HLB第四次向FDA重新申报肝癌联合疗法（rivoceranib+camrelizumab），工厂核查以VAI关闭但仍待第四次审评

HLB Refiles for FDA Approval of Liver Cancer Drug on Fourth Attempt - Seoul Economic Daily
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HLB corporate identity. Photo courtesy of HLB
HLB (028300) has again applied for U.S. Food and Drug Administration approval of its combination therapy of rivoceranib and camrelizumab for liver cancer. After three rejections delayed the launch, the company has wrapped up inspections of its manufacturing facilities and is making a fourth bid for approval.
HLB said on the 12th that its U.S. subsidiary Elevar Therapeutics and Chinese partner Hengrui Pharmaceuticals submitted applications (NDA and BLA) to the FDA on the 9th, local time, seeking approval of the rivoceranib-camrelizumab combination as a first-line treatment for liver cancer. The two companies consulted with the FDA on a complete response letter received in July this year and completed the refiling in about three months after addressing the issues raised.
The combination therapy had previously received three complete response letters, in May 2024, March 2025 and July this year. A complete response letter is issued when the FDA determines during its review that additional information or corrections are needed, requiring the applicant to address the cited deficiencies and reapply. The most recent letter stemmed from issues at Hengrui's drug substance manufacturing facility.
Inspections of the drug substance and finished product manufacturing facilities have since been closed out in sequence, which, according to observers, has reduced manufacturing-related uncertainty. In July this year, the FDA classified its inspection of the rivoceranib drug substance facility as Voluntary Action Indicated, or VAI. Elevar also received a letter from Hengrui on the 3rd of this month stating that the inspection of the finished product facility had been closed out as VAI. A VAI classification means that while improvements are needed, the agency considers them issues the company can correct voluntarily and recommends no formal regulatory action.
The application is based on results from the global Phase 3 trial CARES-310. In the final analysis, patients with unresectable or metastatic liver cancer who received the rivoceranib-camrelizumab combination had a median overall survival of 23.8 months, longer than the 15.2 months in the control group treated with sorafenib. The risk of death was 36% lower than in the control group, and consistent treatment effects were confirmed across various patient subgroups.
"Unresectable liver cancer remains an area of high unmet medical need," said Kim Dong-gun, CEO of Elevar Therapeutics. "Now that the manufacturing facility inspections have been completed, we will work closely with the FDA to ensure this review is successfully concluded, based on the clinical value confirmed in the global Phase 3 trial."
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Original reporting by
Lee Yeon-soo
for Seoul Economic Daily.
AI-translated from Korean. Quotes from foreign sources are based on Korean-language reports and may not reflect exact original wording.
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