（文章来源：证券日报） 证券日报网讯 11月25日晚间，恒瑞医药发布公告称，近日，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核准签发关于注射用瑞康曲妥珠单抗的《药物临床试验批准通知书》，将于近 期开展临床试验。 ...

（文章来源：证券日报） 证券日报网讯 11月25日晚间，恒瑞医药发布公告称，近日，公司收到国家药品监督管理局核准签发关 于HRS-8364片的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection Rituximab, indicating a significant step in the development of this new drug [1] Company Summary - The drug, injection Rituximab, targets HER2-expressing tumor cells, inducing apoptosis through a mechanism that involves the release of a highly permeable toxin [1] - The total research and development investment for injection Rituximab has reached approximately 141.4 million yuan [1] Industry Summary - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which have also been approved for sale in China [1] - The global sales of similar products are projected to reach approximately 6.557 billion USD by 2024 [1] - The approval process for drugs in China requires clinical trials to be conducted and reviewed by the National Medical Products Administration before they can be marketed [2]

受 理 号：CXSL2500754 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9月1日受理的注射用瑞康曲妥珠单抗临床试验申请符合药品注册的有关要求， 同意本品单药在 HER2 扩增实体瘤患者中开展临床试验。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-188 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。 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"）核准签 发关于注射用瑞康曲妥珠单抗的《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：注射用瑞康曲妥珠单抗 剂 型：注射剂 申请事项：临床试验 二、药品的已获批适应症情况 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 ...

Market Overview - The Hong Kong stock market showed a significant recovery on November 24, with all three major indices ending a streak of declines[9] - Large tech stocks performed strongly, with Kuaishou rising over 7%, and NetEase and Bilibili increasing over 5%[9] - The Hang Seng Tech Index closed at 5,546, up 2.78% for the day and 24.11% year-to-date[3] Sector Performance - Innovative pharmaceuticals and outsourcing concepts saw notable gains, with companies like Innovent Biologics rising over 6%[9] - Military stocks also performed well, with China Shipbuilding Defense up over 13%[9] - Oil stocks were weak, with China National Offshore Oil Corporation and China Oilfield Services both declining over 1%[9] U.S. Market Insights - On the same day, U.S. markets saw all three major indices close higher, driven by increased bets on a Federal Reserve rate cut[9] - The "Magnificent Seven" tech stocks, including Google and Nvidia, all rose, with Google gaining over 6%[9] - The S&P 500 index is projected to achieve double-digit annual growth according to HSBC strategists[14] Economic Indicators - The Federal Reserve is expected to cut rates in December, with market predictions showing a 70% probability[14] - The U.S. economy's third-quarter GDP report has been delayed due to a government shutdown, affecting economic analysis[14] Investment Trends - The Nasdaq Golden Dragon China Index rose by 2.82%, indicating a positive trend for Chinese concept stocks[13] - Significant inflows into semiconductor stocks were noted, with companies like Broadcom surging 11%[13]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection drug Rukang Qutuzumab in patients with HER2-positive solid tumors [1] Group 1 - The approval allows for the clinical trial of Rukang Qutuzumab as a monotherapy [1] - The focus of the trial is on patients with HER2 amplification in solid tumors [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of injection Rituximab, indicating a significant step in the development of this new drug [1] Company Summary - The drug, injection Rituximab, targets HER2-expressing tumor cells, inducing apoptosis through a mechanism that involves the release of a highly permeable toxin [1] - The total research and development investment for injection Rituximab has reached approximately 141.4 million yuan [1] Industry Summary - Similar products already on the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's Fam-trastuzumab deruxtecan, both of which are available domestically [1] - The global sales of similar products are projected to reach approximately 6.557 billion USD by 2024 [1] - Other competitors in the domestic market include Rongchang Biopharmaceutical's Vidi-situzumab, approved in 2021, and Kelun-Botai's Bodu-trastuzumab, expected to be approved in 2025 [1]

HRS-8364 片是公司自主研发的创新型抗肿瘤药物，拟用于治疗晚期实体瘤。经查询，目前国内外尚无 同类药物获批上市。截至目前，HRS-8364 片相关项目累计研发投入约2165万元。 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知书后，尚需开展临床试验并 经国家药监局审评、审批通过后方可生产上市。 格隆汇11月25日丨恒瑞医药(600276.SH)公布，近日，公司收到国家药监局核准签发关于HRS-8364片的 《药物临床试验批准通知书》，将于近期开展临床试验。药物名称：HRS-8364 片，受理号： CXHL2500944、CXHL2500945。 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of HRS-8364 tablets, an innovative anti-tumor drug developed by the company, aimed at treating advanced solid tumors [1] Group 1 - The company has announced the approval of a clinical trial for HRS-8364 tablets [1] - HRS-8364 is an innovative anti-tumor drug developed independently by the company [1] - The clinical trial is set to commence in the near future [1]

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 9 月 2 日受理的 HRS-8364 片临床试验申请符合药品注册的有关要求，同意本 品单药在晚期实体瘤中开展临床试验。 药物名称：HRS-8364 片 剂 型：片剂 申请事项：临床试验 受 理 号：CXHL2500944、CXHL2500945 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-187 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。 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 HRS-8364 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、药物的基本情况 江苏恒瑞医药股份有限公司董事会 2025 年 11 月 25 日 二、药物的其他情况 HRS-8364 片是公司自主研发的创新型抗肿瘤药物，拟用于治疗晚期实体瘤。 经查询，目前国内外尚无同类药物获 ...