贝达药业公告称，公司产品盐酸埃克替尼片、盐酸恩沙替尼胶囊、甲磺酸贝福替尼胶囊、伏罗尼布片纳 入《国家基本医疗保险、生育保险和工伤保险药品目录（2025年）》，协议有效期为2026年1月1日至 2027年12月31日。此外，公司产品贝伐珠单抗注射液纳入国家医保乙类药品目录。产品纳入医保将提高 可及性，对销售有积极作用，但对当期业绩影响暂无法准确估计。 ...

公示显示，该药的临床试验申请由一家名不见经传的"杭州景曜生物科技有限公司"（简称"景曜生物"） 提交。这与该药品广为人知的研发主体——上市公司贝达药业产生了令人费解的"署名冲突"。 这究竟是两家公司针对同名药物的独立竞争，还是贝达药业管线布局中尚未披露的权益安排？南都N视 频记者就此发函并致电贝达药业，但截至发稿前并未得到回复。 近日，国家药品监督管理局药品审评中心（CDE）的一则受理公示，让不少关注贝达药业股份有限公司 （简称"贝达药业"300558.SZ）的投资者的目光聚焦在抗癌新药"BPI-572270"上。 "双生花"：从科学源头到申报主体 "BPI-572270"项目的科学本源如何？ 追溯至今年4月，贝达药业BPI-572270等四项研究成果亮相2025第116届美国癌症研究协会（AACR）年 会。 贝达药业介绍，"BPI-572270"针对的是非常具有挑战性的靶点，即KRAS突变。这是导致多种癌症发生 （如胰腺癌，非小细胞肺癌和结直肠癌）的致癌驱动因素，在所有癌症中的突变频率为20%-30%。 | | | | | | | | P. B.J 402V 230 WE TI-S | | 11.000 | ...

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant step forward in its drug development pipeline [1] Group 1: Company Developments - The company and its subsidiaries, including Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval for several products [1] - The approved products include HRS-7058 capsules, HRS-7058 tablets, SHR-9839(sc), Adebali monoclonal antibody injection, Bevacizumab injection, and SHR-A2102 injection [1] Group 2: Industry Implications - The approval of these clinical trials reflects ongoing advancements in the biopharmaceutical sector, showcasing the company's commitment to expanding its therapeutic offerings [1] - The initiation of these trials may enhance the company's competitive position in the market, potentially leading to new revenue streams upon successful development and commercialization of the drugs [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant step forward in its drug development pipeline [1] Group 1: Company Developments - The company and its subsidiaries, including Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval for several products [1] - The approved products include HRS-7058 capsules, HRS-7058 tablets, SHR-9839(sc), Adebali monoclonal antibody injection, Bevacizumab injection, and SHR-A2102 injection [1] Group 2: Industry Implications - The approval of these clinical trials reflects ongoing advancements in the biopharmaceutical sector, showcasing the company's commitment to expanding its therapeutic offerings [1] - The initiation of these clinical trials may enhance the company's competitive position in the market, potentially leading to new revenue streams upon successful development and commercialization of the drugs [1]

Core Viewpoint - Heng Rui Medicine (600276) 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 Trial Approvals - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have received approval for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, which will commence shortly [1] - Additionally, the company and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted approval for clinical trials of several products, including HRS-7058 Capsules, HRS-7058 Tablets, SHR-9839(sc), Adebali Injection, Bevacizumab Injection, and SHR-A2102 Injection, with trials set to begin soon [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of multiple drug candidates, indicating a significant step forward in its research and development efforts [1] Group 1: Clinical Trial Approvals - The company and its subsidiaries, including Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval for HRS-7058 capsules, HRS-7058 tablets, SHR-9839(sc), Adebali monoclonal antibody injection, Bevacizumab injection, and SHR-A2102 injection [1] - The approved clinical trials will focus on the safety, tolerability, and efficacy of HRS-7058 in combination with anti-tumor drugs in subjects with solid tumors, specifically a Phase II clinical study [1] Group 2: Regulatory Compliance - The approved drug candidates were reviewed and found to meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - The approval was based on the submission received on August 18, 2025, confirming compliance with relevant regulations [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of several new drugs, indicating progress in its drug development pipeline [1] Drug Development - The company and its subsidiaries have been granted clinical trial approval for the following drugs: - HRS-7058 capsules - HRS-7058 tablets - SHR-9839(sc) - Adebali monoclonal antibody injection - Bevacizumab injection - SHR-A2102 injection [1] Investment in R&D - The cumulative R&D investments for these drugs are as follows: - HRS-7058: approximately 72.31 million yuan - SHR-9839(sc): approximately 968.98 million yuan - Adebali monoclonal antibody: approximately 364.73 million yuan - Bevacizumab injection: approximately 248.22 million yuan - SHR-A2102: approximately 63.91 million yuan [1] Regulatory Process - Following the approval of clinical trial notifications, these drugs must undergo clinical trials and receive further evaluation and approval from the National Medical Products Administration before they can be manufactured and marketed [1]

探索"新优药械"从研发到使用的高效对接机制，优化临床急危重症抢救不可替代新药的入院流程，逐步 实现由30个工作日缩减至15个工作日。 为持续鼓励创新药品、医疗器械产品的实际应用，上海的政策支持不断升级。 日前，上海印发《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若干措施》（下称 《若干措施》），提出六个方面共22项内容，通过监管制度的改革，来助推药械产业发展。这也是继 2024年7月上海出台《关于支持生物医药产业全链条创新发展的若干意见》（下称《若干意见》）后， 又一次大力度的政策指引。 加快创新产品应用 创新药械产品如何在审批、应用阶段提速是企业重点关切。为此，《若干措施》提出"加快创新产品应 用"，即"持续优化完善我市新上市药品挂网服务，积极申请成为新上市药品首发挂网省份""探索'新优 药械'从研发到使用的高效对接机制，优化临床急危重症抢救不可替代新药的入院流程，逐步实现由30 个工作日缩减至15个工作日""对符合规定的'新优药械'产品，及时研究纳入医保支付范围，鼓励商业健 康险产品覆盖更多'新优药械'"等。 第一财经了解到，与《若干意见》相协同的《上海市生物医药"新优药械"产品目录》今年 ...

Core Viewpoint - Heng Rui Medicine (01276) 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 Trial Approvals - The company and its subsidiaries have been granted clinical trial approval for HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, Adalimumab injection, Bevacizumab injection, SHR-A2102 for injection, Famitinib malate capsules, and Darsylis sulfate tablets [1] - The approved clinical trials are set to commence in the near future, reflecting the company's ongoing commitment to expanding its product offerings [1]

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]