HLB Says Key Reason for Liver Cancer Drug CRL Has Been Resolved

Rivoceranib Facility cGMP Inspection Concludes with 'VAI' Classification
FDA Letter States "Inspection Outcome Will Not Affect Ongoing Application Review"
HLB Initiates Swift Inquiry with FDA and Begins Talks to Resume Approval Process

On July 15, HLB announced that the general cGMP inspection for the active pharmaceutical ingredient (API) manufacturing facility, which had been cited as the reason for the U.S. approval hold (CRL) of the liver cancer treatment Rivoceranib, was ultimately classified as 'VAI' (Voluntary Action Indicated).

HLB company logo image. HLB

HLB's U.S. subsidiary, Elevar Therapeutics, reported on July 14 (local time) that it received a close-out letter from its partner Hansoh Pharma regarding the FDA's cGMP inspection of the Rivoceranib API manufacturing facility. The letter stated that the facility was found by the FDA to be largely compliant with current cGMP standards, and that the inspection result was classified as VAI.

According to HLB, the letter also explicitly said that "the VAI classification itself does not affect the FDA's evaluation of the currently pending application linked to this manufacturing facility."

Previously, the FDA indicated in the last CRL that the reason for holding the approval of the Rivoceranib·Camrelizumab combination therapy was the outcome of the general cGMP inspection at Hansoh Pharma’s Jinchao facility. This issue is distinct from the manufacturing process problem with Camrelizumab, which was the reason cited in the first and second CRLs. In order to confirm the FDA's position on the closure of this inspection, Elevar plans to quickly raise an official inquiry, separately from a formal Type A Meeting.

Meanwhile, it was reported that FDA Form 483 for the finished drug product (DP) manufacturing facility also included comments in a similar category to those for the API manufacturing facility. Hansoh Pharma plans to submit a response along with a Corrective and Preventive Action (CAPA) plan to the FDA by July 24 (local time).

An HLB official said, "Regarding the supplementary items requested in the last CRL related to Camrelizumab, the FDA has completed its review without any particular issues. Now that the cGMP inspection for Hansoh Pharma’s API manufacturing facility, which was cited as the reason in this CRL, has also been concluded with a VAI classification, we believe that many of the previously raised issues have been substantially resolved." They added, "We will work to swiftly consult with the FDA so the approval process can resume."

The Rivoceranib·Camrelizumab combination therapy has received a CRL for the third time this year, following CRLs in May 2024 and March 2025.

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