北京商报讯(记者王寅浩实习记者宋雨盈)9月17日，恒瑞医药（600276）发布公告称，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下发的《受理通知书》，公司注射用瑞康曲妥珠单抗 (SHR—A1811)用于治疗既往接受过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成 人乳腺癌患者的新适应症上市许可申请获国家药监局受理，且已被纳入优先审评程序。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapies by the National Medical Products Administration's Drug Review Center, indicating potential for significant advancements in hepatitis B treatment [1] Group 1 - HRS-5635 injection is a new generation liver-targeting siRNA drug developed by the company [1] - The Phase II clinical study results show that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B [1] - The drug also demonstrates good safety characteristics alongside its therapeutic potential [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapies by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1 - HRS-5635 injection is a new generation liver-targeted siRNA drug independently developed by the company [1] - The Phase II clinical study results indicate that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B, while also demonstrating good safety characteristics [1]

Core Insights - Company subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. received a Notice of Acceptance from the National Medical Products Administration for the new indication application of SHR-A1811 for treating locally advanced or metastatic HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies, and it has been included in the priority review process [1] Group 1 - SHR-A1811-Ⅲ-301 study is a randomized, open-label, positive drug-controlled, multi-center Phase III clinical trial designed to compare the efficacy and safety of SHR-A1811 with pyrotinib combined with capecitabine in HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies [2] - The primary endpoint is progression-free survival (PFS) assessed by a blinded independent radiology committee (BIRC) based on RECIST v1.1, with secondary endpoints including investigator-assessed PFS, overall survival (OS), objective response rate (ORR), and duration of response (DoR) [2] - In July 2025, the Independent Data Monitoring Committee (IDMC) reviewed the data and confirmed that the primary endpoint of BIRC-assessed PFS met the pre-specified superiority criteria, indicating that SHR-A1811 significantly reduces the risk of disease progression/death compared to the control group, with good safety [2] Group 2 - SHR-A1811 was approved for marketing in China in May 2025 for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [3]

据悉，SHR-A1811-Ⅲ-301 研究为一项随机、开放、阳性药物对照、多中心设计的Ⅲ 期临床试验，旨在 比较 SHR-A1811 与吡咯替尼联合卡培他滨在既往接受过一种或一种以上抗 HER2 药物治疗的 HER2 阳 性乳腺癌患者中的有效性和安全性。本研究由中山大学孙逸仙纪念医院宋尔卫院士、姚和瑞教授共同担 任主要研究者，全国54 家中心共同参与。主要终点为盲态独立影像评审委员会(BIRC)基于 RECIST v1.1 评估的无进展生存期(PFS)。次要终点包括研究者基于 RECIST v1.1 评估的 PFS、总生存期(OS)、客观 缓解率(ORR)、缓解持续时间(DoR)等。2025 年 7 月，独立数据监查委员会(IDMC)审查数据并确认，在 方案预设的期中分析中，主要研究终点 BIRC 评估的 PFS 达到预设的优效标准。结果表明，与对照组 相比，瑞康曲妥珠单抗可显著降低患者疾病进展/死亡风险，且安全性良好。 公司注射用瑞康曲妥珠单抗已于 2025年5月在国内获批上市，适用于治疗存在 HER2(ERBB2)激活突变 且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC) ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the new indication of SHR-A1811, a drug for treating HER2-positive breast cancer in patients previously treated with one or more anti-HER2 therapies, which has been included in the priority review process [1] Group 1 - The drug SHR-A1811 is intended for adult patients with locally advanced or metastatic HER2-positive breast cancer [1] - The acceptance of the new indication application indicates potential growth opportunities for the company in the oncology market [1] - The inclusion in the priority review process may expedite the approval timeline, enhancing the company's competitive position [1]

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"）子公司福建盛迪医药 有限公司的HRS-5635注射液被国家药品监督管理局药品审评中心（以下简称"药 审中心"）纳入拟突破性治疗品种公示名单，公示期7日。现将相关情况公告如下： 一、药物的基本情况 证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-146 江苏恒瑞医药股份有限公司 关于药物纳入拟突破性治疗品种公示名单的公告 慢性乙型肝炎（简称"慢乙肝"）是由乙型肝炎病毒（HBV）持续感染引起的肝 脏慢性炎症性疾病。据报道，全球约2.57亿例HBV感染者，每年约88.7万人死于 HBV感染相关疾病[1]。中国作为慢乙肝大国，2020年疾控中心流调数据估算的现存 HBV感染者约7500万，其中约3000万人未察觉已经感染 [2]。此外，慢乙肝是肝硬化 和原发性肝细胞癌（HCC）的主要病因，国内肝硬化和HCC患者中由HBV感染所致者 分别高达77%和84% [2]。功能性治愈作为慢乙肝的理想治疗目标，旨在通过有限疗程 治疗 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-145 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并纳入优先审评程序 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"）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》，公司注射用瑞康曲妥珠单抗（SHR-A1811）用于治疗既往接受 过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成人乳腺癌患 者的新适应症上市许可申请获国家药监局受理，且已被纳入优先审评程序。现将 相关情况公告如下： 一、药品的基本情况 药品名称：注射用瑞康曲妥珠单抗 剂型：注射剂 申请人：苏州盛迪亚生物医药有限公司 拟定适应症（或功能主治）：本品适用于治疗既往接受过一种或一种以上抗 HER2 药物治疗的局部晚期或转移性 HER2 阳性成人乳腺癌患者。 受理号：CXSS2500094 申报阶段：上市 二、药品的临床试验情况 SHR-A1811-Ⅲ-30 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, indicating potential for significant advancements in hepatitis B treatment [1] Group 1 - HRS-5635 injection is a new generation liver-targeted siRNA drug independently developed by the company [1] - The Phase II clinical study results show that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B, while also demonstrating good safety characteristics [1] - The public announcement period for the proposed breakthrough therapy is set for 7 days [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapies by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1 - HRS-5635 injection is a new generation liver-targeted siRNA drug developed by the company for the treatment of chronic hepatitis B [1] - Phase II clinical trial results indicate that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B while demonstrating good safety characteristics [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2 - The cumulative research and development investment for the HRS-5635 injection project has reached approximately 151.68 million yuan [1]