HLB Resolves Key Reasons for Liver Cancer Drug CRL: "Concluded with Voluntary Action Indicated"

On the 15th, HLB announced that the general cGMP inspection of the manufacturing site of rivoceranib's active pharmaceutical ingredient (API), which was cited as the reason for the FDA's hold on the U.S. approval of its liver cancer treatment, has been officially classified as Voluntary Action Indicated (VAI).

HLB's U.S. subsidiary, Elevar Therapeutics, received the close-out letter for the completion of the FDA’s general cGMP inspection of the rivoceranib API manufacturing site from its partner, Jiangsu Hengrui Pharmaceuticals, the previous day.

The FDA determined that the facility is generally compliant with current Good Manufacturing Practice (cGMP) regulations for pharmaceuticals and ultimately classified the cGMP inspection result as VAI.

The letter specifies, "The VAI classification itself does not affect the FDA’s review of any ongoing applications linked to this manufacturing site."

The FDA had previously specified that the reason for the Complete Response Letter (CRL) for this liver cancer treatment was the outcome of the general cGMP inspection at the Jin Qiao site. To confirm the FDA's stance following the closure of the inspection with a VAI classification, Elevar plans to submit a formal inquiry through a faster process, separate from the upcoming Type A meeting. In addition, Form 483 remarks for the drug product (DP) manufacturing facility are also known to include observations similar in nature to those of the API manufacturing site. Jiangsu Hengrui Pharmaceuticals is scheduled to submit its response and Corrective and Preventive Action (CAPA) plan to the FDA by July 24 (U.S. time).

A company representative stated, "Regarding the matters related to camrelizumab that required supplementation in the previous CRL, the FDA has notified us that the review was completed without any particular issues." He added, "As the general cGMP inspection of Hengrui’s API manufacturing facility has also been concluded with a VAI classification, we believe that most of the key issues that were obstacles in the new drug approval process have now been resolved."

This content was produced with the assistance of AI translation services.