君實生物(688180.SH):特瑞普利單抗獲得歐洲藥品管理局人用藥品委員會積極意見
格隆匯7月28日丨君實生物(688180.SH)公佈,公司產品特瑞普利單抗(歐洲商品名:LOQTORZI®)的上市許可申請獲得歐洲藥品管理局(簡稱“EMA”)人用藥品委員會(簡稱“CHMP”)的積極意見,建議批准其用於治療兩項適應症:特瑞普利單抗聯合順鉑和吉西他濱用於復發、不能手術或放療的,或轉移性鼻咽癌成人患者的一線治療,以及特瑞普利單抗聯合順鉑和紫杉醇用於不可切除的晚期/復發或轉移性食管鱗癌成人患者的一線治療。歐盟委員會(簡稱“EC”)將把
CHMP 的積極意見納入考慮,以便對特瑞普利單抗的上市許可申請做出最終審評決議,本次上市許可申請能否獲得批准存在不確定性。
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