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Chinese PD-1s Eye US Approvals Despite Lack Of Action Dates

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Executive Summary

Although Novartis/BeiGene’s tislelizumab and Coherus /Junshi’s toripalimab have not received a new Prescription Drug User Fee Act (PDUFA) decision date for their biologics license applications in the US, the companies remain hopeful that potential approvals will be granted in the third quarter at the earliest.

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