君實生物(01877.HK):特瑞普利單抗注射液相關生產設施首次通過歐盟成員國GMP認證
格隆匯7月10日丨君實生物(01877.HK)公吿,近日,公司全資子公司蘇州眾合生物醫藥科技有限公司收到愛爾蘭健康產品監督管理局(The IrelandHealth Products Regulatory Authority)依據歐洲藥品管理局(European MedicinesAgency,以下簡稱“EMA”)相關法規頒發的《CERTIFICATE OF GMPCOMPLIANCE OF A MANUFACTURER》(《藥品GMP證書》)。認證產線:原液車間1、製劑車間1。
本次系公司核心產品特瑞普利單抗注射液的相關生產設施首次通過歐盟成員國GMP認證。根據歐盟成員國之間的GMP互認制度,本次通過GMP認證表明本次接受認證的生產設施已符合歐盟GMP標準。
特瑞普利單抗注射液聯合順鉑和吉西他濱用於局部復發或轉移性鼻咽癌患者的一線治療、特瑞普利單抗聯合紫杉醇和順鉑用於不可切除局部晚期/復發或轉移性食管鱗癌患者的一線治療的上市許可申請(MAA)已獲得EMA受理,根據當地法規要求,特瑞普利單抗注射液於歐盟上市前尚需獲得歐盟上市許可申請批准。
歐盟市場是公司海外商業化戰略的重要構成部分,本次通過GMP認證,有利於公司進一步推進海外市場的拓展,提高公司的市場競爭力,未來將對公司經營產生積極影響。
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