香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2026年3月25日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 江苏恒瑞医药股份有限公司 2025 年年度报告 公司代码：600276 ...

Core Viewpoint - The article discusses the challenges and potential catalysts for Hengrui Medicine, highlighting the need for stable revenue contributions from BD transactions and the growth of innovative drug sales to restore market confidence [5][52]. Group 1: Current Market Situation - Hengrui Medicine has not seen significant market performance recently, contrasting with peers like Rongchang Biopharmaceutical and Geely Pharmaceutical, which have experienced double-digit stock price increases [4]. - Despite a warming capital market, Hengrui has faced a rare "eleven consecutive declines" in stock price, leading to negative annual fluctuations [4][5]. Group 2: BD Transactions and Performance - BD transactions have become a crucial driver for Hengrui's performance since 2024, but concerns about the sustainability of this model have emerged due to delayed revenue recognition [9][17]. - In 2023, Hengrui received €160 million (approximately RMB 1.2 billion) from BD transactions, and in 2024, it expects to confirm $100 million (approximately RMB 700 million) from Kailera Therapeutics [9][10]. - The company completed five BD transactions before September 2025, securing $783 million and €15 million in upfront payments, along with potential milestone payments totaling $15.8 billion, indicating a significant increase in transaction frequency and scale [13]. Group 3: Innovation and Product Pipeline - Hengrui's innovative drug sales and licensing revenue reached RMB 95.61 billion in the first half of 2025, accounting for about 60% of total revenue, indicating a shift towards "innovation-driven" growth [24]. - The company has received approvals for 17 innovative drugs from 2021 to 2024, creating a diversified product matrix that reduces reliance on single blockbuster products [23]. - Hengrui's innovative drugs, such as Haiqubopai, have shown strong market potential, with sales expected to exceed RMB 1 billion in 2024 [23]. Group 4: Challenges Ahead - Hengrui faces challenges, including a reliance on a "fast-follow" research model, which raises concerns about competition from similar products in the market [30]. - The company lacks a globally recognized blockbuster product, with its most successful products primarily concentrated in the domestic market [32][33]. - Hengrui's internationalization efforts are still in the early stages, with no innovative products approved for sale in overseas markets yet [34]. Group 5: Future Catalysts - Key signals to watch for include the maturation of the BD business model, sustained growth in innovative drug revenue (targeting a compound annual growth rate of over 25%), and breakthroughs in the research pipeline [39][41][42]. - The upcoming FDA review of Hengrui's "dual-Ai" therapy for liver cancer is a critical milestone that could significantly impact the company's international strategy and market perception [49][50].

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, indicating progress in its drug development pipeline [1] Group 1: Drug Information - Drug Name: SHR-A2102 [1] - Dosage Form: Injection [1] - Application Type: Clinical trial [1] - Acceptance Numbers: CXSL2500879, CXSL2500881 [1] Group 2: Clinical Trial Details - The approval allows for two clinical trials: 1. A trial combining SHR-A2102 with Vedolizumab in patients with advanced solid tumors [1] 2. A trial assessing the safety, tolerability, and efficacy of SHR-A2102 combined with Atezolizumab or other PD-(L)1 inhibitors in patients with locally advanced or metastatic esophageal cancer [1] - The trials are categorized as multicenter, open-label, Phase I/II studies [1] Group 3: Regulatory Approval - The clinical trial applications were reviewed and approved based on the requirements of the Drug Administration Law of the People's Republic of China [1] - The approval was granted for applications received on October 13 and 14, 2025 [1]

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, a targeted antibody-drug conjugate aimed at treating advanced solid tumors and esophageal cancer [1] Group 1: Clinical Trials - The company will conduct two clinical trials for SHR-A2102, one in combination with Vedolizumab for advanced solid tumors and another with Atezolizumab or other PD-(L)1 drugs for locally advanced or metastatic esophageal cancer [1] - The trials will assess the safety, tolerability, and efficacy of SHR-A2102 in a multicenter, open-label Phase I/II study [1] Group 2: Product Details - SHR-A2102 is an antibody-drug conjugate (ADC) targeting Nectin-4, with its active payload being a topoisomerase I inhibitor (TOP1i) [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of its drug SHR-A2102, indicating progress in its oncology pipeline and potential market entry for a new targeted therapy [1] Group 1: Clinical Trials - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have been authorized to conduct two clinical trials for SHR-A2102 [1] - The first trial will evaluate SHR-A2102 in combination with Vedolizumab for advanced solid tumors [1] - The second trial will assess SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer in a multicenter, open-label Phase IB/II study [1] Group 2: Product Details - SHR-A2102 is a targeted antibody-drug conjugate (ADC) that targets Nectin-4, with an effective payload of topoisomerase I inhibitor (TOP1i) [1] - Currently, there is one similar product, Enfortumab vedotin (brand name: Padcev), which has been approved and is projected to generate global sales of approximately $1.949 billion in 2024 [1] Group 3: Investment and Development - The total investment in the SHR-A2102 development project has reached approximately 248.22 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-A2102, indicating progress in its drug development pipeline [1] Group 1: Drug Information - Drug Name: SHR-A2102 [1] - Dosage Form: Injectable [1] - Application Type: Clinical trial [1] Group 2: Approval Details - Acceptance Numbers: CXSL2500879, CXSL2500881 [1] - Approval Conclusion: The clinical trial applications for SHR-A2102, submitted on October 13 and 14, 2025, meet the requirements for drug registration and are approved for two clinical trials [1] Group 3: Clinical Trials - The first trial will investigate the combination of SHR-A2102 with Vedolizumab in patients with advanced solid tumors [1] - The second trial will assess the safety, tolerability, and efficacy of SHR-A2102 combined with Atezolizumab or other PD-(L)1 inhibitors, with or without other anti-tumor treatments, in patients with locally advanced or metastatic esophageal cancer [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Heng Rui Medicine Co., Ltd., have received approval from the National Medical Products Administration for the clinical trial of SHR-A2102, which will commence shortly [1] Group 1: Clinical Trial Approval - The clinical trial application for SHR-A2102 was accepted on October 13 and 14, 2025, and meets the requirements for drug registration [1] - Two clinical trials will be conducted: one involving SHR-A2102 in combination with Vedolizumab for advanced solid tumors, and the other involving SHR-A2102 in combination with Atezolizumab or other PD-(L)1 inhibitors for locally advanced or metastatic esophageal cancer [1]

Investment Rating - The report maintains a "Buy" rating for the company [4][6]. Core Insights - The company achieved a revenue of 23.188 billion yuan in the first three quarters of 2025, representing a year-on-year increase of 14.85%. The net profit attributable to the parent company was 5.751 billion yuan, up 24.50%, and the net profit after deducting non-recurring gains and losses was 5.589 billion yuan, an increase of 21.08% [1][4][6]. Summary by Sections Internationalization and Partnerships - In Q3 2025, the company secured three overseas licensing agreements, including a collaboration with GSK to develop up to 12 innovative drugs, receiving an upfront payment of 500 million USD, with potential total payments of approximately 12 billion USD [2]. - The company also entered into a New-Co transaction with Braveheart Bio for HRS-1893, receiving an upfront payment of 65 million USD and potential milestone payments of up to 1.013 billion USD [2]. - Additionally, the company licensed part of its international market rights for a drug to Glenmark, receiving an upfront payment of 18 million USD and potential milestone payments of up to 1.093 billion USD [2]. Innovation and R&D - The company increased its R&D expenditure to 4.945 billion yuan in the first three quarters of 2025. New products were approved for market, including EZH2 inhibitors and a new oral hypoglycemic combination [3]. - The company has over 100 self-developed innovative products in clinical development and more than 400 clinical trials ongoing domestically and internationally [3]. - At the 2025 ESMO annual meeting, the company presented 46 research results in the oncology field, with significant findings published in The Lancet [3]. Financial Forecast - The company is projected to achieve net profits of 8.803 billion yuan, 10.277 billion yuan, and 12.151 billion yuan for 2025, 2026, and 2027, respectively, with year-on-year growth rates of 38.9%, 16.8%, and 18.2% [4][10].

Core Viewpoint - HengRui Medicine has signed a licensing agreement with Glenmark Specialty for the innovative drug SHR-A1811, expanding its market reach and enhancing its global presence in cancer treatment [1][3]. Group 1: Licensing Agreement Details - The agreement allows Glenmark Specialty to license SHR-A1811, an antibody-drug conjugate targeting HER2, which is designed to induce apoptosis in tumor cells [1]. - Glenmark Specialty will pay an upfront fee of $18 million to HengRui, with potential milestone payments related to registration and sales reaching up to $1.093 billion [2]. Group 2: Clinical Development and Approvals - SHR-A1811 has received approval for use in adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations, marking it as the first Chinese-developed ADC for this indication [1]. - Multiple clinical studies are ongoing, with SHR-A1811 receiving orphan drug designation from the FDA for use in gastric cancer and related conditions, and a new indication for breast cancer under priority review by the National Medical Products Administration [2]. Group 3: Strategic Implications - The agreement is expected to broaden the overseas market for SHR-A1811, providing high-quality treatment options for global patients and enhancing HengRui's innovative brand and international performance [3]. - The company aims to strengthen international cooperation while maintaining a focus on independent research and development, facilitating rapid transformation of research outcomes into marketable products [3].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The upcoming World Conference on Lung Cancer (WCLC) is expected to showcase significant advancements in innovative drugs, generating new business development expectations [1] - The A-share pharmaceutical index has increased by 3% this week and 25% year-to-date, outperforming the CSI 300 by 0.7% and 18.2% respectively [4][9] - The report highlights the strong performance of the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [10][11] Industry Trends - The WCLC will take place from September 6 to September 9, 2025, in Barcelona, featuring over 1,500 presentations, with a significant number from Chinese researchers [17][18] - Chinese innovation is prominently represented, with over 400 submissions, indicating a shift towards the commercialization of innovative drugs [18][19] Stock Performance - Notable stock performances include a 69% increase for Sainuo Medical and a 94% increase for Paig Biological in the H-share market [4][9] - The report provides a detailed overview of stock performance, highlighting both top gainers and losers in the pharmaceutical sector [9][13] Recommendations - The report suggests a focus on specific sub-sectors, ranking them as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10] - Specific stock recommendations include companies like Bory Pharmaceutical, Singlera Genomics, and Innovent Biologics based on various therapeutic angles [11][12]