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 ...

恒瑞医药公告，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。 ...

Investment Rating - The report does not explicitly provide an investment rating for the industry. Core Insights - The report highlights significant advancements in the pharmaceutical industry, particularly in the development and approval of innovative drugs, with a focus on oncology and immunotherapy [5][6][10]. Summary by Sections 1. Latest Policy Updates - The National Medical Products Administration (NMPA) has issued several key announcements, including guidelines to strengthen the supervision of entrusted drug production and the release of the 2025 Clinical Application Guidelines for Antitumor Drugs [10][15][18]. - New regulations aim to support the development of innovative drugs and ensure the quality and safety of pharmaceuticals through enhanced management practices [11][12][14]. 2. Domestic New Drug Approvals - In January 2026, a total of 172 new drugs were approved for clinical trials, a decrease of 55 from the previous month. Among these, 78 were chemical drugs, 88 were biological products, and 6 were traditional Chinese medicines [22][23]. - The majority of new drug approvals were in the fields of oncology and immune modulation, accounting for 53% of the total [22]. 3. Global Innovative Drug Development - The report lists several drugs that have shown positive clinical results, including Neumora Therapeutics' NMRA-511 and GSK's new hepatitis B drug, which achieved success in phase 3 studies [6][10]. - Notable approvals include the BCL-2 inhibitor from BeiGene, which received dual indications for chronic lymphocytic leukemia and mantle cell lymphoma [40][41]. 4. New Drug Listings - The report details new drug listings, including the approval of the combination drug for ADHD treatment by Aikobai, which has shown significant efficacy in clinical trials [41][43]. - The approval of Merck's drug for pulmonary arterial hypertension represents a new treatment option that addresses the underlying causes of the disease rather than just symptomatic relief [40].

Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has received acceptance for its drug application for SHR-A1811 (注射用瑞康曲妥珠单抗) from the National Medical Products Administration, which has been included in the priority review process [1] Group 1: Drug Application and Clinical Trials - The drug application is based on a randomized, open-label, positive-controlled, multi-center Phase III clinical trial [1] - The trial aims to evaluate the efficacy and safety of SHR-A1811 compared to standard treatment in HER2-positive advanced colorectal cancer patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1] - The study is led by Dr. Li Jin from Shanghai Gaobo Cancer Hospital and Professor Yuan Ying from the Second Affiliated Hospital of Zhejiang University School of Medicine, with participation from 40 centers nationwide [1] Group 2: Study Outcomes - The primary endpoint of the study is progression-free survival (PFS) assessed by an independent imaging review committee (IRC) according to RECIST v1.1 [1] - Results indicate that SHR-A1811 significantly extends PFS in HER2-positive advanced colorectal cancer patients compared to standard treatment, reducing the risk of disease progression or death [1] - Overall survival (OS) data shows a trend of benefit, although it is currently only observed [1]

Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has received a notice from the National Medical Products Administration (NMPA) regarding the acceptance of its drug application for injection of Rukang Trastuzumab, which is now included in the priority review process [1] Group 1 - The drug name is Rukang Trastuzumab for injection [1] - The dosage form is an injection [1] - The acceptance number for the application is CXSS2600018 [1] Group 2 - The application is currently in the listing phase [1] - The applicant for the drug is Suzhou Merdia Biopharmaceutical Co., Ltd., a subsidiary of the company [1] - The proposed indication is for the treatment of adult patients with HER2-positive colorectal cancer who have failed treatment with oxaliplatin, fluorouracil, and irinotecan [1]

本次新适应症申报是基于一项随机、开放、阳性药物对照、多中心设计的Ⅲ 期临床试验，该研究旨在 评估瑞康曲妥珠单抗(SHR-A1811)对比标准治疗方案在经奥沙利铂、氟尿嘧啶类和伊立替康治疗失败的 HER2阳性晚期结直肠癌受试者中的有效性和安全性，并探索该药物的免疫原性及药代动力学特征。本 研究由上海高博肿瘤医院李进院长和浙江大学医学院附属第二医院袁瑛教授共同担任主要研究者，全国 40家中心共同参与。主要终点为独立影像评审委员会(IRC)依据RECIST v1.1 评估的无进展生存期 (PFS)。研究结果显示，与标准治疗方案相比，瑞康曲妥珠单抗能显著延长HER2 阳性晚期结直肠癌患 者的PFS，降低疾病进展或死亡风险。总生存期(OS)数据目前观察到获益趋势。 智通财经APP讯，恒瑞医药(01276)发布公告，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的药品上市许可申请获受理，且已被纳入优先审评程序。 ...