Onradivir: First Approval

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Authorship and Conflict of interest</b> Arnold Lee is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p><p><br></p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> not applicable</p><p><br></p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="https://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here</a></p><p><br></p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">Onradivir (安睿威®, 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.</p><p><br></p><p dir="ltr">© Springer Nature Switzerland AG 2025</p>