Syed Yahiya Y
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2025 Sep 4. doi: 10.1007/s40265-025-02224-7.
Clesrovimab (ENFLONSIA™; clesrovimab-cfor) is a long-acting monoclonal antibody developed by Merck & Co., Inc. to prevent respiratory syncytial virus (RSV) disease in infants. It binds a highly conserved epitope at antigenic site IV of the RSV fusion protein, blocking viral entry into host cells and conferring passive immunity. Incorporation of a YTE triple amino acid substitution in the Fc region enhances binding to the neonatal Fc receptor, extending serum half-life and allowing a single, body weight-independent dose. Clesrovimab received its first US approval on 9 June 2025 for preventing RSV lower respiratory tract disease in neonates and infants born during, or entering, their first RSV season. This article summarises the milestones leading to this first approval.
克勒罗维单抗（ENFLONSIA™；clesrovimab-cfor）是默克公司研发的一种长效单克隆抗体，用于预防婴儿呼吸道合胞病毒（RSV）疾病。它结合RSV融合蛋白抗原位点IV上的一个高度保守表位，阻止病毒进入宿主细胞并赋予被动免疫。在Fc区域引入YTE三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，并允许使用单一的、与体重无关的剂量。克勒罗维单抗于2025年6月9日首次获得美国批准，用于预防在其第一个RSV季节期间出生或进入该季节的新生儿和婴儿的RSV下呼吸道疾病。本文总结了促成这一首次批准的各个里程碑事件。
