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]

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 application of SHR-A1811, an injection for treating locally advanced or metastatic HER2-positive breast cancer in adults who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [1] Company Summary - Heng Rui Medicine's subsidiary has made progress in the development of SHR-A1811, which targets a specific patient population with HER2-positive breast cancer [1] - The acceptance of the new indication application signifies a potential expansion of the company's product offerings in the oncology market [1] - The inclusion in the priority review process may expedite the approval timeline, enhancing the company's competitive position in the biopharmaceutical sector [1]

Market Overview - The Shanghai Composite Index rose by 0.37% on September 17, with 20 industries experiencing gains, led by the power equipment and automotive sectors, which increased by 2.55% and 2.05% respectively [1] - Conversely, the agriculture, forestry, animal husbandry, and fishery sectors, along with retail, saw declines of 1.02% and 0.98% respectively [1] - The pharmaceutical and biotechnology sector fell by 0.23% [1] Capital Flow Analysis - The main capital outflow from the two markets totaled 38.306 billion yuan, with five industries seeing net inflows [1] - The power equipment sector led the net inflow with 1.835 billion yuan, followed by the automotive sector with 1.142 billion yuan [1] - The non-bank financial sector experienced the largest net outflow, totaling 5.229 billion yuan, followed by the computer sector with a net outflow of 4.455 billion yuan [1] Pharmaceutical and Biotechnology Sector - The pharmaceutical and biotechnology sector saw a net outflow of 3.977 billion yuan, with 474 stocks in the sector; 135 stocks rose while 327 fell [2] - The top net inflow stocks included WuXi AppTec with 352 million yuan, followed by Hengrui Medicine and Boteng Co., with inflows of 312 million yuan and 55.426 million yuan respectively [2] - Nine stocks in the sector experienced net outflows exceeding 100 million yuan, with the largest outflows from Guangsheng Tang, Sino Medical, and Ganli Pharmaceutical, amounting to 253 million yuan, 164 million yuan, and 140 million yuan respectively [2] Top Gainers in Pharmaceutical Sector - WuXi AppTec: +2.09%, turnover rate 2.01%, net inflow 351.585 million yuan [2] - Hengrui Medicine: +1.42%, turnover rate 0.92%, net inflow 312.024 million yuan [2] - Boteng Co.: -0.93%, turnover rate 6.09%, net inflow 55.426 million yuan [2] Top Losers in Pharmaceutical Sector - Guangsheng Tang: -4.40%, turnover rate 9.74%, net outflow -252.737 million yuan [3] - Sino Medical: -1.74%, turnover rate 5.85%, net outflow -164.152 million yuan [3] - Ganli Pharmaceutical: -1.74%, turnover rate 2.88%, net outflow -139.861 million yuan [3]

Group 1 - The chemical pharmaceutical sector experienced a decline of 0.2% on September 17, with Warner Pharmaceuticals leading the drop [1] - The Shanghai Composite Index closed at 3876.34, up 0.37%, while the Shenzhen Component Index closed at 13215.46, up 1.16% [1] - Notable gainers in the chemical pharmaceutical sector included ST Tian Sheng, which rose by 4.97% to a closing price of 5.28, and Bai Li Tian Heng, which increased by 4.08% to 372.00 [1] Group 2 - Warner Pharmaceuticals saw a significant decline of 9.22%, closing at 57.92, contributing to the overall downturn in the sector [2] - Other notable decliners included Anglikang, down 4.53% to 41.28, and Guangsheng Tang, down 4.40% to 111.91 [2] - The sector experienced a net outflow of 1.541 billion yuan from major funds, while retail investors saw a net inflow of 1.516 billion yuan [2][3] Group 3 - Major fund inflows were observed in companies like Heng Rui Pharmaceutical, which had a net inflow of 3.43 million yuan, while retail investors showed a net outflow of 58.13 million yuan [3] - The top net inflows from retail investors were seen in Hai Zheng Pharmaceutical, with 34.03 million yuan, and Hua Yuan Biological, with 30.05 million yuan [3] - The overall trend indicates a shift in investment dynamics within the chemical pharmaceutical sector, with retail investors showing resilience despite major fund outflows [3]

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 who have previously received one or more anti-HER2 therapies [1] Group 1 - The drug SHR-A1811 is now accepted for a new indication to treat locally advanced or metastatic HER2-positive adult breast cancer patients [1] - The application has been included in the priority review process by the National Medical Products Administration [1] - SHR-A1811 is already approved in China for treating non-small cell lung cancer (NSCLC) patients with HER2 activation mutations who have received at least one systemic therapy [1]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapeutic products 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 HBV 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 Viewpoint - Heng Rui Medicine announced that its 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 (Injection of Rukang Qutuzumab) for the treatment of locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [1] Group 1 - The application for SHR-A1811 has been accepted for a new indication [1] - The drug is intended for patients with locally advanced or metastatic HER2-positive breast cancer [1] - The application has been prioritized for review by the National Medical Products Administration [1]