Onradivir：首次批准。

IF 14.4 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2025-09-25 DOI:10.1007/s40265-025-02242-5

Arnold Lee

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引用次数: 0

摘要

Onradivir（®，Anruiwei）是一种小分子RNA聚合酶抑制剂，可与RNA聚合酶的PB2帽结合结构域有效结合，抑制甲型流感病毒的复制。该药物由广东Raynovent生物技术公司开发，并于2025年5月在中国获得首次批准，基于NCT04683406 III期试验的结果。这篇文章总结了onradivir发展的里程碑，它首次被批准用于治疗成人无并发症的甲型流感，但不包括那些有流感相关并发症高风险的人。

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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Onradivir: First Approval.

Onradivir (^®, Anruiwei) is a small molecule RNA polymerase inhibitor that potently binds to the PB2 cap-binding domain of RNA polymerase to inhibit the replication of the influenza A virus. It was developed by Guangdong Raynovent Biotech and received its first approval in May 2025 in China based on results from the NCT04683406 phase III trial. This article summarizes the milestones in the development of onradivir leading to this first approval for the treatment of uncomplicated influenza A in adults, excluding those at high risk for influenza-related complications.

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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.