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恒瑞医药获得HRS-7535片临床试验批准通知书
Zhi Tong Cai Jing· 2026-01-29 09:40
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-7535, a novel oral small molecule GLP-1 receptor agonist, which shows promise in treating chronic kidney disease and obesity-related conditions [1] Group 1: Product Development - HRS-7535 is designed to activate GLP-1 receptors, promoting insulin secretion and reducing glucagon secretion while also suppressing gastric emptying [1] - The drug has shown significant improvement in preclinical models of chronic kidney disease (CKD) [1] - The total research and development investment for HRS-7535 has reached approximately 36.94 million yuan (unaudited) [1] Group 2: Market Context - There are currently no oral small molecule GLP-1 receptor agonists available in the global market [1]
恒瑞医药子公司HRS-7535片获临床试验批准,拟用于高血压合并超重或肥胖治疗
Xin Lang Cai Jing· 2026-01-12 23:09
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]