君实生物全资子公司特瑞普利单抗获英国上市批准

财中社
17 Nov 2024

  财中社11月17日电君实生物(688180/01877)发布自愿披露公告,宣布其全资子公司TopAlliance Biosciences Inc.的特瑞普利单抗(英国商品名:LOQTORZI®)已获得英国药品和保健品管理局(MHRA)批准上市。该药物用于治疗两项适应症,包括联合顺铂和吉西他滨用于复发、不能手术或放疗的转移性鼻咽癌患者的一线治疗,以及联合顺铂和紫杉醇用于不可切除的晚期/复发性食管鳞癌患者的一线治疗。特瑞普利单抗成为英国首个且唯一用于鼻咽癌治疗的药物。

  此次获批基于JUPITER-02和JUPITER-06两项重要临床研究的结果,前者显示特瑞普利单抗联合化疗使患者的疾病进展风险降低48%,死亡风险降低37%;而后者则表明其可显著延长晚期食管鳞癌患者的中位生存期6个月,达到17个月。该药物的上市将有助于公司在海外市场的拓展,提升国际影响力,并对公司的长期经营业绩产生积极影响。

  2024年前三季度,君实生物-U实现收入12.71亿元,归母净利润-9.27亿元。

(文章来源:财中社)

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