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康方生物(09926.HK):安尼可®(派安普利,PD-1)獲美國FDA批準,兩項適應症用於治療晚期鼻咽癌

格隆匯4月25日丨康方生物(09926.HK)發佈公告,安尼®(派安普利,PD-1)已獲得美國食品藥品監督管理局(FDA)批準上市,用於治療復發或轉移性鼻咽癌的一線治療和以鉑類爲基礎的至少一線化療治療失敗後治療的2項適應症。派安普利由公司自主研發並由正大天晴康方負責後續開發和商業化,也是公司第一個獲得美國FDA批準上市的自主研發創新生物藥。

目前,派安普利用於晚期鼻咽癌一線和二線後線治療的2項適應症也已在中國獲得批準。主要基於國際多中心III期臨牀研究AK105-304(NCT04974398)和關鍵註冊性研究AK105-202(NCT03866967),FDA批準了派安普利2項適應症的生物製品許可申請(BLA)。

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