君實生物(01877.HK)特瑞普利單抗聯合化療一線治療鼻咽癌獲美國突破性療法認定
君實生物(01877.HK)公布,公司產品特瑞普利單抗(商品名:拓益/產品代號:JS001)聯合吉西他濱╱順鉑作為晚期復發或轉移性鼻咽癌患者的一線治療獲得美國食品藥品監督管理局(FDA)突破性療法認定。
是次獲得的第二項突破性療法認定拓寬了FDA對特瑞普利單抗治療鼻咽癌適應症的認定範圍,將加快相關適應症在FDA的審批速度,公司預計將在今年第三季度內完成特瑞普利單抗聯合化療一線治療復發或轉移性鼻咽癌適應症,和特瑞普利單抗單藥二線及以上治療復發或轉移性鼻咽癌適應症的BLA提交。
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