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中生製藥(01177.HK):“派安普利”三線治療轉移性鼻咽癌獲FDA快速審批通道資格
格隆匯 10-27 12:22

格隆匯10月27日丨中國生物製藥(01177.HK)宣佈,由集團與康方生物-B(09926.HK)共同開發及商業化的抗PD-1單抗藥物“派安普利”(商品名:安尼可;研發代號:AK105)用於三線治療轉移性鼻咽癌,獲得美國食品藥品監督管理局(“FDA”)授予快速審批通道資格(“FTD”)。此次成功獲FDA授予三治療轉移性鼻咽癌FTD,將顯著的支持並加速派安普利單抗在美國的商業拓展計劃。

FDA的快速審批通道旨在加速或促進用於治療當前並無有效治療方案的嚴重或危及生命的疾病或病情、且展示出有滿足這一疾病當前未被滿足的醫療需求潛力的新藥的評審過程。具FTD的候選藥物有資格與FDA進行更頻繁的溝通、參與優先評審(如果符合相關標準)及參與新藥申請的滾動評審。這將加快相關藥物的開發及上市進程。

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