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Lilly To Decide Next Steps After Formal FDA 'Nay' For First Chinese PD-1

A Chance To Reflect?

 
• By Brian Yang

The official verdict is in for sintilimab and the results are not surprising. But some view the setback for "Made In China" innovation as a chance to reflect and move forward.

FDA Complete response stamp holder
US FDA ISSUES COMPLETE RESPONSE LETTER TO LILLY/INNOVENT'S SINTILIMAB • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

The US Food and Drug Administration has issued an official complete response letter to Eli Lilly and Company for the immuno-oncology agent, Tvvyt (sintilimab), developed by its partner Innovent Biologics, Inc.

The CRL follows an expert committee vote in February that recommended rejecting the approval of the first anti-PD-1 antibody from...

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