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  • FDA approval delayed and retry¡¦what¡¯s 'Rivoceranib'?
  • by Son, Hyung-Min | translator Kang, Shin-Kook | May 21, 2024 05:56am
HLB received a CRL request for Rivoceranib plus camrelizumab
Acquired rivoceranib from Bukwang Pharm in 2018¡¦effective in treatments for liver cancer and stomach cancer
It has shown significant improvements in survival period¡¦"Due to Jiangsu Hengrui Pharmaceuticals¡¯ monitoring issue...we will cooperate and retry to get approval"
HLB¡¯s rivoceranib, which was expected to be an FDA-approved new drug candidate, failed to receive final approval.

Although HLB confirmed that Rivoceranib combined with immunotherapy camrelizumab extended overall survival in the first-line treatment for liver cancer, they received request for supplementary documents. The current request for supplementation is not related to the drug¡¯s effectiveness but rather to an issue concerning the monitoring of Jiangsu Hengrui Pharmaceuticals¡¯ Chemistry, Manufacturing and Controls (CMC) process. Therefore, HLB plans to cooperate and reapply for approval soon.

HLB announced on the 17th that they received a complete response letter (CRL) request from the US FDA regarding t
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