The U.S. Food and Drug Administration (FDA) concluded its routine inspection of HLB’s manufacturing facility for the liver cancer treatment drug, rivoceranib, with a Voluntary Action Indicated (VAI) classification. This development has prompted HLB to accelerate its preparations for resubmitting its New Drug Application (NDA).
HLB announced on Tuesday that its U.S. subsidiary, Elevar Therapeutics, received confirmation from partner Jiangsu Hengrui Medicine that the FDA’s routine Current Good Manufacturing Practice (cGMP) inspection of the rivoceranib manufacturing facility had concluded with a VAI classification.
A VAI classification indicates that while the FDA identified some issues during the inspection, they determined these could be resolved through voluntary corrective actions. This classification is applied when no formal regulatory action is deemed necessary.
The recent inspection focused on the manufacturing facility for rivoceranib. Elevar is currently finalizing the NDA resubmission materials in collaboration with Jiangsu Hengrui Medicine for FDA submission.
HLB intends to resubmit the NDA to the FDA as soon as all necessary documentation is completed.
Previously, HLB had been seeking U.S. approval for the combination therapy of rivoceranib and camrelizumab as a first-line treatment for liver cancer. Last year, the FDA requested additional information due to manufacturing facility issues. The results of this recent inspection represent a crucial step in the NDA resubmission process.
An HLB spokesperson stated that Elevar will work closely with Jiangsu Hengrui Medicine to swiftly complete preparations for the liver cancer drug NDA resubmission. It’s committed to addressing any FDA review requirements without delay.
In related news, HLB Therapeutics is set to release global Phase 3 clinical trial results for its neurotrophic keratitis (NK) treatment, RGN-259, in November. The U.S. subsidiary, Regenerative Medicine, recently completed the final patient visit in the Phase 3 trial (SEER-2), conducted across 50 medical institutions in the U.S. and Europe. The company is currently processing data and conducting statistical analyses.
RGN-259 is an eye drop formulation primarily composed of the protein thymosin beta-4. The company plans to announce topline results in November. Positive efficacy and safety outcomes in these clinical trials could significantly enhance the potential for future technology transfers and commercialization opportunities.
