君實生物(688180.SH):特瑞普利單抗獲得FDA批准上市
格隆匯10月29日丨君實生物(688180.SH)公佈,公司的合作伙伴 Coherus BioSciences,
Inc.(稱“Coherus”)收到美國食品藥品監督管理局(稱“FDA”)的通知,特瑞普利單抗(美國商品名:LOQTORZI™)聯合順鉑/吉西他濱作為轉移性或複發性局部晚期鼻咽癌成人患者的一線治療,以及作為單藥治療既往含鉑治療過程中或治療後疾病進展的複發性、不可切除或轉移性鼻咽癌的成人患者的生物製品許可申請(Biologics
License Application,稱“BLA”)已獲得批准,特瑞普利單抗成為美國首款且唯一獲批用於鼻咽癌治療的藥物,也是FDA批准上市的首箇中國自主研發和生產的創新生物藥。
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