US FDA Rejects HLB’s Liver Cancer Drug for the Second Time

· FDA issues Complete Response Letter for HLB’s liver cancer drug.

 

HLB Chairman Jin Yang-gon announced that the FDA has issued a second CLR to HLB. (Credit: HLB)

The U.S. Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) to HLB, a South Korean biopharmaceutical company, regarding its New Drug Application (NDA) for a liver cancer treatment. The decision, announced by HLB Chairman Jin Yang-gon, centers on unresolved issues related to the manufacturing process of camrelizumab, a crucial component of the drug.

Chairman Jin addressed investors and the public via the company's official YouTube channel at 3:00 AM KST on March 21, 2024. He confirmed that the FDA's concerns pertain to the Chemistry, Manufacturing, and Controls (CMC) process at the manufacturing facility of Jiangsu Hengrui Pharmaceuticals, the developer of camrelizumab. HLB intends to submit a copy of the CRL to the Korea Exchange.

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US FDA Rejects HLB’s Liver Cancer Drug for the Second Time - IT타임스