石药集团(01093)发布公告，集团开发的GLP-1/GIP受体双偏向性激动多肽注射液(SYH2069注射液)已获 得中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。此前，该产品亦已获得美国食品 药品监督管理局(FDA)批准在美国开展临床试验。 本 次获批的临床适应症为肥胖或超重合并至少一种体重相关合并症人群的体重管理。此外，该产品亦 具备用于改善成人2型糖尿病(T2DM)患者的血糖控制的潜力，具有较高的临床开发价值。 该 产品有望成为中国首款进入临床阶段的GLP-1/GIP受体双偏向激动剂，可选择性激活c AMP通路，显 著降低b-arrestin募集，从而减少受体内吞及脱敏，提高药效和效果持续性。同时，结合长半衰期修饰平 台技术，该产品能实现更深度、更持久的减重效果。在饮食诱导肥胖(DIO)小鼠和非人灵长类的研究 中，该产品在减重及代谢改善方面的效果均显著优于同类上市产品。非人灵长类重复给药毒理研究显 示，该产品耐受性良好，未观察到任何呕吐及胃肠道不良反应。该产品具备出色的药效及良好的安全 性，有望成为超重╱肥胖及其他代谢类疾病的新一代疗法。 ...

本次获批的临床适应症为肥胖或超重合并至少一种体重相关合并症人群的体重管理。此外，该产品亦具 备用于改善成人2型糖尿病(T2DM)患者的血糖控制的潜力，具有较高的临床开发价值。 该产品有望成为中国首款进入临床阶段的GLP-1/GIP受体双偏向激动剂，可选择性激活cAMP通路，显 著降低b-arrestin募集，从而减少受体内吞及脱敏，提高药效和效果持续性。同时，结合长半衰期修饰平 台技术，该产品能实现更深度、更持久的减重效果。在饮食诱导肥胖(DIO)小鼠和非人灵长类的研究 中，该产品在减重及代谢改善方面的效果均显著优于同类上市产品。非人灵长类重复给药毒理研究显 示，该产品耐受性良好，未观察到任何呕吐及胃肠道不良反应。该产品具备出色的药效及良好的安全 性，有望成为超重╱肥胖及其他代谢类疾病的新一代疗法。 格隆汇12月29日丨石药集团(01093.HK)公告，集团开发的GLP-1/GIP受体双偏向性激动多肽注射液 (SYH2069注射液)("该产品")已获得中华人民共和国国家药品监督管理局批准，可在中国开展临床试 验。此前，该产品亦已获得美国食品药品监督管理局(FDA)批准在美国开展临床试验。 ...

Core Insights - The company Shiyao Group (01093) has received FDA approval for its GLP-1/GIP receptor dual agonist peptide injection (SYH2069), allowing clinical trials to commence in the United States [1] - This product is expected to be the first GLP-1/GIP dual agonist to enter clinical stages in China, with a mechanism that selectively activates the cAMP pathway while significantly reducing β-arrestin recruitment, leading to improved efficacy and sustained effects [1] - The product demonstrates superior weight loss and metabolic improvement in studies involving diet-induced obesity (DIO) mice and non-human primates compared to existing products [1] - Toxicology studies in non-human primates indicate good tolerability with no observed vomiting or gastrointestinal adverse reactions, suggesting excellent efficacy and safety [1] - The approved clinical indication focuses on weight management for obese or overweight individuals with at least one weight-related comorbidity, and it also shows potential for improving blood glucose control in adults with type 2 diabetes mellitus (T2DM), indicating high clinical development value [1]

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, potentially offering a new treatment for obesity and metabolic diseases [1] Group 1: Product Development - The product is designed to selectively activate the cAMP pathway while significantly reducing β-arrestin recruitment, which minimizes receptor internalization and desensitization, thereby enhancing efficacy and duration of effect [1] - The long half-life modification technology allows for deeper and more sustained weight loss effects [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 overweight or obese with at least one weight-related comorbidity [1] - The product also shows potential for improving blood glucose control in adults with type 2 diabetes mellitus (T2DM), indicating high clinical development value [1]