U.S. FDA Inspection Classified as VAI, Boosting HLB's Renewed Bid for Liver Cancer Drug Approval

[Financial News] HLB has eased the manufacturing-facility risk that had hindered approval of its liver cancer drug.
HLB said on the 6th that the U.S. Food and Drug Administration (FDA) classified its routine cGMP inspection of the finished-drug manufacturing facility for Rivoceranib as Voluntary Action Indicated (VAI).
Elevar Therapeutics, HLB's U.S. subsidiary, confirmed that the inspection had been finalized with a VAI classification after receiving an inspection closeout letter from its Chinese partner, Hengrui Pharmaceuticals, on the 3rd.
VAI is a classification issued when an FDA inspection identifies some observations but determines that the company can address them voluntarily, making separate formal regulatory action unnecessary.
Elevar is finalizing the materials required to resubmit the new drug application (NDA) for the liver cancer drug in cooperation with Hengrui Pharmaceuticals. It plans to resubmit the application to the FDA as soon as possible.
An HLB official said, "The VAI classification is the result of Hengrui Pharmaceuticals' active response and company-wide efforts to address the observations identified during the inspection. Elevar will work closely with Hengrui Pharmaceuticals to complete preparations for the NDA resubmission as soon as possible and respond to the subsequent FDA review without any setbacks."
 
[email protected] Reporter Jung Myung-jin