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康方生物-B(09926.HK):AK104治療復發或轉移性宮頸鱗癌獲准納入“突破性治療藥物品種”
格隆匯 10-12 08:21

格隆匯 10 月 12日丨康方生物-B(09926.HK)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(研發代號:AK104)用於治療復發或轉移性宮頸鱗癌,獲得國家藥品監督管理局(“NMPA”)藥品審評中心(“CDE”)審核同意,納入“突破性治療藥物品種”,並在CDE官網公示。

為鼓勵研究和創制具有明顯臨牀優勢的藥物,CDE發佈了《突破性治療藥物審評工作程序(試行)》文件。對納入突破性治療藥物程序的藥物,CDE將優先配置資源進行溝通交流,並加強指導並促進藥物研發。另外,經評估符合相關條件的藥物,也可以在申請藥品上市許可時,提出附條件批准申請和優先審評審批申請。公司相信相關程序將有助於AK104加速藥物研發和產品上市。

目前,AK104正在澳大利亞、新西蘭、美國開展二線╱三線治療復發或轉移性宮頸癌的單臂註冊性臨牀試驗。於2020年8月,AK104治療晚期宮頸癌的臨牀試驗獲得美國食品藥品監督管理局(FTD)授予快速審批通道資格(FTD)。AK104的主要適應症還包括肝癌、胃癌、肺癌、食管鱗癌及鼻咽癌等。

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