Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-4298 injection, a novel anti-tumor drug [1] Group 1: Product Development - SHR-4298 injection is a first-class therapeutic biological product developed independently by the company [1] - The drug has shown good anti-tumor activity in preclinical animal models and is intended for the treatment of advanced solid tumors [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-4298 injection project has reached approximately 28.79 million yuan [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-2329 tablets in patients with advanced solid tumors carrying RAS mutations or amplifications [1] Group 1: Company Developments - HRS-2329 tablets are an innovative anti-tumor drug independently developed by the company, with no similar drugs approved for market domestically or internationally [1] - The total research and development investment for the related project has reached approximately 60.15 million yuan [1] Group 2: Regulatory and Market Context - Following the approval of the clinical trial notification, the drug must undergo clinical trials and receive further review and approval from the National Medical Products Administration before it can be produced and marketed [1]

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 (NMPA) for the clinical trial of SHR-4298 injection, which will commence shortly [1] Group 1: Product Development - SHR-4298 injection is a self-developed Class 1 therapeutic biological product that has demonstrated good anti-tumor activity in preclinical animal models [1] - The drug is intended for the treatment of advanced solid tumors, and currently, there are no similar drugs approved for marketing domestically or internationally [1] - The total research and development investment for the SHR-4298 injection project has reached approximately 28.79 million yuan [1]

Core Insights - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for the clinical trial of HRS-2329 tablets, an innovative anti-tumor drug developed by the company [1] - HRS-2329 tablets have shown promising anti-tumor activity in preclinical animal models and are intended for the treatment of advanced solid tumors with RAS mutations or amplifications [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - The total research and development investment for the HRS-2329 project has reached approximately 60.15 million yuan [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]

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 apple acid famitinib capsules, for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1 - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., have had their application accepted for a new treatment regimen [1] - Injection Karilizumab has been approved for multiple indications in China, including treatment for advanced hepatocellular carcinoma patients who have previously received sorafenib and/or oxaliplatin-based chemotherapy since March 2020 [1] - Apple acid famitinib capsules were approved in May 2025 for use in combination with injection Karilizumab for recurrent or metastatic cervical cancer patients who failed platinum-based chemotherapy but have not received bevacizumab treatment [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-159 江苏恒瑞医药股份有限公司 董监高减持股份结果公告 本公司董事会、全体董事及相关股东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。 重要内容提示： 董监高持股的基本情况 本次减持计划实施前，江苏恒瑞医药股份有限公司（以下简称"公司"）董 事、高级副总裁孙杰平先生持有公司股份 1,907,032 股，占公司总股本的 0.029%。 减持计划的实施结果情况 公司于 2025 年 6 月 16 日披露了《江苏恒瑞医药股份有限公司董监高减持股 份计划公告》（公告编号：临 2025-092），孙杰平先生计划自减持计划公告披露 之日起 15 个交易日后的 3 个月内（窗口期不减持），通过集中竞价交易方式减持 其所持有的公司股份合计不超过 476,700 股,即减持比例不超过其本人持有公司 股份的 25%，且不超过公司总股本的 0.007%。截至本公告披露之日，本次减持计 划实施完毕，孙杰平先生累计减持公司股份 237,040 股，占公司总股本的比例为 0.004%。 | 股东名称 | 孙 ...

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 SHR-4298 injection, which is expected to commence soon [1] Group 1 - SHR-4298 injection is a self-developed Class 1 therapeutic biological product by the company [1] - The product has demonstrated good anti-tumor activity in preclinical animal models [1] - SHR-4298 is intended for the treatment of advanced solid tumors [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of HRS-2329 tablets, an innovative anti-tumor drug developed by the company [1] Group 1 - HRS-2329 tablets are designed for the treatment of advanced solid tumors with RAS mutations or amplifications [1] - The drug has shown promising anti-tumor activity in preclinical animal models [1] - The clinical trials are set to commence shortly following the approval [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 of Carrelizumab combined with Apalutamide capsules, intended for first-line treatment of recurrent or metastatic cervical cancer patients [1] Group 1 - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., are involved in the development of innovative drugs [1] - The acceptance of the drug registration application marks a significant step towards potential market entry for the treatment of cervical cancer [1]