Core Viewpoint - The approval of the innovative drug Rilaforp α injection by the National Medical Products Administration marks a significant advancement in the treatment of advanced gastric cancer, addressing a critical need in the market [1] Company Summary - The company, through its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd., has developed Rilaforp α injection, a dual-function fusion protein targeting PD-L1 and TGF-βRII, which is expected to improve treatment outcomes for patients with advanced gastric cancer [1] - The total research and development investment for the Rilaforp α injection project has reached approximately 71.13 million yuan [1] Industry Summary - Gastric cancer has nearly one million new cases globally each year, with over 655,000 deaths, highlighting the severity of the disease and the urgent need for effective treatment options [1] - Current immunotherapy options, particularly immune checkpoint inhibitors, have shown limited long-term survival benefits for patients, especially those with liver metastases, indicating a gap in the market for innovative therapies [1]

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） 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-004 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 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1月7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 ...

Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of over 4%, currently trading at 77.8 HKD, with a transaction volume of 103 million HKD, following the announcement of two innovative drugs receiving approval for clinical trials in prostate cancer treatment [1]. Group 1: Drug Approvals - Heng Rui Medicine announced that its two self-developed innovative drugs, HRS-4357 injection and HRS-5041 tablets, have been approved by the National Medical Products Administration for clinical trials targeting prostate-specific membrane antigen (PSMA) positive prostate cancer [1]. - HRS-4357 is a Class 1 radioactive therapeutic drug, and this approval represents an expansion based on its previous single-agent clinical trials [1]. - HRS-5041 is a novel androgen receptor protein degradation-targeting chimeric small molecule drug, designed to treat prostate cancer by degrading AR proteins, with potential to overcome resistance to existing therapies [1]. - The announcement highlighted that there are currently no similar products approved for market release domestically or internationally [1].

Group 1 - The majority of Hong Kong pharmaceutical stocks experienced an increase, with 恒瑞医药 (Hengrui Medicine) and 和黄医药 (Hutchison China MediTech) rising over 3% [1] - 康龙化成 (Crown Bioscience), 石药集团 (Shijiazhuang Pharmaceutical Group), and 泰凌医药 (Tianling Pharmaceutical) saw increases of over 2% [1]

Core Viewpoint - Company has received approval from the National Medical Products Administration for clinical trials of HRS9531 and HRS-5817 injection solutions, which are expected to enhance its product pipeline in the obesity treatment market [1][2] Group 1: HRS9531 Injection - HRS9531 is a novel dual agonist targeting GLP-1R and GIPR, designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [1] - The global sales forecast for ZEPBOUND, a similar drug by Eli Lilly, is approximately $4.926 billion for 2024, indicating a significant market opportunity for HRS9531 [1] - Cumulative R&D investment for HRS9531 has reached approximately 51.854 million yuan [1] Group 2: HRS-5817 Injection - HRS-5817 is a self-developed Class 1 chemical drug, showing weight loss effects in preclinical studies on obese animal models with good safety profiles [2] - Currently, there are no approved drugs targeting the same receptor as HRS-5817 in both domestic and international markets, highlighting its potential uniqueness [2] - Cumulative R&D investment for HRS-5817 has reached approximately 2.489 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-4357 injection and HRS-5041 tablets, indicating progress in their drug development pipeline [1] Group 1: Clinical Trial Approval - Jiangsu Heng Rui Medicine Co., Ltd. and its subsidiaries Chengdu Shengdi Pharmaceutical Co., Ltd. and Tianjin Heng Rui Medicine Co., Ltd. have been granted the Clinical Trial Approval Notice for HRS-4357 injection and HRS-5041 tablets [1] - The approval is based on the review under the Drug Administration Law of the People's Republic of China, confirming that the drugs meet the registration requirements [1] - The clinical trials will focus on the safety, tolerability, and preliminary efficacy of HRS-4357 in combination with HRS-5041 for the treatment of PSMA-positive prostate cancer, conducted as an open-label, multi-center, phase Ib/II study [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS9531 and HRS-5817 injection solutions, indicating progress in their drug development pipeline [1][2] Group 1: HRS9531 Injection - HRS9531 injection is a novel dual agonist targeting GLP-1R and GIPR, aimed at regulating glucose and lipid metabolism, suppressing appetite, and enhancing insulin sensitivity, which can improve blood sugar levels and aid in weight loss [1] - The only other drug targeting the same indications globally is Eli Lilly's Zepbound, which is expected to generate approximately $4.926 billion in global sales in 2024 [1] - The total R&D investment for the HRS9531 project has reached approximately 51.854 million yuan [1] Group 2: HRS-5817 Injection - HRS-5817 injection is a self-developed Class 1 chemical drug, showing weight loss effects in preclinical studies on obese animal models with good safety profiles [2] - Currently, there are no approved drugs targeting the same receptor as HRS-5817 in both domestic and international markets [2] - The cumulative R&D investment for HRS-5817 injection has reached approximately 2.489 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-4357 injection and HRS-5041 tablets, marking a significant step in the development of innovative cancer treatments [1] Group 1: Product Development - HRS-4357 injection is a self-developed innovative drug for radioactive therapy, now approved for clinical trials in combination with HRS-5041 for treating prostate cancer patients with PSMA positivity [1] - HRS-4357 injection has accumulated research and development investment of approximately 67.55 million yuan [1] - HRS-5041 is a new, efficient, and selective ARPROTAC small molecule aimed at treating prostate cancer, showing significant degradation effects on wild-type and most mutant AR proteins [1] Group 2: Market Position - Currently, there are no similar products approved for market release domestically or internationally for both HRS-4357 and HRS-5041 [1] - HRS-5041 has the potential to overcome resistance compared to second-generation AR inhibitors, indicating a competitive edge in the market [1] - The accumulated research and development investment for HRS-5041 is approximately 92.66 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS9531 and HRS-5817 injection solutions, which will be conducted in overweight or obese adult patients [1] Group 1: Company Developments - Jiangsu Heng Rui Medicine Co., Ltd.'s subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has been granted the clinical trial approval notice for HRS9531 and HRS-5817 injection solutions [1] - The approval is based on the review under the Drug Administration Law of the People's Republic of China, confirming that the injection solutions meet the requirements for drug registration [1] Group 2: Clinical Trial Details - The clinical trials will focus on the combination treatment of HRS9531 and HRS-5817 injection solutions in adult patients who are overweight or obese [1] - The approval for the clinical trials was granted on October 14, 2025, indicating a timeline for the commencement of these studies [1]

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。 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。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-003 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 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（ ...