Core Viewpoint - Heng Rui Medicine (600276.SH) has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1: Drug Approval and Indications - The injection Karilizumab has been approved for multiple indications in China, including treatment for advanced hepatocellular carcinoma patients who have previously received Sorafenib and/or systemic chemotherapy with Oxaliplatin since March 2020 [1] - Apalutamide capsules were approved in May 2025 for use in combination with injection Karilizumab for recurrent or metastatic cervical cancer patients who have failed platinum-based chemotherapy but have not received Bevacizumab treatment [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with apple acid famitinib capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1 - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., have had their application accepted for a new treatment regimen [1] - Injection Karilizumab has been approved for multiple indications in China, including treatment for advanced hepatocellular carcinoma patients who have previously received sorafenib and/or oxaliplatin-based chemotherapy since March 2020 [1] - Apple acid famitinib capsules were approved in May 2025 for use in combination with injection Karilizumab for recurrent or metastatic cervical cancer patients who failed platinum-based chemotherapy but have not received bevacizumab treatment [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-159 江苏恒瑞医药股份有限公司 董监高减持股份结果公告 本公司董事会、全体董事及相关股东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。 重要内容提示： 董监高持股的基本情况 本次减持计划实施前，江苏恒瑞医药股份有限公司（以下简称"公司"）董 事、高级副总裁孙杰平先生持有公司股份 1,907,032 股，占公司总股本的 0.029%。 减持计划的实施结果情况 公司于 2025 年 6 月 16 日披露了《江苏恒瑞医药股份有限公司董监高减持股 份计划公告》（公告编号：临 2025-092），孙杰平先生计划自减持计划公告披露 之日起 15 个交易日后的 3 个月内（窗口期不减持），通过集中竞价交易方式减持 其所持有的公司股份合计不超过 476,700 股,即减持比例不超过其本人持有公司 股份的 25%，且不超过公司总股本的 0.007%。截至本公告披露之日，本次减持计 划实施完毕，孙杰平先生累计减持公司股份 237,040 股，占公司总股本的比例为 0.004%。 | 股东名称 | 孙 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-4298 injection, which is expected to commence soon [1] Group 1 - SHR-4298 injection is a self-developed Class 1 therapeutic biological product by the company [1] - The product has demonstrated good anti-tumor activity in preclinical animal models [1] - SHR-4298 is intended for the treatment of advanced solid tumors [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of HRS-2329 tablets, an innovative anti-tumor drug developed by the company [1] Group 1 - HRS-2329 tablets are designed for the treatment of advanced solid tumors with RAS mutations or amplifications [1] - The drug has shown promising anti-tumor activity in preclinical animal models [1] - The clinical trials are set to commence shortly following the approval [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection of Carrelizumab combined with Apalutamide capsules, intended for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1 - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., are involved in the development of innovative drugs [1] - The acceptance of the drug registration application marks a significant step towards potential market entry for the treatment of cervical cancer [1]

Core Event - Heng Rui Medicine received the acceptance notice from the National Medical Products Administration for the marketing authorization application of the innovative drug injection of Carrelizumab combined with Apalutamide capsules for first-line treatment of recurrent or metastatic cervical cancer patients [1] Clinical Trial Data - Trial Design: Phase III randomized controlled multicenter study involving 45 domestic centers with 443 patients enrolled [2] - Trial Results: The trial met its primary endpoint, with the experimental group showing significantly better progression-free survival (PFS) and overall survival (OS) compared to the control group [2] Market Background - Indication: Cervical cancer has the highest incidence and mortality rates among female reproductive system tumors in China, indicating an unmet clinical need [2] - Competitive Landscape: The global sales of anti-PD-1 antibodies are projected to reach approximately $41.546 billion in 2024 [2] R&D Investment - Cumulative R&D investment in Carrelizumab is approximately 3.026 billion yuan [2] - Cumulative R&D investment in Apalutamide is approximately 258 million yuan [2]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-156 药物名称：SHR-4298 注射液 剂 型：注射剂 申请事项：临床试验 受 理 号：CXXSL2500558 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 8 日受理的 SHR-4298 注射液临床试验申请符合药品注册的有关要求，同 意本品开展晚期实体瘤的临床试验。 二、药物的其他情况 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 SHR-4298 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。现将相关情况公告如下： 一、药物的基本情况 SHR-4298 注射液是公司自主研发的 1 类治疗用生物制品，在临床前动物模 型中展现出良好的抗肿瘤活性，拟用于治疗晚期实体瘤。经查询，目前国内外尚 无同 ...

苹果酸法米替尼胶囊已于 2025 年 5 月获批，适应症为联合注射用卡瑞利珠 单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移 性宫颈癌患者。 四、药品的其他情况 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-158 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 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"）及子公司苏州盛迪 亚生物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"）下发 的《受理通知书》，公司创新药注射用卡瑞利珠单抗联合苹果酸法米替尼胶囊用 于复发或转移性宫颈癌患者一线治疗的药品注册上市许可申请获受理。现将相关 情况公告如下： 二、药品的临床试验情况 本次申报上市，是基于一项卡瑞利珠单抗联合苹果酸法米替尼对比含铂类化 疗治疗复发或转移性宫颈癌的随机、开放、对照、多中心的Ⅲ期临床研究。该研 究由复旦大学附属肿瘤医院吴小华教授担任主要研究者，共有 45 家国内中心参 与，共入组 443 例患者 ...

受 理 号：CXHL2500682、CXHL2500683、CXHL2500684 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-157 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。 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 10 日受理的 HRS-2329 片临床试验申请符合药品注册的有关要求，同意本 品单药在携带 RAS 突变或扩增的晚期实体瘤患者中开展临床试验。 近日，江苏恒瑞医药股份有限公司（以下简称"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 HRS-2329 片的《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：HRS-2329 片 剂 型：片剂 申请事项：临床试验 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药品 ...