基石藥業-B(02616.HK):EMA及MHRA就舒格利單抗上市申請正進行審評工作
基石藥業-B(02616.HK)表示,今日(20日)舉辦近期業務進展交流會,並指出舒格利單抗在歐盟和美國等主要海外市場上市申請審批進展順利,歐洲藥品管理局(EMA)和英國藥品和醫療保健用品管理局(MHRA)就就舒格利單抗用於一線治療轉移性NSCLC的上市許可申請的審評工作正在進行中,同時EMA已完成了對一個臨床中心的核查工作,剩餘的GCP核查工作預計將於明年2月初完成。
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