The U.S. Food and Drug Administration has accepted for substantive review resubmitted applications for HLB’s rivoceranib-camrelizumab combination as a first-line treatment for advanced hepatocellular carcinoma, setting an April 9, 2027, Prescription Drug User Fee Act target date. Elevar Therapeutics, HLB’s California-based drug development arm, resubmitted the New Drug Application for rivoceranib, while Hengrui Pharma resubmitted camrelizumab’s Biologics License Application; the FDA will review both applications together. The Class 2 designation generally entails a six-month review and follows three previous Complete Response Letters, later than Chairman Jin Yang-gon’s earlier expectation of a decision before the end of 2026. The filing is supported by the Phase 3 CARES-310 trial, which showed median overall survival of 23.8 months versus 15.2 months with sorafenib in patients with unresectable or metastatic hepatocellular carcinoma. The hazard ratio for overall survival was 0.64, with a 95% confidence interval of 0.52 to 0.79 and a P value below 0.0001. The trial’s final results were published in The Lancet Oncology in December 2025, and the combination appeared in 2025 Barcelona Clinic Liver Cancer and European Society for Medical Oncology recommendations. HLB shares fell 19.9% to 32,600 won on KOSDAQ after the Class 2 designation, while affiliates HLB bioStep, HLB Pharma and HLB Life Science also declined. If approved, the therapy could become HLB’s second FDA-approved cancer drug after LYRFIGTU, which was approved in September 2026 for certain previously treated cholangiocarcinoma patients.