申请事项：临床试验 受 理 号：CXSL2500583 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 7 月 11 日受理的注射用 SHR-A2102 符合药品注册的有关要求，同意本次临床 试验申请，具体为：一项注射用 SHR-A2102 联合其他抗肿瘤治疗在晚期实体瘤受 试者中的安全性、耐受性及有效性的多中心、开放Ⅱ期临床研究。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-162 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。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司苏州盛迪亚 生物医药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局（以下简称 "国家药监局"）核准签发关于注射用 SHR-A2102 的《药物临床试验批准通知书》， 将于近期开展临床试验。现将相关情况公告如下： 一、药物的基本情况 药物名称：注射用 SHR-A2102 剂 型：注射剂 二、药物的其他情况 注射用 SHR-A2 ...

Core Viewpoint - Heng Rui Medicine has received approval for clinical trials of SHR-A2102, indicating progress in its drug development pipeline [1] Group 1: Company Developments - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Heng Rui Medicine Co., Ltd. have obtained the clinical trial approval notice from the National Medical Products Administration for SHR-A2102 [1] - The company plans to commence clinical trials in the near future [1] Group 2: Financial Overview - For the year 2024, Heng Rui Medicine's revenue composition is projected to be 89.37% from the pharmaceutical manufacturing sector and 10.63% from other businesses [1] - As of the report date, Heng Rui Medicine's market capitalization stands at 444.6 billion yuan [1]

Core Viewpoint - Heng Rui Medicine announced the approval of clinical trials for SHR-1905 injection by the National Medical Products Administration, indicating a significant step in the development of a new therapeutic option targeting inflammation [1] Group 1: Company Developments - The subsidiary Guangdong Heng Rui Medicine Co., Ltd. received the clinical trial approval notice for SHR-1905 injection [1] - SHR-1905 is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which plays a role in blocking the release of inflammatory cytokines [1] Group 2: Product Information - SHR-1905 injection aims to inhibit downstream inflammatory signaling pathways, ultimately improving inflammatory conditions and controlling disease progression [1]

格隆汇10月13日丨恒瑞医药(600276.SH)公布，公司子公司广东恒瑞医药有限公司收到国家药品监督管 理局核准签发关于SHR-1905注射液的《药物临床试验批准通知书》，将于近期开展临床试验。SHR- 1905注射液是胸腺基质淋巴细胞生成素（TSLP）单克隆抗体，可以阻断炎症细胞因子的释放，抑制下 游炎症信号的传导，最终改善炎症状态并控制疾病进展。 ...

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: Product Development - SHR-A2102 is a self-developed antibody-drug conjugate (ADC) targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Research indicates that high expression of Nectin-4 in tumors is closely related to tumor progression and poor prognosis [1]

Core Viewpoint - Heng Rui Medicine's subsidiary has received approval for clinical trials of SHR-1905 injection, a monoclonal antibody targeting TSLP, which aims to improve inflammation and control disease progression [1] Group 1: Company Developments - Heng Rui Medicine (600276.SH) announced that its subsidiary, Guangdong Heng Rui Medicine Co., Ltd., has received the clinical trial approval notice from the National Medical Products Administration for SHR-1905 injection [1] - The SHR-1905 injection is designed to block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] Group 2: Market Context - There is a similar product, Tezepelumab (AstraZeneca/Amgen, marketed as Tezspire), which has been approved and is projected to generate approximately $1.22 billion in global sales in 2024 according to EvaluatePharma database [1]

Core Viewpoint - Heng Rui Medicine has received clinical trial approval for three drug candidates, indicating progress in its research and development pipeline [1] Group 1: Clinical Trial Approvals - The company’s subsidiaries have received approval from the National Medical Products Administration for clinical trials of SHR-A2102, Adebeli monoclonal antibody injection, and SHR-1802 [1] - SHR-A2102 is an antibody-drug conjugate targeting Nectin-4, with only one similar product approved globally [1] - SHR-1802 is a humanized monoclonal antibody developed by the company, with no similar products approved in China [1] - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company [1]

Core Insights - The company announced that its subsidiaries Suzhou Shengdiya, Shanghai Hengrui, and Shanghai Shengdi Pharmaceutical received clinical trial approval from the National Medical Products Administration for three injectable drugs [1] Group 1: Drug Development - SHR-A2102 is an antibody-drug conjugate developed by the company, with a cumulative R&D investment of approximately 225 million yuan [1] - SHR-1802 is a humanized monoclonal antibody, with a cumulative R&D investment of about 62.09 million yuan [1] - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody, with a cumulative R&D investment of around 939 million yuan [1] Group 2: Clinical Research - These drugs will be used in Phase I B/II clinical studies for advanced solid tumors [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) announced a share buyback of 170,000 A-shares at a total cost of RMB 11.35 million, with a buyback price range of RMB 66.18 to 67.01 per share [1] Related Events - Heng Rui Medicine (01276.HK) conducted a buyback on October 13, spending RMB 11.35 million to repurchase 170,000 A-shares [1] - The company plans to hold a board meeting on October 27 to approve its quarterly performance [1]

Core Viewpoint - Heng Rui Medicine (01276) announced a share buyback of 170,000 A-shares at a cost of 11.35 million yuan on October 13, 2025 [1] Summary by Category - **Company Actions** - The company plans to repurchase shares, indicating confidence in its stock value and future prospects [1] - **Financial Details** - The total expenditure for the buyback is 11.35 million yuan, which translates to approximately 1.135 million dollars [1]