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Elevar Therapeutics (HLB)
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.