Glitch For HLB/Hengrui’s Liver Cancer Combo After US CRL

Quick Resolution Of CMC Issues Expected

 
• By Jung Won Shin

The US approval of HLB and Hengrui’s liver cancer combination therapy looks set to be delayed after the FDA issues a CRL related mainly to CMC data, but the two companies appear positive on a quick resolution to the setback given a lack of other efficacy or safety concerns.

rejection
HLB, Hengrui To Communicate With FDA, Refile As Soon As Possible • Source: Shutterstock

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