Onradivir: First Approval

Arnold Lee

doi:10.1007/s40265-025-02242-5

2025-09-25

PRE

Arnold Lee *

DOI：10.1007/s40265-025-02242-5

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安睿威®（Onradivir, Anruiwei）是一种小分子RNA聚合酶抑制剂，可强力结合RNA聚合酶的PB2帽结合结构域，从而抑制甲型流感病毒的复制。该药物由广东瑞诺威生物科技有限公司开发，基于NCT04683406三期临床试验结果，于2025年5月首次在中国获得批准。本文总结了安睿威®在开发过程中的关键里程碑，这些里程碑促成了该药物在成人中用于治疗非复杂性甲型流感（不包括流感相关并发症的高风险人群）的首个批准。

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