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Ark Biopharma’s China NDA for RSV Therapy Accepted for Priority Review

publication date: Dec 9, 2022

Shanghai Ark Biopharma reported that its China NDA for a respiratory syncytial virus (RSV) infection therapy was accepted and granted Priority Review. Ziresovir is a novel small-molecule RSV fusion (F) protein inhibitor that works by preventing viral entry into human cells. The molecule also suppresses virus transmission by blocking cell fusion via syncytia, a common problem during RSV infection. Ziresovir is a Class I novel drug, the first RSV therapy to complete a global Phase III clinical study and the first non-oncology drug granted Priority Review in China. It is Ark’s lead candidate. More details....

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