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康方生物(09926.HK)自研治療宮頸癌新藥獲美國孤兒藥資格認定
阿思達克 02-23 08:21
康方生物(09926.HK)公布,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Cadonilimab(PD-1/CTLA-4雙特異性抗體,研發代號:AK104)獲得美國食品藥品監督管理局授予的孤兒藥資格認定,用於治療宮頸癌(除極早期IA1期之外)。

這是繼2020年,Cadonilimab治療經標準治療後的復發或轉移性宮頸癌獲得FDA授予快速審批通道資格(FTD)和中國國家藥品監督管理局授予「突破性治療藥物品種」後的又一重要進展。

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