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 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-2329 tablets and SHR-4298 injection, indicating progress in its drug development pipeline [1] Group 1: Clinical Trial Approvals - The company announced that it has received the clinical trial approval notice for HRS-2329 tablets from the National Medical Products Administration [1] - Its subsidiary, Suzhou Sediya Biopharmaceutical Co., Ltd., has also received approval for SHR-4298 injection [1] Group 2: Drug Registration Application - Heng Rui Medicine announced that its innovative drug, a combination of injectable Carrelizumab and Apalutamide capsules, has had its drug registration application accepted for the first-line treatment of recurrent or metastatic cervical cancer patients [1]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-4298 injection, aimed at treating advanced solid tumors [1] Company Summary - SHR-4298 injection is a Class 1 therapeutic biological product independently developed by the company [1] - The total research and development investment for the related project has reached approximately 28.79 million yuan [1] - The drug must undergo clinical trials and receive further review and approval from the National Medical Products Administration before it can be produced and marketed [1] Industry Summary - The approval for clinical trials indicates a potential advancement in the treatment options available for advanced solid tumors within the biopharmaceutical industry [1] - The development of innovative therapies like SHR-4298 reflects ongoing investment and research efforts in the biopharmaceutical sector [1]

Core Points - Heng Rui Medicine announced that its director and senior vice president, Sun Jieping, reduced his holdings by 237,000 shares from July 9, 2025, to September 25, 2025, accounting for 0.004% of the company's total share capital [1] - The total amount of the reduction was 15.6332 million yuan, with the share price ranging from 57.01 to 73.95 yuan per share [1]

恒瑞医药公告，公司董事、高级副总裁孙杰平已于2025年7月9日至2025年9月25日通过集中竞价减持 23.7万股，减持比例0.004%，成交价57.01～73.95元/股，套现1563.32万元。本次减持计划已完成，原拟 减持不超47.67万股；减持后其持股167万股，占0.025%。 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 江蘇恒瑞醫藥股份有限公司 呈交日期： 2025年9月30日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 A | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | A股（於上海證券交易所上市） | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | 佔有關事件 ...