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君實生物(01877.HK):特瑞普利單抗獲得歐盟委員會批准上市

格隆匯9月23日丨君實生物(01877.HK)公吿,近日,公司產品特瑞普利單抗(歐洲商品名:LOQTORZI)獲得歐盟委員會(EC)批准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。此項批准適用於歐盟全部27個成員國以及冰島、挪威和列支敦士登,特瑞普利單抗成為歐洲首個且唯一用於鼻咽癌治療的藥物,也是歐洲唯一用於不限 PD-L1 表達的晚期或轉移性食管鱗癌一線治療藥物。

鼻咽癌是一種發生於鼻咽部上皮的惡性腫瘤,是常見的頭頸部惡性腫瘤之一。根據 GLOBOCAN 2022 發佈的數據顯示,2022 年鼻咽癌在全球範圍內確診的新發病例數超過 12 萬。由於原發腫瘤位置的原因,很少採用手術治療。歐洲腫瘤內科學會(以下簡稱“ESMO”)指南推薦免疫治療聯合化療用於復發或轉移性鼻咽癌的一線治療。

本次獲批適用於歐盟全部 27 個成員國以及冰島、挪威和列支敦士登,特瑞普利單抗成為歐洲首個且唯一用於鼻咽癌治療的藥物,也是歐洲唯一用於不限PD-L1 表達的晚期或轉移性食管鱗癌一線治療藥物。歐洲市場是公司海外商業化戰略的重要構成部分,本次獲批有利於公司進一步推進海外市場的拓展,提升公司產品的國際影響力,有望對公司長期經營業績產生積極影響。

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