Clesrovimab: First Approval

doi:10.1007/s40265-025-02224-7

2025-09-04

PRE

Yahiya Y. Syed *

DOI：10.1007/s40265-025-02224-7

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Clesrovimab (ENFLONSIA™; clesrovimab-cfor) 是由Merck & Co., Inc.开发的一种长效单克隆抗体，用于预防婴幼儿呼吸道合胞病毒（RSV）疾病。它结合RSV融合蛋白抗原位点IV上的高度保守表位，阻断病毒进入宿主细胞并赋予被动免疫。在Fc区域引入YTE三重氨基酸取代可增强与新生儿Fc受体的结合，延长血清半衰期，并允许单次、体重无关的给药剂量。Clesrovimab于2025年6月9日首次获得美国批准，用于预防新生儿和出生时或进入其首个RSV季节的婴幼儿的RSV下呼吸道疾病。本文总结了导致此次首次批准的里程碑事件。

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