The FDA has rejected a liver cancer regimen from HLB and Hengrui for the third time, extending uncertainty over the rivoceranib plus camrelizumab program. The reported basis for the continued complete response is manufacturing deficiencies identified during a facility inspection. HLB’s Elevar Therapeutics subsidiary received the CRL following an amended submission, according to the company disclosure. HLB and partners have repeatedly adjusted applications, but this sequence highlights that CMC and inspection outcomes remain decisive even when clinical rationale stays intact. For sponsors of oncology combinations, the repeated rejection underscores how manufacturing quality systems and site readiness can dominate timelines—sometimes independent of the underlying therapeutic hypothesis.