康方生物-B(09926.HK):派安普利單抗(PD-1)三線治療轉移性鼻咽癌獲FDA授予快速審批通道資格
格隆匯10月27日丨康方生物-B(09926.HK)發佈公告,公司與中國生物製藥有限公司(01177.HK)共同開發的PD-1單抗藥物派安普利單抗(安尼可)(研發代號:AK105)治療三線轉移性鼻咽癌,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”)。派安普利單抗三線治療轉移性鼻咽癌獲FDA授予FTD能夠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的快速審批通道專案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。有FTD的候選藥物可有資格與FDA進行更頻繁的溝通、優先評審(如果符合相關標準)及新藥申請的滾動評審,加快相關藥物的開發及上市進程。公司將會與FDA密切協作,保證藥品開發計劃高效實施。
2020年9月,派安普利單抗用於三線治療轉移性鼻咽癌註冊性臨牀試驗達到了由獨立影像評估的客觀緩解率(ORR)主要終點。派安普利單抗在既往經過多線治療後的鼻咽癌患者中,展示了良好的臨牀療效和安全性。公司擬於近期向中國國家藥品監督管理局(“NMPA”)進行新藥上市申請前溝通。
2020年5月,派安普利單抗用於治療至少經過二線系統化療復發或難治性(r/r)經典型霍奇金淋巴瘤(r/rcHL)的新藥上市申請已經獲得NMPA受理。目前派安普利單抗的主要適應症包括肝癌、胃癌、肺癌、霍奇金淋巴瘤、鼻咽癌等疾病。
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