HLB Faces FDA Hurdle for Liver Cancer Drug Due to Chinese Partner's Facility Issues

South Korean biopharmaceutical company HLB has encountered another obstacle in its pursuit of U.S. Food and Drug Administration (FDA) approval for its novel liver cancer drug. The company announced it received a Complete Response Letter (CRL) from the FDA, which signifies that the agency has identified deficiencies in the drug application and cannot approve it in its current form.

HLB stated that the issues raised by the FDA are not related to the drug's clinical efficacy or safety. Instead, the delay is reportedly due to problems identified during the inspection of the manufacturing facilities of its co-developer, China-based Hengrui Medicine. Specifically, the inspection focused on Hengrui Medicine's compliance with Current Good Manufacturing Practice (cGMP) standards.

The CRL means HLB, through its U.S. subsidiary Eleva Therapeutics, must address the FDA's concerns before the drug can be reconsidered for approval. This setback is particularly significant given the potential market for a new liver cancer treatment and the extensive development process already undertaken by HLB.