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")及子公司苏州盛迪亚生 物医药有限公司、上海恒瑞医药有限公司、上海盛迪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 HRS-4642 注射液、 SHR-1701 注射液、SHR-7367 注射液、SHR-8068 注 射液、阿得贝利单抗注射液、贝伐珠单抗注射液、注射用 SHR-A2102、苹果酸法米替尼胶囊和羟乙磺 酸达尔西利片的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

Core Viewpoint - Recently, Jiangsu Hengrui Medicine Co., Ltd. and its subsidiaries received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in their drug development pipeline [1] Group 1: Clinical Trial Approvals - The company has received approval for clinical trials of HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Abediteran injection, Bevacizumab injection, SHR-A2102 injection, Apalutamide capsules, and Darsylis sulfate tablets [1] - The approval is based on compliance with the relevant drug registration requirements as per the Drug Administration Law of the People's Republic of China [1] - The specific study includes a Phase I/II trial to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with anti-tumor drugs in subjects with solid tumors [1]

每经AI快讯，恒瑞医药（SH 600276，收盘价：61.8元）11月17日晚间发布公告称，近日，江苏恒瑞医 药股份有限公司（以下简称"公司"）及子公司苏州盛迪亚生物医药有限公司、上海恒瑞医药有限公司、 上海盛迪医药有限公司收到国家药品监督管理局核准签发关于HRS-4642注射液、SHR-1701注射液、 SHR-7367注射液、SHR-8068注射液、阿得贝利单抗注射液、贝伐珠单抗注射液、注射用SHR-A2102、 苹果酸法米替尼胶囊和羟乙磺酸达尔西利片的《药物临床试验批准通知书》，将于近期开展临床试验。 2024年1至12月份，恒瑞医药的营业收入构成为：医药制造业占比89.37%，其他业务占比10.63%。 截至发稿，恒瑞医药市值为4102亿元。 每经头条（nbdtoutiao）——展望"十五五" | 专访尹艳林：让有钱且愿消费的人顺利消费；个税起征点可 提高，最高边际税率可下调，让有关群体少缴税、多收入 （记者 王晓波） ...

恒瑞医药（600276）(600276.SH)发布公告，近日，公司及子公司苏州盛迪亚生物医药有限公司、上海 恒瑞医药有限公司、上海盛迪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HRS-4642注射液、SHR-1701注射液、SHR-7367注射液、SHR-8068注射液、阿得贝利单抗注射 液、贝伐珠单抗注射液、注射用SHR-A2102、苹果酸法米替尼胶囊和羟乙磺酸达尔西利片的《药物临床 试验批准通知书》，将于近期开展临床试验。具体为：一项HRS-4642联合抗肿瘤药物在实体瘤受试者 中的安全性、耐受性及有效性的ⅠB/Ⅱ期研究方案。 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1] Group 1: Clinical Trials - The company and its subsidiaries have received approval for clinical trials of HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, SHR-A2102 for injection, Apalutamide capsules, and Darsylis sulfate tablets [1] - A specific trial for HRS-4642 will focus on its safety, tolerability, and efficacy in combination with anti-tumor drugs in solid tumor subjects, categorized as a Phase I/II study [1]

（文章来源：每日经济新闻） 每经AI快讯，11月17日，恒瑞医药(600276.SH)公告称，公司及子公司近日收到国家药监局核准签发的 关于HRS-4642注射液、SHR-1701注射液、SHR-7367注射液、SHR-8068注射液、阿得贝利单抗注射 液、贝伐珠单抗注射液、注射用SHR-A2102、苹果酸法米替尼胶囊和羟乙磺酸达尔西利片的《药物临床 试验批准通知书》，同意开展临床试验。其中HRS-4642注射液、SHR-1701注射液、SHR-7367注射液国 内外暂无同类产品获批上市。 ...

Core Viewpoint - The company has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Drug Information - Drug Names: Injection Karilizumab (injection) and Apalutamide capsules (capsule) [1] - The application is based on a Phase III clinical study comparing Karilizumab combined with Apalutamide to platinum-based chemotherapy for recurrent or metastatic cervical cancer [1] - The study was led by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, involving 45 domestic centers and enrolling 443 patients [1] - The study achieved its primary endpoint by July 2025, demonstrating that the experimental group significantly outperformed the control group in terms of progression-free survival (PFS) and overall survival (OS) [1] - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for recurrent or metastatic cervical cancer patients [1]

Core Viewpoint - Heng Rui Medicine (01276) has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1: Drug Development - The application for market approval is based on a Phase III clinical study comparing Karilizumab combined with Apalutamide against platinum-based chemotherapy for recurrent or metastatic cervical cancer [1] - The study was led by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, involving 45 domestic centers and enrolling 443 patients [1] - The study achieved its primary endpoint by July 2025, demonstrating that the experimental group significantly outperformed the control group in terms of progression-free survival (PFS) and overall survival (OS) [1] Group 2: Efficacy and Safety - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for patients with recurrent or metastatic cervical cancer [1]

Core Viewpoint - Heng Rui Medicine has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1: Drug Development - The application for market approval is based on a Phase III clinical study comparing Karilizumab combined with Apalutamide to platinum-based chemotherapy for recurrent or metastatic cervical cancer [1] - The study was led by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, involving 45 domestic centers and enrolling 443 patients [1] - The study achieved its primary endpoint by July 2025, demonstrating that the experimental group significantly outperformed the control group in terms of progression-free survival (PFS) and overall survival (OS) [1] Group 2: Efficacy and Safety - The results confirm the efficacy and safety of Karilizumab combined with Apalutamide as a first-line treatment for patients with recurrent or metastatic cervical cancer [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received a drug registration application acceptance notice from the National Medical Products Administration for its innovative drug, injection Karilizumab combined with Apalutamide capsules for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1: Drug Approval and Indications - The injection Karilizumab has been approved for multiple indications in China, including treatment for advanced hepatocellular carcinoma patients who have previously received Sorafenib and/or systemic chemotherapy with Oxaliplatin since March 2020 [1] - Apalutamide capsules were approved in May 2025 for use in combination with injection Karilizumab for recurrent or metastatic cervical cancer patients who have failed platinum-based chemotherapy but have not received Bevacizumab treatment [1]