Elevar Therapeutics developed rivoceranib, whose combination with camrelizumab has beaten sorafenib in liver cancer but has been refused by the FDA three times on manufacturing grounds.
Elevar Therapeutics is a subsidiary of Korea's HLB. CARES-310 showed median OS 23.8 vs 15.2 months versus sorafenib. The FDA issued complete response letters in 2024, 2025 and again at the 23 July 2026 PDUFA date, each citing cGMP inspection findings at the partner manufacturing site rather than efficacy or safety.
A Chinese immunotherapy-plus-anti-angiogenic pill combination that clearly beat sorafenib in liver cancer, yet remains unapproved in the US after three manufacturing-related rejections.
An oral FGFR2 inhibitor approved in September 2026 for bile duct cancer whose tumour carries an FGFR2 fusion or rearrangement, after earlier treatment.
Shares Camrelizumab + rivoceranib, Hepatocellular carcinoma.
Shares Camrelizumab + rivoceranib, Hepatocellular carcinoma.
Shares Camrelizumab + rivoceranib, Hepatocellular carcinoma.