The FDA again rejected a liver cancer regimen combining Hengrui’s camrelizumab and Elevar Therapeutics’ rivoceranib, marking the third CRL for the program. The latest setback was attributed to issues identified from a drug-manufacturing facility inspection, according to the report. The review history now extends back across multiple submission cycles, with the program repeatedly blocked not by efficacy alone but by manufacturing-related deficiencies. The CRL implies continued work for site readiness, quality systems alignment, and inspection remediation before regulatory review can proceed. For oncology developers, the repeated manufacturing hurdle highlights how supply chain and CMC readiness can dominate timelines for combination regimens. It also raises pressure on partners to coordinate quality strategies early when moving investigational assets toward late-stage and global registration pathways.