[Edaily Reporter KIM SAE-MI ] Following the inspection of the active pharmaceutical ingredient (API) manufacturing facility for HLB INC.(028300)’s new liver cancer drug, riboceranib, the U.S. Food and Drug Administration (FDA) inspection of the finished drug product (FDP) manufacturing facility has also concluded with a “Voluntary Action Recommendation” (VAI).

HLB INC. announced on the 6th that the FDA classified its routine Current Good Manufacturing Practice (cGMP) inspection of the Riboceranib finished product manufacturing facility as a VAI.

HLB INC.’s U.S. subsidiary, Eleva Therapeutics, received the FDA’s inspection closure Seohan from Hengrui Pharmaceuticals on the 3rd. This confirmed that the FDA inspection of the riboceranib finished product manufacturing facility had been finalized with a VAI classification.

A “VAI” classification is assigned when an FDA inspection identifies some non-compliance issues but does not require formal regulatory action; instead, it calls for voluntary corrective action by the company.

With the conclusion of this inspection, the manufacturing facility-related procedures for resubmitting the New Drug Application (NDA) for the combination therapy of riboceranib and camrelizumab as a first-line treatment for liver cancer have advanced a step further. However, the VAI classification itself does not guarantee NDA approval; the application must still undergo another round of review by the FDA after it is resubmitted.

Currently, Eleva and Hangzhou Pharmaceutical are finalizing the documentation required for the NDA resubmission. The company plans to resubmit the application to the FDA as soon as preparations are complete.

An HLB INC. official stated, “This VAI classification is the result of Hangzhou Pharmaceutical’s company-wide efforts to address the issues raised during the inspection,” adding, “We will work closely with Hangzhou Pharmaceutical to swiftly finalize preparations for the resubmission of the NDA for the new liver cancer drug and ensure a smooth response to the subsequent FDA review.”