HLB's (KOSDAQ:028300) US subsidiary Elevar Therapeutics and partner Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) have resubmitted a New Drug Application and Biologics License Application to the US Food and Drug Administration for rivoceranib combined with camrelizumab as a liver cancer treatment.

The resubmission follows a Complete Response Letter issued by the FDA in July, which centered on manufacturing facility inspection observations.

The filing is supported by data from the global Phase 3 CARES-310 trial, showing a median overall survival of 23.8 months compared with 15.2 months for sorafenib, representing a 36% reduction in the risk of death, according to a joint statement on Monday.

The combination therapy has already been recognized in the 2025 Barcelona Liver Cancer Clinic treatment strategy and ESMO guidelines as a first-line treatment option.