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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.

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

HLB LifeScience Co., Ltd. and Jiangsu Hengrui Medicine Co., Ltd.’s combination therapy for liver cancer has hit a stumbling block in the form of a US complete response letter (CRL), mainly related to issues around chemistry, manufacturing and controls (CMC), along with bioresearch monitoring (BIMO).

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