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PegBio Co., Ltd. — Interim / Quarterly Report 2025
Aug 26, 2025
50676_rns_2025-08-26_3a566f1c-4fca-42d9-a28b-59682ec5b8b6.pdf
Interim / Quarterly Report
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Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.

PegBio Co., Ltd.
派格生物醫藥(杭州)股份有限公司
(A joint stock company incorporated in the People's Republic of China with limited liability)
(Stock Code: 2565)
ANNOUNCEMENT OF INTERIM RESULTS FOR THE SIX MONTHS ENDED JUNE 30, 2025
The Board of Directors of PegBio Co., Ltd. is pleased to announce the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2025, together with comparative figures for the same period of 2024. The consolidated financial statements of the Group for the Reporting Period have been reviewed by the Audit Committee and the Company's auditor.
Certain amounts and percentage figures included in this announcement have been subject to rounding adjustments or have been rounded to one or two decimal places, as appropriate. Any discrepancies in any table, chart or elsewhere totals and sums of amounts listed therein are due to rounding.
FINANCIAL HIGHLIGHTS
OPERATING RESULTS
| Six months ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| (unaudited) | (unaudited) | |
| Loss from operations | (92,135) | (154,330) |
| Loss for the period | (93,672) | (155,490) |
| Loss per share – Basic and diluted (RMB) | (0.25) | (0.42) |
| FINANCIAL POSITION | ||
| At | At | |
| June 30, | December 31, | |
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| (unaudited) | (audited) | |
| Non-current assets | 37,268 | 28,063 |
| Current assets | 346,079 | 190,294 |
| Total assets | 383,347 | 218,357 |
| Non-current liabilities | 10,363 | 3,221 |
| Current liabilities | 112,535 | 157,666 |
| Total liabilities | 122,898 | 160,887 |
| Total equity | 260,449 | 57,470 |
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BUSINESS HIGHLIGHTS
As of the date of this announcement, we have made significant progress in advancing our technology innovations, product pipeline and business operations in the U.S. and China.
As of the date of this announcement, PegBio has successfully established a pipeline matrix covering 6 investigational drugs for chronic diseases. The Company’s core strategy focuses on the treatment of metabolic diseases and complications thereof. Through continuous innovation, our internal assessments show that multiple drug candidates possess the dual value potential of “First-in-Class” (FIC) and “Best-in-Class” (BIC), laying a solid foundation for future market competitiveness. Leveraging the unique integrated strategic system of “Target Selection – Clinical Development – Commercialization”, the Company has made an all-out effort to achieve the following key milestones in the first half of 2025.
I. RESEARCH AND DEVELOPMENT AND COMMERCIALIZATION PROGRESS OF THE CORE PRODUCT
Self-developed long-acting GLP-1 receptor agonists for PB-119 (Visepegenatide injection)
Review dynamics:
During the Reporting Period, PB-119 officially entered the supplementary review stage with the National Medical Products Administration of China (NMPA) on 22 May 2025. The Company is efficiently organizing resources and sparing no effort to advance the submission and communication of supplementary materials.
Marketing plan:
Based on the current review progress and active interaction with regulatory authorities, new drug application (NDA) approval is expected to be obtained in the third quarter of 2025. The Company has simultaneously completed key preparations for commercial production, ensuring a rapid and stable supply upon approval to meet clinical needs.
Market strategies:
The product positioning will strengthen its differentiated evidence-based medical value of “high safety, long-acting blood glucose control advantages, and potential cardiovascular benefits”. Strategically, the Company shall:
- actively implement market access: accelerating the process of hospital access and tendering on the procurement platform;
- build a full-channel coverage network: strategically positioning in core hospitals, direct-to-patient pharmacies and online platforms to enhance patient accessibility;
- explore innovative payment solutions: collaborating with multiple payment parties to reduce the burden of medication costs on patients; and
- strengthen academic drive: building brand recognition and expert consensus through high-quality clinical evidence and professional medical communication.
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II. PROGRESS OF OTHER INVESTIGATIONAL PIPELINES
Projects in clinical stage:
All projects in the clinical research stage (including Phases I/II) are in strict compliance with the established R&D plan and quality standards, systematically advancing subsequent clinical trial enrollment, data collection, and analysis work.
Preclinical projects:
Projects in the preclinical research stage achieve phased R&D goals based on the preset key milestones, such as candidate molecule identification, completion of pharmacodynamic studies, and achievement of safety evaluation standards, laying the foundation for subsequent IND applications.
MANAGEMENT DISCUSSION & ANALYSIS
I. OVERVIEW
Founded in 2008, we are a biotechnology company focused on the in-house discovery and development of innovative therapies, primarily peptide and small molecule drugs, for chronic diseases with a particular emphasis on metabolic disorders. We have self-developed one Core Product and other five product candidates to capture the market potential in prevalent chronic and metabolic diseases, including type 2 diabetes mellitus (“T2DM”, also known as type 2 diabetes), obesity, non-alcoholic steatohepatitis (“NASH”), opioid-induced constipation (“OIC”, a gastrointestinal disorder induced by the usage of opioid drugs) and congenital hyperinsulinemia (a rare endocrine disease whose patients experience constant hypoglycemia).
II. BUSINESS REVIEW
Our Products and Product Pipeline
We focus on leveraging our industry experience and established R&D capabilities for the in-house discovery and development of differentiated therapeutics primarily for chronic and metabolic diseases. As of June 30, 2025, we had developed a diverse pipeline of six product candidates, among which three were undergoing clinical trials and one had received IND clearance. We have applied our polyethylene glycol (“PEG”) technology to our product candidates to optimize their physiochemical properties to achieve features such as long-acting efficacy and selective targeting of receptors in the digestive tract but not in the brain.
The following chart summarizes the development status of our drug candidates as of June 30, 2025.

Core Product PB-119, a near-commercialized, long-acting GLP-1 receptor agonist
Our Core Product PB-119 is a self-developed, near-commercialized, long-acting GLP-1 receptor agonist primarily designed for the first-line treatment of T2DM and obesity. PB-119 is a GLP-1 derivative derived from exenatide backbone with PEG chains covalently conjugated to the peptide to extend the half-life of exenatide in the circulation by increasing the relative molecular mass and decreasing the renal clearance rate. Conjugating PEG chains to drug molecules, also referred to as PEGylation, is a proven method of extending half-life of compound and enhancing long-acting efficacy, improving compound stability and reducing immunogenicity. With PEGylation, we are able to further extend the half-life of PB-119 to enable once-weekly administration compared to daily administration for exenatide.
PB-119 features a single-dose formulation without dose titration resulted from its safety and rapid, significant and sustained efficacy at relatively low dose levels. Such a single-dose formulation eases administration that potentially enhances patient compliance, and differentiates PB-119 from the other peer products currently on the market that may be prone to misuse due to the complexity of dose titration.
In September 2023, the NMPA accepted our NDA of PB-119 for the treatment of T2DM in China, marking a key milestone for its upcoming commercialization. We expect to receive the NDA approval from the NMPA and commercially launch PB-119 for the treatment of T2DM in China in 2025. We plan to price PB-119 at a competitive level to make it broadly accessible to patients in need, and we intend to partner with pharmaceutical companies who have strong commercialization capability and rich experience in the therapeutic fields we are focusing on, to utilize their well-established sales networks and other resources to cost-efficiently maximize the commercial value of PB-119.
In addition, in China, we plan to initiate two more Phase III clinical trials for combination therapies of PB-119 with either basal insulin to evaluate the efficacy of PB-119 in T2DM patients with poor glycemic control treated with insulin glargine or with SGLT-2 inhibitor to evaluate the efficacy and safety of PB-119 in T2DM patients with poor glycemic control after dagliflozin monotherapy, and one Phase III clinical trial for PB-119 to evaluate cardiovascular outcomes in T2DM patients in 2025. In light of the weight-loss efficacy of PB-119 observed in its Phase III clinical trials for T2DM, we also plan to assess the efficacy of PB-119 in the treatment of obesity. In June 2021, the NMPA approved our IND application of PB-119 for the treatment of obesity in China. We finalized the clinical trial protocol in February 2024 and received the approval from the NMPA to commence the clinical trial in April 2024. We are initiating the Phase Ib/IIa clinical trial of PB-119 for the treatment of obesity, and we completed participant enrollment in June 2024.
During the Reporting Period, PB-119 officially entered the supplementary review stage with the National Medical Products Administration of China (NMPA) on 22 May 2025. The Company is efficiently organizing resources and sparing no effort to advance the submission and communication of supplementary materials.
Marketing plan:
Based on the current review progress and active interaction with regulatory authorities, new drug application (NDA) approval is expected to be obtained in the third quarter of 2025. The Company has simultaneously completed key preparations for commercial production, ensuring a rapid and stable supply upon approval to meet clinical needs.
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Market strategies:
The product positioning will strengthen its differentiated evidence-based medical value of "high safety, long-acting blood glucose control advantages, and potential cardiovascular benefits". Strategically, the Company shall:
- actively implement market access: accelerating the process of hospital access and tendering on the procurement platform;
- build a full-channel coverage network: strategically positioning in core hospitals, direct-to-patient pharmacies and online platforms to enhance patient accessibility;
- explore innovative payment solutions: collaborating with multiple payment parties to reduce the burden of medication costs on patients; and
- Strengthen academic drive: building brand recognition and expert consensus through high-quality clinical evidence and professional medical communication.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET PB-119 SUCCESSFULLY.
PB-718, a long-acting GLP-1/GCG dual receptor agonist
PB-718 is a novel long-acting GLP-1/glucagon (“GCG”) dual receptor agonist primarily designed for the treatment of obesity and NASH. PB-718 simultaneously activates both the GLP-1 and GCG receptors. This dual activation leads to a synergistic effect that surpasses the efficacy of either receptor agonist alone, characterized by significant weight loss and reduced appetite. Composed of a combination of GLP-1 receptor agonist and GCG receptor agonist, we believe that PB-718 may offer the flexibility of balancing the activation of GLP-1/GCG receptors to achieve optimal efficacy and safety profiles. This is because complementary mechanisms of action provide the opportunity to achieve earlier and more sustainable glycemic control with increased patient adherence and reduced side-effect profiles. There is also the potential to reduce disease progression and vascular complication risk. In addition, our preliminary study results showed that PB-718 decreased lipid accumulation in liver which prevents hepatic inflammation and subsequent liver fibrosis.
We also applied PEGylation to extend the half-life of PB-718, thereby reducing the dosing frequency to just once a week, which we believe could similarly enhance the patient compliance and convenience of administration. We completed a Phase I clinical trial (PB718-001) for PB-718 on healthy participants in the United States which demonstrated good safety and efficacy profiles of PB-718. We have also completed the participant follow-up for a Phase Ib/IIa clinical trial to evaluate PB-718 for the treatment of obese patients in China.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET PB-718 SUCCESSFULLY.
PB-1902, a potential first-in-class oral selective opioid receptor antagonist for the treatment of OIC
PB-1902 is a potential first-in-class oral selective opioid receptor antagonist for the treatment of OIC, a common adverse reaction in patients undergoing long-term opioid therapy for cancer pain and other chronic pain conditions. OIC can lead to severe gastrointestinal complications and adversely impact the quality of life for patients. Constipation may manifest early in the administration of opioid drugs and persist throughout their usage. Conventional medications for chronic constipation offer limited efficacy in addressing OIC. Opioid receptor antagonists are proved to be an effective therapeutic approach for improving OIC. However, such opioid receptor antagonists could partially hinder the central pain-relieving effect of opioid drugs. Additionally, all approved opioid receptor antagonists in China require daily subcutaneous injection, posing inconvenience to patients.
We are developing PB-1902 as the potential first-in-class oral selective opioid receptor antagonist in China. It is designed to effectively alleviate opioid-induced bowel dysfunction without diminishing the central pain-relieving effects of opioids, rendering PB-1902 as an ideal treatment option for OIC. We have completed two Phase I clinical studies which showed good safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles of PB-1902 in healthy participants in China. In October 2022, the NMPA responded in writing with no objection for us to conduct a Phase II clinical trial of PB-1902 for the treatment of OIC in China. We plan to commence the Phase II clinical trial in China in 2025.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET PB-1902 SUCCESSFULLY.
PB-722, a GCG receptor agonist being developed for the treatment of congenital hyperinsulinemia
PB-722 is a GCG receptor agonist being developed for the treatment of congenital hyperinsulinemia and has been granted the Orphan Drug Designation by the FDA in May 2021. PB-722 has demonstrated its safety in several animal models and its efficacy in raising and maintaining blood glucose levels in a hypoglycemic animal model. In May 2023, the NMPA approved our IND application to conduct clinical trial of PB-722 for the treatment of congenital hyperinsulinemia in China, rendering PB-722 the first drug candidate with IND approval for the treatment of congenital hyperinsulinemia in China. We plan to initiate a randomized, double-blind, placebo-controlled, dose-escalating Phase I clinical trial to test the safety, tolerability, PK and PD profiles of PB-722 single dose subcutaneous injection in 2026. We expect to initiate a Phase II clinical trial in 2027.
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WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET PB-722 SUCCESSFULLY.
PB-2301, a GLP-1/GIP dual receptor agonist for the treatment of T2DM, NASH and obesity
PB-2301 is a GLP-1/glucose-dependent insulinotropic polypeptide (“GIP”) dual receptor agonist for the treatment of T2DM, NASH and obesity. We are conducting multiple preclinical studies to test the safety and efficacy profiles of PB-2301. We believe PB-2301 has the potential to further enhance the performance of current GLP-1 receptor agonist candidates. We plan to advance PB-2301 to clinical development for the treatment of T2DM, NASH and obesity and submit the IND applications to the NMPA in 2026.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET PB-2301 SUCCESSFULLY.
PB-2309, a GLP-1/GIP/GCG triple receptor agonist for the treatment of T2DM, NASH and obesity
PB-2309 is a GLP-1/GIP/GCG triple receptor agonist for the treatment of T2DM, NASH and obesity. We are conducting multiple preclinical studies to test the safety and efficacy profiles of PB-2309. We believe PB-2309 has the potential to further enhance the performance of current GLP-1 receptor agonist candidates. We plan to advance PB-2309 to clinical development for the treatment of T2DM, NASH and obesity and submit the IND applications to the NMPA in 2025.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET PB-2309 SUCCESSFULLY.
Research and Development
We have established an R&D team with strong expertise, deep understanding and broad development experience in chronic and metabolic diseases. Our R&D team members conduct drug discovery, clinical development and regulatory affairs. The majority of our drug discovery team members had over a decade of relevant work experience. We have worked on our product candidates’ advancement for more than 13 years and developed our product candidates in-house for losing fat and building muscle. The majority of our drug discovery team members have obtained post-graduate degrees, with respective expertise in biology, medicinal chemistry, drug metabolism and pharmacokinetics, chemistry and early clinical areas, which together support our product development. Our proprietary in-house drug discovery capabilities comprise (i) identifying medical needs and integrating real-world data, improving Artificial intelligence compound design, and establishing multi-target molecules with desired therapeutic benefits to design novel and multifunctional drug candidates; (ii) performing efficacy evaluation of drug candidates including but not limited to pharmacological activities, pharmacokinetics and toxicities; and (iii) developing formulations, and analytical assays for quality control and assurance. During the drug discovery stage, our R&D team carries out synthesis and optimization for potential drug candidates. During the drug evaluation stage, our drug discovery team coordinates and accomplishes preclinical R&D activities in relation to the product candidates’ pharmacology, pharmacokinetics and toxicology.
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As of June 30, 2025, our clinical development team consisted of scientists and physicians with strong drug development experience, who participate in clinical development strategy development, clinical trial protocol design, clinical trial operation organization, drug safety monitoring, and clinical trial quality control.
For the six months ended June 30, 2025 and 2024, our R&D expenses were RMB26.3 million and RMB64.0 million, respectively.
Chemistry, Manufacturing & Controls ("CMC")
As of June 30, 2025, our CMC team consisted of professionals with extensive experience in process development, production and quality management from well-known biopharmaceutical and pharmaceutical companies. Many of the CMC team members had over a decade of relevant work experience. Our CMC team specialized in preclinical and clinical support throughout the drug development process. The CMC function in our Company plays a critical role in drug development. It is responsible for developing safe, robust, and economically sound production processes for our drug substances and drug products, and ensuring their quality meets regulatory requirements.
As of the date of this announcement, we did not have commercialization-scale manufacturing facility. Currently we do not have any plans to establish our own manufacturing facilities to support our preclinical and clinical studies or produce future commercial supplies. We collaborate with CDMOs (including CMOs) to conduct and support our preclinical and clinical studies in line with industry practice. We believe our major CDMO partners possess sufficient production capacity and commercial production experience in the key compounds for our R&D activities such as peptide compounds.
Commercialization
As of June 30, 2025, we did not have any commercialized product.
We have established an in-house marketing team that is primarily responsible for the related business activities, such as formulation of commercialization strategies, conducting academic marketing campaigns, and collaboration discussions with potential business partners. However, considering the potentially significant sales cost, we do not intend to build our internal sales team. Instead, we plan to form a win-win cooperation with selected commercialization partners to leverage their access to a wide range of pharmacies, clinics and hospitals, to better capture the market potential and maximize the value of our Core Product. In particular, we plan to partner with pharmaceutical companies who have strong commercialization capability and rich experience in the therapeutic fields we are focusing on, to utilize their well-established sales networks and other resources to achieve mutually beneficial results and maximize the commercial value of our drug candidates.
While we plan to continue developing our current pipeline products and future candidates in-house in the short - to mid-term, we may also seek commercialization collaboration opportunities with potential domestic and overseas partners to further propel our product development.
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For the overseas market, we generally plan to take a step-wise approach and plan to formulate a more concrete plan after we commercialize PB-119 in China, to ensure we allocate our resources and focus on the most important and imminent milestones. As of the date of this announcement, we had not selected or initiated any negotiations with a local partner in the United States for any potential co-development and/or commercialization of PB-119. We may also seek collaborations to conduct clinical development and launch our product candidates upon regulatory approval in other overseas markets such as Europe and jurisdictions amongst the "Belt and Road Initiative" countries, including countries in the Middle East and South Asia.
To ensure the successful launch and subsequent success of our core product in the PRC market, Paidakang®(派達康®) (PB-119), the Company has comprehensively established a systematic commercial preparation system. Currently, all work is progressing in an orderly manner in line with the predetermined launch plan:
- Pre-launch planning and execution:
The overall pre-launch strategic planning for Paidakang® (派達康®) has been completed and is in the process of strict implementation according to the timetable.
- Formulation of pricing strategy:
Based on a comprehensive analysis of product value, market positioning, and competitive landscape, a scientific and competitive pricing strategy has been established to ensure effective implementation after launching.
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Academic promotion and expert network development:
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actively organizing multi-level academic conferences, covering core and regional key opinion leaders (KOLs), effectively reaching a large group of endocrinology doctors, and communicating the clinical value of products.
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collaborating with authoritative experts to publish in-depth academic interviews through professional media platforms, precisely covering target professionals and generating widespread attention.
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Promotion methods and materials preparation:
Core promotional materials (including key visual (KV), drug mechanism videos, and standardized training materials) and materials required for the launch event have been completed, and related activity plans are ready.
- Patient support and welfare system:
The plan of "Patient Care Program" has been finalized, and preliminary preparatory work (including communication with relevant foundations and the integration of the pharmacovigilance (PV) system) is currently under active advancement, with immediate implementation subject to product approval.
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- Innovative payment and market access:
In response to the competitive landscape in market, the final planning for the innovative payment project is nearing completion, aiming to tailor a more advantageous patient accessibility solution for Paidakang® (派達康®).
- Establishment of long-term medical values:
We have initiated planning for investigator-initiated trials (IITs), and concurrently, expert consensus/guideline participation and indication expansion strategy research in relevant disease areas are being advanced to lay the academic foundation for maximizing product value throughout its lifecycle.
Collaboration arrangement for commercializing PB-119
We entered into a commercialization collaboration arrangement (the “Collaboration Agreement”) on September 13, 2024 with a commercialization partner (the “Commercialization Partner”) regarding the future marketing and commercialization activities of PB-119 in Mainland China. As disclosed in the Prospectus, according to the Collaboration Agreement, if we fail to obtain the drug registration certificate for PB-119 from the NMPA by March 31, 2025, our Commercialization Partner has the right to unilaterally terminate the agreement upon written notice, and if such termination notice is not provided by the Commercialization Partner by June 30, 2025, the Collaboration Agreement will remain in effect, in which case both parties may need to engage in further negotiations regarding potential adjustments to the milestone events and payments.
In view of the development status of PB-119, the Collaboration Agreement was terminated in June 2025, with the parties being in negotiation of potential new arrangement for marketing and commercialization of PB-119 taking into account of its latest development status. Meanwhile, we will also identify other potential collaboration partners and explore possible collaboration arrangements for commercializing PB-119.
Intellectual Property
Intellectual property rights are pivotal to the success of our business. Our commercial future will depend, in part, on our ability to acquire and protect our intellectual property rights for commercially significant technologies, inventions and know-how. This includes acquisition of new patents, defense of existing patents, and protection of our trade secrets. We will also have to operate without infringing, misappropriating, or otherwise violating third parties' valid, enforceable intellectual property rights.
As of June 30, 2025, we held 83 patents and patent applications, including 13 patents and 15 patent applications in relation to our Core Product. As of June 30, 2025, all of our material patents and patent applications were self-owned and all of our clinical-stage drug candidates were derived out of our HECTOR® platform and PEGylation technologies.
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Future and Prospects
Looking ahead, the Company will continue to firmly execute our established strategy, focusing on chronic disease areas with significant social value and market potential, and committing to addressing critical unmet clinical needs in such areas. To this end, we will focus on promoting the following three core strategic initiatives:
Accelerating the commercialization process of core products to benefit Chinese patients:
Currently, our core investigational product PB-119 is undergoing a critical review phase with the National Medical Products Administration of China (NMPA). The Company will continue to invest resources, fully cooperate and efficiently advance the phased work of various review and approval requirements, ensuring a smooth and orderly review process. We aim to successfully launch PB-119 in the Mainland China market in the third quarter of 2025, bringing this innovative therapy to Chinese patients in urgent need as soon as possible. Meanwhile, the Company has commenced comprehensive market access preparations and commercialization layout, laying a solid foundation for the successful promotion of the product after its launch.
Deepening the R&D pipeline value and planning for future growth drivers:
While promoting the commercialization of our core products, the Company will continue to invest in research and development, and deeply explore the potential of our existing pipeline. We plan to actively promote two early-stage R&D projects with potential BIC prospects. Currently, both projects are progressing smoothly, and the Company is allocating resources to accelerate their preclinical research and development work. The Company aims to complete the relevant preparatory work as soon as possible following the Reporting Period and formally submit the investigational new drug (IND) application, with the view of entering the clinical research phase early and reserving new growth engines for the Company's long-term development. These projects demonstrate our continuous commitment to innovation and addressing unmet clinical needs.
Expanding the global cooperation network and building an internationalized development pattern:
Internationalization is an essential long-term strategic direction for the Company. For PB-119, a core product to be launched in the PRC, we have simultaneously initiated its registration pathway planning in the Middle East market, actively researching the regulatory requirements of the target market to prepare for subsequent registration applications. We aim to expand market access opportunities in the "Belt and Road Initiative" countries and unleash the potential of emerging markets. In addition, the Company will continue to actively explore and evaluate diversified cooperation opportunities with multinational pharmaceutical companies, such as joint development, license-in, or license-out of R&D pipelines. By building an open and win-win global cooperation network, the Company aims to accelerate the global development process of innovative drugs, maximize product value, diversify R&D risks, and enhance our international competitiveness and influence.
The Company is confident in our future development. By focusing on core strategies, namely accelerating the commercialization of PB-119, deepening the value realization of high-potential pipelines, and actively building a global cooperation network, we aim to consolidate and enhance our leading position in the field of chronic disease treatment, continuously create value, reward investors with excellent performance, and make positive contributions to improving health for global patients.
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III. FINANCIAL REVIEW
Overview
We currently have no products approved for commercial sale and have not generated any revenue from product sales. We had not been profitable and incurred operating losses during the Reporting Period. For the six months ended June 30, 2025, we had a total loss of RMB93.7 million, compared to the total loss of RMB155.5 million for the six months ended June 30, 2024. Our total loss mainly resulted from research and development expenses, as well as administrative expenses.
As the NDA for PB-119 have been accepted by the NMPA, we expect to commercialize PB-119 in China in the near future. Subsequent to the Listing, we expect to incur costs associated with operating as a public company. We expect that our financial performance will fluctuate from period to period due to the development status of our drug candidates, timeline and terms of potential collaboration with our partners, regulatory approval timeline and commercialization of our drug candidates.
Loss for the Period
Net loss was RMB93.7 million for the six months ended June 30, 2025, representing a decrease of RMB61.8 million from RMB155.5 million for the six months ended June 30, 2024. The decrease was primarily due to the decrease in share-based compensation expenses and the reduction in R&D expenses as PB-119 was in the NDA stage.
Non-HKFRS Measure
To supplement the Group's consolidated net loss which is presented in accordance with the HKFRS Accounting Standards, the Company has provided adjusted net loss as additional financial measure, which is not required by, or presented in accordance with, the HKFRS Accounting Standards.
Adjusted net loss for the period represents the net loss excluding the effect of a non-cash item, namely the share-based compensation expenses. The term adjusted net loss is not defined under the HKFRS Accounting Standards.
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The table below sets forth a reconciliation of the loss to adjusted loss during the periods indicated:
| Six months ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| RMB’000 | RMB’000 | |
| (Unaudited) | (Unaudited) | |
| Loss for the period | (93,672) | (155,490) |
| Add: | ||
| Share-based compensation expenses | 42,572 | 87,660 |
| Adjusted net loss | (51,100) | (67,830) |
The Company believes that the adjusted non-HKFRS measure is useful for understanding and assessing the underlying business performance and operating trends, and that the Company's management and investors may benefit from referring to this adjusted financial measure in assessing the Group's financial performance by eliminating the impact of certain unusual, non-recurring, non-cash and/or non-operating items that the Group does not consider indicative of the performance of the Group's core business. This non-HKFRS measure, as the management of the Group believes, is widely accepted and adopted in the industry in which the Group is operating. However, the presentation of this non-HKFRS measure is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with the HKFRS Accounting Standards. Shareholders of the Company and potential investors should not view the adjusted results on a stand-alone basis or as a substitute for results under HKFRS Accounting Standards, and this non-HKFRS measure may not be comparable to similarly-titled measures represented by other companies.
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Revenue
We currently have no products approved for commercial sale and have not generated any revenue from product sales.
R&D Expenses
| Six months ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| RMB’000 | RMB’000 | |
| (Unaudited) | (Unaudited) | |
| Third-party contracting expenses | 13,854 | 20,859 |
| Staff costs | 8,318 | 11,112 |
| Cost of materials and consumables | 1,490 | 7,081 |
| Share-based compensation expenses | 1,143 | 23,417 |
| Depreciation and amortization expenses | 526 | 832 |
| Others | 963 | 737 |
| Total | 26,294 | 64,038 |
R&D expenses are RMB26.3 million for the six months ended June 30, 2025, representing a decrease of RMB37.7 million from RMB64.0 million for the six months ended June 30, 2024, primarily due to (i) the decreased share-based compensation expenses by RMB22.3 million, mainly due to the one-off impacts of the cancellation and the modification of the vesting conditions of restricted share units ("RSUs") during the six months ended June 30, 2024; and (ii) the reduction in R&D expenses as PB-119 was in the NDA stage.
Administrative Expenses
| Six months ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| RMB’000 | RMB’000 | |
| (Unaudited) | (Unaudited) | |
| Share-based compensation expenses | 41,429 | 64,243 |
| Staff costs | 6,356 | 7,478 |
| Professional and consulting service fees | 10,139 | 16,972 |
| Depreciation and amortization expenses | 993 | 360 |
| Others | 2,337 | 2,283 |
| Total | 61,254 | 91,336 |
Administrative expenses are RMB61.3 million for the six months ended June 30, 2025, representing a decrease of RMB30.0 million from RMB91.3 million for the six months ended June 30, 2024, primarily due to (i) the decreased share-based compensation expenses by RMB22.8 million, mainly due to the impacts of the above-mentioned cancellation and modification of RSUs during the six months ended June 30, 2024; and (ii) the decrease in listing expenses as we completed the Listing in May 2025.
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Liquidity and Capital Resources
We monitor and maintain a level of cash and cash equivalents deemed adequate to finance our operations and mitigate the effects of fluctuations in cash flows. In addition, we monitor the utilization of borrowings and, from time to time, evaluate the options to renew the borrowings upon expiry based on our actual business requirement. We relied on equity financing as the major sources of liquidity during the Reporting Period.
During the Reporting Period, we incurred negative cash flows from our operations and substantially all of our operating cash outflows resulted from our research and development and administrative activities. Our operating activities used RMB106.2 million and RMB78.0 million of cash for the six months ended June 30, 2024 and 2025, respectively.
We expect to generate more cash flow from our operating activities, through launching and commercializing our products and enhancing our cost containment capacity and operating efficiency. In order to bring to fruition our research and development objectives, we will ultimately need additional funding sources and there can be no assurances that they will be made available.
The following table sets forth our cash flows for the periods indicated:
| Six months ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| (Unaudited) | (Unaudited) | |
| Net cash used in operating activities | (78,035) | (106,194) |
| Net cash generated from investing activities | 86,841 | 72,988 |
| Net cash generated from financing activities | 228,805 | 7,816 |
| Net increase/(decrease) in cash and cash equivalents | 237,611 | (25,390) |
| Cash and cash equivalents at the beginning of the period | 28,392 | 77,147 |
| Effect of foreign exchange rate changes | (1,474) | - |
| Cash and cash equivalents at the end of the period | 264,529 | 51,757 |
Net Cash Used in Operating Activities
For the six months ended June 30, 2025, our net cash used in operating activities was RMB78.0 million, which was primarily attributable to the R&D and administrative expenses. For the six months ended June 30, 2024, our net cash used in operating activities was RMB106.2 million, which was primarily attributable to the R&D and administrative expenses.
17
Net Cash Generated from Investing Activities
For the six months ended June 30, 2025, our net cash generated from investing activities was RMB86.8 million, which was primarily attributable to the redemption of financial assets. For the six months ended June 30, 2024, our net cash generated from investing activities was RMB73.0 million, which was primarily attributable to the redemption of financial assets.
Net Cash Generated from Financing Activities
For the six months ended June 30, 2025, our net cash generated from financing activities was RMB228.8 million primarily attributable to the proceeds from the Listing. For the six months ended June 30, 2024, our net cash generated from financing activities was RMB7.8 million primarily attributable to the increase in interest-bearing borrowings.
Cash and Cash Equivalents
The Group’s cash and cash equivalents as at June 30, 2025 were RMB264.5 million, representing an increase of RMB236.1 million compared to RMB28.4 million as at December 31, 2024. The increase was mainly due to net proceeds from the Listing.
Borrowing and Gearing Ratio
The Group’s total borrowings, including interest-bearing borrowings, as at June 30, 2025 were RMB75.1 million, representing a decrease of RMB24.9 million compared to RMB100.0 million as at December 31, 2024.
As at June 30, 2025 and December 31, 2024, all of the Group’s interest-bearing borrowings are unsecured.
As at June 30, 2025, the Group’s interest-bearing borrowings will mature within one year with the interest rate of 2.5%-2.9% (as at December 31, 2024: 2.6%-3.1%).
The gearing ratio (calculated by dividing the sum of interest-bearing borrowings and lease liabilities by total equity) of the Group as at June 30, 2025 was 32.3% (as at December 31, 2024: 176.6%).
Lease Liabilities
The lease liabilities of the Group were related to properties leased for our offices and R&D premises. The Group recognized lease liabilities for all leases except for short-term leases and leases of low-value assets.
Our lease liabilities increased to RMB9.0 million as at June 30, 2025 from RMB1.5 million as at December 31, 2024, mainly due to our lease of new office in Hangzhou during the Reporting Period.
18
Significant Investments
During the Reporting Period, we held the following negotiable certificate of deposits with banks, each of which accounts for 5% or more of the Group’s total assets as of June 30, 2025:
(i) one deposit in the principal amount of RMB20 million with The China Construction Bank Suzhou Industrial Park Sub-branch (中國建設銀行蘇州工業園區支行) deposited on April 4, 2023. The maturity date for this deposit is on April 4, 2026 and the contractual yield is 3.10%. The reported gain on changes in fair value from this deposit during the Reporting Period was approximately RMB1.39 million and the fair value amounted to approximately RMB21.39 million as at June 30, 2025; and
(ii) two deposits in the aggregate principal amount of RMB30 million with Evergrowing Bank Co., Ltd. Shanghai Branch Business Department (恒豐銀行股份有限公司上海分行營業部) deposited on September 21, 2023 and August 1, 2024. The maturity date for these two deposits is August 1, 2026, and the contractual yields are both 3.20%. The aggregate reported gain on changes in fair value from these deposits during the Reporting Period was approximately RMB1.61 million and the aggregate fair value amounted to approximately RMB31.84 million as at June 30, 2025
Saved as disclosed above, we did not hold any significant investments (including any investment in an investee company) with a value of 5% or more of the Group’s total assets during the Reporting Period.
Material Acquisitions and Disposals
During the six months ended June 30, 2025, we did not have material acquisitions or disposals of subsidiaries, associates and joint ventures.
Foreign Exchange Risk
The Group has entities operating in the People’s Republic of China. Certain of our bank balances are dominated in foreign currencies and are exposed to foreign currency risk.
As at June 30, 2025, the Group had no foreign exchange hedging instruments and foreign currency hedging policy. However, our management constantly monitors the economic situation and our Group’s foreign exchange exposure and will consider appropriate hedging measures in the future should the need arise.
Capital Expenditure
For the six months ended June 30, 2025, the Group’s total capital expenditure amounted to approximately RMB0.2 million, which was mostly used in payment for decoration design fees and office equipment.
Charge on Assets
As at June 30, 2025 and December 31, 2024, the Group did not have any charge on assets.
Contingent Liability
As at June 30, 2025, the Group did not have any material contingent liabilities. We confirm that as of the date of this announcement, there had been no material changes or arrangements to our contingent liabilities.
19
Employees and Remuneration Policies
As of June 30, 2025, we had a total of 58 employees, compared to 64 employees as at December 31, 2024.
In compliance with the applicable labor laws, we enter into individual employment contracts with our employees covering salaries, employee benefits, workplace safety, confidentiality and non-competition, work product assignment clause and grounds for termination. We normally enter into an employment contract and a non-competition agreement with our key management members and technical personnel, with a term of three years. The non-competition obligation is effective during the course of employment and within 12 months after the termination of the employment, unless written consent from the Company otherwise has been obtained. The agreements also typically include undertakings regarding assignment of inventions and discoveries made during the course of his or her employment.
During the Reporting Period and up to the date of this announcement, we did not experience any strikes, labor disputes or industrial action which had a material effect on our business. We believe we have not experienced any significant difficulty in recruiting staff for our operations.
Our employees' remuneration comprises salaries, bonuses, provident funds, social security contributions, and other welfare payments. We have made contributions to our employees' social security insurance funds (including pension plans, medical insurance, work-related injury insurance, unemployment insurance and maternity insurance) and housing funds pursuant to applicable laws and regulations. We had complied with all statutory social security insurance fund and housing fund obligations applicable to us under the laws and regulations in China in all material aspects during the Reporting Period and as of the date of this announcement.
To maintain our workforce's quality, knowledge, and skill levels, we provide continuing education and training programs, including internal training, to improve their technical, professional or management skills. We also provide training programs to our employees from time to time to ensure their awareness and compliance with our policies and procedures in various aspects. Furthermore, we provide various incentives and benefits to our employees, including competitive salaries, bonuses and share-based payment, particularly our key employees.
Future Plans for Material Investments and Capital Asset
Save as disclosed in this announcement, we had not authorized any plan for the material investments or acquisition of capital asset as of the date of this announcement.
IV. PRINCIPAL RISKS AND UNCERTAINTIES
We believe that there are certain risks involved in our operations, many of which are beyond our control. These risks are set out in the section headed "Risk Factors" in our Prospectus. Some of the major risks we face include:
- We may face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced, or more effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize our drug candidates.
-
We could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of our drug candidates through intellectual property rights, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties may compete directly against us.
-
Our business, financial condition, results of operations and prospects for the next couple of years are substantially dependent upon the successful approval and sales of PB-119. If we are unable to successfully obtain regulatory approvals, achieve commercialization or complete clinical development to expand indications for PB-119 in our targeted markets, or if we experience significant delays or cost overruns in doing any of the foregoing, our business, financial condition, results of operations and prospects could be materially and adversely affected.
-
Clinical drug development involves a lengthy and expensive process with uncertain outcomes, and we may need to deprioritize certain drug candidates, and may be unable to commercialize our drug candidates at all.
-
If our drug candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or may ultimately be unable to complete, the development and commercialization of our drug candidates.
-
Our drug candidates may cause undesirable adverse events.
-
Negative results from off-label drug use of our drug products could negatively impact our business, financial condition, results of operations and prospects and expose us to liability.
-
We work with various third parties to develop our drug candidates. If these third parties fail to duly perform their contractual obligations or meet expected timelines, we may be unable to obtain regulatory approvals for, or commercialize, our drug candidates, and our business, financial condition and results of operations could be materially and adversely affected.
-
We intend to work with third parties for the commercialization of our drug candidates. We may fail to identify competent third parties for such purposes, fail to achieve the expected synergies with the clinical development partners, and have little or no control over the marketing and sales efforts of the commercialization partners.
-
We work with third parties to manufacture a portion of our drug candidates for clinical development and future commercialization. Our business could be harmed if those third parties fail to deliver sufficient quantities of products.
-
The market size of our drug candidates might be smaller than we expected.
-
We have incurred significant net losses since inception and we may continue to incur net losses and may fail to achieve or maintain profitability in the future. As a result, you may lose substantially all of your investment in us if our business fails.
For further details of the risk factors stated above, please see section headed "Risk Factors" in our Prospectus.
20
21
CORPORATE GOVERNANCE AND OTHER INFORMATION
I. INTERIM DIVIDEND
The Board has resolved not to recommend the payment of an interim dividend for the six months ended June 30, 2025 (six months ended June 30, 2024: nil).
II. COMPLIANCE WITH THE MODEL CODE FOR SECURITIES TRANSACTIONS
The Company has adopted the Model Code to regulate all dealings by the Directors, the Supervisors and relevant employees of securities in the Company and other matters covered by the Model Code since the Listing Date. Specific enquiries have been made to all Directors and Supervisors, all of the Directors and Supervisors have confirmed that they have complied with the Model Code during the period from the Listing Date to the date of this announcement.
The Company's employees, who are likely to be in possession of inside information of the Company, have also been subject to the Model Code for securities transactions. No incident of non-compliance of the Model Code by the employees was noted by the Company during the period from the Listing Date to the date of this announcement.
III. COMPLIANCE WITH THE CORPORATE GOVERNANCE CODE
The Company recognizes the importance of good corporate governance for enhancing the management of the Company as well as preserving the interests of the Shareholders as a whole. The Company has adopted and applied the principles and code provisions as set out in the Part 2 of Corporate Governance Code as its own code of corporate governance practices.
During the period from the Listing Date to the date of this announcement, the Company has complied with all the applicable code provisions as set out in the Corporate Governance Code, except for code provision C.2.1 described in the paragraph below. The Board will continue to review and monitor the code of corporate governance practices of the Company with an aim to maintaining a high standard of corporate governance.
Pursuant to paragraph C.2.1 of Part 2 of the Corporate Governance Code, companies listed on the Stock Exchange are expected to comply with, but may choose to deviate from the requirement that the responsibilities between chairman and chief executive should be segregated and should not be performed by the same individual. We do not have a separate chairman and chief executive and Dr. Michael Min XU ("Dr. XU") currently performs the roles of the chairman of our Board and the general manager of our Company. Dr. XU has assumed the role of general manager of our Company since May 2008. He has extensive experience in the business operations and management of our Group. Our Board believes that, in view of his experience, personal profile and his roles in our Company, Dr. XU is the Director best suited to identify strategic opportunities and focus of the Board due to his extensive understanding of our business as our general manager. The Board also believes that vesting the roles of both chairman and general manager in the same person has the benefit of (i) ensuring consistent leadership within the Group, (ii) enabling more effective and efficient overall strategic planning and execution of strategic initiatives of the Board, and (iii) facilitating the flow of information between the management and the Board for the Group.
The Board considers that the balance of power and authority for the present arrangement will not be impaired, and this arrangement will enable the Company to make and implement decisions promptly and effectively. In addition, all major decisions are made in consultation with members of the Board, including the relevant Board committees, and three independent non-executive Directors. The Board will continue to review and consider splitting the roles of chairman of the Board and general manager of the Company at a time when it is appropriate by taking into account the circumstances of the Group as a whole.
IV. AUDIT COMMITTEE AND REVIEW OF INTERIM RESULTS
We have established an Audit Committee with written terms of reference in compliance with Rule 3.21 of the Listing Rules and paragraph D.3 of Part 2 of the Corporate Governance Code. The Audit Committee consists of three Directors, namely Ms. Xinpeng FAN, Dr. Xiangjun ZHOU and Dr. Yangyang CHEN. Ms. Xinpeng FAN, who holds the appropriate professional qualifications as required under Rules 3.10(2) and 3.21 of the Listing Rules, serves as the chairperson of the Audit Committee. The primary duties of the Audit Committee include, but not limited to, the following:
- proposing the appointment or change of external auditors to our Board, and monitoring the independence of external auditors and evaluating their performance;
- guiding internal audit work;
- examining the financial information of our Company, reviewing financial reports and statements of our Company and giving comments on relevant matters;
- assessing the effectiveness of internal control;
- coordinating the communication among management, internal audit department, related departments and external audit agency; and
- dealing with other matters that are authorized by the Board or involved in relevant laws and regulations.
The Audit Committee has reviewed and agreed with the accounting principles and practices adopted by the Group and has discussed matters in relation to internal controls and financial reporting with the management, including the review of the unaudited condensed consolidated interim financial results of the Group for the six months ended June 30, 2025. The Audit Committee considers that the interim financial results for the six months ended June 30, 2025 are in compliance with the relevant accounting standards, rules and regulations and appropriate disclosures have been duly made.
22
V. PURCHASE, SALE OR REDEMPTION OF THE COMPANY'S LISTED SECURITIES
During the period from the Listing Date to the date of this announcement, neither the Company nor any of its subsidiaries purchased, sold or redeemed any of the Company's listed securities (including sale of treasury Shares (as defined under the Listing Rules)).
As of June 30, 2025, there were no treasury Shares (as defined under the Listing Rules) held by the Company and no Shares repurchased but pending cancellation.
VI. USE OF PROCEEDS FROM THE GLOBAL OFFERING
The Company's H Shares, each with nominal value of RMB1.00, were listed on the Stock Exchange on May 19, 2025 with a total of 19,283,500 offer shares issued at an issued price of HK$15.6 and the net proceeds raised from the Global Offering were approximately HK$231.8 million (equivalent to RMB212.6 million) after the deduction of underwriting fees, and related expenses in connection with the Global Offering.
The net proceeds from the Global Offering have been and will be utilized in accordance with the purposes set out in the Prospectus. As of June 30, 2025, the Group had used the net proceeds from the Global Offering for the following purposes:
| Use of proceeds | Approximate % of total net proceeds (%) | Planned allocation of net proceeds (RMB million) | Utilized Net Proceeds during the Reporting Period (RMB million) | Unutilized Net Proceeds (as of June 30, 2025) (RMB million) | Expected timeline for application of unutilized net proceeds |
|---|---|---|---|---|---|
| Commercialization and indication expansion of our Core Product PB-119 | 50.2 | 106.7 | – | 106.7 | Expected to be fully utilized by the end of 2027 |
| Further development of our key product PB-718 | 34.5 | 73.3 | – | 73.3 | Expected to be fully utilized by the end of 2027 |
| Ongoing and planned research and development of our other pipeline product candidates | 5.3 | 11.3 | – | 11.3 | Expected to be fully utilized by the end of 2026 |
| Business development activities and enhancing our overseas presence | 1.0 | 2.1 | – | 2.1 | Expected to be fully utilized by the end of 2026 |
| Working capital and other general corporate purposes | 9.0 | 19.2 | – | 19.2 | Expected to be fully utilized by the end of 2025 |
| Total | 100 | 212.6 | – | 212.6 |
23
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VII. EVENTS AFTER THE REPORTING PERIOD
The Group has no significant event occurred after the Reporting Period which require additional disclosures or adjustments as at the date of this announcement.
VIII. CONTINUING DISCLOSURE OBLIGATIONS PURSUANT TO THE LISTING RULES
The Company does not have any disclosure obligations under Rules 13.20, 13.21 and 13.22 of the Listing Rules.
IX. PUBLICATION OF INTERIM RESULTS AND 2025 INTERIM REPORT
This interim results announcement is published on the website of the Company (www.pegbio.com) and the website of the Stock Exchange (www.hkexnews.hk). The interim report of the Company for the six months ended June 30, 2025 containing all the information required by the Listing Rules will be despatched to the Shareholders who have requested corporate communications in printed copy and published on the respective websites of the Company and the Stock Exchange within the prescribed time and in accordance with the requirements under the Listing Rules.
25
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
for the six months ended 30 June 2025 (unaudited)
(Expressed in Renminbi)
| Note | Six months ended 30 June | ||
|---|---|---|---|
| 2025 RMB'000 | 2024 RMB'000 | ||
| Other net income | 3 | 178 | 4,053 |
| Selling and marketing expenses | (4,765) | (3,009) | |
| Research and development expenses | (26,294) | (64,038) | |
| Administrative expenses | (61,254) | (91,336) | |
| Loss from operations | (92,135) | (154,330) | |
| Finance costs | 4(a) | (1,537) | (1,160) |
| Loss before taxation | 4 | (93,672) | (155,490) |
| Income tax | 5 | - | - |
| Loss for the period | (93,672) | (155,490) | |
| Other comprehensive income for the period | |||
| (after tax and other adjustments) | - | - | |
| Total comprehensive income for the period | (93,672) | (155,490) | |
| Attributable to: | |||
| Equity shareholders of the Company | (93,618) | (155,367) | |
| Non-controlling interests | (54) | (123) | |
| Loss and total comprehensive income for the period | (93,672) | (155,490) | |
| Loss per share | |||
| Basic and diluted (RMB) | 6 | (0.25) | (0.42) |
26
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
at 30 June 2025 (unaudited)
(Expressed in Renminbi)
| Note | At 30 June 2025 RMB'000 | At 31 December 2024 RMB'000 | |
|---|---|---|---|
| Non-current assets | |||
| Property, plant and equipment | 3,121 | 3,572 | |
| Right-of-use assets | 7 | 8,895 | 1,527 |
| Intangible assets | 709 | 863 | |
| Other non-current assets | 24,543 | 22,101 | |
| 37,268 | 28,063 | ||
| Current assets | |||
| Inventories | 68 | - | |
| Prepayments and other receivables | 8 | 13,297 | 8,247 |
| Financial assets at fair value through profit or loss (“FVPL”) | 9 | 68,185 | 153,655 |
| Cash and cash equivalents | 264,529 | 28,392 | |
| 346,079 | 190,294 | ||
| Current liabilities | |||
| Trade and other payables | 10 | 35,872 | 56,394 |
| Interest-bearing borrowings | 11 | 75,059 | 100,003 |
| Lease liabilities | 1,604 | 1,269 | |
| 112,535 | 157,666 | ||
| Net current assets | 233,544 | 32,628 | |
| Total assets less current liabilities | 270,812 | 60,691 |
27
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
at 30 June 2025 (unaudited)
(Expressed in Renminbi)
| Note | At 30 June 2025 | At 31 December 2024 | |
|---|---|---|---|
| RMB’000 | RMB’000 | ||
| Non-current liabilities | |||
| Lease liabilities | 7,363 | 221 | |
| Deferred income | 3,000 | 3,000 | |
| 10,363 | 3,221 | ||
| NET ASSETS | 260,449 | 57,470 | |
| CAPITAL AND RESERVES | |||
| Share capital | 12 | 385,956 | 366,672 |
| Reserves | (130,733) | (314,482) | |
| Total equity attributable to equity shareholders of the Company | 255,223 | 52,190 | |
| Non-controlling interests | 5,226 | 5,280 | |
| TOTAL EQUITY | 260,449 | 57,470 |
28
NOTES
(Expressed in Renminbi unless otherwise indicated)
1 BASIS OF PREPARATION
派格生物醫藥(杭州)股份有限公司(PegBio Co., Ltd.) (the “Company”) and its subsidiaries (together, the “Group”) are engaged in research and development therapies in chronic disease. The Company completed the listing of H shares on the Main Board of The Stock Exchange of Hong Kong Limited in May 2025.
This interim financial report has been prepared in accordance with the applicable disclosure provisions of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, including compliance with Hong Kong Accounting Standard (“HKAS”) 34, Interim financial reporting, issued by the Hong Kong Institute of Certified Public Accountants (“HKICPA”). It has been reviewed by the audit committee of the Company and was authorised for issue on 26 August 2025.
The interim financial report has been prepared in accordance with the same accounting policies adopted in the accountant’s report disclosed in Appendix I to the prospectus of the Company dated 19 May 2025 (the “Accountants’ Report”), except for the accounting policy changes that are expected to be reflected in the 2025 annual financial statements. Details of any changes in accounting policies are set out in Note 2.
The preparation of an interim financial report in conformity with HKAS 34 requires management to make judgments, estimates and assumptions that affect the application of policies and reported amounts of assets and liabilities, income and expenses on a year-to-date basis. Actual results may differ from these estimates.
The interim financial report contains condensed consolidated financial statements and selected explanatory notes. The notes include an explanation of events and transactions that are significant to an understanding of the changes in financial position and performance of the Group since the Accountants’ Report. The condensed consolidated interim financial statements and notes thereon do not include all of the information required for a full set of financial statements prepared in accordance with HKFRS Accounting Standards.
This interim financial report is unaudited, but has been reviewed by KPMG in accordance with Hong Kong Standard on Review Engagements 2410, Review of interim financial information performed by the independent auditor of the entity, issued by the HKICPA.
The financial information relating to the financial year ended 31 December 2024 that is included in the interim financial report as comparative information does not constitute the Company’s annual consolidated financial statements for that financial year but is derived from those financial statements.
2 CHANGES IN ACCOUNTING POLICIES
The Group has applied the amendments to HKAS 21, The effects of changes in foreign exchange rates – Lack of exchangeability issued by the HKICPA to this interim financial report for the current accounting period. The amendments do not have a material impact on this interim report as the Group has not entered into any foreign currency transactions in which the foreign currency is not exchangeable into another currency.
The Group has not applied any new standard or interpretation that is not yet effective for the current accounting period.
29
3 OTHER NET INCOME
| Six months ended 30 June | ||
|---|---|---|
| 2025 RMB'000 | 2024 RMB'000 | |
| Net realised and unrealised gain on financial instruments carried at FVPL | 1,523 | 3,280 |
| Government grants | 1 | 202 |
| Interest income on bank deposits | 174 | 638 |
| Foreign exchange loss | (1,532) | (3) |
| Others | 12 | (64) |
| 178 | 4,053 |
4 LOSS BEFORE TAXATION
Loss before taxation is arrived at after charging:
(a) Finance costs
| Six months ended 30 June | ||
|---|---|---|
| 2025 RMB'000 | 2024 RMB'000 | |
| Interest on interest-bearing borrowings | 1,391 | 1,093 |
| Interest on lease liabilities | 146 | 67 |
| 1,537 | 1,160 |
(b) Other items
| Six months ended 30 June | ||
|---|---|---|
| 2025 RMB'000 | 2024 RMB'000 | |
| Depreciation of property, plant and equipment | 451 | 388 |
| Depreciation of right-of-use assets | 926 | 724 |
| Amortisation of intangible assets | 154 | 140 |
| Equity-settled share-based payment expenses | 42,572 | 87,660 |
5 INCOME TAX
The Company's subsidiaries established and operated in the People's Republic of China (the "PRC") are subject to the PRC corporate income tax at the rate of 25%.
According to the tax incentive policies promulgated by the State Tax Bureau of the PRC in September 2022, an additional 100% of qualified research and development expenses incurred for the six months period ended 30 June 2024 and 2025 is allowed to be deducted from taxable income.
During the six months period ended June 30, 2024 and 2025, the Group did not have any assessable profits.
30
6 LOSS PER SHARE
(a) Basic loss per share
During the six months ended 30 June 2025, the calculation of basic loss per share is based on the loss attributable to equity shareholders of the Company of RMB93,618,000 (six months ended 30 June 2024: RMB155,367,000) and the weighted average of 370,380,000 ordinary shares (six months ended 30 June 2024: 366,672,000) in issue during the period.
(b) Diluted loss per share
During the six months ended 30 June 2025, the Company did not have any outstanding ordinary shares or potential ordinary shares (six months ended 30 June 2024: nil) with potential dilution effects. Therefore, diluted loss per share is the same as basic loss per share.
7 RIGHT-OF-USE ASSETS
During the six months ended 30 June 2025, the Group entered into a lease agreement for use of office building, and recognised the additions to the right-of-use assets of RMB9,559,000 (six months ended 30 June 2024: nil).
8 PREPAYMENTS AND OTHER RECEIVABLES
| At 30 June 2025 RMB'000 | At 31 December 2024 RMB'000 | |
|---|---|---|
| Prepayments to suppliers | 9,312 | 2,886 |
| Prepayments for listing expenses | - | 1,999 |
| Other debtors and deposits | 3,985 | 3,362 |
| 13,297 | 8,247 |
All the prepayments and other receivables are expected to be recovered or recognised as expenses within one year.
9 FINANCIAL ASSETS AT FVPL
| At 30 June 2025 RMB'000 | At 31 December 2024 RMB'000 | |
|---|---|---|
| Negotiable certificate of deposits with banks | 53,231 | 138,522 |
| Wealth management products | 14,954 | 15,133 |
| 68,185 | 153,655 |
During the six months ended 30 June 2025, the Group invested in certain negotiable certificate of deposits with banks in the PRC. The negotiable certificate of deposits were transferable and carried fixed interest rates ranged from 3.1% to 3.2% per annum (six months ended 30 June 2024: 3.1% to 3.2%). The directors of the Company determine such negotiable certificate of deposits are mainly for the purpose of short-term fund management, which will be sold in the secondary market within one year, depending on the cash needs. Therefore, the negotiable certificate of deposits are classified as current financial assets at FVPL.
The maturity date of wealth management products is within 1 year from each reporting date or redeemable on demand.
31
10 TRADE AND OTHER PAYABLES
| At 30 June 2025 RMB’000 | At 31 December 2024 RMB’000 | |
|---|---|---|
| Within 1 year | 26,640 | 34,933 |
| Over 1 year | 338 | 190 |
| Trade payables | 26,978 | 35,123 |
| Accrued payroll | 2,416 | 3,958 |
| Tax payables | 312 | 429 |
| Other payables and accruals | 6,166 | 16,884 |
| 35,872 | 56,394 |
All of trade and other payables are expected to be settled within one year or are repayable on demand.
11 INTEREST-BEARING BORROWINGS
| At 30 June 2025 RMB’000 | At 31 December 2024 RMB’000 | |
|---|---|---|
| Bank loans | 75,059 | 91,582 |
| Letter of credit facilities | – | 8,421 |
| 75,059 | 100,003 |
As at 30 June 2025, all of the above interest-bearing borrowings are unsecured and carried at amortised cost. All these interest-bearing borrowings are to be settled within one year.
12 CAPITAL, RESERVES AND DIVIDENDS
(a) Share capital and capital reserve
In May 2025, the Company issued 19,284,000 new H shares of RMB1 each at a price of HK$15.60 per share by way of the initial public offering on The Stock Exchange of Hong Kong Limited (the "Offering"). The amount of total proceeds raised from the Offering was HK$300,823,000 (equivalent to approximately RMB275,924,000). Consequently, RMB19,284,000 was recorded in share capital and the corresponding premium of RMB234,795,000 (after deduction of transaction costs directly attributable to the Offering amounted to RMB21,845,000) was recognised in capital reserve.
(b) Dividends
The directors of the Company did not propose the payment of any dividend during the six months ended 30 June 2025 (six months ended 30 June 2024: nil).
(c) Equity-settled share-based transactions
Restricted Share Unit Scheme
Pursuant to a written shareholders’ resolution of the Company passed on 27 March 2021, a restricted share unit (the “RSU”) scheme (“the Scheme”) was adopted for purpose of providing incentives to eligible employees of the Group. The participant of the RSU Scheme invested in the Company by the way of acquiring share capital of the Company from the existing shareholder through an employee share purchase platform (the “Platform”).
The Scheme contains certain service conditions and non-market performance conditions. The RSUs shall vest upon the completion of initial public offering (“IPO”) of the Company and if the Company still incurred loss when the IPO completed, these RSUs shall vest upon the 3 fiscal years after the completion of IPO of the Company.
Pursuant to a resolution passed at the shareholders’ meeting of the Company in February 2024, certain terms and conditions of the Scheme was modified. The implicit service period was changed from the full 3 fiscal years after the completion of an IPO to 12 months following the completion date of the IPO.
Set out below are details of the movements of RSUs:
| Six months ended 30 June | ||
|---|---|---|
| 2025 | 2024 | |
| Number of underlying shares of the Company | Number of underlying shares of the Company | |
| At the beginning of the period | 29,175,230 | 25,244,458 |
| Granted | – | 11,356,166 |
| Forfeited | – | (97,737) |
| Cancelled | – | (7,327,657) |
| At the end of the period | 29,175,230 | 29,175,230 |
Fair value of RSUs
The Group recognised equity-settled share-based payment expense of RMB42,572,000 during the six months ended 30 June 2025 (for the six months ended 30 June 2024: RMB87,660,000).
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DEFINITIONS
"affiliate" with respect to any specified person, any other person, directly or indirectly, controlling or controlled by or under direct or indirect common control with such specified person
"Articles of Association" the articles of association of the Company, as amended from time to time, which was effective from the Listing Date
"associate(s)" has the meaning ascribed to it under the Listing Rules
"Audit Committee" the audit committee of the Company
"Board of Directors", "Board" or "our Board" the board of Directors
"BVI" the British Virgin Islands
"China" or "PRC" the People's Republic of China, which for the purpose of this announcement and for geographical reference only, excludes Hong Kong, Macau and Taiwan
"Company", "our Company", "the Company" and "PegBio" PegBio Co., Ltd. (派格生物醫藥(杭州)股份有限公司) (formerly known as PegBio Co., Ltd. (派格生物醫藥(蘇州)股份有限公司)), a limited liability company incorporated in the PRC on May 13, 2008 and converted into a joint stock company with limited liability on December 30, 2020
"Core Product" has the meaning ascribed to it in Chapter 18A of the Listing Rules and in this context, refers to PB-119
"Corporate Governance Code" the Corporate Governance Code set out in Appendix C1 to the Listing Rules
"Director(s)" the director(s) of the Company
"FDA" U.S. Food and Drug Administration
"Global Offering" the initial public offering of the shares on the terms and subject to the conditions as described in the Prospectus
"Group", "our Group", "we", "us" or "our" our Company and its subsidiaries
"H Share(s)" listed ordinary share(s) in the share capital of our Company with a nominal value of RMB1.00 each, which is/are to be subscribed for and traded in HK dollars and to be listed on the Hong Kong Stock Exchange
"HKFRS" HKFRS Accounting Standards
"HK$" or "Hong Kong Dollars" or "HK Dollars" and "HK cents" Hong Kong dollars, the lawful currency of Hong Kong
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“Hong Kong” or “HK” the Hong Kong Special Administrative Region of the People’s Republic of China
“Hong Kong Stock Exchange” or “Stock Exchange” The Stock Exchange of Hong Kong Limited, a wholly owned subsidiary of Hong Kong Exchanges and Clearing Limited
“Listing” the listing of our H Shares on the Main Board
“Listing Date” May 27, 2025
“Listing Rules” the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, as amended, supplemented or otherwise modified from time to time
“Model Code” Model Code for Securities Transactions by Directors of Listed Issuers set out in Appendix C3 to the Listing Rules
“NMPA” the National Medical Products Administration of China (國家藥品監督管理局) or, where the context so requires, its predecessor, the China Food and Drug Administration (國家食品藥品監督管理總局), or CFDA
“NPC” the National People’s Congress of the PRC (中華人民共和國全國人民代表大會)
“Prospectus” the prospectus issued by the Company on May 19, 2025 in connection with the Hong Kong Public Offering
“Reporting Period” the period from January 1, 2025 to June 30, 2025
“RMB” Renminbi, the lawful currency of China
“SFC” the Securities and Futures Commission of Hong Kong
“SFO” the Securities and Futures Ordinance (Cap. 571), as amended, supplemented or otherwise modified from time to time
“Share(s)” ordinary share(s) in the capital of our Company with a nominal value of RMB1.00 each
“Shareholder(s)” holder(s) of Shares of the Company
“subsidiary(ies)” has the meaning ascribed to it in section 15 of the Companies Ordinance
“Supervisor(s)” supervisor(s) of the Company
“United States” or “U.S.” the United States of America, its territories, its possessions and all areas subject to its jurisdiction
“US$” or “U.S. Dollars” United States dollars, the lawful currency of the United States
“%” per cent
GLOSSARY
"Agonist" an agonist is an agent that activates a receptor to produce a biological response
"CAGR" compound annual growth rate
"CDMO" contract development and manufacturing organization, a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing
"clinical trial/study" a type of research carried out on human for validating or finding the therapeutic effects and side effects of test drugs in order to determine the therapeutic value and safety of such drugs
"CMC" chemistry, manufacturing, and controls
"CMO" contract manufacturing organization, a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services for drug manufacturing
"diabetes" a complex, chronic metabolic disease characterized by elevated levels of blood glucose, which over time leads to serious damage to the heart, blood vessels, eyes, kidneys, nerves and other organs, comprised of two categories including type 1 diabetes mellitus and type 2 diabetes mellitus
"GCG" glucagon, the main catabolic hormone of the body, produced by alpha cells of the pancreas; it raises the concentration of glucose and fatty acids in the bloodstream
"GLP-1" glucagon-like peptide-1; a peptide hormone that decreases blood sugar levels in a glucose-dependent manner by enhancing the secretion of insulin
"glycemic control" the management of blood sugar levels
"IND" investigational new drug, an application in the drug review process required by a regulatory authority to decide whether a new drug is permitted to initiate clinical trials; also known as clinical trial application, or CTA, in China
"NASH" or "non-alcoholic steatohepatitis" the liver manifestation of a metabolic disorder, and the most severe form of non-alcoholic fatty liver disease, also known as metabolic dysfunction-associated steatohepatitis (MASH)
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“NDA” new drug application, a process required by an regulatory authority to approve a new drug for sale and marketing
“obesity” abnormal or excessive fat accumulation in the body; defined as an individual having a body mass index over 28kg/m² or more in China and 30 kg/m² or more in the United States, respectively
“OIC” opioid-induced constipation; opioid drugs inhibit gastric emptying and peristalsis in the gastrointestinal tract which results in delayed absorption of medications and increased absorption of fluid
“opioid” a class of drugs used to reduce pain
“PD” pharmacodynamics; the study of how a drug affects an organism, which, together with pharmacokinetics, influences dosing, benefit, and adverse effects of the drug
“PEG” polyethylene glycol
“PEGylation” a process through which PEG chains are attached to proteins, peptides or other molecules to alter certain properties, such as molecular mass, solubility, stability and half-life in the body
“Phase I clinical trial” a study in which a drug is introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion, and if possible, to gain an early indication of its efficacy
“Phase II clinical trial” a study in which a drug is administered to a limited patient population to preliminarily evaluate the efficacy of the product for specific targeted diseases, to identify possible adverse effects and safety risks, and to determine optimal dosage
“Phase III clinical trial” a study in which a drug is administered to an expanded patient population generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to provide adequate information for the labeling of the product
“placebo” a medical treatment or preparation with no specific pharmacological activity
“preclinical study” a study testing a drug on non-human subjects, to gather efficacy, toxicity, pharmacokinetic and safety information and to decide whether the drug is ready for clinical trials
“R&D” research and development
“receptor agonist” a receptor agonist is an agent that activates a receptor to produce a biological response
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“SGLT-2” sodium-glucose cotransporter-2; SGLT-2 is the major cotransporter involved in glucose reabsorption in the kidney, responsible for reabsorption of 80-90% of the glucose filtered by the kidney glomerulus
“SGLT-2i” sodium-glucose cotransporter-2 inhibitors, a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with T2DM
“T2DM” type 2 diabetes mellitus, a form of diabetes characterized by high blood sugar, insulin resistance and relative lack of insulin; the pancreas in T2DM patient makes less insulin, and the body becomes resistant to insulin
In the case of inconsistency, the English text of this announcement shall prevail over the Chinese text.
By Order of the Board
PegBio Co., Ltd.
派格生物醫藥(杭州)股份有限公司
Michael Min XU
Chairman of the Board, Executive Director and General Manager
Hangzhou, the PRC, August 26, 2025
As of the date of this announcement, the board of directors of the Company comprises: (i) Dr. Michael Min XU and Ms. Xiaojun WANG as executive directors; (ii) Dr. Xiangjun ZHOU, Dr. Yuhong XU, Ms. Ting ZHAI and Mr. Hongkai LI as non-executive directors; and (iii) Dr. Jiancun ZHANG, Dr. Yangyang CHEN and Ms. Xinpeng FAN as independent non-executive directors.