Clesrovimab：首次批准。

IF 14.4 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2025-09-04 DOI:10.1007/s40265-025-02224-7

Yahiya Y Syed

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引用次数: 0

摘要

Clesrovimab （ENFLONSIA™；Clesrovimab -cfor）是默克公司开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的一个高度保守的表位，阻断病毒进入宿主细胞并赋予被动免疫。在Fc区加入一个YTE三氨基酸取代，增强了与新生儿Fc受体的结合，延长了血清半衰期，并允许单剂量，与体重无关。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在或进入第一个RSV季节的婴儿的RSV下呼吸道疾病。本文总结了导致首次批准的里程碑。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Clesrovimab: First Approval.

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.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.