Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-6257 tablets, aimed at treating acute and chronic pain, with no similar drugs approved in the domestic market [1] Company Summary - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has been granted a Clinical Trial Approval Notice for HRS-6257 tablets [1] - The total research and development investment for the HRS-6257 project has reached approximately 15.58 million yuan [1] Industry Summary - Currently, there are no approved drugs targeting the same mechanism as HRS-6257 in the domestic market [1]

Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of HRS-6257 tablets, aimed at treating acute and chronic pain, with no similar drugs approved in the domestic market [1] Company Summary - The clinical trial approval for HRS-6257 tablets is a significant milestone for Heng Rui Medicine, indicating progress in its drug development pipeline [1] - The total research and development investment for the HRS-6257 project has reached approximately 15.58 million yuan [1] Industry Summary - Currently, there are no approved drugs targeting the same mechanism as HRS-6257 in the domestic market, highlighting a potential market opportunity for Heng Rui Medicine [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for multiple clinical trials of new injectable drugs, indicating progress in its drug development pipeline [1] Group 1: Clinical Trial Approvals - Jiangsu Heng Rui Medicine Co., Ltd. and its subsidiaries have been granted clinical trial approval for SHR-4375 injection, Abediteranib injection, SHR-8068 injection, Bevacizumab injection, HRS-4642 injection, and SHR-9839 injection [1] - The approval is based on compliance with the relevant requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - The specific study for SHR-4375 injection will focus on its safety, tolerability, and efficacy in combination with anti-tumor treatment in patients with advanced solid tumors, conducted as a multicenter, open-label Phase Ib/II clinical study [1]

Core Insights - The article discusses the transformation of Chinese pharmaceutical companies from merely selling products to actively participating in global value chains, with a significant increase in outbound licensing deals reaching over $100 billion by November 2025, a 75% increase year-on-year [3][4]. Group 1: Major Transactions - In 2024, major deals like Hengrui's $5 billion GLP-1 product and a $12.5 billion upfront payment from Pfizer to 3SBio for a dual antibody drug highlight the trend of billion-dollar collaborations becoming standard [4][6]. - Hengrui's partnership with GSK for $12.5 billion includes not only current products but also options for 11 early-stage projects, indicating a shift towards long-term strategic partnerships [4][10]. Group 2: Licensing Strategies - Chinese companies are moving from "one-off sales" to retaining rights in core markets while sharing rights in other regions, allowing them to benefit from both local and global markets [5][6]. - The new strategy involves keeping rights for the Greater China region while sharing development costs and rights for other markets, enhancing long-term revenue potential [6][10]. Group 3: Innovative Drug Categories - Antibody-drug conjugates (ADCs) and dual antibodies are emerging as key areas for Chinese companies, with significant deals reflecting their growing importance in the global market [6][7]. - The shift from traditional cancer drugs to innovative metabolic drugs like GLP-1 is notable, with companies like FOSUN and Hansoh making substantial deals in this area [14][15]. Group 4: Independent Global Expansion - Companies are increasingly opting for "self-driven" global expansion rather than simply licensing out, as seen with Kangfang Biopharma's approach to leading its own global clinical trials [8][9]. - This strategy, while riskier, offers higher potential returns compared to traditional licensing agreements [9]. Group 5: Platform-Based Collaborations - The trend is shifting from selling individual products to offering entire R&D platforms, as demonstrated by Hengrui's collaboration with GSK, which includes options for future projects [10][11]. - This model allows companies to monetize their ongoing research capabilities, enhancing their value proposition to partners [10][11]. Group 6: Regulatory and Pricing Developments - The introduction of a drug pricing registration system by China's National Healthcare Security Administration is expected to alleviate concerns about domestic pricing affecting global pricing strategies [12][13]. - This regulatory change has led to increased foreign investment in Chinese R&D, with a 28% year-on-year growth in 2025 [13]. Group 7: Market Valuation Changes - The market's evaluation criteria for Chinese innovative drug companies have shifted from focusing on generic drug revenues to assessing the value of outbound pipelines and global clinical progress [19][21]. - The average price-to-earnings ratio for innovative drug companies in China has risen significantly, reflecting a revaluation of their market potential [21].

药品 名称 SHR-4375 注射液 阿得贝利单抗 注射液 SHR-8068 注射液 贝伐珠单抗 注射液 HRS-4642 注射液 注射用 SHR-9839（sc） 剂型 注射剂 申请 事项 临床试验 受理号 CXSL2500845 CXSL2500842 CXSL2500844 CXSL2500847 CXHL2501051 CXHL2501052 CXSL2500848 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 28 日受理的 SHR-4375 注射液、阿得贝利单抗注射液、SHR-8068 注射液、贝伐珠单抗注射液、HRS-4642 注射液、注射用 SHR-9839（sc）符合药品注册的有关要求，同意开展临床试验。具体为：一项 SHR-4375 注射液 联合抗肿瘤治疗在晚期实体肿瘤患者中的安全性、耐受性及有效性的多中心、开放的Ⅰb/Ⅱ期临 床研究。 一、药品的基本情况 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激 活免疫系统的抗肿瘤活性，从而 ...

一、药物的基本情况 药物名称：HRS-6257 片 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-212 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"）子公司上海恒瑞医 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-6257 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： 江苏恒瑞医药股份有限公司董事会 剂 型：片剂 三、风险提示 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。药品 从研制、临床试验报批到投产的周期长、环节多，药品研发及至上市容易受到一 些不确定性因素的影响，敬请广大投资者谨慎决策，注意防范投资风险。公司将 按国家有关规定积极推进上述研发项目，并及时对项目后续进展情况履行信息披 露义务。 特此公告。 申请事项：临床试验 受 ...

Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of HRS-6257 tablets, aimed at treating acute and chronic pain, with no similar drugs approved in the domestic market [1] Group 1: Clinical Trial Approvals - The company’s subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has been granted a clinical trial approval notice for HRS-6257 tablets [1] - The company and its subsidiaries have also received approval for clinical trials of SHR-4375 injection, Adalimumab injection, SHR-8068 injection, Bevacizumab injection, HRS-4642 injection, and SHR-9839 (sc) injection [1] - These clinical trials are set to commence in the near future [1]

恒瑞医药12月29日公告，公司子公司上海恒瑞医药有限公司收到国家药品监督管理局核准签发关于 HRS-6257片的《药物临床试验批准通知书》，将于近期开展临床试验。根据审批结论，HRS-6257片临 床试验申请符合药品注册的有关要求，同意本品开展用于术后镇痛的临床试验。HRS-6257片拟用于治 疗急慢性疼痛。 ...

格隆汇12月29日丨恒瑞医药(600276.SH)公布，公司子公司上海恒瑞医药有限公司收到国家药品监督管 理局核准签发关于HRS-6257片的《药物临床试验批准通知书》，将于近期开展临床试验。HRS-6257片 拟用于治疗急慢性疼痛。 ...

Core Viewpoint - Heng Rui Medicine announced the approval of multiple clinical trial applications for new drug candidates by the National Medical Products Administration, indicating a significant step forward in its research and development efforts [1] Group 1: Clinical Trial Approvals - The company and its subsidiaries received approval for clinical trials of SHR-4375 injection, Adalimumab injection, SHR-8068 injection, Bevacizumab injection, HRS-4642 injection, and SHR-9839 (sc) injection [1] - The approved clinical trials are set to commence in the near future, reflecting the company's ongoing commitment to expanding its product pipeline [1]