China's Hengrui Pharmaceuticals has received a Complete Response Letter (CRL) from US regulator the Food and Drug Administration (FDA) regarding the Biologics Licence Application (BLA) for the combination of camrelizumab (a PD-1 inhibitor) plus rivoceranib (a VEGFR-2 TKI) for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).

The CRL did not cite deficiencies in the clinical efficacy or safety data, which were derived from the positive Phase III CARES-310 trial (median OS 23.8 months). Instead, the feedback relates to observations from a current Good Manufacturing Practice (cGMP) inspection of the rivoceranib manufacturing site conducted in April 2026. That same site passed an EU inspection in 2025.

Hengrui is working closely with the FDA and its US partner, Elevar Therapeutics, to address the observations and define the path forward. The combination is already approved in China (January 2023) and is recommended in the National Health Commission, CSCO, ESMO and BCLC guidelines for first-line advanced HCC.