HLB announced Wednesday that the U.S. Food and Drug Administration (FDA) inspection of the Rivoceranib manufacturing facility has concluded with a Voluntary Action Indicated (VAI) classification. Rivoceranib, the active ingredient in a new liver cancer drug, was previously cited as the reason for the FDA’s delayed approval.
Elevar Therapeutics, HLB’s U.S. subsidiary, received confirmation from its partner Jiangsu Hengrui that the FDA had completed its Good Manufacturing Practice (GMP) inspection of the Rivoceranib facility.
The FDA determined that the facility generally complies with pharmaceutical manufacturing and quality control standards (GMP), resulting in the VAI classification.
The Close-out Letter noted that this classification does not impact the FDA’s evaluation of ongoing applications related to this facility.
Previously, the FDA cited the GMP inspection results at Jiangsu Hengrui’s Jinqiao facility as grounds for issuing a Complete Response Letter (CRL) for the liver cancer drug.
In response to the VAI classification, Elevate plans to initiate an expedited formal inquiry and a Type A meeting to clarify the FDA’s position.
Jiangsu Hengrui is set to submit a response and corrective action plan to the FDA by July 24 regarding Form 483 issued for the finished product manufacturing facility.
An HLB spokesperson stated that the FDA has concluded its review of previously raised issues regarding camrelizumab without significant concerns. With the GMP inspection of the active ingredient facility also receiving a VAI classification, HLB believes most key issues in the drug approval process have been resolved.
The spokesperson added that with the CRL issues largely addressed, HLB will work diligently to re-engage with the FDA to resume the approval process.
Meanwhile, HLB Group has several late-stage clinical results slated for release in the second half of the year.
HLB Therapeutics’ U.S. subsidiary Regeneron plans to unveil global Phase 3 (SEER-2) topline results for RGN-259, a treatment for neurotrophic keratitis.
HLB Innovation’s U.S. subsidiary Verismo Therapeutics intends to release interim results from the Phase 1 trial of SynKIR-310, a CAR-T therapy for blood cancer, later this year.