HLB (028300) is accelerating preparations to seek U.S. Food and Drug Administration approval for its liver cancer drug rivoceranib after a second manufacturing site cleared a key regulatory review. With both the active pharmaceutical ingredient plant and the finished-drug plant classified as "Voluntary Action Indicated" (VAI) in the FDA's routine current good manufacturing practice (cGMP) inspections, uncertainty over the manufacturing facilities that triggered a third Complete Response Letter (CRL) has eased considerably, according to the company.
HLB said on the 6th that its U.S. subsidiary Elevar Therapeutics received an establishment inspection report from partner China's Hengrui Pharmaceuticals on the 3rd of this month regarding the FDA's inspection of the finished-drug manufacturing site for rivoceranib. The FDA gave the facility a final VAI classification following its routine cGMP inspection.
A VAI classification is issued when the FDA identifies issues requiring improvement during an inspection but judges them to be matters the company can correct on its own, without recommending separate administrative or regulatory action. The agency classifies inspection outcomes as No Action Indicated (NAI), VAI, or Official Action Indicated (OAI). A VAI classification does not itself constitute product approval, but unlike OAI, it means the agency did not deem the manufacturing site to be in a state requiring regulatory action.
Rivoceranib is an oral targeted cancer therapy that selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR2), blocking the formation of blood vessels that feed tumors. Elevar is seeking approval for the drug as a first-line treatment for hepatocellular carcinoma in combination with Hengrui's immunotherapy camrelizumab. The approval process has been set back, however, by three CRLs — two received between May 2024 and March 2025, and a third in July 2026 — disrupting the drug's launch timeline. The most recent CRL stemmed from problems at Hengrui's active pharmaceutical ingredient manufacturing site.
HLB says it is resolving the manufacturing-related issues in sequence. The FDA closed out its routine cGMP inspection of the rivoceranib active ingredient plant with a VAI classification in July of this year. The establishment inspection report at the time also stated that the VAI classification itself would not affect the evaluation of approval applications linked to that facility, according to the company. With the finished-drug plant now also classified as VAI, both manufacturing sites have moved beyond the stage requiring formal regulatory action.
Elevar, together with Hengrui, is finalizing the materials needed to resubmit the new drug application (NDA) for the liver cancer treatment and plans to file with the FDA again as quickly as possible.
An HLB official said the VAI classification reflects Hengrui's concentration of company-wide resources on actively addressing the issues raised during the inspection. "Elevar will work closely with Hengrui to promptly complete preparations for resubmitting the liver cancer NDA and will respond to the subsequent FDA review without disruption," the official said.
