COF - China Oncology Focus says socazolimab wins NMPA's breakthrough therapy status

China Oncology Focus Limited (COF) announces that anti-PD-L1 antibody, socazolimab, licensed from Sorrento Therapeutics (SRNE) for the greater China territory, has been granted breakthrough therapy designation ((BTD)) by the China National Medical Products Administration ((NMPA)) to treat recurrent or metastatic cervical cancer.Products with BTD from the NMPA may be considered for conditional approval and priority review when submitting a new drug application.Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB library platform.China Oncology's affiliate Lee’s Pharma plans to file new drug application in China in Q2 2021 for the drug, the company said.

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China Oncology Focus says socazolimab wins NMPA's breakthrough therapy status