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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).

But the South Korean and Chinese partners appear to be confident the issues are likely to be minor and quickly resolved, once they can confirm details of the Food and Drug Administration’s demands relating to the product, which contains

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