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，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。临床前数据显示 HRS-7535 可显著改善动物慢性肾脏病(CKD)症状。 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(未经审计)。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"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(以下简称"国家药监局")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。 ...

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]