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先声通知

Simcere

Simcere Pharmaceutical Group Limited

先聲藥業集團有限公司

(Incorporated in Hong Kong with limited liability)

(Stock code: 2096)

ANNOUNCEMENT OF INTERIM RESULTS FOR THE SIX MONTHS ENDED JUNE 30, 2025

FINANCIAL HIGHLIGHTS

For the six months ended June 30, 2025, the Group recorded the following unaudited financial results:

Revenue was RMB3,585 million, representing an increase of 15.1% as compared to RMB3,114 million for the same period of 2024.
Revenue from the innovative pharmaceutical business was RMB2,776 million, accounting for 77.4% of the total revenue and representing an increase of 26.0% as compared to RMB2,203 million for the same period of 2024.
Revenue of the Group was mainly derived from the therapeutic areas where its businesses are focused. Of which, revenue from the field of neuroscience was RMB1,249 million, accounting for 34.8% of the total revenue and representing an increase of 37.3% as compared to RMB909 million for the same period of 2024. Revenue from the field of anti-oncology was RMB874 million, accounting for 24.4% of the total revenue and representing an increase of 41.1% as compared to RMB619 million for the same period of 2024. Revenue from the field of autoimmune was RMB878 million, accounting for 24.5% of the total revenue and representing an increase of 3.3% as compared to RMB850 million for the same period of 2024. Revenue from other fields was RMB584 million, accounting for 16.3% of the total revenue and representing a decrease of 20.5% as compared to RMB736 million for the same period of 2024.
Profit attributable to equity shareholders of the Company was RMB604 million, representing an increase of RMB147 million or 32.2% as compared to RMB457 million for the same period of 2024. Adjusted profit attributable to equity shareholders of the Company¹ was RMB651 million, representing an increase of RMB113 million or 21.1% as compared to RMB538 million for the same period of 2024.

¹ To supplement the financial information presented in accordance with Hong Kong Financial Reporting Standards, the Group also uses adjusted profit attributable to equity shareholders of the Company as a non-Hong Kong Financial Reporting Standards measure. Such measure is unaudited in nature and is not required by, or presented in accordance with, Hong Kong Financial Reporting Standards.

The adjusted profit attributable to equity shareholders of the Company is defined by the Group as profit attributable to equity shareholders of the Company adjusted for the following items: (i) net realized and unrealized losses on financial assets at fair value through profit or loss; (ii) net realized and unrealized gain on associates at fair value through profit or loss; (iii) interest expenses arising from redemption liability; and (iv) income tax effect related to the above items.

The board (the "Board") of directors (the "Directors") of Simcere Pharmaceutical Group Limited (the "Company") is pleased to announce the unaudited condensed consolidated financial results of the Company together with its subsidiaries (collectively the "Group") for the six months ended June 30, 2025 (the "Reporting Period" or the "Period"), together with the comparative figures for the same period in 2024. The unaudited condensed consolidated financial information for the Reporting Period have been reviewed by the audit committee of the Company (the "Audit Committee").

GROUP OVERVIEW

The Group is an innovation and R&D-driven pharmaceutical company with a focus on the areas of neuroscience, anti-oncology, autoimmune and anti-infection, with forward-looking layout of disease areas that have significant clinical needs in the future, aiming to achieve the corporate mission of "born for the patients".

The Group has ten innovative drugs approved for marketing and sale in the focus areas. As of June 30, 2025, the Group had been recommended in guidelines and consensuses issued by over 100 prestigious professional associations, and had over 45 products included in the National Reimbursement Drug List (the "NRDL").

The Group pays high attention to the establishment of innovative pharmaceutical R&D capability, and has established R&D innovation centers in Shanghai, Nanjing, Beijing, Boston and Hong Kong, as well as a State Key Laboratory of Neurology and Oncology Drug Development. The Group's R&D system has achieved functions covering the whole process from drug discovery, pre-clinical development, clinical trial to registration, and owns leading platforms of protein engineering, PAb/TCE, ADC, AI-aided drug discovery and protein degradation. As of June 30, 2025, the Group had a R&D team of approximately 963 personnel in total with approximately 183 doctors and 532 masters.

The Group has a nationwide marketing network and leading commercialization capability, and will continuously strengthen its professional marketing capability, so as to enhance the coverage and accessibility of medicines. As of June 30, 2025, the Group's sales department, which was divided into four business units (neuroscience, anti-oncology, autoimmune & comprehensive and retail) and other support departments had a total of approximately 4,179 personnel across 31 provinces, municipalities and autonomous regions in China, with its products covering over 3,000 Class III hospitals, approximately 17,000 other hospitals and medical institutions as well as more than 200 large-scale national or regional chain pharmacies.

The Group has established manufacturing infrastructures and quality management systems in line with international standards and has continuously improved its manufacturing capabilities of pharmaceuticals. The Group has put into use six PRC GMP certified production facilities for the manufacturing of its pharmaceutical products, and has received the EU GMP certification or passed the U.S. Food and Drug Administration (“FDA”) inspection for some of its production workshops.

Driven by its in-house R&D efforts and synergistic innovation, the Group has established strategic cooperation partnerships with many innovative companies, research institutes and clinical centers at home and abroad, exploring multiple collaborative modes in various aspects such as cooperative R&D and achievement transfer, and continuously developing products that patients urgently need and have significant market potential. The Group has established the Scientific Advisory Board (SAB) comprising over 10 world-renowned scientists in the areas of anti-oncology, neuroscience and autoimmune, etc., so as to bring their professional capabilities and industrial experiences to provide scientific advice for the Group’s early drug discovery and clinical development and explore and create unprecedented treatments.

MAJOR PRODUCTS

Neuroscience Products
- Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection)
- Sanbexin® sublingual tablets (Edaravone and Dexborneol sublingual tablets)
- QUVIVIQ® (daridorexant hydrochloride tablets)

Anti-oncology Products
- Endostar® (Recombinant Human Endostatin Injection)
- ENWEIDA® (Envafolimab Injection)
- COSELA® (Trilaciclib Hydrochloride for Injection)
- ENLITUO® (Cetuximab Beta Injection)
- ENZESHU® (Suvemcitug Injection)

Autoimmune Products
- Iremod® (Iguratimod Tablets)
- ANTINE® (Diclofenac Sodium Sustained Release Capsules/Gel)

Anti-infection Products
- XIANNUOXIN® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged))

MANAGEMENT DISCUSSION AND ANALYSIS

INDUSTRY REVIEW

In the first half of 2025, the pharmaceutical industry of China continued to deepen reforms, with innovation-driven becoming increasingly clear. In January, the NMPA issued the Deepening Drug Review and Approval Reform Plan (Draft for Comment), introducing a “rolling submission + staged review” mechanism; on June 16, it issued the Announcement on Optimizing Clinical Trial Reviews for Innovative Drugs (Draft for Comment), reducing the time for IND approvals from 60 days to 30 days, significantly improving review efficiency. In June, the NMPA and the National Health Commission of the PRC jointly issued the Measures to Support High-Quality Development of Innovative Drugs, which for the first time proposed a full-chain support policy, including a commercial insurance directory for innovative drugs, to provide diversified payment guarantees for innovative drugs. With policy support, China’s pharmaceutical industry is booming, with innovative drugs and internationalization becoming the most prominent themes. The transition from a “pharmaceutical powerhouse” to a “pharmaceutical superpower” is accelerating, and the industry as a whole is moving toward a new stage of high-quality development.

BUSINESS REVIEW

Innovative drug products have been commercialized continuously, which bring long-term healthy growth momentum for the Group. As of the date of this announcement, innovative drugs that entered the commercialization stage increased to ten (Endostar®, Iremod®, Sanbexin®, ENWEIDA®, COSELA®, XIANNUOXIN®, ENLITUO®, Sanbexin® sublingual tablets, QUVIVIQ® and ENZESHU®), two innovative drugs (QUVIVIQ® and ENZESHU®) were approved for marketing, and the New Drug Application (“NDA”) of two innovative drugs (Deunoxavir Marboxil Tablets (adults/adolescentes) and Rademikibart®) were accepted.

Based on the unmet clinical demands, the Group promotes the R&D pipelines of innovative drugs effectively. As of the date of this announcement, the Group has over 60 R&D pipelines of innovative drugs. The Group added four investigational new drug applications (“IND(s)”)¹, completed three First-in-human (“FIH(s)”)² and three Last-Patient-In (“LPI(s)”)³.

Four INDs added namely SIM0505 (advanced solid tumors, January 2025, China), SIM0686 (advanced solid tumors, April 2025, China; July 2025, the United States), SIM0508 (in combination with Olaparib to be used in advanced solid tumors, August 2025, China)
Three studies completed FIH, namely SIM0505 (advanced solid tumors, phase I, January 2025), SIM0686 (advanced solid tumors, phase I, May 2025), SIM0500 (relapsed/refractory multiple myeloma, phase I, June 2025, the United States)
A total of three studies completed LPI, namely Deunoxavir Marboxil (influenza in children, phase III, February 2025), LNK01001 (RA, phase III, March 2025) and TGRX-326 (non-small cell lung cancer, phase III)

KEY MILESTONES

During the Reporting Period and up to the date at this announcement, the Group made a series of advances in respect of its product candidates, business operations and business development, including the following key milestones and achievements:

January 13, 2025
The Group’s self-developed drug candidate SIM0500 (GPRC5D-BCMA-CD3) has entered into an option to license agreement (the “Agreement”) with AbbVie (AbbVie). Under terms of the Agreement, AbbVie would have the option to license SIM0500, while the Group would retain its rights in the Greater China region.

January 17, 2025
The Group has entered into a cooperation agreement with Guangzhou Fermion Technology Co., Ltd. (廣州費米子科技有限責任公司) in respect of FZ002-037, an analgesic innovative drug candidates in clinical stage targeting SSTR4, pursuant to which, the Group obtained exclusive rights to develop and commercialize the product in the Greater China region.

March 15, 2025
The NDA of Deunoxavir Marboxil, a category 1 innovative anti-influenza drug, jointly developed by the Group and Andicon Bio, was accepted by the NMPA, Deunoxavir Marboxil are for treating uncomplicated influenza A and B in adults and adolescents.

June 16, 2025
The Group has achieved strategic cooperation with NextCure, Inc. (NextCure) in relation to a new ADC drug SIM0505 (CDH6-ADC), NextCure obtains global rights (excluding the Greater China region) to SIM0505.

June 20, 2025
QUVIVIQ® (daridorexant hydrochloride tablets), an anti-hypnotic drug jointly developed by the Group and Idorsia, was approved for marketing by the NMPA. The indication of QUVIVIQ® is for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance and QUVIVIQ® has not been designated as a controlled substance.

June 30, 2025

ENZESHU® (Suvemcitug for injection), a next-generation anti-tumor angiogenesis (anti-VEGF antibody) category 1 biological new drug jointly developed by the Group and Pyxis Oncology, was approved for marketing by the NMPA. ENZESHU® is indicated for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received no more than one systemic therapy after platinum resistance.

July 9, 2025

The NDA of the innovative drug Rademikibart, jointly developed by the Group and Connect Biopharma, was accepted by the NMPA for the treatment of atopic dermatitis.

For details of each milestone above, please refer to the following sections of this announcement and, where appropriate, previous announcements of the Company published on the websites of The Stock Exchange of Hong Kong Limited (the "Stock Exchange") and the Company.

SUMMARY OF PRODUCT PIPELINES

As of the date of this announcement, the Group has over 60 R&D pipelines of innovative drugs. Six drug candidates are in NDA/pivotal clinical stage¹ and 12 molecules entered early clinical stage. The forms of innovative drugs under development contain monoclonal antibodies, bispecific antibodies, multi-specific antibodies, fusion proteins, antibody-drug conjugates ("ADC") and small molecule drugs, etc. The extensive pipeline reserves have huge clinical and commercialization potential, which are expected to help more patients.

The table below summarizes the therapeutic targets, therapeutic areas, rights and development of principal R&D pipelines of the Group as of the date of this announcement.

¹ Including products with commercial rights, namely Deunoxavir Marboxil, LNK01001 and TGRX-326

Territory	Product candidate (Target/Mechanism)	Pre-clinical	Phase III
		Anti-Oncology
Global	Endostar® New indication (Angiogenesis)	Thoracoabdominal effusions (COP/IMAP study)

Global	SIM0270 (SERD BM)	Breast cancer
China (commercialization right)	TGRX-326 (ALK/ROS1)	Non-small cell lung cancer
Global	Docetaxel polymeric micelles for injection (Tubulin inhibitor)	Malignant ascites
Global	SIM0237 (PD-L1/IL15v bispecific antibody)	Non-muscle Invasive bladder cancer
Global	SIM0501 (USP1)	Solid tumors (China and U.S.)
China (Option to license from AbbVie for rights outside Greater China)	SIM0500 (GPRC5D-BCMA-CD3 trispecific antibody)	Multiple myeloma (China and U.S.)
China	SIM0395 (PI3K/mTOR)	Orioblastoma	(GBM/AGILE study)
Global	SIM0508 (PolB)	Solid tumors (China and U.S.)
China (licensed-out to NextCure outside of China)	SIM0505 (CDH6-ADC)	Solid tumors (China and U.S.)
Global	SIM0686 (FGFR2b-ADC)	Solid tumors (China and U.S.)
China	SIM0323 (CD80/IL2)	Solid tumors
Global	SIM0609 (CDH17-ADC)	Solid tumors
Global	SIM0610 (EGFR/cMet-ADC)	Solid tumors
Global	SIM0613 (LRRC15-ADC)	Solid tumors
Global	SIM0682 (B7H3/cMet-ADC)	Solid tumors
Global	SIM0532 (PanRAS)	Solid tumors
Global	SIM0512 (WRN)	Solid tumors
		Neuroscience
Global	Sanbexin® sublingual tablets (Free radicals and inflammatory cytokines)	AD, HL63
		PKCI
Global	Sanbexin® injection New Indication (Free radicals and inflammatory cytokines)	ICH
China	SIM0800 (AQP4)	Stroke with cerebral edema
Global	SIM0811	AD, HL etc.
		Autoimmune
China	Rademikibart (IL-4Rα)	Atopic Dermatitis
		Asthma
China (licensed-out to Almirall outside of China)	SIM0278 (IL-2-mu-Fc)	AD, LN, etc.

Global	SIM0708 (IL-4Rα ADC)	NE-SYNX ASSOUS
Global	SIM0711 (IRAK4 PROTAC)	AD, etc.
Global	SIM0709 (TL1A/IL23p19)	HD and CD
China (commercialization right)	LNK01001 (JAK1)	RA and AS
		Anti-infective
China (commercialization right)	Deunoxavir Marboxil (PA)	Influenza(adult) (dolescent)
		Influenza (child)
		Deurex (adult) (children) (Total Carcinoma)

Development status of the Group

Development status of partner(s)

INNOVATIVE DRUGS AT THE COMMERCIALIZATION STAGE

Up to the date of this announcement, the Group has successfully expanded its commercialized portfolio of innovative drugs into ten: Endostar®, Iremod®, Sanbexin®, ENWEIDA®, COSELA®, XIANNUOXIN®, ENLITUO®, Sanbexin® sublingual tablets, QUVIVIQ® and ENZESHU®, spanning over multiple areas, including neuroscience, anti-oncology, autoimmune and anti-infection, which have significant market potentials and synergistic effects. For the six months ended June 30, 2025, revenue from innovative pharmaceutical business was approximately RMB2,776 million, accounting for 77.4% of the total revenue.

MILESTONES AND ACHIEVEMENTS DURING THE REPORTING PERIOD

Neuroscience Products

Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection)

Sanbexin® is a category I innovative drug developed by the Group with proprietary intellectual property right used to treat acute ischemic stroke (“AIS”). Sanbexin® was approved for marketing in China in July 2020 and has been included in the NRDL since December 2020 and renewed its inclusion in the NRDL in November 2024.

For the six months ended June 30, 2025, Sanbexin® Injection, accounting for approximately 29% of the market share in stroke injection, covered approximately 0.91 million patients and over 5,900 medical institutions.

Data Release

In April 2025, the Chinese Expert Consensus on Clinical Practice for Cerebral Cell Protection in Bchemic Stroke was published. The consensus recommends the individualized use of Edaravone and Dexborneol during the hyperacute and acute phases of acute ischemic stroke, provided that it does not interfere with the implementation of vascular recanalization therapy.

Sanbexin® sublingual tablets (Edaravone and Dexborneol sublingual tablets)

Sanbexin® sublingual tablets is a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell injury or impairment caused by AIS. Such unique sublingual tablets formulation can quickly disintegrate once in contact with the saliva under the tongue and can be absorbed into the blood through the sublingual venous plexus, which is expected to increase the flexibility of stroke treatment. Sanbexin® sublingual tablets are expected to form a sequential therapy combined with Sanbexin® injection, enabling patients to receive a complete course of treatment in and outside of the hospital.

In December 2024, Sanbexin® sublingual tablets was approved for marketing in China, aiming at improving the neuro symptoms, the daily living abilities and dysfunction caused by AIS. In August 2024, Sanbexin® sublingual tablets was granted the “Breakthrough Therapy” designation by the FDA, which was the first innovative drug in the global stroke treatment sector receiving such designation and the first innovative drug in the Chinese neuroscience sector receiving such designation.

Data Release

In May 2025, Peking Union Medical College Hospital’s multi-center, randomized, double-blind and placebo-controlled TASTE-SVD study, which focuses on acute cerebral small vessel disease, premiered at the 11th European Stroke Organisation Conference (ESOC).
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QUVIVIQ® (daridorexant hydrochloride tablets)

QUVIVIQ® is a dual orexin receptor antagonist (“DORA”). Unlike traditional sedative-hypnotic drugs that promote sleep by sedating the brain, QUVIVIQ® works by blocking the binding of wake-promoting orexin neuropeptides (orexin A and orexin B) to their receptors. As a result, QUVIVIQ® reduces wake drive and facilitates the onset of sleep, decreases wake time after sleep onset, and extends total sleep duration, without altering sleep architecture. Clinical study results have shown that QUVIVIQ® has a favorable safety and tolerability profile, with no evidence of rebound insomnia, withdrawal symptoms, or drug abuse. In addition to improving nighttime sleep in adults with insomnia disorder, QUVIVIQ® also enhances daytime functioning. It is the only DORA insomnia medication approved by the European Medicines Agency (EMA) for improving daytime functioning. The Guidelines for the Diagnosis and Treatment of Insomnia Disorders in China (2nd Edition), published in 2025, strongly recommend QUVIVIQ® with Grade A evidence. Previously, QUVIVIQ® has been approved for marketing in 11 countries including the United States, the United Kingdom, Switzerland, Canada, as well as in the Hong Kong SAR of China.

Registration Progress

On June 17, 2025, QUVIVIQ® was approved for marketing in China. QUVIVIQ® is for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance and QUVIVIQ® has not been designated as a controlled substance.

Data Release

In January 2025, the Guidelines for the Diagnosis and Treatment of Insomnia Disorders in the PRC (2nd Edition), which was edited by the Chinese Sleep Research Society and published by the People’s Medical Publishing House, strongly recommended Daridorexant with Grade A evidence. The guidelines recommended Daridorexant’s efficacy in improving nighttime sleep and daytime functioning in adult insomnia patients, coupled with favorable safety and requiring no dosage adjustment for elderly patients.
In June 2025, the multi-center, randomized, double-blind, parallel and placebo-controlled Daridorexant Phase III clinical trial in China, which was led by the Xuanwu Hospital, Capital Medical University and participated by 33 research centers, published preliminary results in SLEEP magazine, demonstrating Daridorexant 50mg’s statistically significant improvements in both objective and subjective sleeping conditions of the Chinese insomnia patients, coupled with favorable safety.
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Oncology Products

Endostar® (Recombinant Human Endostatin Injection)

Endostar® is the first anti-angiogenic targeted drug in China and the first endostatin approved for sale worldwide. Endostar® has been included in the NRDL since 2017 and is recommended as a first-line treatment for patients with advanced non-small cell lung cancer (“NSCLC”) by a number of oncology clinical practice guidelines issued by the National Health Commission of the PRC (“NHC”), Chinese Medical Association (中華醫學會) and Chinese Society of Clinical Oncology (“CSCO”). Also, it has been included in the recommendations by various guidelines in relation to nasopharyngeal carcinoma, melanoma, esophageal carcinoma and osteosarcoma.

Data Release

In January 2025, as stated in the China Esophagus Cancer Radiotherapy Guidelines 2024 (《中國食管癌放射治療指南(2024年版)》）jointly issued by the Chinese Society of Radiation Oncology (branch association of the Chinese Medical Association) (中華醫學會放射腫瘤治療分會), the Chinese Association for Therapeutic Radiation Oncologists (branch association of the Chinese Medical Doctor Association) (中國醫師協會放射腫瘤治療醫師分會) and the Society of Radiation Therapy of the China Anti-Cancer Association (中國抗癌協會腫瘤放射治療專業委員會), Endostar® was recommended by the consensus in the section on anti-angiogenic therapy for esophageal cancer again. The recommendation was as follows: recombinant human endostatin + oxaliplatin + radiotherapy or recombinant human endostatin + Paclitaxel + Nedaplatin (squamous cell carcinoma, first-line, Grade II recommendation, Category 2B evidence), or recombinant human endostatin + Irinotecan + cisplatin (squamous cell carcinoma, second-line, Grade II recommendation, Category 2B evidence).
In June 2025, the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago. Two studies on Endostar® were selected for this meeting, with the following titles: (1) Sintilimab + Nab-PP Combined with Recombinant Human Vascular Endothelial Inhibitor for Locally Advanced/Advanced and Recurrent Metastatic Squamous Non-Small Cell Lung Cancer: Study Protocol for a Single-Arm, Multi-Centre Phase II Clinical Study; and (2) Real-world research on the effect and safety of gemcitabine combined with PD-1 inhibitors and recombinant human endostatin in refractory recurrent nasopharyngeal carcinoma.
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ENWEIDA® (Envafolimab Injection)

ENWEIDA® is the world's first PD-(L)1 antibody to be administered by subcutaneous injection approved for marketing. Its unique method of injection differentiates itself from other PD-(L)1 products currently on the market, with the differentiation advantages of short administration time and good safety. In March 2020, the Group entered into a tripartite cooperation agreement in relation to ENWEIDA® with 3D (Beijing) Medicines Inc. (思路迪(北京)醫藥科技有限公司) and Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (江蘇康寧傑瑞生物製藥有限公司). The above-mentioned agreement provides the Group with the exclusive right to promote ENWEIDA® for all oncology indications and the right of first refusal of external licensing or assignment in the Chinese mainland.

Data Release

In January 2025, American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) was held in San Francisco, California, United States. ENWEIDA® had two poster presentations selected for this conference, covering the latest applications of ENWEIDA in gastric/gastroesophageal junction adenocarcinoma and pancreatic cancer.
In May 2025, ENWEIDA® continued to be included in two key CSCO guidelines: CSCO Clinical Application Guidelines for Gastric Cancer 2025 (《2025 CSCO胃癌臨床應用指南》) (Level I) and CSCO Clinical Application Guidelines for Colorectal Cancer 2025 (《2025 CSCO結直腸癌臨床應用指南》) (Level II).
In June 2025, the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago. ENWEIDA® had 11 researches selected for this conference, covering aspects of non-small-cell lung cancer, small-cell lung cancer, pancreatic cancer, biliary tract cancer, cholangiocarcinoma, esophageal squamous cell carcinoma, osteosarcoma and soft tissue sarcoma.
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COSELA® (Trilaciclib Hydrochloride for Injection)

COSELA® is an effective, selective and reversible cycl in-dependent kinases 4 and 6 (CDK4/6) inhibitor. COSELA® is the world's first-in-class comprehensive myeloprotection innovative drug that can de-administered prior to a chemotherapy. In August 2020, the Group entered into the exclusive license agreement with G1 Therapeutics, Inc. to develop and commercialize COSELA® in the Greater China region. In February 2021, COSELA® was approved for marketing by the FDA. In July 2022, the marketing of COSELA® in China has obtained the conditional approval by the NMPA. In April 2023, the Group has obtained full rights to the sales milestones of COSELA®. In December 2023, the localization application of COSELA® has been approved by the NMPA and it can be produced by the production enterprises of the Group in Haikou, Hainan Province, which further improved its accessibility to patients with cancer in China. Currently, the product has been recommended by the related key guidelines of National Comprehensive Cancer Network Guidelines (NCCN), CSCO and other organizations. In November 2024, COSELA® was successfully included in NRDL.

Data Release

In May 2025, COSELA® continued to be included in CSCO Diagnosis and Treatment Guidelines for Small-Cell Lung Cancer 2025 (《2025 CSCO小细胞肺癌診療指南》) (Level I).
In June 2025, the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago. COSELA® had 4 researches selected for this conference, covering aspects of non-small-cell lung cancer, small-cell lung cancer, etc.

ENLITUO® (Cetuximab Beta Injection)

ENLITUO® is a recombinant anti-epidermal growth factor receptor (“EGFR”) chimeric monoclonal antibody for first-line treatment of RAS/BRAF wild-type metastatic colorectal cancer (“mCRC”) in combination with FOLFIRI. ENLITUO® is prepared using a specific expression process, effectively avoiding glycosylation modification that may lead to hypersensitivity without black box warnings in the instruction. In June 2024, ENLITUO® was approved for marketing in China by the NMPA and is the first anti-EGFR monoclonal antibody innovative drug developed in China with independent intellectual property rights which has been approved by the NMPA for first-line treatment of mCRC. The successful launch of ENLITUO® will provide high quality and affordable biological targeted remedy for Chinese mCRC patients. In November 2024, ENLITUO® was successfully included in NRDL.

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Data Release

In April 2025, the 2025 CSCO Guideline Meeting was held in Jinan City. ENLITUO® was included in the recommendations of the CSCO Guidelines for Colorectal Cancer 2025 (《2025 CSCO結直腸癌指南》) for patients of first-line treatment with wild-type RAS and BRAF that are potentially resectable: Left-sided colorectal cancer – Cetuximab B and FOLFIRI (Level I); Right-sided colon cancer - Cetuximab B and FOLFIRI (Level II).
In May 2025, research information from the ENLITUO® phase III registration clinical studies was published in Nature’s journal Signal Transduction and Targeted Therapy (impact factor 40.8). Pivotal clinical information: progression-free survival (“PFS”) - the median PFS in the ENLITUO® combination group was 13.1 months, which was 3.5 months longer than that in the chemotherapy-only group; overall survival (“OS”) – the median OS in the ENLITUO® combination group was 28.3 months, which was significantly better than the 23.1 months of the chemotherapy group. The study results marked a major breakthrough in the treatment of metastatic colorectal cancer in China and filled the gap in domestically produced anti-EGFR monoclonal antibodies.

ENZESHU® (Suvemcitug for Injection)

ENZESHU® is a next-generation recombinant humanized anti-vascular endothelial growth factor (“VEGF”) monoclonal antibody developed by the Group and Pyxis Oncology, Inc., and is the first anti-angiogenic therapy for patients with platinum-resistant ovarian cancer.

By potently blocking the binding of VEGF to its receptor, ENZESHU® inhibits tumor angiogenesis, thereby achieving an anti-tumor effect. With a unique molecular design featuring a differentiated VEGF-binding epitope, ENZESHU® has demonstrated significantly greater inhibitory activity against the binding of VEGF to its receptor (VEGFR2) compared to bevacizumab, as well as stronger suppression of human vascular endothelial cell proliferation. Preclinical studies have shown that ENZESHU® exhibits enhanced biological activity and superior tumor-inhibitory effects relative to bevacizumab at the same dosage across multiple tumor models. The randomized double-blind placebo controlled registrational Phase III clinical trial of ENZESHU® (the SCORES study) demonstrated significant benefits in the primary efficacy endpoint of PFS assessed by the Blinded Independent Review Committee (BIRC) as well as investigator-assessed PFS. For the key secondary endpoint, OS was prolonged in the treatment group compared to the control group.

Registration Progress

On June 30, 2025, ENZESHU® was approved for marketing in China. It is indicated for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received no more than one systemic therapy after platinum resistance.

Autoimmune Products

Iremod® (Iguratimod Tablets)

Iremod® is the first Iguratimod pharmaceutical product approved for marketing in the world. Iremod® has been included in the NRDL since 2017. The indication is the active rheumatoid arthritis. Iremod® is recommended as the primary therapy drug for the treatment of active rheumatoid arthritis by a number of clinical practice guidelines and pathways issued by the NHC, Chinese Medical Association, Asia Pacific League of Associations for Rheumatology and Labor and Welfare of Japan. Since its launch in 2012, Iremod® has benefited over 1 million patients in China, which further consolidated its leading market position in the traditional DMARDs sector.

Data Release

In May 2025, the Regional Traditional Chinese Medicine (Rheumatology) Diagnosis and Treatment Center of the National Administration of Traditional Chinese Medicine and the National Regional Diagnosis and Treatment Center Specialist Alliance of Integrated Traditional Chinese and Western Medicine Rheumatology jointly released the Expert Consensus on the Diagnosis and Treatment of Rheumatoid Arthritis with Integrated Traditional Chinese and Western Medicine (2025 Edition) («類風濕關節炎中西醫結合診療專家共識(2025版)»). The consensus states: if monotherapy with csDMARDs (including Iremod®) shows no clinical improvement after three months or fails to achieve treatment goals by six months, it is recommended to combine with other csDMARDs. Alternatively, csDMARDs may be combined with bDMARDs or tsDMARDs (strength of recommendation: A, evidence level: 1a), or it may be combined with Tripterygium compound preparations (strength of recommendation: A, evidence level: 1a) or nux vomica compound preparations or aconite compound preparations (strength of recommendation: B, evidence level: 3).
In June 2025, the 2025 European League Against Rheumatism (EULAR) Annual Meeting was held in Barcelona, Spain. Iremod® had one study selected for this conference, titled Efficacy and Safety of Tofacitinib Combined with Iguratimod in Patients with Rheumatoid Arthritis with Inadequate Response to csDMARDS.
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Anti-infection Products

XIANNUOXIN® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged))

XIANNUOXIN® is the first domestic 3CL small molecule anti-SARS-CoV-2 innovative drug with independent intellectual rights in China. On November 17, 2021, the Group entered into a technology transfer contract with Shanghai Institute of Materia Medica and Wuhan Institute of Virology, Chinese Academy of Sciences, pursuant to which, the Group obtained the development, production and commercialization rights on an exclusive basis of Simnotrelvir worldwide. In July 2024, XIANNUOXIN® has been reviewed and approved by the NMPA for conversions from conditional approval to regular approval, which became the first oral anti-SARS-CoV-2 innovative drug which has obtained regular approval in China.

Data Release

In April 2025, a study in Antimicrobial agents and chemotherapy evaluated the efficacy of Simnotrelvir against various Omicron variants, reaffirming its potent in vitro inhibitory activity against virus replication, and also effectively suppressing some of the Nirmatrelvir variants. Clinical trials have demonstrated that the combination of Simnotrelvir and Ritonavir has significantly shortened the relief of SARS-CoV-2 patients, and that patients have not developed refractory mutation.
In July 2025, a real-world study confirmed that while Simnotrelvir/Ritonavir was comparable to Nirmatrelvir/Ritonavir in reducing the cumulative risks such as 28-day compound disease progression, all-cause mortality and respiratory support in hospitalized patients with SARS-CoV-2 infections, Simnotrelvir/Ritonavir was more advantageous in improving clinical outcomes in hospitalized patients with SARS-CoV-2.
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DRUG CANDIDATES AT THE NDA TRIAL STAGE

Anti-infection Products

Deunoxavir Marboxil (PA)¹

Deunoxavir Marboxil is an inhibitor for influenza polymerase acidic (PA) protein. Preclinical studies have shown that Deunoxavir Marboxil demonstrates several benefits, including the absence of central nervous system side effects, no effect of food intake on oral drug absorption and higher safety dose. The entire oral dose of Deunoxavir Marboxil is merely “one tablet” and is capable of stopping influenza virus replication in 24 hours, having a prospect of bringing great convenience to a large number of patients, including child patients.

Milestone of Clinical Progress

In January 2025, the children’s granules of Deunoxavir Marboxil phase III clinical study has completed the LPI.
In February 2025, the children’s granules of Deunoxavir Marboxil has obtained the IND Approval issued by the NMPA, which is intended for commencing the clinical trial for post-exposure prevention of influenza type A and B among population aged 2 years old and above.

Registration Progress

In March 2025, the NDA of Deunoxavir Marboxil Tablets has been accepted by the NMPA, which can be used to treat of uncomplicated influenza A and B in adults and adolescents.

¹ A product with commercial right

– 17 –

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Autoimmune Products

Rademikibart (IL-4R $\alpha$)

Rademikibart is a fully human monoclonal antibody targeting IL-4R $\alpha$, a common subunit of IL-4 receptor and IL-13 receptor. By binding with IL-4R $\alpha$, Rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the Th2 inflammatory pathway, thus achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma.

Registration Progress

In July 2025, the NDA of Rademikibart has been accepted by the NMPA, which can be used to treat of atopic dermatitis in adults and adolescents.

Milestone of Clinical Progress

The phase III clinical study of Rademikibart in asthma is underway.

DRUG CANDIDATES AT PHASE III TRIAL STAGE

Anti-oncology Products

SIM0270 (SERD)

SIM0270 is a second-generation oral SERD with blood-brain barrier penetration characteristics independently developed by the Group. SIM0270 was significantly more effective than fulvestrant a marketed intramuscular SERD product, in an in vivo model, comparable to the leading compound in the clinical trial phase, and reflected a brain-blood ratio significantly better than competitive compounds and showed a much better tumor inhibition effect than fulvestrant in the orthotropic model of breast cancer brain. It is expected to be used for the treatment of breast cancer with brain metastases.

Milestone of Clinical Progress

SIM0270 in combination with everolimus compared the treatment selected by investigators, which is intended for ER+/HER2-locally advanced or metastatic breast cancer after treatment with a CDK4/6 inhibitor, where subjects in the clinical trial were randomized, open and under recruitment for phase III investigation.

TGRX-326 (ALK/ROS1)¹

TGRX-326 is the latest generation of novel type 1 drug for the treatment of NSCLC driven by ALK/ROS1 positive fusion gene cooperated by the Group and Shenzhen TargetRx, Inc. (深圳市塔吉瑞生物醫藥有限公司), pursuant to which, the Group obtained the exclusive commercialization rights of the product in Chinese Mainland. TGRX-326 has high blood-brain barrier permeability, and is effective for the treatment of NSCLC with brain metastasis.

Milestone of Clinical Progress

The phase III clinical study of TGRX-326 has completed the LPI.

¹ A product with commercial right

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Autoimmune Products

LNK01001 (JAK1)

LNK01001 is a highly selective JAK1 inhibitor which has completed 3 phase II clinical studies for patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and atopic dermatitis (AD), all of which have successfully met their corresponding primary and secondary endpoints. No related adverse effects of approved JAK1 inhibitors, such as major adverse cardiovascular events, blood clots, serious infection or formation of malignant tumors, were observed. In March 2022, the Group entered into a cooperation agreement with Lynk Pharmaceuticals Co., Ltd. (资料藥業(杭州)有限公司) (“Lynk Pharmaceuticals”), pursuant to which, the Group obtained the exclusive commercialization interest of LNK01001 for rheumatoid arthritis and ankylosing spondylitis indications in China and be responsible for promotion after regulatory approval.

Milestone of Clinical Progress

In March 2025, the phase III clinical study of the RA indication of LNK01001 has completed LPI.

A product with commercial right

DRUG CANDIDATES AT PHASE I TRIAL STAGE (SELECTED)

Anti-oncology Products

SIM0237 (PD-L1/IL15v bispecific antibody)

SIM0237 is an anti-PD-L1 monoclonal antibody fused with IL-15/IL15R α sushi protein and developed in-house by utilizing the Group’s protein engineering platform. It can block the PD1/PD-L1 immunosuppressive pathway via binding to PD-L1 and activate the immune system through its IL-15 part, thus playing a synergistic role of relieving immunosuppression and boosting the immune system to exhibit antitumor effect. Preclinical studies showed that SIM0237 is more effective than PD-L1 or IL-15 mono treatment in mouse tumor models, suggesting a high potential for clinical development.

Milestone of Clinical Progress

Phase I clinical trial of SIM0237 mono treatment bladder installation for non-muscle invasive bladder cancer (“NMIBC”) is under active recruitment, which has positive initial clinical effect data and good safety.
The Centre for Drug Evaluation (“CDE”) has approved the research of the usage of SIM0237 in combination with BCG in NMIBC, and has completed the FPI.

SIM0501 (USP1 small molecule inhibitor)

SIM0501 is an oral, non-covalent and highly selective small molecule inhibitor of Ubiquitin Specific Peptidase 1 (“USP1”) independently developed by the Group with global inerllectual property rights. In preclinical in vitro and in vivo pharmacology studies, SIM0501 has shown significant anti-proliferation activity against HRD tumors as a monotherapy or in combination with PARPi, which demonstrates high potential for clinical development.

Milestone of Clinical Progress

SIM0501 tablets mono treatment is under the progress of phase I clinical study of advanced malignant solid tumors.
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SIM0500 (humanized GPRC5D-BCMA-CD3 trispecific antibody)

SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3, developed independently by the Group using T-cell engager poly-specific antibody technology platform. This molecule features a low affinity/high target-activating CD3 engaging arm and binding sites for the two tumor antigens: G-Protein-coupled receptor class 5 member D (GPRC5D) and B-cell maturation antigen (BCMA). SIM0500 has shown strong T cell cytotoxicity against multiple myeloma (MM) cells by leveraging a combination of various antitumor effects.

Milestone of Clinical Progress

In June 2025, the phase I clinical trial of SIM0500 completed the FIH in the United States.

Milestone of Strategic Cooperation

In January 2025, the Group has entered into an option to license agreement (the “Agreement”) with AbbVie. Under terms of the Agreement, AbbVie would have the option to license SIM0500, an IND candidate. Under the terms of the Agreement, the Group will receive an upfront payment from AbbVie, and is eligible to receive option fees and milestone payments of up to US$1.055 billion, as well as tiered royalties on net sales outside of the Greater China territory. AbbVie is eligible to receive tiered royalties on net sales in the Greater China territory.

SIM0395 (Paxalisib)

SIM0395 is a BBB-penetrant inhibitor of the PI3K/mTOR pathway. A phase II clinical study showed that Paxalisib has shown highly encouraging signals of clinical efficacy among glioblastoma patients with unmethylated MGMT promoter status. Paxalisib was awarded the GBM orphan drug certification by FDA in 2018 and the fast track certification by FDA, the rare childhood disease and orphan drug certification of diffuse intrinsic pontine glioma (DIPG) in 2020. In March 2021, the Group entered into an exclusive licensing agreement with Kazia to introduce the development and commercialization rights of SIM0395 for all indications in the Greater China region.

SIM0508 (Pol θ small molecule inhibitor)

Pol θ is a DNA polymerase, whose mediation of MMEJ repair pathway is one of the important approaches for repairing DNA double strand breaks.

Milestone of Clinical Progress

SIM0508 tablets mono treatment is under the progress of phase I clinical research of advanced malignant solid tumors.
In August 2025, the IND application of SIM0508, which was in combination with Olaparib to be used in locally advanced or metastatic solid tumors patients, was approved by the NMPA.

SIM0505 (CDH6-ADC)

CDH6, a Class II classical cadherin, is highly expressed in a variety of tumors but with very limited expression in normal tissues. SIM0505 is a CDH6-targeting ADC molecule developed by the Group, which consists of CDH6 monoclonal antibody specifically binding to tumor cells and the Group’s proprietary camptothecin derivative toxin, conjugated by a linker. By combining the tumor-specific targeting antibody with the high-efficiency killing effect of toxin molecules, SIM0505 can specifically target tumor cells and reduce the toxic side effects compared to traditional chemotherapies. Such ADC is intended for the treatment of malignant tumors such as ovarian and renal cancer.

Milestone of Clinical Progress

In February 2025, the phase I clinical trial of SIM0505 completed the FIH at the Fudan University Shanghai Cancer Center (復旦大學附屬腫瘤醫院).

Milestone of Strategic Cooperation

In June 2025, a subsidiary of the Company, Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (海南先聲再明醫藥股份有限公司) (“Simcere Zaiming”), entered into a license agreement (the “License Agreement”) with NextCure, Inc. (“NextCure”). Pursuant to the License Agreement, (i) NextCure obtains global rights (excluding the Greater China region) to SIM0505; (ii) NextCure is eligible to access Simcere Zaiming’s proprietary TOPO isomerase I inhibitor (“TOPOi”) payload for a NextCure novel target ADC in preclinical development; and (iii) Simcere Zaiming will have Greater China rights to the novel target ADC.
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SIM0686 (FGFR2b-ADC)

SIM0686 is an ADC drug targeting FGFR2b. Fibroblast growth factor receptor (FGFR) is a transmembrane tyrosine kinase receptor of fibroblast growth factor (FGF). At present, there are four known subtypes, namely FGFR1, FGFR2, FGFR3 and FGFR4. Such ADC is intended to be developed for the treatment of advanced malignant tumors like gastric cancer and lung cancer.

Milestone of Clinical Progress

In April 2025, the IND application for SIM0686 was approved by the NMPA, which was intended for commencing the clinical trial for advanced solid tumors.
In May 2025, the FIH for the aforementioned clinical trial was completed at Nanjing Tianyinshan Hospital (南京天印山醫院).
In July 2025, the IND for SIM0686 was approved by the FDA.

Autoimmune Products

SIM0278 (IL2muFc)

SIM0278 is an Fc fusion protein (IL2muFc) with an IL2 mutein of Regulatory T cells ("Treg"), developed based on the Group's protein engineering technology platform. By introducing the mutation, the affinity of SIM0278 to effector T cells is reduced, while the high affinity of Treg cells is retained and then the selectivity of Treg cells is improved. In September 2022, the Group entered into a licensing agreement with Almirall S.A. ("Almirall"), which is an international biopharmaceutical company. Pursuant to the agreement, the Group grants Almirall an exclusive rights and interests in the development and commercialization of SIM0278 outside Greater China, and retains all rights and interests in the Greater China region.

Neuroscience Products

SIM0800 (AQP4)

SIM0800 is an Aquaporin-4 (AQP4) inhibitor developed based on the Aquaporin water channel theory which has been awarded the Nobel Prize. It is intended for the treatment of acute severe ischemic stroke complicated by cerebral oedema, as a first-in-class small molecule drug with a novel mechanism of action for brain oedema therapy. The Group entered into a license agreement with Aeromics, Inc. in October 2019, pursuant to which, the Group obtained a proprietary and sublicensable license for its self-funded research, development, production and commercialization of SIM0800 in the Greater China region.

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DRUG CANDIDATES AT THE IND/PRE-CLINICAL STAGE (SELECTED)

The Group has approximately 40 pre-clinical drug candidates and its in-house pipelines focus on differentiated targets with FIC and BIC potential, which provide strong and diversified product pipelines for the long-term sustainable growth of the Group. Certain research and development assets with high potential are as follows.

SIM0609 (CDH17-ADC)

SIM0609 is a new antibody-drug conjugate targeting CDH17. It comprises a humanized monoclonal antibody conjugated via the Group’s proprietary new water-soluble cleavable linker to a new Topoisomerase I (TOP-I) inhibitor independently developed by the Group. CDH17 is highly expressed in various cancers, including gastric cancer, colorectal cancer, pancreatic cancer, and ovarian cancer, demonstrating potential as a therapeutic target for advanced solid tumors, particularly gastrointestinal tumors.

Milestone of Clinical Progress

In July 2025, the IND application of SIM0609 has been submitted to the CDE.

INTELLECTUAL PROPERTY RIGHTS

The Group attaches great importance to the protection of intellectual property rights. For the six months ended June 30, 2025, the Group had 149 new patent applications (including domestic and overseas unpublished patent applications), being 148 invention patents and an appearance design patent. As of June 30, 2025, the Group has accumulatively obtained 317 invention patents, 99 utility model patents and 32 appearance design patents.

FINANCIAL REVIEW

Revenue

For the six months ended June 30, 2025, the Group recorded revenue of approximately RMB3,585 million, representing an increase of approximately 15.1% as compared to RMB3,114 million for the same period of 2024.

Revenue of the Group was mainly derived from the therapeutic areas where its businesses are focused. Of which, revenue from the field of neuroscience was RMB1,249 million, accounting for 34.8% of the total revenue and representing an increase of 37.3% as compared to RMB909 million for the same period of 2024. Revenue from the field of anti-oncology was RMB874 million, accounting for 24.4% of the total revenue and representing an increase of 41.1% as compared to RMB619 million for the same period of 2024. Revenue from the field of autoimmune was RMB878 million, accounting for 24.5% of the total revenue and representing an increase of 3.3% as compared to RMB850 million for the same period of 2024. Revenue from other fields was RMB584 million, accounting for 16.3% of the total revenue and representing a decrease of 20.5% as compared to RMB736 million for the same period of 2024.

THE EXPENDITURE ON RESEARCH AND DEVELOPMENT ACTIVITIES

The expenditure on research and development activities of the Group includes research and development costs and the addition of intangible assets with in-licensed rights.

For the six months ended June 30, 2025, the total expenditure on research and development activities of the Group amounted to RMB1,028 million, representing an increase of 68.0% as compared to RMB612 million for the same period of 2024. The expenditure on research and development activities accounted for 28.7% of the revenue, representing an increase of 9 percentage points as compared to 19.7% for the same period of 2024.
For the six months ended June 30, 2025, the research and development costs amounted to RMB632 million, representing an increase of 11.7% as compared to RMB566 million for the same period in 2024. The research and development costs accounted for 17.6% of the revenue, representing a decrease of 0.6 percentage point as compared to 18.2% for the same period of 2024.
For the six months ended June 30, 2025, the addition of intangible assets with in-licensed rights amounted to RMB396 million, representing a significant increase as compared to RMB46 million for the same period in 2024. The addition of intangible assets with in-licensed rights accounted for 11.0% of the revenue, representing an increase of 9.5 percentage points as compared to 1.5% for the same period in 2024.

PROFIT ATTRIBUTABLE TO EQUITY SHAREHOLDERS OF THE COMPANY

The Group recorded a profit attributable to equity shareholders of the Company of RMB604 million for the six months ended June 30, 2025, representing an increase of 32.2% as compared to RMB457 million for the same period in 2024.

NON-HKFRS MEASURE – ADJUSTED PROFIT ATTRIBUTABLE TO EQUITY SHAREHOLDERS OF THE COMPANY

To supplement the financial information presented in accordance with HKFRS, the Group also uses adjusted profit attributable to equity shareholders of the Company as a non-HKFRS measure. Such measure is unaudited in nature and is not required by, or presented in accordance with, HKFRS. The Group defines adjusted profit attributable to equity shareholders of the Company as profit attributable to equity shareholders of the Company after adjusting the following items: (i) net realized and unrealized losses on financial assets at fair value through profit or loss; (ii) net realized and unrealized gain on associates at fair value through profit or loss; (iii) interest expenses arising from redemption liability; and (iv) income tax effect related to the above items. The Group is of the view that the Group’s management and investors may benefit from referring to such measure in assessing the financial performance of the Group’s core businesses by eliminating the impacts of certain non-recurring, non-cash and/or non-operating items. However, the presentation of adjusted profit attributable to equity shareholders of

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the Company may not be comparable to similarly titled measures presented by other companies as it does not have a standardized meaning. The application of the non-HKFRS measure has limitations as an analytical tool, and the Shareholders and investors should not consider it in isolation from, or as substitute for analysis of, the results of operations or financial condition of the Group as reported under HKFRS.

For the six months ended June 30, 2025, the adjusted profit attributable to equity shareholders of the Company amounted to RMB651 million, representing an increase of 21.1% as compared to RMB538 million for the same period of last year.

The following table presents the Group's adjusted profit attributable to equity shareholders of the Company and the most directly comparable financial measure calculated and presented in accordance with HKFRSs, which is profit attributable to equity shareholders of the Company:

	Six months ended June 30
	2025	2024
	RMB'000	RMB'000
	(unaudited)	(unaudited)
Profit attributable to equity shareholders of the Company	603,607	456,600
Add/(less):
Net realized and unrealized losses on financial assets at fair value through profit or loss(1)	21,388	84,175
Net realized and unrealized gain on associates at fair value through profit or loss	(4,893)	-
Interest expenses arising from redemption liability(2)	34,865	5,103
Effect of corresponding income tax	(3,745)	(8,208)
Adjusted profit attributable to equity shareholders of the Company	651,222	537,670

Notes:

(1) Net realized and unrealized losses on financial assets at fair value through profit or loss arises from the remeasurement of the Group's investments in certain private companies and investment funds, listed equity securities, structured deposits and wealth management products at fair value.

(2) Interest expenses arising from redemption liability represent the change in the carrying amount of the financial liability issued in connection with the capital contributions in Simcere Zaiming (as defined below).

LIQUIDITY AND FINANCIAL RESOURCES

The Group maintained a sound financial position. For the six months ended June 30, 2025, the net cash generated from operating activities was RMB867 million, while the net cash generated from operating activities for the same period of last year was RMB863 million. As of June 30, 2025, the Group had cash and cash equivalents of RMB2,671 million (as of December 31, 2024: RMB1,943 million), time deposits of RMB519 million (as of December 31, 2024: RMB498 million). As of June 30, 2025, the Group had a balance of bank loans of RMB1,059 million (as of December 31, 2024: RMB1,059 million), of which RMB1,051 million (as of December 31, 2024: RMB1,051 million) would mature within one year. As of June 30, 2025, RMB1,059 million of the Group's bank loan balances bore interest at fixed rates, and the effective interest rate range for these loans was 0.95% to 1.15% per annum.

As of June 30, 2025, the current ratio (calculated by total current assets divided by total current liabilities) of the Group was 173.3% (as of December 31, 2024: 200.4%), while the gearing ratio (calculated by total liabilities divided by total assets) was 42.6% (as of December 31, 2024: 38.6%). The decrease in current ratio was mainly due to: (1) in January, 2025, the Company entered into an option to license SIM0500, an investigational new drug candidate, with AbbVie Inc. and received an upfront payment of RMB358 million, (2) in June, 2025, the Group entered into an amendment agreement with Idorsia and made upfront payment and a regulatory milestone payment of RMB359 million, and (3) in June, 2025, the Company's milestone payment for the approval for marketing of ENZESHU® of RMB20 million were accrued, and these contract payments were all accounted as liabilities. The increase in gearing ratio was mainly due to the receipt of an investment amount of RMB1,070 million by Simcere Zaiming, a subsidiary of the Company, from third party investors which was accounted for as financial liabilities, as well as the effect of the aforesaid contract payments were all accounted as liabilities.

Currently, the Group follows a set of funding and treasury policies to manage its capital resources and prevent risks involved. The Group expects to fund the working capital and other capital requirements from a combination of various sources, including but not limited to external financing at reasonable market rates. In order to better control and minimize the cost of funds, the treasury management activities of the Group are managed on a centralized basis.

The assets and liabilities of the Group were denominated in RMB, USD, GBP and HKD. During the Reporting Period, the Group did not employ financial derivatives or enter into foreign derivative contracts to hedge against foreign exchange risk. However, the Group manages the foreign exchange risks by closely monitoring the net exposure of foreign exchange risk to minimize the impact of foreign exchange fluctuations.

PLEDGE OF GROUP'S ASSETS

As of June 30, 2025, the Group pledged bills receivable of approximately RMB41 million for issuance of bank acceptance bills and pledged bank deposits of approximately RMB22 million for issuance of letter of guarantee. As of June 30, 2025, leasehold land with net book value of approximately RMB109 million was pledged as security for banking facilities, which were not utilized as of June 30, 2025. Save as disclosed above, as of June 30, 2025, none of the Group's assets were pledged.

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CONTINGENT LIABILITIES

As of June 30, 2025, the Group did not have material contingent liabilities.

MATERIAL LITIGATION

One of the Group’s subsidiaries was involved in an economic dispute with a customer. In May 2025, an arbitration award confirmed that the Group was required to make a compensation to the customer and bear the related litigation costs amounting to RMB20.93 million. As a result, the Group recorded a litigation loss of RMB20.93 million during the Reporting Period.

Save as disclosed above, during the Reporting Period and as of the date of this announcement, no member of the Group has been involved in any other material litigation, arbitration or claims. So far as is known to the Directors, no member of the Group has any other pending or threatened material litigation, arbitration or claims.

SIGNIFICANT INVESTMENTS HELD

As of June 30, 2025, the Group did not hold any significant investments.

FUTURE PLANS FOR MATERIAL INVESTMENTS AND CAPITAL ASSETS

Save as disclosed in “Use of Proceeds from the Listing” in this announcement, as of June 30, 2025, the Group did not have any other future plans for material investments and capital assets.

MATERIAL ACQUISITIONS AND DISPOSALS

For the six months ended June 30, 2025, the Group had no material acquisition or disposal of subsidiaries, associates and joint ventures.

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EMPLOYEES AND REMUNERATION POLICY

As of June 30, 2025, the Group had a total of 6,815 full-time employees. The Group attached great importance to the recruitment, training and retention of outstanding employees, maintaining a high standard in selecting and recruiting talents worldwide, and offered competitive compensation packages. The remuneration of employees mainly included basic salary, performance-based bonus and long-term incentives. Remuneration of the Directors and senior management who worked full time for the Company shall be determined by the remuneration and appraisal committee of the Company under the Board with reference to the principal duties, the results of performance assessment as well as the remuneration level in the market of the relevant managerial positions. During the six months ended June 30, 2025, staff costs of the Group (including emoluments of the Directors, social insurance and other benefits) amounted to RMB1,101 million. The Group established Simcere Institute, which provides employees with training on a regular basis, including orientation programs and technical training for new employees, professional and management training for middle and senior management and health and safety training across all staff. In addition, the Group has also adopted a restricted share unit ("RSU") scheme on May 20, 2021 (the "2021 RSU Scheme"), with an aim to (1) incentivise the existing and incoming directors, senior management and employees for their contribution to the Group; and (2) attract, motivate and retain skilled and experienced personnel to strive for the future development and expansion of the Group by providing them with the opportunity to own equity interests in the Company.

During the Reporting Period, the Board resolved on March 25, 2025 to grant an aggregate of 1,777,000 RSUs, representing 1,777,000 underlying Shares, to an aggregate of 45 eligible participants (all of whom are employees of the Group) under the 2021 RSU Scheme at nil consideration. For details of such grant, please refer to the announcement of Company dated March 25, 2025.

INTERIM DIVIDEND

The Board resolved not to declare any interim dividend for the six months ended June 30, 2025.

USE OF PROCEEDS FROM THE LISTING

The net proceeds from the initial public offering of the shares of the Company in October 2020 and allotment and issuance of shares of the Company pursuant to the partial exercise of the over-allotment option in November 2020 (the "Net Proceeds"), amounted to HK$3,513.09 million in aggregate. The proposed use of the Net Proceeds was disclosed in the prospectus of the Company dated October 13, 2020 (the "Prospectus").

The following table sets out the utilization of the Net Proceeds as of the June 30, 2025 and the expected timeline for utilization:

Purpose	Percentage of the total amount	Amount of Net Proceeds received (HK$ in million)	Amount of Net Proceeds utilized during the six months ended June 30, 2025 (HK$ in million)	Accumulative amount of Net Proceeds utilized as of June 30, 2025 (HK$ in million)	Amount of Net Proceeds unutilized as of June 30, 2025 (HK$ in million)	Expected timeline for utilization
Continuous research and development of the Group's selected product candidates in its strategically focused therapeutic areas	60%	2,107.85	174.30	1,893.48	214.37	The actual Net Proceeds are expected to be fully utilized by 2027.
Reinforcement of the Group's sales and marketing capabilities	10%	351.31	–	351.31	–	The actual Net Proceeds have been fully utilized.
Investment in companies in the pharmaceutical or biotechnology sector	10%	351.31	–	351.31	–	The actual Net Proceeds have been fully utilized.
Repayment of certain of the Group's outstanding bank loans	10%	351.31	–	351.31	–	The actual Net Proceeds have been fully utilized.
Working capital and other general corporate purposes	10%	351.31	–	351.31	–	The actual Net Proceeds have been fully utilized.
Total	100%	3,513.09	174.30	3,298.72	214.37

On December 23, 2024, the Board has resolved that: (i) part of the unutilized Net Proceeds amounted to HK$228.90 million which originally proposed to be used in selected oncology product candidates that were then in clinical stages or pending clinical trials (including Bevacizumab Biosimilar, PEG-ENDO (Pegylated recombinant human endostatin for injection) and SIM-201), (ii) part of the unutilized Net Proceeds amounted to approximately HK$180.02 million which originally proposed to be used in selected innovative oncology product candidates that were then pending IND approvals or in preclinical stages (including SIM323, subcutaneous PD-L1 single domain antibody combination therapy 1 and subcutaneous PD-L1 single domain antibody combination therapy 2), (iii) part of the unutilized Net Proceeds amounted to approximately HK$31.74 million which originally proposed to be used in other selected innovative central nervous system product candidates that were then preparing for the IND application or in pre-clinical stages, and (iv) part of the unutilized Net Proceeds amounted to approximately HK$0.79 million which originally proposed to be used in selected autoimmune disease product candidates SIM-335, to be reallocated to the continuous R&D of selected autoimmune disease product candidates and oncology disease product candidates that are currently under development (including Rademikibart (IL-4R α), SIM0500 (humanized GPRC5D-BCMA-CD3 trispecific antibody), SIM0270 (oral SERD inhibitor), SIM0237 (PD-L1/IL15v bispecific antibody) and SIM0505 (CDH6ADC)). For details of the change in use of proceeds, please refer to the announcements of the Company dated April 15, 2021, August 31, 2022 and December 23, 2024 (the "Announcements"). As of June 30, 2025, the accumulative amount of Net Proceeds utilized was HK$3,298.72 million and the Net Proceeds unutilized was HK$214.37 million. The Company intends to apply the unutilized Net Proceeds as of June 30, 2025 in the manner and proportion set out in the Prospectus and the Announcements.

PROSPECTS

In the current financial year and future, the Group will uphold the corporate mission of "born for the patients" actively, enhance market distribution and deepen the cooperation with medical institutions at all levels while exploring diversified sales channels, so as to increase the market share and accessibility of its launched products and lay a solid foundation for sustainable development. In addition, the Group will also provide more quality treatment options for patients and contribute more to the health and wellbeing of the community by way of enhancing R&D processes, enhancing the cooperation in production and research, improving R&D efficiency continuously, strengthening the gradient of pipelines, commencing overseas clinical trials proactively as well as promoting the overseas licensing of pipelines under research.

32 -

OTHER INFORMATION

1. PURCHASE, SALE OR REDEMPTION OF THE COMPANY'S LISTED SECURITIES

The Directors have been granted a general mandate by the shareholders of the Company (the "Shareholders") at the annual general meeting of the Company held on June 14, 2024 (the "2023 AGM") to repurchase up to 260,976,161 shares of the Company (the "Shares") on the Stock Exchange, representing 10% of the total number of issued Shares as of the date of the 2023 AGM (the "Repurchase Mandate"). During the Reporting Period, the Company repurchased a total of 11,623,000 Shares (the "Repurchased Shares") on the Stock Exchange pursuant to the Repurchase Mandate at a total consideration (excluding expenses) of HK$80,369,080 (the "Share Repurchase"), which was funded by internal resources of the Company. All the Repurchased Shares were cancelled on June 6, 2025. As of the date of this announcement, there are no Repurchased Shares were outstanding. Details of the Shares repurchased by the Company during the Reporting Period are as follows:

Month of Share Repurchase	Total number of Shares repurchased	The highest purchase price per Share (HK$)	The lowest purchase price per Share (HK$)	Total consideration (excluding expense) (HK$)
January 2025	8,336,000	6.93	6.3383	55,107,010
April 2025	3,287,000	7.9692	7.30	25,262,070
Total	11,623,000			80,369,080

The Share Repurchase was governed by section 257 of the Hong Kong Companies Ordinance. The total amount paid on the Repurchased Shares of HK$80,369,080 (equivalent to RMB74,302,000) was paid wholly out of retained profits of the Company.

The Board believes that the Share Repurchase demonstrates the Company's confidence in its own business outlook and prospects and would, ultimately, benefit the Company and create value for the Shareholders. In addition, the Board believes that the current financial resources of the Company enable it to implement the Share Repurchase while maintaining a solid financial position.

Save as disclosed above, during the Reporting Period, neither the Company nor any of its subsidiaries had purchased, sold or redeemed any of the Company's listed securities (including sale of treasury shares (if any)). The Company did not hold any treasury shares during the Reporting Period and as of June 30, 2025.

33 -

34 -
IMPORTANT EVENTS AFTER THE REPORTING PERIOD

After the Reporting Period and up to the date of this announcement, there were no material events affecting the Company or any of its subsidiaries.

COMPLIANCE WITH THE CORPORATE GOVERNANCE CODE

The Group is committed to maintaining and promoting stringent corporate governance. The principles of the Group’s corporate governance are to promote effective internal control measures, uphold a high standard of ethics, transparency, responsibility and integrity in all aspects of business, so as to ensure that its business and operation are conducted in accordance with applicable laws and regulations, enhance the transparency of the Board and strengthen the accountability to all Shareholders. The Group’s corporate governance practices are based on the principles and code provisions prescribed in the Corporate Governance Code (the “CG Code”) as set out in Appendix C1 to the Rules governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the “Listing Rules”).

Save as disclosed below, the Group has complied with the code provisions contained in Part 2 of the CG Code during the Reporting Period.

Under code provision C.2.1 of Part 2 of the CG Code, the roles of chairman and chief executive officer should be separate and should not be performed by the same individual. During the Reporting Period and as of June 30, 2025, the roles of chairman of the Board (the “Chairman”) and chief executive officer of the Company (the “Chief Executive Officer”) were not separated and Mr. REN Jinsheng (“Mr. REN”) currently performs these two roles. Mr. REN is the founder of the Group, the Chairman and the Chief Executive Officer. He has been primarily responsible for overall corporate business strategies and business operation of the Group and making significant business and operational decisions for the Group. The Directors jointly consider that vesting the roles of both the Chairman and the Chief Executive Officer in Mr. REN is beneficial to the business prospects of the Group by ensuring consistent leadership to the Group as well as prompt and effective decision making and implementation. In addition, the Directors jointly believe that this structure will not impair the balance of power and authority between the Board and the management of the Company, given that: (i) any decision to be made by the Board requires approval by at least a majority of the Directors; (ii) Mr. REN and other Directors are aware of and undertake to fulfill their fiduciary duties as the Directors, which require, among other things, that he acts for the benefit and in the best interests of the Company and will make decisions for the Company accordingly; (iii) the balance of power and authority is ensured by the operations of the Board, which consists of four executive Directors (including Mr. REN) and four independent non-executive Directors, and has a fairly strong independence element; and (iv) the overall strategic and other key business, financial, and operational policies of the Company are made collectively after thorough discussion at both Board and senior management levels.

35 -

4. COMPLIANCE WITH THE MODEL CODE FOR SECURITIES TRANSACTIONS BY DIRECTORS

The Group has adopted the Model Code for Securities Transactions by Directors of Listed Issuers (the "Model Code") as set out in Appendix C3 to the Listing Rules as the Group's code of conduct regarding the Directors' securities transactions. Having made specific enquiries of all the Directors, all the Directors confirmed that they have strictly complied with the Model Code during the Reporting Period.

5. AUDIT COMMITTEE AND REVIEW OF FINANCIAL INFORMATION

The Group established the Audit Committee with written terms of reference in compliance with the CG Code. The main duties of the Audit Committee are to review and supervise the financial reporting process and internal control system of the Group, oversee the audit process, review and oversee the existing and potential risks of the Group and perform other duties and responsibilities as assigned by the Board.

As of the date of this announcement, the Audit Committee consists of three members, all of which are independent non-executive Directors, namely Mr. WANG Xinhua, Mr. SONG Ruilin and Mr. WANG Jianguo. The chairperson of the Audit Committee is Mr. WANG Xinhua, who possesses the appropriate professional qualifications and accounting and related financial management expertise.

The Audit Committee has reviewed the financial reporting processes, risk management and internal control systems of the Group and the unaudited condensed consolidated interim financial statements, interim report of the Group for the six months ended June 30, 2025 and this interim results announcement, and is of the opinion that these statements have complied with the applicable accounting standards, the Listing Rules and legal requirements, and that adequate disclosure has been made.

6. INDEPENDENT REVIEW OF AUDITOR

The interim financial report for the six months ended June 30, 2025 is unaudited, but has been reviewed by KPMG, in accordance with Hong Kong Standard on Review Engagements No.2410 "Review of interim financial information performed by the independent auditor of the entity" issued by the Hong Kong Institute of Certified Public Accountants, whose unmodified review report is included in the 2025 interim report.

7. PUBLICATION OF THE INTERIM RESULTS ANNOUNCEMENT AND INTERIM REPORT

This interim results announcement is published on the websites of the Stock Exchange (www.hkexnews.hk) as well as the Group (www.simcere.com), respectively. The Group's 2025 interim report will be published on the aforementioned websites in due course and to be sent to the Shareholders.

36 -

CONSOLIDATED STATEMENT OF PROFIT OR LOSS

For the six months ended June 30, 2025 – unaudited

	Note	Six months ended June 30,
		2025	2024
		RMB'000	RMB'000
Revenue	4	3,584,912	3,113,524
Cost of sales		(691,062)	(651,592)
Gross profit		2,893,850	2,461,932
Other income	5(a)	68,595	71,476
Other net loss	5(b)	(29,814)	(90,519)
Research and development costs		(632,421)	(566,129)
Selling and distribution expenses		(1,350,545)	(1,155,619)
Administrative and other operating expenses		(264,192)	(230,806)
(Provision for)/reversals of impairment loss on trade and other receivables		(827)	1,825
Profit from operations		684,646	492,160
Finance income	6(a)	26,548	25,411
Finance costs	6(a)	(13,671)	(18,366)
Interest expenses arising from redemption liability	6(a)	(34,865)	(5,103)
Net finance (costs)/income		(21,988)	1,942
Share of (losses)/profits of associates		(1,908)	18
Share of profits of joint ventures		1,735	573
Profit before taxation	6	662,485	494,693
Income tax	7	(58,878)	(38,093)
Profit for the period		603,607	456,600

CONSOLIDATED STATEMENT OF PROFIT OR LOSS (CONTINUED)

For the six months ended June 30, 2025 – unaudited

	Note	Six months ended June 30,
		2025	2024
		RMB’000	RMB’000
Attributable to:
Equity shareholders of the Company		603,607	456,600
Non-controlling interest		-	-
Profit for the period		603,607	456,600
Earnings per share	8
Basic (RMB)		0.25	0.18
Diluted (RMB)		0.25	0.18

– 37 –

38 -

CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

For the six months ended June 30, 2025 – unaudited

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Profit for the period	603,607	456,600
Other comprehensive income for the period
(after tax adjustments)
Items that will not be reclassified to profit or loss:
Financial assets at fair value through other comprehensive income (FVOCI) – net movement in fair value reserves (non-recycling), net of tax	7,574	(1,055)
Exchange difference on translation of company level financial statements	(20,005)	(1,116)
Items that will be reclassified to profit or loss:
Exchange difference on translation of financial statements of overseas subsidiaries	(1,445)	2,229
Other comprehensive income for the period	(13,876)	58
Total comprehensive income for the period	589,731	456,658
Attributable to:
Equity shareholders of the Company	589,731	456,658
Non-controlling interest	-	-
Total comprehensive income for the period	589,731	456,658

At June 30, 2025 – unaudited

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

	Note	June 30,	December 31,
		2025	2024
		RMB'000	RMB'000
Non-current assets
Property, plant and equipment		2,265,580	2,269,544
Intangible assets		1,389,319	1,025,438
Goodwill		142,474	142,474
Interest in associates		59,575	50,870
Interest in joint ventures		104,154	102,342
Prepayments, deposits and other receivables		181,730	178,191
Financial assets at fair value through other comprehensive income		288,899	279,989
Financial assets at fair value through profit or loss		925,014	961,502
Loan to a third party		100,096	100,105
Time deposits	10(c)	513,455	498,140
Deferred tax assets		519,585	435,589
		6,489,881	6,044,184
Current assets
Inventories		571,387	593,649
Contract assets		7,684	4,611
Trade and bills receivables	9	2,630,649	2,699,825
Prepayments, deposits and other receivables		184,482	178,525
Pledged deposits	10(b)	21,763	24,050
Restricted deposits	10(b)	22,885	22,014
Time deposits	10(c)	5,717	-
Cash and cash equivalents	10(a)	2,670,518	1,943,069
		6,115,085	5,465,743

40 -

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (CONTINUED)

At June 30, 2025 – unaudited

| | Note | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- | --- |
| Current liabilities | | | |
| Bank loans | 11 | 1,050,817 | 1,051,139 |
| Lease liabilities | | 79,153 | 67,559 |
| Trade and bills payables | 12 | 187,908 | 275,725 |
| Other payables and accruals | 13 | 2,099,828 | 1,156,198 |
| Taxation payable | | 88,956 | 154,358 |
| Provisions | | 22,000 | 22,000 |
| | | 3,528,662 | 2,726,979 |
| Net current assets | | 2,586,423 | 2,738,764 |
| Total assets less current liabilities | | 9,076,304 | 8,782,948 |
| Non-current liabilities | | | |
| Bank loans | 11 | 7,889 | 8,254 |
| Lease liabilities | | 91,691 | 82,417 |
| Deferred income | | 366,279 | 377,686 |
| Deferred tax liabilities | | 67,578 | 72,704 |
| Other financial liability | 14 | 1,143,637 | 1,008,772 |
| Other non-current liability | | 165,000 | 165,000 |
| | | 1,842,074 | 1,714,833 |
| NET ASSETS | | 7,234,230 | 7,068,115 |

41 -

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (CONTINUED)

At June 30, 2025 – unaudited

| | Note | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- | --- |
| CAPITAL AND RESERVES | | | |
| Share capital | | 3,184,369 | 3,173,805 |
| Reserves | | 4,049,861 | 3,894,310 |
| Total equity attributable to equity shareholders
of the Company | | 7,234,230 | 7,068,115 |
| Non-controlling interest | | - | - |
| TOTAL EQUITY | | 7,234,230 | 7,068,115 |

NOTES TO THE UNAUDITED INTERIM FINANCIAL REPORT

(Expressed in Renminbi unless otherwise indicated)

1 GENERAL INFORMATION

Simcere Pharmaceutical Group Limited (the “Company”) was incorporated in Hong Kong on November 30, 2015 as a limited liability company with its registered office at Room 703, 7/F, Block 20E, Hong Kong Science Park Phase 3, Pak Shek Kok, New Territories, Hong Kong. The Company’s shares were listed on the Main Board of the Stock Exchange of Hong Kong Limited on October 27, 2020. The Company is an investment holding company. The Company and its subsidiaries (together, “the Group”) are principally engaged in the research and development, manufacturing and sales of pharmaceutical products as well as rendering promotion service of pharmaceutical products that are not manufactured by the Group.

2 BASIS OF PREPARATION

This unaudited interim financial information was extracted from the interim financial report of the Group for the six months ended June 30, 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”).

The interim financial report has been prepared in accordance with the same accounting policies adopted in the 2024 annual financial statements, 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 3.

The preparation of an interim financial report in conformity with HKAS 34 requires management to make judgements, 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.

This 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 2024 annual financial statements. 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 HKFRSs Accounting Standards.

The 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 December 31, 2024 that is included in the interim financial report as comparative information does not constitute the Company’s statutory annual consolidated financial statements for that financial year but is derived from those financial statements. Further information relating to these statutory financial statements disclosed in accordance with section 436 of the Hong Kong Companies Ordinance (Cap. 622) is as follows:

The Company has delivered the financial statements for the year ended December 31, 2024 to the Registrar of Companies as required by section 662(3) of, and Part 3 of Schedule 6 to, the Companies Ordinance.

The Company’s auditor has reported on those financial statements. The auditor’s report was unqualified; did not include a reference to any matters to which the auditor drew attention by way of emphasis without qualifying its report; and did not contain a statement under section 406(2), 407(2) or (3) of the Companies Ordinance.

42 -

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.

4 REVENUE AND SEGMENT REPORTING

(a) Revenue

Disaggregation of revenue

Disaggregation of revenue by business lines is as follows:

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Sales of pharmaceutical products	3,257,304	2,955,614
Income from promotion business	184,152	130,398
- Promotion service income	103,660	130,398
- Collaborative arrangements	80,492	-
License income	121,987	-
Research service income	21,469	27,512
	3,584,912	3,113,524

The Group's revenue from contracts with customers were recognized at point in time with the amount of RMB3,563,443,000 (six months ended June 30, 2024: RMB3,086,012,000) and were recognized over time with the amount of RMB21,469,000 (six months ended June 30, 2024: RMB27,512,000).

(b) Segment reporting

Operating segments are identified on the basis of internal reports that the Group's most senior executive management reviews regularly in allocating resources to segments and in assessing their performances.

The Group's most senior executive management makes resources allocation decisions based on internal management functions and assess the Group's business performance as one integrated business instead of by separate business lines or geographical regions. Accordingly, the Group has only one operating segment and therefore, no segment information is presented.

HKFRS 8, Operating Segments, requires identification and disclosure of information about an entity's geographical areas, regardless of the entity's organization (i.e. even if the entity has a single reportable segment). The Group operates within one geographical location because primarily all of its revenue was generated in the PRC and primarily all of its non-current operating assets and capital expenditure were located/incurred in the PRC. Accordingly, no geographical information is presented.

OTHER INCOME AND OTHER NET LOSS

(a) Other income

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Government grants	61,791	64,360
Rental income	1,184	435
Property management income	318	628
Consulting and technology service income	4,108	3,459
Others	1,194	2,594
	68,595	71,476

(b) Other net loss

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Net foreign exchange gain/(loss)	7,872	(4,869)
Net (loss)/gain on disposal of property, plant and equipment	(259)	108
Net realized and unrealized losses on financial assets at fair value through profit or loss	(21,388)	(84,175)
Net realized and unrealized gain on interest in associate at fair value through profit or loss	4,893	-
Reversal of provision for litigations	-	902
Loss on litigations	(20,932)	-
Net loss on disposal of intangible assets	-	(2,485)
	(29,814)	(90,519)

PROFIT BEFORE TAXATION

Profit before taxation is arrived at after charging/(crediting):

(a) Net finance costs/(income)

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Interest income from bank deposits	(24,825)	(23,700)
Interest income from loan to a third party	(1,723)	(1,711)
Finance income	(26,548)	(25,411)
Interest expenses on bank loans	11,012	15,242
Interest expenses on lease liabilities	2,659	3,124
Finance costs	13,671	18,366
Interest expenses arising from redemption liability (Note 14)	34,865	5,103
Net finance costs/(income)	21,988	(1,942)

(b) Other items

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Depreciation charge
- owned property, plant and equipment	105,219	108,424
- right-of-use assets	38,556	39,459
Amortization of intangible assets	32,149	13,365
Provision for write-down of inventories	39,067	29,969

7 INCOME TAX

Taxation in the consolidated statements of profit or loss represents:

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Current tax
PRC Corporate Income Tax
Provision for the period	136,305	160,507
Over – provision in respect of prior years	(8,766)	(5,262)
	127,539	155,245
Overseas Corporate Income Tax
Provision for the period	298	75
Deferred tax
Origination and reversal of temporary differences	(68,959)	(117,227)
	58,878	38,093

The provision for PRC income tax is based on the respective corporate income tax rates applicable to the subsidiaries located in the PRC as determined in accordance with the relevant income tax rules and regulations of the PRC.

Taxation for overseas subsidiaries is similarly calculated using the estimated annual effective rates of taxation that are expected to be applicable in the relevant countries.

46 -

EARNINGS PER SHARE

(a) Basic earnings per share

The calculation of basic earnings per share is based on the profit attributable to ordinary equity shareholders of the Company of RMB603,607,000 (six months ended June 30, 2024: RMB456,600,000) and the weighted average of 2,443,816,068 ordinary shares (six months ended June 30, 2024: 2,552,167,209 ordinary shares) in issue during the interim period.

Weighted average number of ordinary shares

	Six months ended June 30,
	2025	2024
Issued ordinary shares at January 1	2,486,320,618	2,616,722,618
Effect of purchase of own shares	(9,110,071)	(30,418,363)
Effect of unvested shares under 2021 RSU Scheme	(33,394,479)	(34,137,046)
Weighted average number of ordinary shares at June 30	2,443,816,068	2,552,167,209

(b) Diluted earnings per share

The calculation of diluted earnings per share is based on the profit attributable to ordinary equity shareholders of the Company of RMB603,607,000 (six months ended June 30, 2024: RMB456,600,000) and the weighted average of 2,447,249,758 ordinary shares (six months ended June 30, 2024: 2,552,167,209 shares).

Weighted average number of ordinary shares (diluted)

	Six months ended June 30,
	2025	2024
Weighted average number of ordinary shares at June 30	2,443,816,068	2,552,167,209
Effect of contingently issuable shares under 2021 RSU scheme	3,433,690	-
Weighted average number of ordinary shares (diluted) at June 30	2,447,249,758	2,552,167,209

TRADE AND BILLS RECEIVABLES

| | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- |
| Trade receivables | 2,357,801 | 2,354,916 |
| Bills receivable | 290,025 | 361,272 |
| | 2,647,826 | 2,716,188 |
| Less: loss allowance | (17,177) | (16,363) |
| | 2,630,649 | 2,699,825 |

All of the trade and bills receivables are expected to be recovered within one year.

As at June 30, 2025, bills receivable of RMB40,566,000 were pledged for issuance of bills payable (2024: RMB44,070,000).

Aging analysis

As of the end of the reporting period, the aging analysis of trade and bills receivables, based on the invoice date and net of loss allowance, is as follows:

| | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- |
| Within 3 months | 2,241,827 | 2,315,332 |
| Over 3 months but within 6 months | 316,810 | 340,237 |
| Over 6 months but within 9 months | 70,820 | 41,365 |
| Over 9 months but within 12 months | 1,192 | 2,891 |
| | 2,630,649 | 2,699,825 |

Trade receivables are due within 30 - 90 days from the date of billing.

10 CASH AND CASH EQUIVALENTS, TIME DEPOSITS, PLEDGED DEPOSITS AND RESTRICTED DEPOSITS

(a) Cash and cash equivalents comprise:

| | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- |
| Cash at bank | 2,670,518 | 1,943,069 |

As of the end of the reporting period, cash and cash equivalents situated in Chinese Mainland amounted to RMB2,170,164,000 (2024: RMB1,851,234,000). Remittance of funds out of Chinese Mainland is subject to relevant rules and regulations of foreign exchange control.

(b) Pledged deposits and restricted deposits comprise:

| | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- |
| Pledged deposits for
– issuance of letter of guarantee | 21,763 | 24,050 |
| | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| Restricted deposits for
– 2021 RSU Scheme | 13,021 | 13,070 |
| – research and development projects | 9,744 | 8,740 |
| – litigations | 120 | 204 |
| | 22,885 | 22,014 |

| | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- |
| Current portion | 5,717 | – |
| Non-current portion | 513,455 | 498,140 |
| | 519,172 | 498,140 |

– 49 –

11 BANK LOANS

The maturity profile for the interest-bearing bank loans of the Group at the end of each reporting period is as follows:

	June 30,	December 31,
	2025	2024
	RMB’000	RMB’000
Short-term bank loans	1,050,104	1,050,423
Current portion of long-term bank loans	713	716
Within 1 year or on demand	1,050,817	1,051,139
After 1 year but within 2 years	664	665
After 2 years but within 5 years	1,991	1,994
After 5 years	5,234	5,595
	7,889	8,254
	1,058,706	1,059,393

As at June 30, 2025 and December 31, 2024, the bank loans were unsecured.

12 TRADE AND BILLS PAYABLES

	June 30,	December 31,
	2025	2024
	RMB’000	RMB’000
Trade payables	178,126	241,356
Bills payable	9,782	34,369
	187,908	275,725

As of the end of the reporting period, the aging analysis of trade and bills payables, based on the invoice date, is as follows:

	June 30,	December 31,
	2025	2024
	RMB’000	RMB’000
Within 3 months	130,970	198,001
3 to 12 months	51,450	52,571
Over 12 months	5,488	25,153
	187,908	275,725

All of the trade and bills payables are expected to be settled within one year or repayable on demand.

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13 OTHER PAYABLES AND ACCRUALS

| | June 30, 2025
RMB'000 | December 31, 2024
RMB'000 |
| --- | --- | --- |
| Accrued expenses (Note i) | 316,267 | 475,667 |
| Contract liabilities (Note ii) | 383,224 | 28,160 |
| Payable for employee reimbursements | 16,952 | 17,660 |
| Payables for staff related costs | 329,796 | 328,041 |
| Payables for acquisition of property, plant and equipment | 24,367 | 32,017 |
| Payable for acquisition of intangible assets | 379,045 | – |
| Dividends payable | 389,324 | – |
| Other tax payables | 122,544 | 158,008 |
| Payables for research and development costs | 61,279 | 51,408 |
| Others | 77,030 | 65,237 |
| | 2,099,828 | 1,156,198 |

Notes:
(i) Accrued expenses primarily comprise marketing and promotion expenses, research and development costs and other expenses.
(ii) Contract liabilities represent the advances received from the contract with customers.

14 OTHER FINANCIAL LIABILITY

On February 24, 2024, Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (“Simcere Zaiming”), a PRC subsidiary of the Group, entered into capital contribution agreement with certain investors (the “2024 Investors”), pursuant to which Simcere Zaiming issued additional 52,559,000 shares for a total consideration of RMB970,000,000. The capital contribution was completed on June 4, 2024 with all consideration received.

On April 21, 2025, Simcere Zaiming entered into capital contribution agreement with another investor (the “2025 Investor”), pursuant to which Simcere Zaiming issued additional 5,418,426 shares for a total consideration of RMB100,000,000. The capital contribution was completed on June 6, 2025 with all consideration received.

In addition to voting rights and dividend rights same as other equity holders of Simcere Zaiming, certain special rights including repurchase rights, liquidation preference rights and anti-dilution rights are granted to these investors.

After occurrence of certain events agreed in the agreement, the 2024 Investors and 2025 Investor shall have the right to require the Company and/or Simcere Zaiming to repurchase their shares in Simcere Zaiming at a repurchase price, which is the higher of (i) the investment amount paid by the 2024 Investors and 2025 Investor, plus an annual compound interest of 7% calculated from the payment date of its investment amount and further adjusted by any dividends; and (ii) the audited consolidated net book asset value of Simcere Zaiming as of the end of the most recent quarter.

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14 OTHER FINANCIAL LIABILITY (CONTINUED)

Since there is an obligation for the Group to purchase its own equity instrument for cash when certain conditions set out in the agreement are met, it gives rise to a financial liability for the present value of the redemption amount. The subsequent changes of the financial liability under amortised costs are recognised in profit or loss directly.

Movements of the redemption liability are as follows:

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Redemption liability
Balance at the beginning of the period	1,008,772	–
Additions during the period	100,000	970,000
Interest expenses arising from redemption liability	34,865	5,103
Balance at the end of the period	1,143,637	975,103

15 DIVIDENDS

Dividends payable to equity shareholders of the Company attributable to the previous financial years, declared and approved during the period:

	Six months ended June 30,
	2025	2024
	RMB'000	RMB'000
Dividends in respect of previous financial years declared and approved during the interim period, RMB0.16 per share (six months ended June 30, 2024: RMB0.16 per share)	395,952	406,946
Less: Dividends attributable to unvested shares under 2021 RSU scheme	(5,206)	(5,462)
	390,746	401,484

The directors did not recommend payment of interim dividends for the six months ended June 30, 2025 and 2024.

By order of the Board

Simcere Pharmaceutical Group Limited

Mr. REN Jinsheng

Chairman and Chief Executive Officer

Hong Kong, August 21, 2025

As at the date of this announcement, the Board comprises Mr. REN Jinsheng as the Chairman and executive Director; Mr. TANG Renhong, Mr. WAN Yushan and Ms. WANG Xi as the executive Directors; and Mr. SONG Ruilin, Mr. WANG Jianguo, Mr. WANG Xinhua and Mr. SUNG Ka Woon as the independent non-executive Directors.

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AI assistant

Simcere Pharmaceutical Group Limited — Interim / Quarterly Report 2025

48856_rns_2025-08-21_fe14437e-fb9b-4ddf-8cb3-09f6c044f4b3.pdf

Simcere Pharmaceutical Group Limited

先聲藥業集團有限公司

ANNOUNCEMENT OF INTERIM RESULTS FOR THE SIX MONTHS ENDED JUNE 30, 2025

FINANCIAL HIGHLIGHTS

GROUP OVERVIEW

MAJOR PRODUCTS

INDUSTRY REVIEW

BUSINESS REVIEW

KEY MILESTONES

SUMMARY OF PRODUCT PIPELINES

INNOVATIVE DRUGS AT THE COMMERCIALIZATION STAGE

MILESTONES AND ACHIEVEMENTS DURING THE REPORTING PERIOD

Neuroscience Products

Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection)

Data Release

Registration Progress

Data Release

Oncology Products

Endostar® (Recombinant Human Endostatin Injection)

Data Release

ENWEIDA® (Envafolimab Injection)

Data Release

Data Release

ENLITUO® (Cetuximab Beta Injection)

ENZESHU® (Suvemcitug for Injection)

Registration Progress

Autoimmune Products

Iremod® (Iguratimod Tablets)

Data Release

Anti-infection Products

Deunoxavir Marboxil (PA)¹

Milestone of Clinical Progress

Registration Progress

Autoimmune Products

Rademikibart (IL-4R $\alpha$)

Registration Progress

Milestone of Clinical Progress

Anti-oncology Products

SIM0270 (SERD)

Milestone of Clinical Progress

TGRX-326 (ALK/ROS1)¹

Milestone of Clinical Progress

Autoimmune Products

LNK01001 (JAK1)

Milestone of Clinical Progress

Anti-oncology Products

SIM0237 (PD-L1/IL15v bispecific antibody)

Milestone of Clinical Progress

SIM0501 (USP1 small molecule inhibitor)

Milestone of Clinical Progress

SIM0500 (humanized GPRC5D-BCMA-CD3 trispecific antibody)

Milestone of Clinical Progress

Milestone of Strategic Cooperation

SIM0395 (Paxalisib)

Milestone of Clinical Progress

SIM0505 (CDH6-ADC)

Milestone of Clinical Progress

Milestone of Strategic Cooperation

SIM0686 (FGFR2b-ADC)

Milestone of Clinical Progress

Autoimmune Products

SIM0278 (IL2muFc)

Neuroscience Products

SIM0800 (AQP4)

DRUG CANDIDATES AT THE IND/PRE-CLINICAL STAGE (SELECTED)

SIM0609 (CDH17-ADC)

Milestone of Clinical Progress

INTELLECTUAL PROPERTY RIGHTS

FINANCIAL REVIEW

Revenue

PROFIT ATTRIBUTABLE TO EQUITY SHAREHOLDERS OF THE COMPANY

NON-HKFRS MEASURE – ADJUSTED PROFIT ATTRIBUTABLE TO EQUITY SHAREHOLDERS OF THE COMPANY

LIQUIDITY AND FINANCIAL RESOURCES

PLEDGE OF GROUP'S ASSETS

CONTINGENT LIABILITIES

MATERIAL LITIGATION

SIGNIFICANT INVESTMENTS HELD

Simcere Pharmaceutical Group Limited Interim / Quarterly Report 2025