智通财经APP讯，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)(该产品)已获得美国食品药品监督管理局(FDA)批准，可在美国开展临床试验。
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，显着降低β-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着优于同类上市产品。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。
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