Green Light for HLB's Liver Cancer Drug NDA Resubmission as FDA Completes Inspection of Finished Dosage Facility

cGMP Inspection of Manufacturing Facility Classified as 'VAI'
Elevar Finalizing Documents for Resubmission

HLB announced on October 6 that the U.S. Food and Drug Administration (FDA) has classified the routine cGMP inspection of the manufacturing facility for the finished dosage form of Rivoceranib as “Voluntary Action Indicated (VAI).”

HLB Company Logo Image. HLB

HLB's U.S. subsidiary, Elevar Therapeutics, received a close-out letter regarding the inspection from its partner, Jiangsu Hengrui Pharmaceuticals, on October 3. As a result, it was confirmed that the FDA’s routine cGMP inspection of the Rivoceranib finished dosage manufacturing facility has been officially completed with a VAI classification.

VAI is a classification given when certain issues are identified during an FDA inspection, but the company is deemed capable of addressing them voluntarily, so no formal regulatory action is required.

Elevar is currently finalizing the documents required to resubmit the New Drug Application (NDA) for liver cancer in collaboration with Jiangsu Hengrui Pharmaceuticals. Once preparations are complete, the company plans to resubmit the NDA to the FDA.

An HLB official stated, "This VAI classification is a result of Jiangsu Hengrui Pharmaceuticals mobilizing its entire organizational capabilities to actively address the findings from the inspection. Elevar will work closely with Jiangsu Hengrui Pharmaceuticals to expediently complete the preparations for the NDA resubmission for liver cancer, and thereafter, respond seamlessly to the subsequent FDA review."

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