赛诺菲(SNY.US)“明星小分子”蛋白降解剂新药在中国获批临床

智通财经
21 Jan

智通财经APP获悉,1月20日,中国国家药监局药品审评中心(CDE)官网最新公示,赛诺菲(SNY.US)申报的1类新药SAR444656获得临床试验默示许可,拟开发适应症包括特应性皮炎(AD)、化脓性汗腺炎(HS)。

截图来源:CDE官网

公开资料显示,KT-474(SAR444656)是一款IRAK4蛋白降解剂,由Kymera Therapeutics和赛诺菲共同开发。该产品曾被猎药人网站(drughunter.com)列入2023年度十大“明星”小分子。此外,赛诺菲曾在2023年的研发日上介绍其管线中具有重磅潜力的新药名单,其中就包括这款SAR444656。

根据ClinicalTrials官网,赛诺菲正在开展两项国际多中心2期临床研究,分别评估SAR444656治疗中度至重度化脓性汗腺炎成人患者、中度至重度特应性皮炎成人患者的疗效和安全性。本次SAR444656在中国获批临床,意味着该产品也将在中国进入临床研究阶段。

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