Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for the clinical trial of Rivoceranib tablets in combination with HS-20093 injection for prostate cancer treatment [1] Group 1: Product Development - Rivoceranib tablets are a second-generation AR inhibitor, which exhibit stronger AR inhibition compared to first-generation AR inhibitors and do not have agonistic effects [1] - The company’s Rivoceranib tablets were approved for market launch in 2022 for the treatment of high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-171 江苏恒瑞医药股份有限公司 关于回购公司 A 股股份的进展公告 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。 重要内容提示： | 回购方案首次披露日 | 2025/8/21 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 回购方案实施期限 | 2025 年 月 20 8 | 8 | 日~2026 | 年 | 月 | 19 | 日 | | 预计回购金额 | 100,000万元~200,000万元 | | | | | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | | | | | | | □用于转换公司可转债 □为维护公司价值及股东权益 | | | | | | | | 累计已回购股数 | 791.88万股 | | | | | | | | 累计已回购股数占总股本比例 | 0.12% | | | | | | | | 累计已回购金额 | 53, ...

二、药品的其他情况 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"）核准签发关于瑞维鲁胺片的《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、药品的基本情况 药品名称：瑞维鲁胺片 剂 型：片剂 申请事项：临床试验 受 理 号：CXHL2500815 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 8 月 6 日受理的瑞维鲁胺片临床试验申请符合药品注册的有关要求，同意本品 开展联合注射用 HS-20093 用于前列腺癌的临床试验。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-170 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。 瑞维鲁胺片是第二代 AR 抑制剂，相较于第一代 AR 抑制剂，具有更强的 AR 抑制作用，且无激动作用。公司瑞维鲁胺片已于 2022 年获批上市，用于治疗高 瘤负荷的转移性激素敏感性前列腺癌（mHSPC）患者 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-169 江苏恒瑞医药股份有限公司 关于药物拟纳入优先审评程序的公告 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"）子公司成都盛迪医 药有限公司的 HRS-5965 胶囊被国家药品监督管理局药品审评中心（以下简称"药 审中心"）拟纳入优先审评品种公示名单，公示期 7 日。现将相关情况公告如下： 剂型：胶囊剂 申请人：成都盛迪医药有限公司 拟定适应症（或功能主治）：治疗既往未接受过补体抑制剂治疗的阵发性睡 眠性血红蛋白尿症成人患者。 拟优先审评理由：经审核，本申请符合《药品注册管理办法》和《国家药监 局关于发布<突破性治疗药物审评工作程序（试行）>等三个文件的公告》（2020 年第 82 号）有关要求，同意按优先审评范围"(一)临床急需的短缺药品、防治 重大传染病和罕见病等疾病的创新药和改良型新药"纳入优先审评审批程序。 二、药物的其他情况 阵发性睡眠性血红蛋白尿症（PNH）是一种后天获得性溶血性疾病，其特征 为 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of Ruvelimab tablets in combination with HS-20093 for prostate cancer treatment [1] Company Summary - Ruvelimab tablets are a second-generation AR inhibitor, which have a stronger AR inhibition effect compared to first-generation AR inhibitors and do not have agonistic effects [1] - Ruvelimab tablets were approved for market launch in 2022 for the treatment of high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) patients [1]

格隆汇11月3日丨恒瑞医药(01276.HK)发布公告，2025年11月3日耗资人民币632.23万元回购10万股A 股，回购价格每股63-63.28元。 相关事件 恒瑞医药(01276.HK)11月3日耗资632.23万元回购10万股A股 恒瑞医药(600276.SH)：HRS-5965胶囊药物 拟纳入优先审评程序 ...

智通财经APP讯，恒瑞医药(01276)公布，2025年11月3日耗资632.23万元回购10万股A股股份。 该信息由智通财经网提供 ...

Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of Ruvelam tablets in combination with HS-20093 for prostate cancer treatment [1] Group 1: Clinical Trials - The company has been granted permission to conduct clinical trials for Ruvelam tablets in conjunction with HS-20093 for prostate cancer [1] - The approval signifies a potential advancement in the treatment options available for prostate cancer patients [1] Group 2: Product Development - Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of the company, has its HRS-5965 capsules listed for priority review by the National Medical Products Administration [1] - The intended indication for HRS-5965 is for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria who have not previously received complement inhibitor therapy [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for the clinical trial of Ruvelimab tablets, which will commence shortly [1] Group 1: Company Developments - The company has been granted a "Drug Clinical Trial Approval Notice" for Ruvelimab tablets [1] - Ruvelimab tablets are classified as a second-generation AR inhibitor, offering stronger AR inhibition compared to first-generation AR inhibitors [1] - The new drug is noted for having no agonistic effects, distinguishing it from earlier treatments [1]

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has announced that its HRS-5965 capsule is proposed to be included in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1: Product Information - HRS-5965 capsule is a complement factor B inhibitor designed to suppress complement-mediated hemolytic reactions, thereby increasing hemoglobin levels [1] - The condition targeted by HRS-5965, Paroxysmal Nocturnal Hemoglobinuria (PNH), is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] Group 2: Market Context - PNH has a low incidence/prevalence rate and has been included in the National "First Batch of Rare Diseases Directory" [1]