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 has received approval from the National Medical Products Administration for the clinical trial of HRS-2329 tablets, an innovative anti-tumor drug targeting late-stage solid tumors with RAS mutations or amplifications [1] Drug Information - Drug Name: HRS-2329 Tablets [1] - Dosage Form: Tablets [1] - Application Matter: Clinical Trial [1] - Acceptance Numbers: CXHL2500682, CXHL2500683, CXHL2500684 [1] - Approval Conclusion: The clinical trial application for HRS-2329 tablets, accepted on July 10, 2025, meets the requirements for drug registration and is approved for trials in patients with late-stage solid tumors carrying RAS mutations or amplifications [1] Development Status - HRS-2329 tablets are independently developed by the company and have shown good anti-tumor activity in preclinical animal models [1] - The drug is intended for the treatment of late-stage solid tumors with RAS mutations or amplifications [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - The cumulative R&D investment for the HRS-2329 project is approximately 60.15 million yuan [1]

Group 1 - The core point of the article is that Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Suzhou Hengrui Medicine Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-4298 injection, which is intended for the treatment of advanced solid tumors [1] - SHR-4298 injection is a self-developed Class 1 therapeutic biological product that has shown good anti-tumor activity in preclinical animal models [1] - The clinical trial application for SHR-4298 injection was accepted on July 8, 2025, and it meets the requirements for drug registration according to the relevant regulations [1] Group 2 - There are currently 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]

Group 1 - Heng Rui Medicine announced on September 30 that the share reduction plan has been completed, with Mr. Sun Jieping reducing his holdings by a total of 237,040 shares, accounting for 0.004% of the company's total share capital [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, which shows promising anti-tumor activity in preclinical animal models and is intended for the treatment of advanced solid tumors with RAS mutations or amplifications [1] Group 1 - HRS-2329 tablets are a self-developed innovative anti-tumor drug by the company [1] - The drug has demonstrated good anti-tumor activity in preclinical animal models [1] - There are currently no similar drugs approved for marketing domestically or internationally [1] Group 2 - The company has invested approximately 60.15 million yuan in the research and development of the HRS-2329 project to date [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-2329 tablets, an innovative anti-tumor drug developed by the company [1] Group 1: Product Development - HRS-2329 tablets are designed to treat advanced solid tumors with RAS mutations or amplifications [1] - The drug has shown promising anti-tumor activity in preclinical animal models [1] - Currently, there are no similar drugs approved for sale in both domestic and international markets [1] Group 2: Financial Investment - The total research and development investment for the HRS-2329 project has reached approximately 60.15 million yuan [1]

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]