HLB's Liver Cancer Drug Manufacturing Facility Classified as 'Voluntary Action Indicated' After Inspection

HLB's finished drug manufacturing facility for Rivoceranib has been classified as 'Voluntary Action Indicated (VAI)' based on the results of a routine cGMP inspection by the United States Food and Drug Administration (FDA).

According to HLB on October 6, its U.S. subsidiary Elevar Therapeutics received a close-out letter from its partner, Hengrui Pharma, on October 3. Through this, the company confirmed that the FDA's routine cGMP inspection of the finished drug manufacturing facility for Rivoceranib was ultimately classified as VAI.

VAI is a classification given when some issues are identified during an FDA inspection, but the company is deemed able to voluntarily correct them, making no further official regulatory action necessary.

Currently, Elevar, together with Hengrui Pharma, is finalizing the materials required for resubmission of the new drug application (NDA) for liver cancer, with plans to resubmit the application to the FDA as soon as possible.

An HLB representative said, "This VAI classification is the result of Hengrui Pharma's company-wide efforts and active measures to resolve the inspection issues. Elevar will work closely with Hengrui Pharma to swiftly complete the preparation for NDA resubmission for the liver cancer drug, and will respond thoroughly to the subsequent FDA review."

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