||
| Actual | 112.32% | Actual | 30.63% | |||
| Acquisition of Equipment - Chengdu Plant | Amount Utilized | Planned | 64,500 | Planned | 109,680 | As the Company completed the funding process only by the end of February 2025 in coordination with the bank's internal procedures, the equipment acquisition schedule and the utilization of funds were slightly deferred. Nevertheless, following the fund availability, the Chengdu plant commenced payment for the relevant equipment in accordance with the plan. |
| Actual | 22,434 | Actual | 59,646 | |||
| Implementation Progress (%) | Planned | 100.00% | Planned | 36.18% | ||
| Actual | 34.78% | Actual | 19.67% | |||
| Reinforcement of Working Capital | Amount Utilized | Planned | - | Planned | 132,820 | Execution has been completed in accordance with the planned schedule. |
| Actual | - | Actual | 132,820 | |||
| Implementation Progress (%) | Planned | - | Planned | 100.00% | ||
| Actual | - | Actual | 100.00% | |||
| Total | Amount Utilized | Planned | 234,500 | Planned | 552,000 | |
| Actual | 157,220 | Actual | 327,252 | |||
| Implementation Progress (%) | Planned | 100.00% | Planned | 46.98% | ||
| Actual | 67.04% | Actual | 27.83% |
Overall, the expansion of the Zhunan new plant and the equipment acquisition projects for the Zhunan and Chengdu plants financed by this cash capital increase are still being carried out in accordance with the planned fund utilization schedule. As the facilities have not yet officially commenced production, the benefits have not yet materialized. However, once the production equipment enters the mass production stage, increases in production capacity, operating revenue, and operating profit are expected to gradually emerge. In addition, the working capital reinforcement project was completed in the fourth quarter of 2024. Based on the Company's current average bank loan interest rate of approximately $2.5\%$ , interest expenses are expected to be reduced by NT$327 thousand in 2025 and by NT$3,921 thousand in each subsequent year. Accordingly, the projected benefits and the actual results achieved are considered reasonable. Furthermore, from the perspective of the Company's capital structure and debt-servicing capacity, the debt ratio decreased from $25.67\%$ prior to the capital raising to $25.52\%$ after the capital raising. Meanwhile, the ratio of long-term capital to property, plant and equipment, the current ratio, and the quick ratio improved from $269.56\%$ , $132.32\%$ , and $124.01\%$ to $316.29\%$ , $709.15\%$ , and $676.31\%$ , respectively. This demonstrates that the Company has secured long-term stable funding and that its financial structure and debt-servicing capacity have been enhanced. Net asset value per share also increased from NT$8.14 in the third quarter of 2024 to NT$8.69 in the fourth quarter of 2024, indicating that the results of this capital increase have been favorable.
Unit: NT$ thousands
| Financial Structure | Period | Q3 2024 (Before Capital Increase) | Q4 2024 (After Capital Increase) | |
|---|---|---|---|---|
| Basic Financial Information | Current Assets | 2,818,605 | 3,325,148 | |
| Total Assets | 8,296,880 | 9,090,440 | ||
| Current Liabilities | 422,858 | 468,894 | ||
| Total Liabilities | 2,130,094 | 2,319,845 | ||
| Net Asset Value per Share (NT$) | 8.14 | 8.69 | ||
| Financial Structure | Debt Ratio (%) | 25.67 | 25.52 | |
| Long-Term Capital to Property, Plant and Equipment Ratio (%) | 269.56 | 316.29 | ||
| Solvency | Current Ratio (%) | 132.32 | 709.15 | |
| Quick Ratio (%) | 124.01 | 676.31 |
V. Operation Overview
I. Business Contents
(I) Scope of Business:
- Main Content of the Business
Polaris Pharmaceutical Group is a fully vertically integrated biological new drug development company, and provides contract development and manufacturing organization (CDMO) services for biological drugs. Through the upstream and downstream division of labor, the group integrates the design and improvement of ADI-PEG20 new drug development, the planning and execution of clinical trials in many countries around the world, the production of ADI-PEG20 clinical trial drugs, the active pharmaceutical ingredients of polypeptide drugs, generic drug development, and CDMO business, quality control, sales and other all-round service projects.
- Proportion of Sales of Major Products
The Group's operating income in the year 2024 was NTD107,000,000, which was derived from the CDMO business of biopharmaceuticals; ADI-PEG20 products are still in the research and development stage and have no operating income yet.
- The Company's current goods (services) projects
| Product | Introduction | Application |
|---|---|---|
| ADI-PEG20 new drug research and development | ADI-PEG 20 is an innovative biological drug produced by coupling arginine deiminase and polyethylene glycol with a molecular weight of 20,000 . After intramuscular injection into the human body, it can completely decompose arginine in the blood circulation. Ultimately, any cancer cells that are unable to synthesize arginine on their own due to a metabolic defect die. It has now entered clinical trials for a variety of cancers around the world. | Hepatic cell carcinoma, mesothelioma, soft tissue sarcoma, acute myeloid leukemia, non-small cell lung cancer, pancreatic cancer, malignant melanoma and brain cancer, etc. |
| CDMO Drug development and production services | Utilizing the Group's sophisticated technology in the production of Escherichia coli and an experienced R&D team, we can provide customers with biological drug development, manufacturing, clinical trials or marketing applications, covering all stages. If there are problems with specific technologies, international standards or regulations, Provide overall project solutions. In addition, Genovior Biotech, a subsidiary of the Group, has the ability to complete product development, production, quality control and regulatory documentation from APIs to sterile preparations, focusing on the one-stop CDMO service model for HPAPIs, peptides, macromolecular APIs and injections. It can provide global customers with convenient, practical and effective pharmaceutical finished products solutions. | A variety of biological drugs, cell therapy, APIs, injections, etc. |
| Multiple peptide drugs Generic drug development | Genovior Biotech, a subsidiary of the Group, is the only company in Taiwan capable of producing polypeptide APIs with more than 30 amino acids through a fully synthetic or microbial process, and can produce polypeptide injections using a combination of API production, aseptic filling of cassette bottles, and medical devices (such as injection pen). At the same time, we focus on the research and development of generic drugs, APIs and injection products, and have obtained more than 20 drug certificates. | Raw materials, biosimilar drugs, peptide drugs, etc. |
- New products (services) planned to be developed
ADI-PEG 20
ADI-PEG 20 is a broad-spectrum innovative biological drug. Due to its different mechanism of action, good efficacy and mild side effects, it is also suitable for use in combination with other cancer drugs. Since 2013, the Group has initiated a series of clinical trials of combination drugs in top cancer hospitals in Europe and the United States. The clinical trials of ADI-PEG 20 combination drugs in progress are as follows:
| Cancer Type | Stage | Lead Cancer Center | Intervention/Treatment |
|---|---|---|---|
| Soft Tissue Sarcoma | Phase III | University of Washington | ADI-PEG 20 |
| + Gemcitabine | |||
| + Docetaxel | |||
| Cerebral cancer | Phase II/III | Linkou Chang Gung Memorial Hospital Taiwan/Global Coalition for adaptive Research | ADI-PEG 20 |
| + Temozolomide | |||
| + Radiotherapy | |||
| Hepatic cell Carcinoma | Phase II/III (Note) | Linkou Chang Gung Memorial Hospital, Taiwan | Monotherapy |
| Acute Myeloid Leukemia | Phase I | MD Anderson Cancer Center Houston, Texas, United States | ADI-PEG 20 |
| + Venetoclax | |||
| + Azacitidine | |||
| NASH | Phase II | Linkou Chang Gung Memorial Hospital, Taiwan | Monotherapy |
Note: Proof of Concept (POC)
(1) Soft Tissue Sarcoma
The Phase III clinical trial program received FDA approval for INA and completed its first patient admission for ADI-PEG 20 combined with Gemcitabine and Docetaxel for leiomyosarcoma. The trial was randomized and double-blind, with multiple countries and centers involving. The main evaluation index was Progression Free Survival and the secondary evaluation index was Overall Survival.
(2) Cerebral cancer
This clinical trial was conducted with ADI-PEG20 combined with radiotherapy and Temozolomide in the treatment of Glioblastoma, GBM. This case was originally a Phase I clinical trial, and after completing this stage, the evaluable subjects were enrolled. The Phase II clinical trial has been continued, with a change to a control placebo group, randomized allocation, and double-blind trial. It is expected that the scale of the trial will be expanded, and the number of cases collected globally will be 100. The main evaluation indicator was the Overall Survival, and the trial physician would observe the Progression-free survival. This experiment was led by Taiwan Linkou Chang Gung Memorial Hospital and collaborated with five renowned medical centers in Korea. Patient enrollment is expected to be completed by mid-2025.
At the same time, the Company joined GBM AGILE, a new clinical trial platform approved by the FDA, which allows simultaneous evaluation of multiple new drugs for cerebral cancer and sharing of patients in control group. And the platform has signed contracts with major international hospitals in order to quickly recruit patients. The Company aims to recruit 300 patients. In August 2023, the ADI-PEG 20 group being trialled on the GBM AGILE platform will enroll patients with newly diagnosed and relapsing GBM. Dr. Nicholas Blondin, assistant professor of clinical neurology at Yale School of Medicine, and Dr. Macarena de la Fuente, associate professor of neuro-oncology and director of neuro-oncology at the Sylvester Comprehensive Cancer Center, University of Miami, will serve as the lead trial program hosts for ADI-PEG 20.
(3) Hepatic cell Carcinoma
In order to accelerate the clinical trial, the Company changed the enrollment condition to screening by arginine concentration. Hepatic cell carcinoma was treated with ADI-PEG 20, the new metabolic therapy. The trial was randomized and double-blind, with multiple countries and centers involving. The main evaluation index was Progression Free Survival and the secondary evaluation index was Overall Survival. In addition to patient enrollment at seven medical centers in Taiwan, approval has been obtained from the Vietnam Ministry of Health (MOH) for the trial, and a memorandum of understanding has been signed with the Vietnam National Cancer Hospital, with patient enrollment expected to commence.
(4) Acute Myeloid Leukemia
This is a Phase 1 clinical trial of ADI-PEG 20 in combination with Venetoclax and Azacitidine in patients with acute myeloid leukemia, led by MD Anderson Cancer Center. In addition to evaluating the safety and tolerability of ADI-PEG 20 in combination with Venetoclax and Azacitidine, the efficacy of this combination in the RP2D (recommended phase 2 dose) arm will also be explored.
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Contract Development and Manufacturing Organization (CDMO)
In addition to the production of ADI-PEG 20, DRX USA, the Group's subsidiary in Northern California, also has a very mature technology that uses E. coli as a production platform. Since officially providing Drug Development and Production (CDMO) services in November 2019, we have received positive feedback. With the success of the Phase III clinical trial for mesothelioma, DRX USA is gradually transitioning to a commercial operation model and actively promoting related preparations, including three batch validation production, GMP inspection preparation, and drug license registration application to meet the regulatory requirements for drug market launch.
In addition, the Group established Subsidiary DRX Chengdu in Chengdu, originally as a support center for new product development and research for the Northern California plant. With the completion of phased tasks, the Company has been planning since the beginning of this year to upgrade DRX Chengdu from a research and development unit to a GMP-compliant production pharmaceutical plant. This is expected to bring stable revenue to the Group in the future.
Genovior Biotech, a subsidiary of the Group, is one of the few CDMO companies in Asia that can actually commercialize API and injection, and now uses its technology and capacity advantages to continuously provide global pharmaceutical customers with technical services such as advanced process development, scale-up, dosage form development and pharmaceutical finished product solutions. The following CDMO/CMO services are available:
- Process development of peptides or protein APIs produced by microbial fermentation or human cell processes
- Development of dosage forms for biological injections
- Provide biological APIs, lyophilized injection, preperfusion syringe and injection pen and other dosage forms. The number of manufacturing services ranges from preclinical and clinical research to commercial volume production.
Polypeptide Product Development and Process Optimization
The Company will strengthen research and innovation in the polypeptide product line at Genovior Biotech Corporation, with a special focus on the development of multiple polypeptide products and process optimization to improve production efficiency and product quality. The following are the Genovior Biotech's main plans for polypeptide product development and process optimization.
(1) Semaglutide
Semaglutide, a drug used to treat diabetes, is a hormone that is a receptor agonist for GLP-1 (glucagon-like peptide-1), an analogue of the insulin hormone that stimulates insulin production and lowers blood sugar levels. In addition, Semaglutide is also used for weight management in obesity, as it can promote appetite reduction and contribute to weight loss. In addition, Semaglutide is expected to continue to expand with the progress of clinical trials of the original company, including the treatment of renal failure in diabetes patients and other related indications. The Company is committed to further optimizing Semaglutide products, including the development of generic drug products from active pharmaceutical ingredients (APIs), injections, and oral formulations. Moreover, the Company also expanded the market size of its products through the development of Class505b2 new drugs to meet the needs of patients and improve therapeutic effectiveness.
The Semaglutide API 200kg production line is scheduled to be completed in 2025. In the aspect of commercial development, the Company is currently focusing on the expansion of the new market (emergingmarket). As the supply of Semaglutide products falls short of demand, the company also plans to cooperate with new market countries to enter major new market countries through joint venture, co-development or technology transfer, etc.
(2) Teriparatide
As a peptide substance used in the treatment of osteoporosis, Teriparatide has a significant effect on enhancing bone mineral density and reducing the risk of fracture. The company is committed to improving the production efficiency and quality of Teriparatide to ensure that patients have access to safe and effective treatments. In 2025, we will continue to develop Teriparatide preparations, drug inspection registration, and marketing planning.
(II) Industry Overview
- Current Status and Development of the Industry
(1) Cancer Medication
According to IQVIA's statistics, including COVID-19 vaccines and drugs, the global drug market size in 2023 is about 1.61 trillion US dollars, an increase of approximately 8.78% compared to 1.48 trillion US dollars in 2022. The market size of advanced countries is about 1.28 trillion US dollars, accounting for approximately 79.50% of the global drug market, which is a significant increase from 73.42% in 2022. The drug market size of the top 10 advanced countries in the United States, Germany, France, the United Kingdom, Italy, Spain, Japan, Canada, Australia, and South Korea in 2023 also reached about 1.0816 trillion US dollars, accounting for 67.18% of the global drug market; emerging drug markets, mainly China, Brazil, India, and Russia, had a drug market size of $303.7 billion in 2023, accounting for about 18.86% of the global drug market, while low-income countries and regions had drug sales of $27.6 billion, accounting for only 1.71%.
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According to IQVIA's survey, the world's top five therapeutic drugs in 2028 are Cancer Medication, immunosuppressants, hypoglycemic drugs, cardiovascular drugs, and central nervous system drugs, as shown in Table 2-2. Among them, cancer remains a major disease that the world is urgently trying to overcome. Including newly approved drugs or items under development in various countries, Cancer Medication remains in the leading position. With the development of various innovative cancer therapies, Cancer Medication is expected to maintain high growth in the future. The market size is projected to reach $444 billion by 2028, with a compound annual growth rate of 14-17% from 2024 to 2028. The sales of immunosuppressants have slowed down due to the approval and listing of biosimilar drugs, with the market size estimated at $192 billion in 2028, and a compound annual growth rate of only 2-5% from 2024 to 2028. It is worth noting that obesity medications show significant growth due to the better effects achieved by using innovative therapies, with the market size projected to reach $74 billion by 2028.
Uni: USD 100M, %
| Field of Drug | 2028 Forecast Sales Volume | Between 2024 and 2028 |
|---|---|---|
| Oncologics (anticancer drug) | 4,440 | 14~17 |
| Immunosuppressants (immunosuppressor) | 1,920 | 2~5 |
| Anti-diabetics (hypoglycemic drugs) | 1,840 | 3~6 |
| Cardiovascular (drugs for cardiovascular diseases) | 1,260 | 2~5 |
| Central Nervous System (central nervous system drugs) | 1,030 | 6~9 |
| Respiratory (respiratory medication) | 990 | 3~6 |
| Mental health (mental health medication) | 810 | 9~12 |
| Infectious diseases (drugs for infectious diseases) | 750 | 3~6 |
| Obesity (anti-obesity drugs) | 740 | 24~27 |
| GU sexual health (drugs for genitourinary and sexual health) | 620 | 3~3 |
Source: Source: Global Use of Medicines 2024: Outlook to 2028, IQVIA, January 2024.
(2) Biopharmaceuticals / Commissioned Development and Manufacturing Services of Biopharmaceuticals (CDMO)
According to IQVIA's research report, the global biologics market size will increase from $503 billion in 2023 to$ 892 billion in 2028, with a compound annual growth rate of about $9.5 - 12.5\%$ . With the development and launch of new types of biological drugs such as cell therapy and gene therapy, along with the continuous growth of monoclonal antibody drugs, the expansion of the biological drugs market is being driven. However, the rapid development of biosimilar drugs, especially the United States' strengthened promotion of biosimilar drugs, will also exert some pressure on the biological drugs market. The development trend of the global biological drugs market is shown in the following figure.

Source: Source: Global Use of Medicines 2024: Outlook to 2028, IQVIA, January 2024.
Biological drugs are new types of drugs that have emerged in the past decade. These drugs can be used to treat common chronic diseases such as cancer, rheumatoid arthritis, and leukemia. These drugs are expensive to produce and require long-term use, so they can easily sell for hundreds of millions of dollars. Amounts make biological preparations the target of research and development, and the market trend of these drugs is also the focus of attention of major pharmaceutical companies. According to the annual reports published by international pharmaceutical companies, the top ten global brand drugs in 2020 are counted, of which five are biological drugs, as shown in the following table.
Uni: USD 0.1 Billion, %
| Brand Name/Manufacturer Name | Major Indications | Sales Volume of 2022 | Sales Volume of 2023 | Growth rate from 2022 to 2023 | Product Name |
|---|---|---|---|---|---|
| Keytruda® (Merck & Co) | Advanced melanoma | 20.937 billion | 25.011 billion | 19.46% | Monoclonal antibody drug |
| Humira® (AbbVie) | Rheumatoid arthritis, Crohn's disease, psoriasis, juvenile idiopathic polyarthritis, etc | 21.237 billion | 14.404 billion | -32.17% | Monoclonal antibody drug |
| Ozempic® (Novo Nordisk) | Diabetes | 8.446 billion | 13.894 billion | 64.50% | Chymotrypsinogen |
| Dupixent® (Sanofi) | Dermatitis, asthma, chronic sinusitis. | 8.720 billion | 11.588 billion | 32.89% | Monoclonal antibody drug |
| Comirnaty® (Pfizer/BioNTech) | COVID-19 | 43.020 billion | 11.202 billion | -73.96% | Vaccine |
| Stelara® (Johnson & Johnson) | Psoriasis | 9.723 billion | 10.858 billion | 11.67% | Monoclonal antibody drug |
| Darzalex® (Johnson & Johnson) | Multiple myeloma | 7.977 billion | 9.721 billion | 21.86% | Monoclonal antibody drug |
| Opdivo® (Bristol-Myers Squibb) | Melanoma | 8.249 billion | 9.009 billion | 9.21% | Monoclonal antibody drug |
| Gardasil®/Gardasil 9® (Merck & Co) | HVP | 6.897 billion | 8.886 billion | 28.84% | Vaccine |
Source: GlobalData, May 2024
According to Grand View Research's report, in 2023, the global emerging therapies CDMO market size is approximately $5.64 billion. The demand for emerging therapies, the increasing number of clinical trials, and treatment methods for emerging therapy products drive the overall growth of the emerging therapies CDMO. The CAGR from 2024 to 2030 is 18.92%.
In addition, in 2019, the Group began to cooperate with Nanotein to develop nanoprotein medium (medium) products, which can be used for cell culture activation and expansion. At present, this main product is mainly used for CAR-T cell therapy, CAR-T cell therapy. The market size of CAR-T was USD467 million in 2018, and it is estimated that the market size of CAR-T will reach USD8.68 billion in 2026, with a compound growth rate of 44.1%, and the market potential is amazing.
(3) GLP-1 Peptide
According to the market research report by Coherent Market Insights in November, the global market for GLP-1 receptor agonists is expected to reach nearly $56 billion by 2031; GlobalData's market research report in June even predicts that the global market size for GLP-1 receptor agonists will reach an astonishing $111 billion by 2033.
In addition to diabetes and weight loss, an increasing number of preliminary efficacy studies further indicate that GLP-1 receptor agonists may have broader pharmacological effects and therapeutic potential in other diseases, with the prospect of expanding to more indications. For example, in March 2024, the United States Food and Drug Administration (FDA) approved Novo Nordisk's Wegovy (semaglutide) for reducing cardiovascular risk in patients who are overweight or have obesity.
The financial report of Novo Nordisk in the year 2024 shows that the global sales of Semaglutide were approximately 201.8 billion Danish Krone (about 29.3 billion US dollars). The sales of the hypoglycemic Semaglutide injection Ozempic in the year 2024 were 120.3 billion Danish Krone (approximately 17.5 billion US dollars), ranking first with a year-on-year increase of 26%. The oral hypoglycemic Semaglutide tablets Rybelsus had sales of 23.3 billion Danish Krone (approximately 3.4 billion US dollars), with the same year-on-year increase of 26%. The weight loss version of Semaglutide injection Wegovy had sales of 58.2 billion Danish Krone (approximately 8.5 billion US dollars), with a year-on-year increase of 86%.
- The relationship between the upper, middle and lower reaches of the industry
| Upstream | Midstream | Downstream |
|---|---|---|
| Material supplier | GM | Medical institutions |
| Raw materials and consumables for the production of medicines | pharmaceutical factory | Drug agent sales and distributors |
| Outsourcing R&D institutions | Production of pharmaceutical raw materials that meet specifications | |
| Assist in the execution of clinical trials or the development of specific assays | Packaging of pharmaceutical raw materials | |
| Engineering Company | Quality and quality control of pharmaceutical raw materials and finished products | |
| cGMP factory design, construction and maintenance |
- Various development trends of products
In recent years, new cancer drugs are mostly targeted drugs, aiming at various possible differences between tumor cells and normal cells, and designing new drugs that can effectively kill tumor cells without affecting normal cells.
The ADI-PEG 20 being developed by the Company is a biological drug developed by taking advantage of the significant difference in metabolism between tumor cells and normal cells. Since the first human clinical trial was carried out at USA MD Anderson Cancer Center in 2001, The Company has completed 24 Phase I, II and III clinical trials, and more than 1,600 terminal cancer patients worldwide are in clinical trials Treated with ADI-PEG 20. In many patients, ADI-PEG 20 effectively inhibited cancer cell growth with minimal side effects. The results of completed clinical trials have been compiled into reports and submitted to the USA FDA and relevant competent authorities, and most of them have also been published in internationally renowned scientific journals.
Development trend of ADI-PEG 20 in the next few years will focus on three directions:
A. WWOX Biomarkers
Due to the existence of single nucleotide polymorphism (SNP) in the gene sequence between people, there are different responses to the occurrence of diseases and the efficacy of drugs. It is a future trend to use this gene detection. In addition to the traditional methods of performing routine tests and genetic testing, modernized precision medicine can select the most suitable treatment methods or drugs for patients, so that the efficacy can be maximized.
WWOX is an oxidoreductase with a WW domain. It is a tumor suppressor. In cells, it can regulate cell growth or death, inhibit cell cancerization, and even inhibit cancer cell invasion. According to the research data of The Company and Linkou Chang Gung, WWOX GG-type hepatic cell carcinoma patients had better tumor shrinkage response and longer survival to ADI - PEG 20 treatment.
The Company's future clinical trials will actively explore the relationship between ADI-PEG 20 and genes, hoping that based on Taiwan's genetic data, suitable patients can be found, and treatment methods suitable for them can be developed, creating a product with fewer side effects and a longer disease control period., Medical care with high survival rate, economic value, and high mobility will drive the development of Taiwan's biotechnology industry and contribute to global patients.
B. Expand the market
Since tumor cells of various cancers have metabolic mutations that cannot produce arginine, the indications of ADI-PEG 20 should include a variety of cancers, and the company will continue to conduct clinical trials on various cancers to expand the market for ADI-PEG 20.
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C. Combined medication to enhance the efficacy
In the future, the treatment of cancer will tend to be a combination of multiple drugs with different mechanisms of action, curative effects and relatively mild side effects. The mechanism of action of ADI-PEG 20 is completely different from that of all drugs currently approved or entering Phase II and III human clinical trials, with clear efficacy and mild side effects, making it suitable for use in combination with any other treatment methods. Currently, the Company has multiple ongoing clinical trials targeting different cancers, combining different drugs with ADI-PEG 20. In the future, The Company will continue to test various combinations to find the most effective and safest combination in order to fully expand the market share of ADI-PEG 20 in each different cancer market.
The Company's subsidiary, Genovior Biotech, focuses on the development, manufacture and distribution of difficult-to-mimic biosimilars, generic drugs and injectable formulations, which are high margin pharmaceutical products with high market potential. Teriparatide, Glucagon Kit, Liraglutide, Semaglutide and other difficult to imitate polypeptide drugs developed by Genovior Biotech have many process steps and technical links in API and preparation, and are difficult to produce. They can be applied to indications such as osteoporosis, glucagon, diabetes, and slimming, making their market potential endless. It is expected that they will be developed and marketed in the next few years. Genovior Biotech's refractory anticancer drug Carfilzomib is designed to treat multiple myeloma in patients who have received at least two prior treatments (bortezomib and immunomodulators). In addition, the Company will actively develop oral preparations for niche products to prepare for the expansion of a larger consumer market.
- Competitive Situation
A. Other Arginine Deprivation Therapy
In addition to Polaris, two companies are also working on reducing arginine to treat cancer, Bio-Cancer Treatment International (BCT) and Aeglea Biotherapeutics (Aeglea), the drug they used was PEGylated recombinant arginase. Arginase is an enzyme in the human body that catalyzes the final step of the urea cycle, decomposing arginine into urea and ornithine. The urea cycle is the body's way of removing excess nitrogen to avoid ammonia poisoning.
Polaris' ADI-PEG 20 (Pegargiminase) has a different mechanism of action. ADI catalyzes the hydrolysis of arginine to produce citrulline and ammonia. Microorganisms use ADI to utilize arginine as an energy source. The human body itself does not produce ADI.
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Arginase is an inherent enzyme in the human body and does not produce antibodies, it has two major differences as a cancer drug and ADI-PEG 20 (Dillon 2002, Keshet 2018): First, Arginase has a low affinity (Km, activity) for arginine and requires a higher dose. Second, the ornithine produced by its action leads to an increase in polyamines and thus cancer progression. The Arginase properties of Polaris' ADI-PEG 20 and the other two companies are compared as follows:
BCT-100
BCT has been testing BCT-100 as a single drug since 2000, and recently published a 27-person Phase 2 hepatic cell carcinoma clinical trial (Chan 2021), because it is a small single-group trial, its survival results cannot be interpreted. There is only one ongoing trial (NCT03455140) on the ClinicalTrials.gov website, last updated March 25, 2020.
Aeglea
In order to solve the problem of low Km of Arginase, Aeglea replaced the original manganese ion with cobalt and renamed it peglizarginase (Stone 2010). In a 2019 report to the U.S. Securities and Exchange Commission (SEC), Aeglea described its trials in small cell lung cancer, which included a phase I/II small (35 participants) monotrial with pembrolizumab, and a phase I multi-tumor trial. But cancer was not mentioned in the 2020 report. The 2021 report only covered studies conducted in collaboration with Immedica Pharma AB for Arginase deficiency, a disease related to arginine metabolism. There was no progress in cancer, and no information regarding the development of cancer indications in cooperation with other manufacturers.
In addition to the two aforementioned companies, Athenex, a company in Buffalo, USA, claims that its new pegylated arginase (Yu 2021) has anticancer effects in preclinical cell and animal studies. A recent literature (Zhang 2021) summarizes possible competitors to current arginine-lowering therapies, including new drugs in preclinical and clinical trials.
To sum up, there are currently no clinical trials from companies other than Polaris actively testing arginine-lowering cancer therapies.
B. Therapies of other mechanisms
The Company's core drug, ADI-PEG 20, has a unique mechanism of action, which is different from traditional chemotherapy or radiotherapy. It has high specificity for cancer cells, which can improve the effect of cancer treatment and its impact on normal cells. Smaller, but also more able to slow down the occurrence of side effects. This drug is also suitable for use in combination with a variety of other treatment modalities, and will have strong competitiveness in the cancer market in the future, and there is currently no homogenous drug (see the aforementioned arginase) and ADI-PEG 20 competition in the future market.
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C. Generic drug market
According to Precedence Research's report, the global generic drug market size in 2023 is approximately $464.98 billion and is estimated to reach $776.78 billion by 2033, with a compound annual growth rate of 5.2%. Among them, North America is the largest market for generic drugs, accounting for approximately 34.69%, followed by Europe at 25.40%. Although the Asia-Pacific region accounts for 22.57%, the growth rate of the market is expected to reach 8% in the future due to the increasing number of people with chronic diseases and changes in lifestyle habits.
The generic drug market is large and crowded with competitors. There are many aspects to consider in order to make a profit, the most important of which is the choice of topic. The Company focuses on difficulto-mimic drugs in the development of chemical synthetic drugs and biological agents, with high technical difficulty of difficulto-mimic drugs, few competitors, and high gross profit margin of products. Supplemented by the Company's integrated development capability from API to injection, the Company can maximize its competitive advantage in the market of generic drugs.
(III) Overview of Technology and Research and Development
- R&D expenses in the most recent year and up to the date of printing the annual report
Unit: NTD1,000
| Items | 2024 | By the end of March 2025 (Note 1) |
|---|---|---|
| R&D expenses (A) | 2,192,469 | - |
| The amount of paid-in capital at the end of the period (B) | 7,702,513 | - |
| (A) / (B)(%) | 28.46 | - |
Note 1: As of the date of publication of the Annual Report, the financial report for the first quarter of 2025 has not yet been issued.
- Successfully developed technology or product
The Company's principal developed drug, ADI-PEG 20, is still in clinical trials and has not yet been licensed for sale. However, ADI-PEG 20 is not only patented in many countries, but also has a certain degree of efficacy against many different cancers due to its innovative and unique mechanism of action. Since the first clinical trial was conducted at MD Anderson Cancer Center in 2001, 24 Phase I, II, and III trials have been completed worldwide.
In addition, the Company has nearly 20 years of experience in R&D and manufacturing of ADI-PEG 20 clinical trial drugs, and has mastered the key technologies of the whole process of biopharmaceuticals (E.coli), which can manufacture high-end protein drugs, including recombinant proteins, recombinant protein vaccines, nano-antibodies, hormones and interferons, etc., and also plans to produce mRNA vaccines in the future. Since the Company's process development platform has excellent R&D capabilities and rich experience in microbial systems (E. coli systems), it has been using the excess production capacity of the United States Northern California plant to provide external biopharmaceuticals commissioned development and production services (CDMO) since the end of 2019.
Genovior Biotecg, a subsidiary of the Group, focuses on the development and production of generic drugs, APIs and injection products, and has obtained more than 20 drug licenses.
(IV) Long-term and Short-term Business Development Plans
- Short-term Development Strategies and Plans
(1) The rolling application for mesothelioma drug license has been submitted to the FDA, and it is expected to complete the submission of all drug license-related information in 2025. The company is actively pursuing the FDA's Priority Review qualification.
(2) Strategically plan clinical trials to obtain global drug licenses as soon as possible to benefit cancer patients worldwide.
(3) Continue to explore the relationship between ADI-PEG 20 and genes, maximize the therapeutic benefit of patients through genetic testing, so as to achieve the ultimate goal of precision medicine, increase the penetration rate of ADI-PEG 20 in various cancer markets, and ultimately expand the market size.
(4) Combining the expertise of Polaris Group and Genovior Biotech Corporation, we will expand our product line to include peptide related apis, difficult generics, and Class 505b2 drugs to better meet the needs of different patients.
(5) Find and co-development or regional licensing with strategic alliance partners to secure working capital and spread risks.
(6) Practically carry out relevant clinical trials on metabolic disease indications, such as severe fatty liver and diabetes, to make ADI-PEG20 the first choice for combination of metabolic therapy and various cancer drugs, so that more patients can benefit.
(7) In regards to Semaglutide products, the Company plans to focus on the expansion of the emerging market, and also plans to cooperate with emerging market countries to enter major emerging market countries through joint venture, co-development, or technology transfer.
(8) Continue to develop Teriparatide preparations, drug inspection registration, and marketing planning.
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- Medium and Long-term Development Strategies and Plans
(1) ADI-PEG 20 will be licensed and marketed for at least two indications, and will actively negotiate drug licensing.
(2) Complete hardware facilities and certification of Taiwan cGMP factory, conduct production and quality control training, and officially produce.
(3) The Company will strengthen research and innovation in the polypeptide product line at Genovior Biotech Corporation, with a special focus on the development of multiple polypeptide products and process optimization to improve production efficiency and product quality. Create dual engines for Polaris Pharmaceuticals' ADI-PEG 20 cancer drug and chemically synthesized peptide products, driving future company growth.
II. Market and Production Overview
(I) Market Analysis
- Sales (supply) Areas of Major Commodities (Services)
The core technology of the Group's research is the new cancer target drug ADI-PEG 20. Clinical trials have been carried out on humans with various cancers around the world. Due to its unique mechanism of action, efficacy and safety have been observed in trials of various cancers. After The Company obtains the drug license, the sales strategy will cover the whole world. In addition, the Company's CDMO business is currently mainly serving the USA.
Genovior Biotech, a subsidiary of the Group, now derives its main revenue from CDMO and its main customers are Japan and Taiwan.
- Market Share
The Company's ADI-PEG 20 have not yet been sold in the market, so there is no complete market share analysis yet. In addition, Genovior Biotech, a subsidiary of the Group, has the ability to complete product development, production, quality control and regulatory documentation from APIs to sterile preparations, focusing on the one-stop CDMO service model for HPAPIs, peptides, macromolecular APIs and injections. It can provide global customers with convenient, practical and effective pharmaceutical finished products solutions.
- The Supply and Demand and Growth Potential of the Market in the Future
According to IQVIA's survey, Cancer Medication is projected to be the leading global therapeutic drug by 2028. Among them, cancer remains a major disease that the world is urgently trying to overcome. Including newly approved drugs or items under development in various countries, Cancer Medication remains in the leading position. With the development of various innovative cancer therapies, Cancer Medication is expected to maintain high growth in the future. The market size is projected to reach $444 billion by 2028, with a compound annual growth rate of 14-17% from 2024 to 2028.
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According to MarketsandMarkets' research report, in 2023, the global pharmaceutical CDMO market size reached $176.5 billion and is expected to grow at a compound annual growth rate of 7.9%, reaching $258.3 billion by 2028. Among them, chemical drugs still account for the biggest proportion of CDMO business opportunities, but the proportion of biological drugs has been rising year by year. Rising biopharmaceutical consumption, increasing demand for advanced therapies, demand for orphan drug discovery, surge in the number of clinical trials, and growing demand for one-stop CDMOS are expected to positively impact the global market.
- Competitive Niche
(1) As an innovative cancer target therapy, ADI-PEG 20 has a completely different mechanism of action than other therapies, and there are currently no similar drugs entering the market or in late-stage clinical trials globally.
(2) In advanced clinical development, more than 1,600 patients with various end-stage cancers worldwide have been treated with ADI-PEG 20 in clinical trials with clear efficacy and mild side effects.
(3) Many different cancers are potentially treatable with ADI-PEG 20 and the market is huge.
(4) Due to its completely different mechanism of action from other therapies and high safety, ADI-PEG 20 can be used in combination with any other therapy, resulting in better efficacy and further expanding the market.
(5) Equipped with vertically integrated manufacturing capabilities, ADI-PEG 20 will have future production lines in the United States and China that meet international specifications, so that drug supply, quality control, storage, transportation and marketing can be planned in a unified manner.
(6) Supported by strong teams, the Company cooperates with the world's top cancer centers and authorities to stay number 1 in the world.
(7) ADI-PEG20 has obtained 49 international patents, covering the USA, Canada, Europe, Australia, Singapore, and South Korea, etc., and another 20 patents are pending.
(8) We have achieved achievements in the development of polypeptides and anticancer refractory drugs, and have the ability to integrate biochemistry, synthesis and formulation to provide customers with one-stop CDMO services from research and development to production.
(9) We're able to produce polypeptide apis with more than 30 amino acids in a fully synthetic or microbial process and to produce polypeptide injections in combination with API production, sterile filling of cassette bottles, and medical devices (such as injection pens)
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- Advantages, Disadvantages and Countermeasures of the Development Prospect
(1) Favorable factors for the development prospect:
(i) With the increase of human lifespan, the number of cancer patients worldwide is increasing rapidly every year.
(ii) ADI-PEG 20 could potentially be used to treat a number of different cancers with a very different mechanism of action and a high safety profile, and it could also be used in combination with other therapies to improve efficacy and expand the market.
(iii) The government has actively promoted the biotechnology industry and included biotechnology medicine into one of the five innovation industry research and development plans to promote the biotechnology industry, making it the country's next economic growth momentum.
(iv) Many important drug patents will expire in the coming years. Under the financial pressure of health insurance, countries are encouraging the use of generic drugs. The importance of generic drugs in the pharmaceutical market is increasing year by year, and the growth rate of the generic drug market will still be significantly higher than that of brand name drugs.
(2) Unfavorable factors and countermeasures of development prospects:
(i) The development of new cancer drugs is the focus of most pharmaceutical companies. In the future, more new drugs will obtain drug certificates and be marketed.
Countermeasures:
ADI-PEG 20 has a unique mechanism of action and is developed into a market different from other drugs. And any new drug may be used in combination with ADI-PEG 20 to enhance the efficacy.
(ii) The development of new drugs is lengthy and risky
The biotechnology and medical profession is an industry that requires the combination of talents, technology and capital, and must be invested in long-term research and development and high-level research and development experience.
Countermeasures:
ADI-PEG 20 is an innovative cancer target therapy with a completely different mechanism of action from other therapies. There are currently no drugs with a similar mechanism of action entering the market or in late-stage clinical trials globally. The Company does not rule out that it will consider a strategic alliance with international manufacturers at an appropriate time in the future. Through the acquisition of technology licensing funds, it will reduce research and development costs and speed up product development.
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(iii) A large number of competitors for new generic drugs, resulting in lower prices and shorter product life cycles.
Countermeasures:
We focus on the development of difficult-to-imitate drugs, and make good use of production advantages to reduce production costs.
(II) Important Uses and Production Processes of Main Products
-
Important uses of main products: The ADI-PEG 20 series developed by the Company is a non-single-indication anticancer drug. Genovior Biotech, a subsidiary of the Group, now derives its main revenue from CDMO and its main products are used as orphan drugs and detox drug. The polypeptide drugs and anticancer drugs that will be listed in the future can be used for different indications such as osteoporosis, glucagon, diabetes, weight loss, myeloma, etc.
-
Production processes of main products: E. coli fermentation, protein purification, raw material modification, preparation bottling, refrigeration.
(III) Supply status of main raw materials: This mainly refers to the consumables required for production. Each consumable has more than two suppliers, so that its supply is stable. Therefore, there is no centralized transaction.
(IV) The names of customers who have accounted for more than 10% of the total purchases (sale) in any one of the last two years, and their purchases (sale) amounts and proportions, and explain the reasons for their increase or decrease:
The Company's AD I - PEG 20 is still in the clinical trial stage, so there is no operating income and operating gross profit yet. The Company's biopharmaceutical CDMO revenue for 2023 and the year 2024 were NTD7,481,000 and NTD107,000,000, respectively.
The Company is mainly engaged in the development of new biologics cancer drug ADI-PEG 20 and drug commissioned development and manufacturing services (CDMO). Since the Company's new cancer drug ADI-PEG 20 is still in the clinical trial stage, and the operating income in 2023 was from the signing of the CDMO business of biopharmaceuticals with the American business Helix BioMedix, Inc. and the joint development agreement with Nanotein Technologies. In the pre-development stage of biological drugs in 2023 and 2024, only the expenses for experimental consumables such as buffers, experimental bottles, and reagents required for the execution of the plan are incurred, and there is no purchase of raw materials, so it is not applicable.
In 2024, purchases accounting for more than 10% of the total purchase amount were from Friend Pharma, Shandong Weigao, and Livzon Group, with purchase amounts of NTD7,065,000, NTD3,203,000, and NTD2,438,000, respectively, accounting for 10.49%, 4.75%, and 3.62% of the purchases during this period, mainly for common packaging materials, consumables, and raw materials required for production.
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Information on Major Sales Customers in the Last Two Years
Unit: NTD1,000
| 2023 | 2024 | As of March 31, 2025 (Note 1) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Items | Name | Amount | Proportion of annual net sales (%) | Relationship with the issuer | Name | Amount | Proportion of annual net sales (%) | Relationship with the issuer | Name | Amount | Proportion of annual net sales (%) | Relationship with the issuer |
| 1 | Helix BioMedix, Inc. | 2,945 | 39 | None | OrphanPacific Inc. | 52,547 | 49 | None | - | - | - | - |
| 2 | MegaPro Biomedical | 2,101 | 28 | None | Hangzhou YidanBiotechnology Co.,Ltd. | 12,143 | 11 | None | - | - | - | - |
| 3 | Hangzhou YidanBiotechnology Co.,Ltd. | 1,166 | 16 | None | - | - | - | - | - | - | - | - |
| 4 | Others | 1,269 | 17 | None | Others | 42,310 | 40 | None | - | - | - | - |
| Net sales volume | 7,481 | 100 | - | Net sales volume | 107,000 | 100 | - | - | - | - | - |
Note 1: As of the date of publication of the Annual Report, the first quarter of 2025 has not yet ended.
III. Information on Employees
Profile of Employees in the Last Two Years and as of the Date of Publication of the Annual Report
| Year | 2023 | 2024 | As of April 15, 2025 | |
|---|---|---|---|---|
| Number of workers | R&D personnel | 322 | 323 | 319 |
| Other personnel | 66 | 242 | 237 | |
| Total | 388 | 565 | 556 | |
| Average age | 38.72 | 38.61 | 38.50 | |
| Average years of service | 3.50 | 2.66 | 2.80 | |
| Education distributed ratio (%) | PhD | 9.54 | 6.73 | 6.83 |
| Master | 30.41 | 28.32 | 28.60 | |
| College | 56.44 | 59.12 | 59.35 | |
| High school | 3.61 | 5.13 | 5.08 | |
| Below high school | 0.00 | 0.71 | 0.14 |
IV. Information on Environmental Protection Expenditure
In the most recent year and up to the date of publication of the annual report, the total amount of losses (including compensation) and punishments suffered as a result of environmental pollution, as well as the future countermeasures (including improvement measures) and possible expenses (including the estimated amount of losses, punishments and compensation that may occur without taking countermeasures, and the fact that it is impossible to reasonably estimate if it is impossible to reasonably estimate): None.
V. Labor Relations
(I) List the Company's various employee welfare measures, further education, training, and retirement systems and their implementation, as well as labor-management agreements and various employee rights and interests protection measures:
- Taiwanese employees
(1) Employee welfare measures
The Company's employee welfare measures are regulated by the Labor Standards Act, Labor Insurance Act and related laws and regulations. The main items of the current welfare system include: Dragon Boat Festival, Mid-Autumn Festival, Spring Festival, wedding and other gifts, funeral subsidies, hospitalization subsidies for injuries and illnesses, maternity condolences, group insurance, etc.
(2) Employees' further education and training
The Company's well-planned education and training system is mainly divided into pre-employment training and on-the-job training. It provides employees with various learning channels and professional course training to achieve the Company's goal of creating a work environment for further study and development and cultivating professional talents.
(3) Retirement system
New system: in accordance with the Labor Pension Act.
(4) The agreement between labor and management and various measures to protect the rights and interests of employees
Through various communication, incentive, education, fellowship campaign and other activities, the company timely understands the needs of employees and actively explores and solves employee problems, so that employees can establish a harmonious relationship with the company, improve their centripetal force force and satisfaction, thus creating a better future with the Company. The Company has formulated relevant protection norms in the work rules for the work rights and interests of female colleagues to protect the relatively disadvantaged female colleagues. The Company also stipulates the way to complain about sex in the workplace, in order to ensure respect for the fundamental human rights of both genders.
- Employees from USA
In addition to complying with the relevant provisions of the United State Federal Government's Social Security Act and labor laws, it also provides employee health insurance and work injury compensation to protect employee benefits.
- Employees from Mainland China
The Company's subsidiaries in Mainland China, in addition to implementing the Labour Contract Law and its relevant sub-laws as the labor policy of the Company's subsidiaries in Mainland China, also adopt the practice of avoiding labor discrimination, not employing child labor, and providing normal and good working conditions for laborers and other measures.
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(II) Set out the losses suffered as a result of labour disputes in the most recent year and up to the date of publication of the annual report, and disclose the estimated amounts and measures currently and possibly in the future and, if not reasonably estimated, the fact that they are not reasonably estimated: None.
VI. Infocomm Security Management
(I) State the Infocomm Security Risk Management Framework, the Infocomm Security Policy, the Specific Management Plan and the Resources Invested in the Infocomm Security Management, Etc.
- Infocomm security risk management framework
The information engineer under the Management Department is responsible for coordinating and implementing information security policies, publicizing information security information, enhancing employees' information security awareness, collecting and improving the Company's information security management system, and ensuring the confidentiality, integrity and availability of information. The Audit Office conducts information security audits on the internal control system - computer information system cycle every year to evaluate the effectiveness of the internal control of the Company's information operations.
-
Infocomm Security Policy
-
Ensure that data access is regulated according to departmental functions.
- Avoid unauthorized access and modification of data and systems to ensure their correctness and integrity.
- Ensure the continuous operation of the information system.
- Regularly perform information security audits to ensure that information security is actually implemented.
-
Regularly publicize information security policies, promote employees' awareness of information security and strengthen their awareness of related responsibilities.
-
The specific management plan and the resources invested in the security management of information communication
The information security business is coordinated, managed and supervised by the information engineer, who is responsible for handling the information security work. The information security business is coordinated, managed and supervised by the information engineer, who is responsible for handling the information security work, including regular Internet information security control, data access control, fulfillment of backup and emergency recovery mechanisms, and provision of relevant information security publicity and education&training courses. Through the implementation of relevant information security policies, the Company's information security can be protected and a safe and secure information security environment can be available. The Company also actively improves and strengthens the data security mechanism and improves data security to ensure the Company's continued security.
(II) Set out the losses suffered in the last two years and up to the date of publication of the annual report as a result of major security incidents, the possible impact and the response measures, and if it is not reasonably possible to estimate the fact that it is not reasonably possible to estimate: None.
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VII. Important Contracts
| Nature of Contract | Party | Duration of Contract | Main Content | Restrictive Clause |
|---|---|---|---|---|
| Cooperative research agreement | Polaris/Ludwig Institute for Cancer Research Ltd | January 3, 2011 to the completion of the contract | USA Human Clinical Trial Study | Confidentiality Clause |
| Clinical research agreement | Polaris/Polaris Pharmaceuticals | July 1, 2020 to the completion of the contract | Human clinical trials in Asia | Confidentiality Clause |
| Mutual licensing agreement | Polaris/Polaris Pharmaceuticals/DRX USA | 2014.12.17 | DRX USA Patent Mutual License | Confidentiality Clause |
| Outsourced manufacturing agreement | Polaris/DRX USA | 2012.10.01 | Manufacture of outsourced clinical medicines | Confidentiality Clause |
| Quasi-contractual service | Polaris/PPI | 2021.01.01-2024.12.31 | Outsourced R&D, clinical trials and administrative service | Confidentiality Clause |
| Land Transfer Contract | DRX Chengdu/Chengdu Municipal Bureau of Land and Resources | August 6, 2013 (the term of land release shall be 50 years from the date of delivery. Prior to the expiration of the useful life, the land user may apply for the contract, which shall be approved by the issuer unless recovered in accordance with the needs of the public interest. However, the term of the use right of the residential construction land shall be automatically renewed.) | State-owned construction land for sale | None |
| Lease agreement | PPI/SAN Diego SYCAMORE, LLC | 2020.02.01-2024.05.31 | USA San Diego Office Rental | None |
| Lease agreement | PPI/Allison Commercial, LLC | 2013.08.01-2028.07.31 | USA Va caville plant lease | None |
| Outsourced manufacturing agreement | PPI/Helix BioMedix, Inc. | 2019.11.14- | Development of E. coli expression system for UVDE-TAT production | Confidentiality Clause |
| Joint Development Agreement | Polaris/Nanotein Technologies., Inc. | 2020.09.30 | Cooperative Development Agreement | Confidentiality Clause |
| Property sale and purchase contract | DRX USA/Agenus West, LLC | 2021.05.14 | Purchase of land | None |
| Clinical research agreement | PPI/Global Coalition for Adaptive Research. | November 19, 2022 to the completion of the study | Clinical trial study of cerebral cancer | Confidentiality Clause |
| Lease agreement | Polaris Pharmaceuticals/WEST FORTUNE INDUSTRIES LIMITED | 2022.10.01-2027.12.31 | Rental of Taipei Office | None |
| Loan contract | DRX Chengdu/Shanghai Commercial & Savings Bank | 2023.03.27-2024.03.26 | Short-term loan in Renminbi 136,000,000 dollars | None |
| Loan contract | DRX Chengdu/Bank of Chengdu | 2023.08.18-2024.08.17 | Short-term loan in Renminbi 20,000,000 dollars | None |
| Loan contract | DRX Chengdu/KGI Bank | 2023.10.12-2028.10.11 | Long-term loan in Renminbi 68,000,000 dollars | None |
| Property sale and purchase contract | DRX USA/Asset Preservation, Inc. | 2023.12.01 | Purchase of land and building | None |
| Property sale and purchase contract | Polaris Pharmaceuticals Inc./Epistar | 2024.01.25 | Purchase of plant | None |
| Authorization supply contract | Genovior Biotech/Company A | 2022.07.26 | Drug distribution | Confidentiality Agreement |
| Inspection guidance agreement | Genovior Biotech/FAMTRIZ PHARMACEUTICAL CONSULTING LDA EMONA BIOPHARMA d.o.o. | 2023.09.11 | Instructed Europe GMP to inspect the plant in Southern Taiwan Science Park | None |
| Audit services agreement | Genovior Biotech/Youth CDMO | 2023.10.11 | EU QP audit and MHRA on-site audit | None |
| Lease agreement | Genovior Biotech/Hsinchu Science Park | 2021.01.01-2028.12.31 | Plant rental in Zhunan | None |
| Lease agreement | Genovior Biotech/Southern Taiwan Science Park | 2024.01.01-2024.12.31 | Plant rental in Southern Taiwan Science Park | None |
| Loan contract | Genovior Biotech/First Bank | 2020.01.20-2025.01.20 | Long-term loan in New Taiwan Dollars 20,000,000 dollars | None |
| Loan contract | Genovior Biotech/First Bank | 2020.04.09-2025.04.09 | Long-term loan in New Taiwan Dollars 17,500,000 dollars | None |
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| Nature of Contract | Party | Duration of Contract | Main Content | Restrictive Clause |
|---|---|---|---|---|
| Loan contract | Genovior Biotech/First Bank | 2020.08.12-2025.08.12 | Long-term loan in New Taiwan Dollars 30,000,000 dollars | None |
| Loan contract | Genovior Biotech/First Bank | 2022.12.09-2027.12.28 | Long-term loan in New Taiwan Dollars 30,000,000 dollars | None |
| Loan contract | Genovior Biotech/First Bank | 2023.07.28-2028.07.28 | Long-term loan in New Taiwan Dollars 34,726,000 dollars | None |
| Loan contract | Genovior Biotech/Hua Nan Commercial Bank Ltd. | 2020.04.09-2025.04.09 | Long-term loan in New Taiwan Dollars 15,000,000 dollars | None |
| Loan contract | Genovior Biotech/Taiwan Cooperative Bank | 2023.12.07-2028.12.07 | Long-term loan in New Taiwan Dollars 30,000,000 dollars | None |
| Loan contract | Genovior Biotech/Taiwan Cooperative Bank | 2023.08.07-2028.05.30 | Long-term loan in New Taiwan Dollars 16,500,000 dollars | None |
| Land lease agreement | Zhunan Science Park | 2024.04.30-2043.12.31 | Land lease agreement in Zhunan Science Park | None |
| Loan contract | Polaris Pharmaceuticals Inc./Polaris | 2024.04.29-2025.04.28 | Short-term loan in US Dollars 1,000,000 dollars | None |
| Loan contract | DesigneRx Pharmaceuticals (Chengdu)/Polaris | 2024.05.14-2025.05.13 | Short-term loan in US Dollars 7,000,000 dollars | None |
| Loan contract | Polaris Pharmaceuticals Inc./Polaris | 2024.07.10-2025.07.09 | Short-term loan in US Dollars 1,000,000 dollars | None |
| Loan contract | Polaris Pharmaceuticals Inc./Shanghai Commercial & Savings Bank | 2024.06.27-2031.06.27 | Long-term loan in New Taiwan Dollars 500,000,000 dollars | None |
| Company Merger Agreement | Polaris Pharmaceuticals Inc./Genovior Biotech | 2024.07.11 | Merger of Polaris Biopharmaceuticals, Inc. and Genovior Biotech. | None |
VI. Review and Analysis of Financial Condition and Financial Performance and Risks
I. Financial Status
Unit: NTD1,000
| Year Accounting items | 2023 | 2024 | Difference | |
|---|---|---|---|---|
| Amount | % | |||
| Current assets | 5,105,125 | 3,325,148 | (1,779,977) | (34.87) |
| Investments using the equity method | - | - | - | - |
| Property, plant and equipment | 1,437,857 | 2,725,805 | 1,287,948 | 89.57 |
| Right-of-use asset | 162,382 | 241,348 | 78,966 | 48.63 |
| Intangible assets | 2,145,356 | 2,180,637 | 35,281 | 1.64 |
| Other assets | 286,401 | 617,502 | 331,101 | 115.61 |
| Total Assets | 9,137,121 | 9,090,440 | (46,681) | (0.51) |
| Current liabilities | 959,373 | 468,894 | (490,479) | (51.12) |
| Non-current liabilities | 505,411 | 1,850,951 | 1,345,540 | 266.23 |
| Total liabilities | 1,464,784 | 2,319,845 | 855,061 | 58.37 |
| Equity attributable to owners of parent company | 7,672,337 | 7,366,027 | (306,310) | (3.99) |
| Share capital | 7,437,592 | 7,702,573 | 264,981 | 3.56 |
| Capital reserve | 11,696,587 | 12,828,313 | 1,131,726 | 9.68 |
| Retained surplus | (12,065,124) | (14,567,766) | (2,502,642) | 20.74 |
| Other equities | 336,139 | 732,294 | 396,155 | 117.85 |
| Non-controlling interests | 267,143 | 75,181 | (191,962) | (71.86) |
| Total Equity | 7,672,337 | 6,770,595 | (901,742) | (11.75) |
| 1. The main reasons for the major changes in assets, liabilities and equity in the last two years and their impact, (analyzing and explaining the changes of more than 20 % in the previous and later periods, and the amount of the changes has reached NTD10 million) (2) Current assets: The principal purchase of equipment, plant, and the maintenance of daily operating activities resulted in a decrease in current assets. (3) Property, plant and equipment: The principal construction of a new plant in Zhunan by the subsidiary Genovior and the addition of equipment by each subsidiary resulted in an increase in property, plant and equipment. (4) Right-of-use asset: Mainly due to the subsidiary Genovior leasing land in Zhunan from the government for constructing a new plant. (5) Other assets: Mainly due to the prepayments for machinery and equipment by the subsidiary Genovior. (6) Current liabilities: Mainly due to the extension of bank loan maturity. (7) Non-current liabilities: It's mainly due to the acquisition of bank loan. (8) Retained surplus: Please refer to the details of the net loss for this year, 2. Financial Performance (1) Business Result Analysis Form. (9) Other equities: Mainly due to exchange profit margin caused by exchange rate fluctuations. (10) Non-controlling interests: It was mainly caused by the acquisition of two subsidiaries, Nanotein Technologies, Inc. and Linyang. 2. Future countermeasures: The above changes have no material adverse effect on the Company or its subsidiaries. |
Data from financial report audited and certified by an accountant.
II. Financial Performance
(I) Business Result Analysis Form
Unit: NTD1,000
| Item\Year | 2023 | 2024 | Increase (Decrease) amount | Change ratio % |
|---|---|---|---|---|
| Operating Income | 7,481 | 107,000 | 99,519 | 1330.29 |
| Operating costs | (10,546) | (183,923) | (173,377) | 1644.01 |
| Operating gross profit | (3,065) | (76,923) | (73,858) | 2409.72 |
| Operating expenses | (1,852,657) | (2,557,962) | (705,305) | 38.07 |
| Operating losses | (1,855,722) | (2,634,885) | (779,163) | 41.99 |
| Non-operating incomes and expenses | 363,579 | 89,342 | (274,237) | (75.43) |
| Net loss before tax | (1,492,143) | (2,545,543) | (1,053,400) | 70.60 |
| Income tax expense | (15,554) | (5,210) | 10,344 | (66.50) |
| Net loss for the current period | (1,507,697) | (2,550,753) | (1,043,056) | 69.18 |
| Other comprehensive profit or loss (net) | (14,087) | 396,155 | 410,242 | (2912.20) |
| Total comprehensive loss for the current period | (1,521,784) | (2,154,598) | (632,814) | 41.58 |
| Change of the increase/decrease ratio of more than 20% and the amount of NTD 10 million or more and its impact analysis are explained as follows : (1) Operating Income: Mainly due to the inclusion of income from Nanotein and Linyang for the entire year of 2024. (2) Operating Costs: Mainly due to the inclusion of costs from Nanotein and Linyang for the entire year of 2024. (3) Operating expenses: Mainly due to the inclusion of expenses from Linyang for the entire year of 2024, as well as an increase in clinical trial expenses and salary expenditures. (4) Non-operating incomes and expenses: Mainly due to the decrease in interest income. (5) Income tax expense: Mainly due to the withholding of income tax by the US subsidiary. (6) Other comprehensive profit or loss: Due to exchange rate fluctuations caused by the reduction of exchange profit margin. |
Data from financial report audited and certified by an accountant.
(II) Expected Sales Volume and Its Basis:
The Company is currently in the stage of new drug research and development, with its revenue mainly from the CDMO business. The Company will actively develop customized CDMO services, with it and its subsidiaries continuing to develop ADI-PEG 20 and provide biopharmaceutical development technology services and OEM production services. Currently, the Company and its subsidiaries have sound finances and have no significant adverse impact on our ongoing research and development plans and financial operations.
(III) Possible impact on the Company's future financial business and corresponding plans: Please refer to V-I-(IV) "Long-term and Short-term Business Development Plans" in this annual report.
III. Cash Flow
(I) Analysis and Explanation of Cash Flow Changes in Recent Years
Unit: NTD1,000
| Items\Year | 2023 | The year 2024 | Increase (Decrease) amount | Increase (Decrease) ratio (%) |
|---|---|---|---|---|
| Increase (Decrease) in ratio (%) | (1,255,446) | (2,025,733) | (770,287) | 61.36 |
| Net cash inflows (outflows) from investing activities | (3,235,367) | (1,629,453) | 1,605,914 | (49.64) |
| Net cash inflows (outflows) from financing activities | 919,161 | 1,851,109 | 931,948 | 101.39 |
| Analysis of cash flow changes : | ||||
| (1) Operating activities: This is mainly due to the rise of net loss before tax for current period. | ||||
| (2) Investing activities: Primarily the acquisition of property, plant and equipment, the acquisition of investments using the equity method, the acquisition of subsidiaries, and the reclassification of time deposits to financial assets measured at amortized cost. | ||||
| (3) Financing activities: This is mainly due to the acquisition of loan. |
(II) Improvement Plan for Insufficient Liquidity:
The Company is in the clinical trial stage of developing new drugs, and the cash remains without insufficient liquidity. However, in order to strengthen the financial structure of the Company, improve the ratio of self owned funds, and pursue the long-term stable development of the Company, the cash capital increase plan will be carried out as appropriate.
(III) Analysis of Cash Flow in the Next Year
Unit: NTD1,000
| Initial cash balance (1) | Expected net cash flow from operating activities throughout the year (2) | Expected net cash flow from other activities throughout the year (3) | Cash surplus (deficit) amount (1)+(2)+(3) | Remedies for insufficient cash | |
|---|---|---|---|---|---|
| Investment plan | Financial plan | ||||
| 1,946,210 | (4,991,717) | 3,628,358 | 582,851 | — | — |
| Cash liquidity in the coming year : | |||||
| (1) In 2024, new drugs are still in the research and development stage. Although there is already income from CDMO. As for the overall net operating activities, there is still in the stage of cash outflow. | |||||
| (2) Investing and financing activities: In 2024, we plan to obtain bank borrowings and support capital expenditure of the Group's various plants. |
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IV. The Impact of Major Capital Expenditures on Financial Business in the Most Recent Year :
The Group's capital expenditures for the most recent year amounted to approximately NTD333,176,000, which were mainly related to the addition of real estate, plant and equipment for future product development and manufacturing. Therefore, there were no adverse events resulting from the increase in capital expenditures to the financial condition of the Company.
V. Reinvestment Policy in the Most Recent Year, the Main Reasons for Its Profit or Loss, Improvement Plan and Investment Plan for the Next Year
(I) Reinvestment Policy
The Company's current re-investment policy is mainly based on investment targets related to the development of its own industry, and does not engage in investment in other industries. The relevant executive departments implement in accordance with the "Investment Cycle" and "Procedures for Acquiring or Disposing of Assets" under the internal control system. The foresaid regulations or procedures have been discussed and approved at the Board of Directors Meeting or the Shareholders' Meeting.
(II) The Main Reasons for the Profit or Loss of Reinvestment in the Most Recent Year and the Improvement Plan :
The reinvestment businesses of the Company are all still in the research and development stage and have not yet generated operating income, so up to now, the reinvestment businesses are still in a state of loss. With the completion of the clinical trial and successful launch of products, the reinvestment businesses will generate revenues and profits.
(III) Investment Plan for the Next Year:
The Company will strengthen research and development and innovation in the polypeptide product line, with a special focus on the development of multiple polypeptide products, while optimizing the process to improve production efficiency and product quality. It is planned to build an injection plant and a peptide API plant in the newly acquired Taiwan Zhunan plant and Chengdu plant, and gradually expand the production capacity according to future demand.
The Semaglutide API 200kg production line is scheduled to be completed in 2025, and focus will be on the expansion of the emerging market. As the supply of Semaglutide products falls short of demand, the company also plans to cooperate with emerging market countries to enter major emerging market countries through joint venture, co-development, or technology transfer, etc.
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VI. Analysis and Evaluation of Risks
(I) The Impact of Interest Rate, Exchange Rate Changes and Inflation on the Company's Profit and Loss and Future Countermeasures
- The impact of interest rate changes on the profit and loss of the Group and future countermeasures
The Company continues to monitor interest rate market dynamics and maintains stable credit relations with financial institutes to secure competitive financing conditions, reduce capital costs, and manage the potential risks posed by rising interest rates. In view of the characteristics of high capital demand and long payback period in new drug research and development, the Company, in its financial planning, will comprehensively consider the amount and cost of different financing tools and flexibly adjust its financial structure to ensure liquidity and cost stability. Overall, the current impact of interest rate changes on the Company's profit and loss remains within a controllable range.
- The impact of exchange rate changes on the profit and loss of the Group and future countermeasures
The Company's operations mainly use NTD, US dollars, and RMB as functional currencies. In daily transactions, the foreign exchange risk adopts the natural write-off principle, achieving a natural hedging effect by matching revenues and expenses in the same currency, thereby reducing the need for currency exchange and consequently minimizing the risk of exchange gains and losses due to exchange rate fluctuations. The overall impact is relatively limited. To further mitigate the potential impact of foreign exchange fluctuations on profit and loss, the Company also maintains close cooperation with correspondent banks, monitors exchange rate market dynamics, and flexibly uses appropriate hedging tools as needed to enhance financial risk management and maintain operational stability.
- Influence of inflation on the profit and loss of the Group and future countermeasures
The Company's profit and loss has so far not been significantly affected by inflation. In view of the fact that the Company's core business is new drug development and CDMO services at this stage, its operational nature has a certain resilience to raw material price fluctuations. The impact of inflation is mainly concentrated on specific Items such as labor costs and equipment procurement. In the face of high global economic uncertainty and potential inflationary pressures, the Company has proactively established a sensitivity monitoring mechanism and strengthened the flexibility of cost structure allocation. In the future, the Company will continue to adjust its operational strategies in real-time based on economic indicators, industry dynamics, and market variables to ensure organizational adaptability and financial stability, maintaining a long-term competitive advantage.
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(II) Policies, Main Reasons for Profit or Loss and Future Countermeasures for Engaging in High-Risk, High-Leverage Investments, Lending Funds to Others, Endorsement Guarantees and Derivatives Trading
The Company focuses on the development of its own business. In the most recent year and up to the date of publication of the annual report, it has not engaged in high-risk, high-leverage investments and transactions, and nor engaged in fund loans to others or endorsed guarantees to others. To strengthen financial discipline and internal control, the Company has established clear systems such as the "Procedures for Acquiring or Disposing of Assets", "Regulations Governing Lending Loans to Others", and "Regulations Governing Endorsement". The relevant operations are carefully executed in accordance with the standardized procedures. Regarding loaning funds and endorsement guarantees between the Company and its subsidiaries, all matters are handled according to the established systems. The related risks are strictly managed within a controllable range to ensure the safety of capital utilization, maintain the integrity of the Company's assets, and protect the rights and interests of all shareholders.
(III) Future R&D Plans and Estimated R&D Expenses
The company's core research and development product, ADI-PEG 20, is a highly promising new drug. Its development history dates back to 1990, initiated at the laboratories of the global non-profit cancer research organization, the Ludwig Institute for Cancer Research. The first human clinical trial began in 2001 at MD Anderson Cancer Center. To date, The Company has successively completed more than 20 clinical trials covering Phase I to Phase III, with a high degree of completeness in the accumulated clinical data, offering strong evidence and subsequent analytical value.
Compared to the development of generic drugs or contract manufacturing, new drug development generally involves high capital investment, long development timelines, and significant technical risks. However, according to current clinical trial results, ADI-PEG 20 has shown stable efficacy potential in multiple cancer indications. The overall development process has entered the later stages, with major indications including mesothelioma, soft tissue sarcoma, and hepatic cell carcinoma. The overall risk structure has significantly reduced compared to the initial development stage. In the future, the Company will continue to maintain close communication with drug regulatory authorities of various countries (including FDA, EMA, TFDA, and CFDA) and actively promote the drug license application process to accelerate the transformation of clinical outcomes. In addition, to enhance the commercial benefits of technology and global market deployment, the company has also initiated a feasibility assessment of strategic alliances, actively seeking partners with complementary and international resource integration capabilities, to further unlock product value and enhance overall R&D synergy.
The Company estimates that research and development expenditure in 2025 will reach NTD 2.4 billion. In the future, adjustments to related investments will be made flexibly based on clinical progress and overall operational resource allocation to ensure resources are focused on key technologies and advantageous product lines. This will continuously strengthen research and development momentum, consolidate technological leadership, and solidify the Company's long-term competitive advantage in the global biotech research and development field.
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(IV) The Impact of Important Domestic and Foreign Policies and Legal Changes on the Company's Financial Business and Countermeasures
In response to the international business expansion and long-term development plan for the capital market, The Company is lawfully established in the British Cayman Islands (hereinafter referred to as "Cayman Islands") and has completed the company establishment and registration procedures according to local laws. Choosing the Cayman Islands as the place of registration is based on an institutional plan for global operational structure allocation and capital market operation flexibility, in order to enhance The Company's overall operational efficiency and international competitiveness.
The Company executes all its operational activities in accordance with the policies and legal regulations of the location, and continuously monitors the trends of domestic and international policy directions and changes in regulations. For potential significant changes, professional consultants (such as lawyers and accountants) are commissioned to conduct risk assessments from legal and financial perspectives, and formulate corresponding strategies to ensure operational compliance and controllable risks. Up to the most recent financial year and the date of publication of the annual report, there have been no significant adverse impacts on the Company's finances or operations due to changes in policies or regulations in various regions. In the future, the Company will also continue to strengthen its compliance monitoring mechanisms, dynamically grasp changes in the policy environment to ensure operational stability, and maintain the foundation of Corporate Governance and protect the rights and interests of all shareholders.
(V) The Impact of Technological Changes (including Information Security Risks) and Industrial Changes on The Company's Financial Business and Countermeasures
The Company possesses highly professional research and development capabilities and continuously keeps abreast of real-time industrial technology development trends and market changes, adjusting its R&D direction and operational strategies in a timely manner to respond to the rapidly evolving technological environment and changes in industry structure. In response to information security risks, the Company has an information security team responsible for formulating and implementing information security policies. Following the spirit of international information security standards, this team establishes internal control mechanisms and contingency procedures to comprehensively enhance information security resilience and operational stability. Up to the most recent financial year and the date of publication of the annual report, technological developments and industrial changes have not yet had a significant impact on the Company's finances or business. In the future, the Company will continue to focus on technological advancements and changes in the industrial environment, enhancing investment and management in information security and the stability of key systems to ensure the Company maintains a long-term competitive advantage amid technological and market changes.
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(VI) The Impact of Corporate Image Change on Corporate Crisis Management and Countermeasures
The Company implements the principles of integrity management and steady development, placing importance on maintaining corporate reputation and external trust. Up to the most recent financial year and the date of publication of the annual report, there have been no significant adverse impacts on the Company's finances or operations due to changes in corporate image. To effectively manage potential reputation risks and enhance the efficiency of external communication, the Company has established a spokesperson system and is gradually improving relevant internal contingency mechanisms. This ensures that in the face of unforeseen events, accurate information can be promptly delivered, maintaining openness and transparency in information disclosure. The Company is also attentive to global sustainable development trends, continuously assessing the feasibility of integrating various practices and governance structures concerning environmental, social responsibility, and corporate governance issues.
(VII) Expected Benefits, Possible Risks and Countermeasures of Merger and Acquisition
As of the publication date of the Annual Report, the Company currently has no major mergers or acquisition plans in progress or planned. In the future, if there are related plans, they will be carefully evaluated based on operational strategies for potential benefits and possible risks and conducted in accordance with relevant legal regulations to ensure the implementation of corporate governance principles, thereby protecting the rights and interests of all shareholders.
The Company also continues to monitor market dynamics and potential merger and acquisition risks. For any situation that might affect operational stability or control, preliminary planning regarding equity structure, internal governance mechanisms, and legal response tools has been conducted. Necessary defensive measures will be taken as required by actual circumstances to ensure that the long-term development benefits of the Company and the overall rights and interests of the shareholders are not affected.
(VIII) Expected Benefits, Possible Risks and Countermeasures of Plant Expansion
The Group's plants in Northern California and Chengdu are built in accordance with the United States and European Union specifications of cGMP, and the production environment and process design are planned and established according to applicable regulations. Among these, the Northern California production plant has sufficient capacity to meet the initial global market demand for the Company's main product after obtaining drug licensing. The Chengdu plant is currently focusing on the research and development of freeze-drying processes for biological agents, aiming to optimize the stability and transportation efficiency of the core product ADI-PEG 20, while also expanding the CDMO business territory.
In addition, after completing the acquisition of Genovior Biotech, the Group further strengthened the technical capabilities and research depth of the peptide product line, focusing on the development of multiple peptide products, and continuously optimizing the process to enhance production efficiency and product quality. It is also planned to build an injection plant and a peptide API plant in the newly acquired plants in Taiwan Zhunan Science Park and Chengdu, and gradually expand the overall production capacity according to market development needs.
The Semaglutide API 200kg production line is scheduled to be completed in 2025.
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(IX) Risks Involving Centralized Purchase or Sale of Goods and Countermeasures
- Risks involving centralized purchase and countermeasures
The Company's main product is ADI-PEG 20. For its production process, a supplier management system has been established for key consumables and equipment. There are at least two alternative qualified sources for the main items, leading to relatively diversified procurement, and the supply risk is controllable. In the future, the Company will also continue to strengthen the evaluation and substitution mechanism of key raw material sources to ensure supply chain stability and operational resilience.
- Risks involving centralized sale and countermeasures
The Company's core product, ADI-PEG 20, is still in the clinical trial stage and has not yet generated substantial sales transactions. However, starting from the year 2024, a small amount of revenue from the CDMO business began to be generated, and it mainly comes from a single customer. Such collaborations are mostly characterized by a high technical threshold and project-oriented nature, which differ slightly from the traditional product-type sales model.
(X) Directors, Supervisors or Major Shareholders Holding More Than 10% of the Shares, the Impact, Risks and Countermeasures of the Large-Scale Transfer or Replacement of Shares on the Company
In the recent year and up to the date of publication of the annual report, there has been no large-scale transfer or replacement of equity interests.
(XI) The Impact, Risks and Countermeasures of the Change of Management Rights on the Company
In the recent year and up to the date of publication of the Annual Report, there is no change in the management rights on the Company.
(XII) Litigation or Non-litigation Event :
Please refer to page 193 of this annual report for the company's litigation or non-litigation matters in the past year and as of the date of publication of the prospectus.
(XIII) Other Important Risks and Countermeasures:
The Company is a fully vertically integrated new drug development company, with the main research project being ADI-PEG20. The new drug development phase costs a lot of money, takes a long time to develop, and needs to go through a series of fairly rigorous review procedures before the drug can be licensed to the market and then be profitable. Therefore, the Company has to bear the risk of huge investment and development failure. The Company may encounter different levels of challenges in the new drug development process and subsequent clinical trials, so the risk analysis and countermeasures of various new drug development plans are as follows:
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- There is a risk that a new drug will not be marketed due to the risk of failure in the development of it, as well as delays in conducting human clinical trials or if the results are not as expected.
The Company is a fully vertically integrated new drug development company, with the main development product being the macromolecular biologic drug ADI-PEG 20. The development of new drugs is a long-term and capital-intensive process, encompassing stages such as pre-clinical trials, Phase I to III clinical trials, and new drug inspection registration. Any stage may face delays or failure due to technical, clinical results, or regulatory requirements, which could affect the product launch timeline or lead to the termination of the development plan.
Countermeasures
Integration of R&D resources and team building:
The Company has established an experienced interdisciplinary R&D team covering drug design, production processes, clinical sample analysis, and quality control. It also employs internationally experienced consultants and outsourcing R&D institutions to assist in technological development at various stages, reducing technical risks in the R&D process.
Establishment of quality and clinical trial system:
The cGMP manufacturing plant built by the company has introduced more than 20 QC testing items that meet international standards, using advanced instruments and equipment for quality control operations to ensure product quality stability and increase the probability of new drug approval.
Strategic Alliances and Academic Collaborations:
The Company has signed cooperation agreements with more than 20 top universities and research institutions worldwide, conducted clinical trials in over 100 cancer hospitals globally, and published more than 100 research findings related to ADI-PEG 20 in international journals. Through the clinical and scientific support of partners, the success rate of new drug development and international visibility are effectively improved.
Mechanism for Risk Diversification:
The Company is conducting multiple clinical trials for various cancer indications simultaneously, with a certain degree of product portfolio diversification mechanism. If the results of individual trials do not meet expectations, there are still other Items that can continue to advance, reducing the impact of a single trial on operations.
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- Risks of product quality control
Medicinal products are directly related to human health and safety, and clinical medicines have extremely strict requirements for their quality, safety, and consistency. If there are quality errors or non-compliance issues in the product development, manufacturing, or distribution processes, it could affect the progress of clinical trials, drug approval applications, commercialization timelines, and even impact the company's reputation and finances.
Countermeasures
The Company is a fully vertically integrated new drug development enterprise, covering all aspects from drug design, R&D, production and manufacturing, GMP plant establishment and validation, to the planning and execution of clinical trials in many countries around the world, all carried out by a dedicated professional team. The company has established a complete internal quality management system and is equipped with QA and QC personnel with practical experience. They rigorously implement quality control processes and equipment verification mechanisms that comply with international standards.
In addition, the company's manufacturing sites are designed and built in accordance with the cGMP standards of the United States and European Union to ensure that drug quality complies with the regulatory requirements of global regulatory agencies. In the future, the Company will continue to optimize the quality management system and strengthen the quality culture through internal audits and continuous training to reduce quality risks and ensure product stability and regulatory compliance.
- Long-term investment and capital requirements for new drug development
New drug research and development requires undergoing long-term clinical trials and regulatory reviews, which take a long time and involve high investment costs. During the development stage, it does not generate immediate Operating Income, resulting in a delayed net cash inflow from operating activities. If drug approval is not obtained and commercialization is not achieved within the expected timeline, it may result in insufficient working capital, thereby affecting the overall research and development progress and the company's financial stability.
Countermeasures
Cash reserves are stable.
As of December 31, 2024, The Company's cash on the books is approximately NTD1.94 billion, which is sufficient to cover more than one year of operating capital and research and development needs.
Diversified Revenue Source Development:
In addition to continuing to advance the clinical trials and drug application of ADI-PEG 20, The Company has initiated CDMO business revenue with Genovior Biotech and accelerated the establishment of Semaglutide API capacity at the Zhunan plant to strengthen the sources of operating cash inflow.
Financing and Resource Integration Strategies:
The Company will, in light of capital market conditions and funding requirements, timely activate diverse financing mechanisms, including equity, debt, or other capital instruments. In addition, it will actively seek strategic alliance opportunities with international pharmaceutical companies to reduce financial pressure and accelerate product advancement through technology licensing, cost-sharing in research and development, or co-development models.
- The impact of information security risks on the Company's financial business and countermeasures:
As the digitalization and information operations of the Company continue to deepen, if information security incidents (including malicious software attacks, improper access, data leaks, etc.) are not properly managed, they may have a substantial impact on the Company's operations.
Countermeasures
Information security management system:
The Company has established an information security department and implemented various information security protection measures, including account identification, password control, firewalls, antivirus software, and system monitoring mechanisms, to prevent unauthorized intrusion, deletion, or data tampering.
Information security equipment and system control:
The Company has deployed multi-layer network security equipment internally, with firewalls and abnormal traffic detection mechanisms in place to address external intrusion risks. Regular tests and updates are conducted. Important data is encrypted and managed with permission control, with log recording and access tracking mechanisms in place.
Workflow and personnel management:
All critical system passwords are regularly updated, important documents and software are encrypted and backed up, information processes are periodically reviewed to strengthen software and hardware upgrades, and information security education and training are conducted to reduce the risk of human error and the likelihood of information security incidents.
The Company will continue to review and strengthen the overall information security framework based on international information security requirements to reduce the impact of potential information security risks on financial and operational stability.
VII. Other Important Matters : None
VII. Special Notes
I. Information about Affiliate Enterprises:
(I) Organization Chart of Affiliated Enterprises

December 31, 2024
(II) Basic Information of Affiliated Enterprises
December 31, 2024 Unit: NTD1,000
| Company name | Date of establishment | Address | Paid-up capital | Main business or production |
|---|---|---|---|---|
| Polaris Group | 2006.02.09 | P.O. Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands | 7,702,513 | Holding Company |
| Polaris Pharmaceuticals, Inc. | 2006.03.29 | 10675 Sorrento Valley Rd. San Diego, CA92121, USA | 150,811 | Biotechnology research and development |
| DesigneRxEurope Limited | 2011.04.27 | 90 High Holborn, London, WC1V 6XX | - | Biotechnology service |
| Polaris Pharmaceuticals Australia Pty Ltd | 2017.01.05 | 58 Gipps Street,Collingwood VIC3066, Australia | 2 | Biotechnology service |
| Polaris Pharmaceuticals Ireland Limited | 2018.12.21 | 88 Harcourt Street, Dublin 2, Ireland | - | Biotechnology service |
| DesigneRx Pharmaceuticals, Inc. | 2002.04.17 | 4941 Allison Parkway, Suite B, Vacaville, CA95688, USA | 4,166,286 | R&D and manufacturing of new drugs |
| Polaris Pharmaceuticals, Inc. | 2003.03.25 | 7F., No. 298, Ruiguang Rd., Neihu Dist., Taipei City, Taiwan (R.O.C.) | 438,000 | Biotechnology research and development, drug testing |
| TDW HK Limited | 2012.12.28 | 6/F Alexandra Hse 18 Chater Rd Central Hong Kong | 2,909,669 | Holding Company |
| Nanotein Technologies, Inc. | 2019.03.13 | 2950 San Pablo Ave Berkeley, CA 94702, USA | 290,115 | Biotechnology service, drug testing |
| DesigneRx Pharmaceuticals (Shanghai) Inc. | 2007.07.03 | 201B, 5F, No. 60 Naxian Rd., Zhangjiang, Pudong New Area, Shanghai | 119,665 | Research and development of new drugs |
| DesigneRx Pharmaceuticals (Chengdu) Inc. | 2013.02.25 | No. 198, Tiansheng Rd., Gaoxin West Dist., Chengdu | 1,639,250 | R&D and manufacturing of new drugs |
| Company name | Date of establishment | Address | Paid-up capital | Main business or production |
|---|---|---|---|---|
| Lin Yang Biopharma, Ltd. | 2018.07.24 | The Grand Pavilion Commercial Centre, Oleander Way, 802 West Bay Road, P.O. Box 32052, Grand Cayman, KY1-1208, Cayman Islands | 489,092 | Holding Company |
| Genovior Biotech Corporation | 2015.04.23 | 4F., No. 50-8, Keyan Rd., Zhunan Township, Miaoli County 350401, Taiwan (R.O.C.) | 1,226,810 | Research and development, manufacturing and production for new drugs |
| Northern Biopharmaceutical Co., Ltd. (Fujian) | 2024.11.21 | ROOM 204, BUILDING 255, JIESHAN VILLAGE, JIESHAN TOWN, QUANZHOU CITY, FUJIAN PROVINCE, CHINA | - | Manufacturing and sales of drugs |
(III) Information on the Same Shareholders of Those Who Are Presumed to Have Control and Affiliation: None.
(IV) Industries Covered by the Business of the Overall Affiliated Enterprise:
The Group is engaged in manufacturing and sales of new drug research and development, biotechnology services, drug testing, etc. The Group's core research is the novel cancer target drug ADI-PEG 20, which is currently undergoing human clinical trials for various cancers worldwide.
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(V) Information on Directors, Supervisors and General Managers of Affiliated Enterprises
| Company name | Title | Name or representative | Name shareholding of Polaris Group (contribution) (Note 1) | |
|---|---|---|---|---|
| Number of share (contribution) | Shareholding % | |||
| Polaris Pharmaceuticals, Inc. | Director | Hsu, Jaan-Pyng | 23,000 | 100% |
| Director | Chen, Shyan Tser | |||
| DesigneRx Europe Limited | Director | Hsu, Jaan-Pyng | 1 | 100% |
| Director | Chen, Shyan Tser | |||
| Polaris Pharmaceuticals Australia Pty Ltd | Director | Hsu, Jaan-Pyng | 100 | 100% |
| Director | Chen, Shyan Tser | |||
| Polaris Pharmaceuticals Ireland Limited | Director | Hsu, Jaan-Pyng | 100 | 100% |
| Director | Chen, Shyan Tser | |||
| Polaris Pharmaceuticals, Inc. | Chairman | Hsu, Jaan-Pyng | 43,800,000 | 100% |
| Director | Chen, Shyan Tser | |||
| Director | Hsu, Jaan-Pyng | |||
| Supervisor | Ke Kaide | |||
| DesigneRx Pharmaceuticals, Inc. | Director | Hsu, Jaan-Pyng | 136,979,257 | 100% |
| Director | Chen, Shyan Tser | |||
| TDW HK Limited | Director | Hsu, Jaan-Pyng | 82,300,001 | 100% |
| DesigneRx Pharmaceuticals (Shanghai) Inc. | Director | Hsu, Jaan-Pyng | 108,950 | 100% |
| Supervisor | Chen, Shyan Tser | |||
| DesigneRx Pharmaceuticals (Chengdu) Inc. | Director | Hsu, Jaan-Pyng | 1,621,858 | 100% |
| Supervisor | Hsu, Jaan-Pyng | |||
| Nanotein Technologies, Inc. | Director | Curtis Hodge | 6,347,330 | 54.89% |
| Director | Greg Hura | |||
| Director | Chris Huxsoll | |||
| Lin Yang Biopharma, Ltd. | Director | Hsu, Jaan-Pyng | 168,138,001 | 100% |
| Director | Ke Kaide | |||
| Director | Chen, He-Chuan | |||
| Director | Chen, Hung-Wen | |||
| Director | Chen, Li-Jue | |||
| Genovior Biotech Corporation | Chairman | Hsu, Jaan-Pyng | 79,806,000 | 65.05% |
| Director | Chen, Hung-Wen | |||
| Director | Chen, Shyan Tser | |||
| Supervisor | Ke Kaide | |||
| Northern Biopharmaceutical Co., Ltd. (Fujian) | Director | Hsu, Jaan-Pyng | - | 100% |
Note 1: DesigneRx Pharmaceuticals (Shanghai) Inc., DesigneRx Pharmaceuticals (Chengdu) Inc., and Northern Biopharmaceutical Co., Ltd. (Fujian) are limited companies, listed as contribution.
(VI)Operational Overview of Affiliated Enterprises
December 31, 2024 Unit: NTD1,000
| Company name | Capital | Total assets | Total liabilities | Net value | Operating income | Operating profit (loss) | Current profit/loss | EPR (after tax) |
|---|---|---|---|---|---|---|---|---|
| Polaris Pharmaceuticals, Inc. | 150,811 | 284,838 | 39,670 | 245,168 | 150,860 | (18,983) | (17,927) | (Note 1) |
| DesigneRx Europe Limited | — | — | — | — | — | — | — | (Note 1) |
| Polaris Pharmaceuticals Australia Pty Ltd | 2 | 281 | 35,593 | (35,311) | — | (1,431) | (3,016) | (Note 1) |
| Polaris Pharmaceuticals Ireland Limited | — | — | — | — | — | — | — | (Note 1) |
| Polaris Pharmaceuticals, Inc. | 438,000 | 88,354 | 40,006 | 48,347 | 150,699 | (10,689) | (7,845) | (Note 1) |
| DesigneRx Pharmaceuticals, Inc. | 4,166,286 | 793,875 | 95,684 | 698,191 | 107,583 | (716,825) | (715,832) | (Note 1) |
| Polaris Biopharmaceuticals, Inc. | — | — | — | — | — | — | — | (Note 1) |
| TDW HK Limited | 2,909,669 | 2,555,501 | 1,499 | 2,554,003 | — | (23) | 161 | (Note 1) |
| DesigneRx Pharmaceuticals (Shanghai) Inc. | 119,665 | 537 | — | 537 | — | — | 9 | (Note 1) |
| DesigneRx Pharmaceuticals (Chengdu) Inc. | 1,639,250 | 1,792,055 | 1,555,869 | 236,186 | 19,401 | (35,786) | (39,449) | (Note 1) |
| Nanotein Technologies, Inc. | 290,115 | 95,658 | 4,014 | 91,645 | 1,208 | (105,741) | (100,835) | (Note 1) |
| Lin Yang Biopharma, Ltd. | 489,092 | 263,779 | — | 263,779 | — | — | (133,565) | (Note 1) |
| Genovior Biotech Corporation | 1,226,810 | 1,752,945 | 998,211 | 754,733 | 106,131 | (326,956) | (330,347) | (Note 1) |
| Northern Biopharmaceutical Co., Ltd. (Fujian) | — | 80,482 | 80,482 | — | — | — | — | (Note 1) |
Note 1: As the Company's consolidated financial statements are its primary financial statements, there is no information about earnings per share.
(VII) Consolidated Financial Statements of Affiliated Enterprises : Please refer to the consolidated financial statements attached hereto.
(VIII) Relationship Report: The Company is not a subsidiary company of other companies, so there is no need to prepare a relationship report.
II. The Handling Status of Private Equity Securities in the Most Recent Fiscal Year and as of the Date of Publication of the Annual Report:
| Items | The First Private Placement in 2019
Issue Date: April 3, 2019 | | | | | The second private placement in 2019
Issue Date: January 17, 2020 | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Types of Private Securities | Common Stock | | | | | Common Stock | | | | |
| Date and amount approved by shareholders meeting | June 26, 2018
The total number of common stocks to be issued shall not exceed 80,000,000 | | | | | June 11, 2019
The total number of common stocks to be issued shall not exceed 300,000,000 | | | | |
| The basis and reasonableness of pricing | The price of common shares in this private placement shall be determined by dividing the sum of the transaction amount of common shares in each business day within the 30 business days prior to the pricing date by the sum of the number of shares in each business day, deducting the value of bonus shares issued as stock dividends or ex-dividend, and the share price after the reversal of the capital reduction or determined based on the net value per share as shown in the latest financial report audited or reviewed by accountants before the date of pricing. The higher of the two prices set out above shall be the reference price, and the price shall be determined at a rate not less than 80% of the reference price. | | | | | The price of common shares in this private placement shall be determined by dividing the sum of the transaction amount of common shares in each business day within the 30 business days prior to the pricing date by the sum of the number of shares in each business day, deducting the value of bonus shares issued as stock dividends or ex-dividend, and the share price after the reversal of the capital reduction or determined based on the net value per share as shown in the latest financial report audited or reviewed by accountants before the date of pricing. The higher of the two prices set out above shall be the reference price, and the price shall be determined at a rate not less than 80% of the reference price. | | | | |
| The way a certain person chosen | The private placement of ordinary shares shall be subject to certain persons in accordance with the provisions of Section 43 (6) of the Securities Exchange Act and (91) Tai-Tsai-Cheng-Yi Zi No. 0910003455 issued by the Financial Supervisory Commission on June 13, 2002. The subscribers are selected for the purpose of directly or indirectly benefiting the Company and providing support for the operation or development of the Company. | | | | | The private placement of ordinary shares shall be subject to certain persons in accordance with the provisions of Section 43 (6) of the Securities Exchange Act and (91) Tai-Tsai-Cheng-Yi Zi No. 0910003455 issued by the Financial Supervisory Commission on June 13, 2002. The subscribers are selected for the purpose of directly or indirectly benefiting the Company and providing support for the operation or development of the Company. | | | | |
| Necessary reasons for handling private placement | To meet the operational needs of the company and the needs of clinical trials of new drugs and working capital, the Company considers that it may not be easy to obtain the required funds smoothly in a short period of time if the funds are raised through the issuance of marketable securities, in addition, private placement is relatively timely, convenient and equity stable in raising capital, so it is necessary to raise funds from specific persons through private placement. | | | | | To meet the operational needs of the company and the needs of clinical trials of new drugs and working capital, the Company considers that it may not be easy to obtain the required funds smoothly in a short period of time if the funds are raised through the issuance of marketable securities, in addition, private placement is relatively timely, convenient and equity stable in raising capital, so it is necessary to raise funds from specific persons through private placement. | | | | |
| Number of shares (or bonds) | 7,065,000 shares | | | | | 300,000,000 shares | | | | |
| Payment completion date | March 07, 2019 | | | | | December 12, 2019 | | | | |
| Delivery date | April 03, 2019 | | | | | January 17, 2020 | | | | |
| Information of subscriber | Object of private placement | Qualification | Subscription number (shares) | Relationship with the Company | Participation in the operation of the Company | Object of private placement | Qualification | Subscription number (shares) | Relationship with the Company | Participation in the operation of the Company |
| | Iconluck Limited | Item 2 | 2,817,224 | None | None | Digital Capital Inc. | Item 2 | 290,000,000 | None | None |
| | G-Technology Investment Co., Ltd. | Item 3 | 2,267,522 | Director of The Company | None | Masterpiece Enterprise Co., Ltd. | Item 2 | 10,000,000 | None | None |
| | Chang, Yue-Chi | Item 2 | 1,130,254 | None | None | | | | | |
| | Henry Shaw | Item 2 | 500,000 | None | None | | | | | |
| | Ultimate Beyond Limited | Item 2 | 350,000 | None | None | | | | | |
| Actual subscription price | NTD 21.83 per share | | | | | NTD 10 per share | | | | |
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| Items | The First Private Placement in 2019 Issue Date: April 3, 2019 | The second private placement in 2019 Issue Date: January 17, 2020 |
|---|---|---|
| Difference between actual subscription price and reference price | The actual subscription price is 80.02% of the reference price, not less than 80% of the reference price. | The actual subscription price is 94.61% of the reference price, not less than 80% of the reference price. |
| Impact of private placement on shareholders' equity (e.g., increase in cumulative losses...) | The value per share has been increased and the liability structure has been improved, which has a positive impact on the liability and equity rights of the company. | The value per share has been increased and the liability structure has been improved, which has a positive impact on the liability and equity rights of the company. |
| The use of private funds and plan implementation progress | It was raised on March 07, 2019 to increase working capital for the Company's future long-term development and to improve its financial ratio. | It was raised on December 12, 2019 to strengthen the working capital needed for the Company's future long-term development and improve the financial ratio. |
| Presentation of private equity benefits | Enrich the working capital to support the operating requirements and various capital needs of the Company and its subsidiaries, support the clinical trials for various indications of new drugs, facilitate the acquisition of drug licenses, improve the financial structure, provide the future long-term business development needs and improve the financial ratio, enhance the overall shareholders' equity, and have a positive impact on the Company's finance and shareholders' equity. | Enrich the working capital to support the operating requirements and various capital needs of the Company and its subsidiaries, support the clinical trials for various indications of new drugs, facilitate the acquisition of drug licenses, improve the financial structure, provide the future long-term business development needs and improve the financial ratio, enhance the overall shareholders' equity, and have a positive impact on the Company's finance and shareholders' equity. |
| Subscribed (converted) share payment certificate (certificates of bond-to-stock conversion), shares and stock grants | None | None |
III. Other Supplementary Information Required: None.
IV. Explanation of the Major Differences with My Country's Provisions on the Protection of Shareholders' Rights and Interests:
Due to the slight inconsistency between the British Cayman Islands Act and the R.O.C. Act, the Taiwan Stock Exchange's recently revised "Checklist for the Protection of Shareholders' Rights and Interests in the Country of Registration of Foreign Issuers" (hereinafter referred to as the "Checklist for the Protection of Shareholders' Rights and Interests") can not be applicable to the Company. The following list describes the differences between the current and effective articles of association of the Company (hereinafter referred to as the "Articles of Incorporation") and the protection of shareholders' rights and interests due to the provisions of the British Cayman Islands Act, as well as the provisions of the Articles of Incorporation of the Company.
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| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| I. Formation and Changes of the Company's Capital | ||
| 1. The Company shall not issue Shares in bearer form. | ||
| 2. A company that has adopted par value shares cannot convert them into no par value shares; likewise, a company that has adopted no par value shares cannot convert them into par value shares. | 1. Article 137 of the Company Act | |
| 2. Article 156-1, Items 5 and 6 of the Company Act. | In response to the amendments to the Tai-Cheng-Shang-Er-Zi No. 11317018041, "Checklist for the Protection of Shareholders' Rights and Interests in the Country of Registration of Foreign Issuers" (hereinafter referred to as the "Checklist for the Protection of Shareholders' Rights and Interests") issued by TSEC on May 2, 2024, and in accordance with the provisions of Taiwan's Company Act, Polaris Pharmaceuticals Inc. (hereinafter referred to as Polaris Company) intends to amend Article 7 of the Articles of Association at the 2024 Shareholders' Meeting. The amendment will state, "...a company that has adopted par value shares cannot convert them into no par value shares; likewise, a company that has adopted no par value shares cannot convert them into par value shares..." to comply with the provisions of the Checklist for the Protection of Shareholders' Rights and Interests. | |
| II. Convening Procedures and Resolution Methods of Shareholders' Meetings | ||
| 1. The Regular Shareholders' Meeting must be convened at least once a year; It should be held within six months after the end of each fiscal year. The Shareholders' Meeting is convened by the Board of Directors of Directors. | ||
| 2. The Articles of Incorporation may provide that the Shareholders' Meeting shall be held by video conference or other means announced by the competent authority of the Company Act of the Republic of China. However, due to acts of God, accidents or other force majeure, the competent authority of the Company Act of the Republic of China may announce that the Company may, within a certain period of time, hold meetings by video conference or public announcement without the provisions of the Articles of Incorporation. | ||
| 3. In case a shareholders' meeting is proceeded via visual communication network, the shareholders attending the meeting remotely shall be deemed to have attended the meeting in person. | 1. Article 170 of the Company Act | |
| 2. Article 172-2 of the Company Act | ||
| 3. Article 172-1 of the Company Act | ||
| 4. Item 1, 2 of Article 173 and Article 173-1 of the Company Act | ||
| 5. Article 172 of the Company Act and Article 26-1, 43-6 of Securities and Exchange Act | In accordance with the Checklist for the Protection of Shareholders' Rights and Interests and the provisions of Taiwan's Company Act, Polaris Company passed a resolution at the Regular Shareholders' Meeting on June 2, 2022, to add provisions allowing the company to hold a Shareholders' Meeting by video conference and to add the word "physical" before the original Shareholders' Meeting designation for distinction. This has no adverse impact on the shareholders' equity. |
| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| 4. The conditions, operating procedures and other matters to be complied with by the Company shall be in accordance with the Securities Act of the Republic of China for the Shareholders' Meeting to be held by video conference. | ||
| 5. The Physical Shareholders' Meeting of the Company shall be held within the territory of the Republic of China. If a Physical Shareholders' Meeting is held outside the Republic of China, the approval of the stock exchange shall be reported to the stock exchange within two days after the resolution of the Board of Directors of Directors or the shareholders' permission for convening by the competent authority. | ||
| 6. A shareholder holding more than one percent of the total number of issued shares may submit a proposal to the Company in writing or electronically. The Board of Directors of Directors shall list the motion as a motion unless it is a resolution on the income of the Shareholders' Meeting, if the proposal is not held by shareholders by 1%, if the proposal is proposed outside the period of acceptance of the public announcement, if the proposal is more than 300 words, or if there is more than one proposal. The Board of Directors still has to include shareholder proposals that urge companies to advance the public interest or fulfill their social responsibilities. | ||
| 7. If a shareholder continues to hold more than 3% of the total number of shares issued for more than one year, he may request the Board of Directors of Directors to call an extraordinary meeting of shareholders by stating in writing the proposed matters and reasons. If the Board of Directors of Directors fails to notify the meeting within 15 days after the request is made, the shareholders may report to the competent authority for permission to convene the meeting on their own. | ||
| 8. Shareholders who continue to hold more than half of the total number of shares issued for more than three months may call an Interim Shareholders Meeting on their own. The period and number of shares held by shareholders shall be calculated on the basis of the shares held at the time of the termination of the transfer of ownership. |
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| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| 9. The following matters shall be enumerated and stated in the cause of convening the Shareholders' Meeting, and shall not be raised by temporary motion; the main contents may be posted on the website designated by the securities authority or the Company, and its web address shall be stated in the notice: | ||
| (1) Election or dismissal of directors or supervisors; | ||
| (2) Change of Articles of Incorporation; | ||
| (3) Capital reduction; | ||
| (4) Apply to suspend the public offerings; | ||
| (5) Dissolution, merger, share conversion and division of the Company; | ||
| (6) Conclude, modify or terminate a contract for leasing all business, entrusting operation, or often cooperating with or with others; | ||
| (7) the transfer of the whole or any material part of the Company's business or assets; and | ||
| (8) The transferee of all the business or property of others has a significant impact on the operation of the Company; | ||
| (9) Private placement of marketable securities with the nature of equity; | ||
| (10) Permission of directors' participation in competitive activities; | ||
| (11) To distribute dividends and bonuses in whole or in part by issuing new shares; | ||
| (12) Where the legal surplus reserve and the capital reserve from issuing premium shares or receiving gifts are distributed to the original shareholders by issuing new shares or cash. | ||
| 1. When holding Shareholders' Meetings, the Company shall list written and electronic forms as one of the channels for exercising voting rights. | ||
| 2. Where the company holds a shareholders' meeting outside the Republic of China, it shall provide shareholders with the right to exercise their voting rights in writing or electronically. | ||
| 2. If the Company exercises its voting right in writing or electronically, the method of exercise shall be specified in the notice of convening the Shareholders' | 1. Article 177-1 of the Company Act | |
| 2. Article 177-2 of the Company Act | Polaris intends to amend Article 66 of the Articles of Association at the 2023 General meeting to: "to the extent permitted by the Cayman Law, the Company shall include electronic means as one of the channels for the exercise of voting rights." delete the last paragraph "Where the company holds a shareholders' meeting outside the Republic of China, it shall provide shareholders with the right to exercise their voting rights in writing or electronically." to |
| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| Meeting. Shareholders who exercise their voting rights in writing or electronically shall be deemed to have attended the shareholders' meeting in person. However, any provisional motion or amendment to the original motion at the meeting shall be deemed as a waiver. | ||
| 3. If a shareholder exercises the right to vote in writing or electronically, the expression of intention shall be delivered to the Company two days before the meeting of the shareholders. In case of any repetition of the expression of intention, the first one delivered shall prevail. Except those who have expressed their intention before the declaration is revoked. | ||
| 4. A shareholder who wishes to attend the Shareholders' Meeting in person after exercising his voting right in writing or electronically shall, two days before the Shareholders' Meeting, revoke the aforesaid expression of intention to exercise the voting right in the same manner as the exercise of the voting right; If the cancellation is delayed, the voting right exercised in writing or electronically shall prevail. | ||
| 5. If a shareholder exercises his voting right in writing or electronically and entrusts an agent to attend the Shareholders' Meeting by proxy, the voting right to be exercised by the entrusted agent shall prevail. | comply with the provisions of the shareholders' rights and interests protection schedule. | |
| 1. The Company shall, 30 days before the meeting of the Regular Shareholders' Meeting or 15 days before the meeting of the Extra Regular Shareholders' Meeting, publish the cause of action and explanatory materials of the notice of Shareholders' Meeting, the power of attorney, the motions relating to recognition and discussion, the matters concerning the election or removal of directors and supervisors. | ||
| 2. The Shareholders' Meeting of the Company shall send the aforesaid information and the paper for the written exercise of the voting right to the shareholders. | ||
| 3. In convening a Shareholders' Meeting, the Company shall prepare a handbook for the proceedings of the Shareholders' Meeting, and shall publish the handbook and other relevant materials of the meeting before the 21st day of the Regular Shareholders' Meeting of | 1. The Handbook of Shareholders' Meeting of the public company shall record and comply with Article 5 of the Measures | |
| 2. The Handbook of Shareholders' Meeting of the public company shall record and comply with Article 6 of the Measures | Polaris Company intends to update the latter paragraph of clause 45 at the 2023 Shareholders' Meeting in accordance with the Checklist for the Protection of Shareholders' Rights and Interests "However, if the paid-in capital of the company reaches NT $10 billion or more on the end of the most recent fiscal year, or if the total shareholding ratio of foreign and domestic shareholders recorded in the shareholders' register of the most recent fiscal year reaches 30% or more, the files delivered electronically shall be completed 30 days before the Regular Shareholders' Meeting." |
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| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| shareholders or the 15th day of the Interim Shareholders' Meeting. However, if the Company has a paid-in capital of NTD10 billion or more as of the end of the most recent fiscal year, or if the total shareholding ratio of foreign and domestic shareholders recorded in the shareholders' register during the most recent fiscal year reaches 30% or more, the file delivered electronically shall be completed 30 days before the Regular Shareholders' Meeting. | ||
| 1. The Company shall, 30 days before the meeting of the Regular Shareholders' Meeting or 15 days before the meeting of the ExtraRegular Shareholders' Meeting, publish the cause of action and explanatory materials of the notice of Shareholders' Meeting, the power of attorney, the motions relating to recognition and discussion, the matters concerning the election or removal of directors and supervisors. | ||
| 2. The Shareholders' Meeting of the Company shall send the aforesaid information and the paper for the written exercise of the voting right to the shareholders. | ||
| 3. In convening a Shareholders' Meeting, the Company shall prepare a handbook for the proceedings of the Shareholders' Meeting, and shall publish the handbook and other relevant materials of the meeting before the 21st day of the Regular Shareholders' Meeting of shareholders or the 15th day of the Interim Shareholders' Meeting. However, if the Company has a paid-in capital of NTD10 billion NTD2 billion or more as of the end of the most recent fiscal year, or if the total shareholding ratio of foreign and domestic shareholders recorded in the shareholders' register during the most recent fiscal year reaches 30% or more, the file delivered electronically shall be completed 30 days before the Regular Shareholders' Meeting. | 1. The Handbook of Shareholders' Meeting of the public company shall record and comply with Article 5 of the Measures | |
| 2. The Handbook of Shareholders' Meeting of the public company shall record and comply with Article 6 of the Measures | Polaris Company intends to amend the latter paragraph of Article 45 at the 2024 Shareholders' Meeting in accordance with the Checklist for the Protection of Shareholders' Rights and Interests as follows: "...if the company's paid-up capital reaches NT $2 billion or more at the end of the most recent financial year, or if the total shareholding ratio of foreign and domestic investors recorded in the register of the most recent financial year shareholders reaches 30% or more, the electronic files shall be completed 30 days before the regular shareholders' meeting." to comply with the provisions of the shareholders' rights and interests protection schedule. | |
| 1. When the Shareholders' Meeting decides on one of the following matters, the opposing shareholders shall have the right to claim for the purchase of shares of the Company: | ||
| (1) Division, merger, acquisition or share conversion of the company; of the Company; | ||
| (2) The operation of the Company is materially affected by the conclusion, alteration or | 1. Article 317, Article 186 of the Company Act. | |
| 2. Article 12 of Business Mergers and Acquisitions Act | There is no difference between the Articles of Incorporation and the Checklist for Protection of Shareholders' Rights and Interests. |
| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| termination of a contract by the Company to lease the whole of its business, to entrust the business or to operate with or from time to time with another person, to assign all or a substantial part of its business or property, or to accept the whole of its business or property from another person. | ||
| 2. Any request made by a shareholder in the preceding paragraph shall be made in writing within 20 days from the date of the resolution of the Shareholders' Meeting, and the purchase price shall be specified. If an agreement is reached between the shareholders and the Company on the purchase price, the Company shall pay the price within 90 days from the date of resolution of the Shareholders' Meeting. If no agreement has been reached, the Company shall, within 90 days from the date of the resolution, pay the price to the shareholder who has not reached an agreement at the price it deems fair; If the company fails to pay, it shall be deemed to agree to the purchase price requested by the shareholder. | ||
| 3. A shareholder who votes against or waives his right to vote at a meeting of shareholders may, in accordance with the matter set out in Item 1 (1), request the Company to purchase all his shares. If the shareholders and the Company fail to reach an agreement on the purchase price within 60 days from the date of resolution of the Shareholders' Meeting, the Company shall, within 30 days after the expiration of such period, apply to the court for the ruling of the price with all the shareholders who have not reached an agreement as their counterparts, and the Taipei District Court of Taiwan shall be the court of first instance. | ||
| 4. The number of shares whose voting rights have been waived in the preceding paragraph shall not be counted as the voting rights of shareholders already present. |
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129
| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| III. Powers and Responsibilities of Directors | ||
| 1. If a director of the Company has a stake in matters at the Board of Directors Meeting, he shall explain to the next Board of Directors the important content of his interest; at the time of the merger and acquisition of the Company, the directors of the Company shall explain to the Board of Directors of Directors and the Board of Directors of Shareholders the important content of their own interests in the merger and acquisition transaction and the reasons for or against the merger resolution. The Company shall also state the important contents of the directors' interests and the reasons for or against the merger resolution in the convening of the Shareholders' Meeting. The contents may be posted on the website designated by the securities authority of the Republic of China or the Company, and the website shall be indicated in the notice. | ||
| 2. The spouses, relatives within the second generation of the directors, or the companies with which the directors have controlling affiliations and have an interest in the matters mentioned in the preceding meeting shall be deemed to have their own interest in the matters. | ||
| 3. Where a director of a company has his own interest in matters at the Board of Directors meeting which may be detrimental to the interests of the company, he/she shall not join in the voting and shall not exercise his/her voting rights on behalf of other directors. The resolution of the Board of Directors of Directors shall not count in the voting rights of the directors present for the directors who are not allowed to exercise their voting rights under the foregoing provisions. | Items 2, 3 and 4, Article 206 of the Company Act, Items 3 and 4, Article 5 of the Business Mergers and Acquisitions Act | There is no difference between the Articles of Incorporation and the Checklist for Protection of Shareholders' Rights and Interests. |
| 1. Shareholder(s) continuously holding 1% or more of the issued and outstanding Shares of the Company for six months or more may, subject to the laws of the Cayman Islands, request an Independent Director of the Audit Committee to file a lawsuit for the Company against the Director(s) in Taipei District Court of Taiwan. | ||
| 2. If the Audit Committee fails to file a lawsuit within 30 days after receiving such request, such qualified Shareholder(s) may file a lawsuit for the Company against the Director(s) in Taipei District Court of Taiwan; and | Article 214 of the Company Act | |
| The Exercise of Powers by Audit Committee of Public Company Article 5 | Polaris intends to amend Article 75, Item D of the Articles of Association at the 2024 Shareholders' Meeting to read: "...Subject to the laws of the Cayman Islands, Shareholder(s) who continuously hold 1% or more of the issued and outstanding Shares of the Company for six months or more may request Independent—Director(s)—of—the Audit Committee in writing to file a lawsuit for the Company against the Director(s) in Taipei District Court of Taiwan. If the |
| Important Matters for the Protection of Shareholders' Rights and Interests | Acts Related to the Corporations Act or the Securities Exchange Act | Articles of Incorporation and Reasons for Differences |
|---|---|---|
| under such circumstances, the Company may request the suing Shareholder(s) to post an appropriate bond as security for the lawsuit proceeding under the Taiwan Laws. | ||
| 3. Unless the Board of Directors fails to convene or is unable to convene the Shareholders' meeting, the Supervisor may, in the interest of the Company, convene the Shareholders' meeting when necessary. | Independent—Director(s) Audit Committee fail to file a lawsuit within 30 days after receiving such request, such qualified Shareholder(s) may file a lawsuit for the Company against the Director(s) in Taipei District Court of Taiwan. Under such circumstances, the Company may request the suing Shareholder(s) to post an appropriate bond as security for the lawsuit proceeding under Taiwan laws." | |
| This amendment is intended to comply with the provisions of the shareholders' rights and interests protection schedule. |
V. In the Most Recent Year and as of the Date of Publication of the Annual Report, Any Event That Has a Material Impact on the Equity of Shareholders or the Price of Securities as Specified in Paragraph 2, Item 3, Article 36 of the Securities Exchange Act Has Occurred: None.
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Polaris Group

Person in Charge: Hsu, Jaan-Pyng
