君實生物(01877.HK)向英國提交特瑞普利單抗上市許可申請
君實生物(01877.HK)宣布,已於近日向英國藥品和保健品管理局(MHRA),提交旗下抗PD-1單抗藥物特瑞普利單抗的上市許可申請,申報適應症包括用於局部復發或轉移性鼻咽癌(NPC)患者的一線治療,及用於不可切除局部晚期/復發或轉移性食管鱗癌(ESCC)患者的一線治療。
公司表示,今次是特瑞普利單抗在歐洲地區的第二項上市申請,產品全球商業化工作正在穩步推進,預期將體現出公司致力推動創新藥物造福全球患者的堅定決心以及高效的執行力,未來將與英國監管機構進行緊密合作,積極推動新興療法在當地的臨床開發與應用。(gc/k)
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