消息面上,歌礼制药-B发布公告,近期已获得美国食品药品监督管理局(FDA)对其ASC35的I期研究的新药临床试验(IND)批准。ASC35是一款有望成为同类最佳(best-in-class)、每月一次皮下注射的GLP-1受体(GLP-1R)/GIP受体 (GIPR)双靶点激动剂多肽,用于治疗肥胖症。体外实验显示,ASC35对GLP-1R和GIPR的激动活性比替尔泊肽强约4倍。结合所有临床前研究,ASC35每毫克多肽的疗效优于替尔泊肽(more efficient on a per-milligram peptide basis)。
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