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君实生物(01877):特瑞普利单抗获得欧洲药品管理局人用药品委员会积极意见

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君实生物(01877)发布公告,特瑞普利单抗(欧洲商品名: LOQTORZI®)的上市许可申请获得欧洲药品管理局人用药品委员会的积极意见,建议批准其用于治疗两项适应症:特瑞普利单抗联合顺铂和吉西他滨用于复发、不能手术或放疗的,或转移性鼻咽癌成人患者的一线治疗,以及特瑞普利单抗联合顺铂和紫杉醇用于不可切除的晚期╱复发或转移性食管鳞癌成人患者的一线治疗。欧盟委员会将把CHMP的积极意见纳入考虑,以便对特瑞普利单抗的上市许可申请做出最终审评决议。

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