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