港股異動 | 康方生物-B一度升超6%,治療晚期宮頸癌新藥獲美國授快速審批通道資格
uSMART友信智投8月13日消息,週四港股,康方生物-B高開高走,截至9:52分,康方生物-B最高觸及29.2港元,升幅高達6.44%。
消息面上,康方生物-B今日早間發佈公告,公司核心自主研發的、全球首創的新型腫瘤免疫治療雙特異性抗體新藥PD-1/CTLA-4(AK104)治療晚期宮頸癌已經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)。這是繼2020年4月AK104單藥針對二線治療復發或轉移性宮頸癌的臨床研究獲得FDA的批准開展註冊性臨床研究後的又一重大進展。
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。有快速審批通道資格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(NDA)的滾動評審,加快相關藥物的開發及上市進程。
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