证券日报网讯2月11日，恒瑞医药（600276）在互动平台回答投资者提问时表示，公司2025年利润分配 方案尚未披露，敬请关注公司后续于交易所网站上发布的相关公告。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a breakthrough therapy designation from the National Medical Products Administration for its injectable drug SHR-A1811, marking the 10th indication for this drug to receive such certification [1] Group 1 - The drug SHR-A1811 is indicated for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring HER2 (ERBB2) activating mutations [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received breakthrough therapy designation from the National Medical Products Administration for its injectable SHR-A1811, marking the 10th indication for this drug [1] Group 1 - The proposed indication for SHR-A1811 is as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations [1] - SHR-A1811 is expected to be approved for domestic market launch in May 2025, targeting adult patients with unresectable locally advanced or metastatic NSCLC who have previously received at least one systemic therapy [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received breakthrough therapy designation for its injectable SHR-A1811, marking the tenth indication for this drug [1] Group 1: Product Development - The injectable SHR-A1811 has been approved for domestic market launch in May 2025, targeting adult patients 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 [1] - The cumulative R&D investment for the injectable SHR-A1811 project has reached approximately 1.7725 billion yuan (unaudited) [1] Group 2: Market Potential - According to EvaluatePharma database, the global sales for similar products are projected to total approximately 6.557 billion USD by 2024 [1]

每经AI快讯，2月11日，恒瑞医药（600276）公告，子公司苏州盛迪亚生物医药有限公司的注射用瑞康 曲妥珠单抗(SHR-A1811)被国家药品监督管理局药品审评中心纳入突破性治疗品种名单。该药品拟定适 应症为HER2(ERBB2)激活突变的局部晚期或转移性非小细胞肺癌患者的一线治疗。 ...

药物类型：治疗用生物制品 格隆汇2月11日丨恒瑞医药(01276.HK)公布，近日，公司子公司苏州盛迪亚生物医药有限公司的注射用 瑞康曲妥珠单抗(SHR-A1811)被国家药品监督管理局药品审评中心(以下简称"药审中心")纳入突破性治 疗品种名单，这是瑞康曲妥珠单抗第10项获得突破性治疗认证的适应症。 药物名称：注射用瑞康曲妥珠单抗 受理号：CXSL2000087 申请日期：2025年12月2日 注册分类：1类 拟定适应症(或功能主治)：HER2(ERBB2)激活突变的局部晚期或转移性非小细胞肺癌患者的一线治疗。 理由及依据：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，同意纳入突破性治疗药物程序。 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)成人患者。 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临2026-025 江苏恒瑞医药股份有限公司 关于药品纳入突破性治疗品种名单的公告 理由及依据：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，同意纳入突破性治疗药物程序。 二、药品的已获批适应症情况 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 物医药有限公司的注射用瑞康曲妥珠单抗（SHR-A1811）被国家药品监督管理局药 品审评中心（以下简称"药审中心"）纳入突破性治疗品种名单，这是瑞康曲妥 珠单抗第10项获得突破性治疗认证的适应症。现将相关情况公告如下： 一、药品的基本情况 药物名称：注射用瑞康曲妥珠单抗 受理号：CXSL2000087 药物类型：治疗用生物制品 注册分类：1类 申请日期：2025年12月2日 拟定适应症（或功能主治）：HER2（ERBB2）激活突变的局部晚期或转移性非 小细胞 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 中國上海 2026年2月11日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 证券代码：600276 证券简称：恒瑞医药 公告编号：临2026-025 ...

Core Viewpoint - The announcement highlights that the company's subsidiary, Suzhou Merrion Biopharmaceutical Co., Ltd., has received a breakthrough therapy designation from the National Medical Products Administration for its injectable SHR-A1811, marking the tenth indication for this drug to achieve such recognition [1] Group 1 - The injectable SHR-A1811 has been included in the list of breakthrough therapies by the National Medical Products Administration [1] - This designation signifies a significant milestone for the company, as it reflects the potential of SHR-A1811 in treating specific medical conditions [1] - The achievement of ten breakthrough therapy certifications for SHR-A1811 indicates the drug's promising therapeutic profile and the company's commitment to advancing its development [1]

Group 1 - The core viewpoint of the news is that the Chinese medical device and equipment trading platform has been launched in Tianjin, which aims to facilitate global trade in medical devices and equipment, thereby promoting the export of domestic medical products and enhancing cross-border industrial cooperation [1] - The China International Medical Equipment and Instrument Trading Platform will provide services such as online display of pharmaceutical products, procurement information, policy information collection and publication, and market operation data analysis [1] - The medical industry is experiencing a new high due to the continuous demand for pharmaceuticals and the increasing unmet needs, along with pharmaceutical companies increasing their R&D investments to meet these demands [1] Group 2 - The CSI Medical and Medical Device Innovation Index (931484) has shown a positive performance, with a 0.34% increase, and notable gains in constituent stocks such as Teva Bio and New Hope [1] - The top ten weighted stocks in the CSI Medical and Medical Device Innovation Index account for 63.9% of the index, including companies like WuXi AppTec, Mindray Medical, and Hengrui Medicine [2] - The medical innovation ETF closely tracks the CSI Medical and Medical Device Innovation Index, reflecting the overall performance of profitable and growth-oriented medical and medical device companies [2]