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]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-7535 tablets, which will commence shortly [1] Group 1: Product Information - HRS-7535 tablets are a novel oral small molecule GLP-1 receptor agonist designed to treat type 2 diabetes (T2DM) and aid in weight loss [1] - The mechanism of HRS-7535 includes activating GLP-1 receptors to promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying [1] - Additionally, HRS-7535 influences the central nervous system to enhance satiety and suppress appetite, leading to a direct reduction in energy intake [1]

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。 恒瑞医药(600276.SH)发布公告，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。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.SH)发布公告，近日,公司子公司苏州盛迪亚生物医药有限公司的注射用SHR-1826被国 家药品监督管理局药品审评中心纳入突破性治疗品种名单。拟定适应症(或功能主治)：单药治疗既往接 受过至少一线系统性治疗失败的c-Met过表达(2-3+，≥50%)驱动基因阴性局部晚期或转移性非鳞状非小 细胞肺癌。 ...

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 monotherapy in patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have previously failed at least one line of systemic therapy [1] - The targeted patient population has c-Met overexpression (2-3+, ≥50%) [1]