Workflow
代谢类疾病疗法
icon
Search documents
石药集团(01093):GLP-1/GIP受体双偏向性激动多肽注射液在美国获临床试验批准
Zhi Tong Cai Jing· 2025-12-05 11:16
Core Viewpoint - The approval of SYH2069 injection by the FDA marks a significant milestone for the company, as it is expected to be the first GLP-1/GIP receptor dual agonist to enter clinical trials in China, offering potential for effective weight management and treatment of metabolic diseases [1]. Group 1: Product Development - The SYH2069 injection has received FDA approval to conduct clinical trials in the U.S. [1] - This product selectively activates the cAMP pathway while significantly reducing β-arrestin recruitment, which minimizes receptor internalization and desensitization, thereby enhancing efficacy and duration of effect [1]. - The product is designed to achieve deeper and more sustained weight loss effects due to its long half-life modification technology [1]. Group 2: Clinical Research Findings - In studies involving diet-induced obesity (DIO) mice and non-human primates, SYH2069 demonstrated significantly better weight loss and metabolic improvement compared to existing products on the market [1]. - Toxicology studies in non-human primates indicated good tolerability, with no observed vomiting or gastrointestinal adverse reactions [1]. Group 3: Clinical Application and Value - The approved clinical indication is for weight management in individuals who are obese or overweight with at least one weight-related comorbidity [1]. - The product also shows potential for improving blood glucose control in adult patients with type 2 diabetes mellitus (T2DM), indicating high clinical development value [1].