Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of HRS-7535, a novel oral small molecule GLP-1 receptor agonist aimed at treating hypertension combined with overweight or obesity [1] Group 1: Drug Development - HRS-7535 is designed to activate GLP-1 receptors to regulate insulin and glucagon secretion, inhibit gastric emptying, and enhance satiety while suppressing appetite through central mechanisms [1] - The drug is the first oral small molecule GLP-1 receptor agonist to be developed globally, indicating a potential market opportunity [1] Group 2: Financial Investment - Approximately 369.4 million RMB has been invested in the research and development of HRS-7535 to date [1] Group 3: Regulatory Process - Following the approval for clinical trials, the drug must complete clinical testing and receive further review and approval from the National Medical Products Administration before it can be marketed, highlighting the uncertainties in the development and commercialization process [1]

Group 1 - Jiangsu Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for clinical trials of HRS-7535 tablets, which are intended for the treatment of hypertension combined with overweight or obesity [1][2] - HRS-7535 is a novel oral small molecule GLP-1 receptor agonist that promotes insulin secretion and reduces glucagon secretion, while also enhancing satiety and suppressing appetite, making it suitable for treating type 2 diabetes and weight loss [2] - The total R&D investment for HRS-7535 has reached approximately 36.94 million yuan [2] Group 2 - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapy drugs by the NMPA [5][6] - SHR-1826 is a therapeutic biological product targeting c-Met, intended for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer in patients who have failed at least one line of systemic therapy [6][7] - The total R&D investment for SHR-1826 has reached approximately 12.55 million yuan [7]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapies by the National Medical Products Administration [1] Group 1: Product Information - SHR-1826 is an antibody-drug conjugate targeting c-Met, designed to specifically bind to tumor cell surface antigens and induce cell death upon internalization [1] - A similar product, ABBV-399 (generic name: telisotuzumab vedotin), received accelerated approval from the FDA in May 2025 for treating adult patients with advanced/metastatic non-squamous non-small cell lung cancer who have previously undergone systemic therapy and exhibit high expression of c-Met protein [1] Group 2: Financial Investment - The cumulative research and development investment related to SHR-1826 has reached approximately 125.5 million yuan [1]

Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of HRS-7535, a novel oral small molecule GLP-1 receptor agonist aimed at treating type 2 diabetes and weight loss [1] Group 1: Product Development - HRS-7535 is designed to activate GLP-1 receptors, promoting insulin secretion from the pancreas, reducing glucagon secretion, and suppressing gastric emptying [1] - The drug also enhances satiety and suppresses appetite through central mechanisms, leading to reduced energy intake [1] - There are currently no oral small molecule GLP-1 receptor agonists available in the global market [1] Group 2: Financial Investment - The cumulative research and development investment for HRS-7535 has reached approximately 369.4 million yuan [1]

Group 1 - Core viewpoint: Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Suzhou Hengrui Medicine Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapeutic varieties by the National Medical Products Administration [1] - Drug name: Injectable SHR-1826, with acceptance number CXSL2300466, classified as a Class 1 therapeutic biological product [1] - Proposed indication: Monotherapy for locally advanced or metastatic non-squamous non-small cell lung cancer with c-Met overexpression (2-3+, ≥50%) in patients who have failed at least one line of systemic treatment [1] Group 2 - Application date: December 1, 2025, for the registration of SHR-1826 [1] - Reason for inclusion: The application meets the requirements of the "Drug Registration Management Measures" and the announcement regarding the "Breakthrough Therapeutic Drug Review Procedures" [1]

根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 10 月 27 日受理的 HRS-7535 片符 合药品注册的有关要求，同意本品开展临床试验。申请的适应症：本品拟用于高血压合并超重或肥胖治 疗。 恒瑞医药（600276）(01276)公布，近日，公司子公司山东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-7535 片的《药物临床试验批准通知书》，将于近期开展临床试验。 据悉，HRS-7535 片是一种新型口服小分子胰高血糖素样肽-1 受体(GLP-1R)激动剂，既可以通过激活人 的 GLP-1R，促进胰腺的胰岛素分泌和降低胰高血糖素分泌并抑制胃排空，还可以通过影响中枢增强饱 腹感和抑制食欲，直接减少能量的摄入等机制用于治疗 2 型糖尿病(T2DM)和减重。全球范围内尚无口 服小分子 GLP-1R 激动剂上市。截至目前，HRS-7535 片相关项目累计研发投入约 36,940 万元。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapies by the National Medical Products Administration [1] Group 1: Product Information - SHR-1826 is an antibody-drug conjugate targeting c-Met, designed to specifically bind to tumor cell surface antigens and induce cell death upon internalization [1] - A similar product, ABBV-399 (generic name: telisotuzumab vedotin), received accelerated approval from the FDA in May 2025 for treating adult patients with advanced/metastatic non-squamous non-small cell lung cancer who have high expression of c-Met protein [1] Group 2: Financial Investment - The cumulative research and development investment for SHR-1826 has reached approximately 125.5 million yuan [1]

Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of HRS-7535 tablets, aimed at treating hypertension combined with overweight or obesity [1] Group 1: Clinical Trial Approval - The clinical trial approval notice for HRS-7535 was issued on October 27, 2025, confirming that the drug meets the registration requirements [1] - The drug is a novel oral small molecule GLP-1 receptor agonist, which promotes insulin secretion and reduces glucagon secretion while enhancing satiety and suppressing appetite [1] Group 2: Market Potential - HRS-7535 is intended for the treatment of Type 2 Diabetes Mellitus (T2DM) and weight loss, with no oral small molecule GLP-1 receptor agonists currently available in the global market [1] - The total research and development investment for HRS-7535 has reached approximately 369.4 million yuan [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of HRS-7535 tablets, which will be conducted soon. The drug is intended for the treatment of hypertension combined with overweight or obesity [2] Group 1: Product Development - HRS-7535 tablets are a novel oral small molecule GLP-1 receptor agonist that activates human GLP-1 receptors to promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying [2] - The drug also enhances satiety and suppresses appetite through central mechanisms, directly reducing energy intake, making it suitable for treating type 2 diabetes (T2DM) and weight loss [2] - There are currently no oral small molecule GLP-1 receptor agonists available on the global market [2] Group 2: Financial Investment - The cumulative research and development investment for the HRS-7535 project has reached approximately 36.94 million yuan [2]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the National Medical Products Administration's list of breakthrough therapies, targeting a specific type of lung cancer [1] Group 1 - The indication for SHR-1826 is for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer that has c-Met overexpression (2-3+, ≥50%) and has failed at least one line of systemic therapy [1]