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康方生物-B(09926.HK):Cadonilimab(PD-1/CTLA-4雙特異性抗體)治療復發或轉移性宮頸癌獲CDE同意提交新藥上市申請並獲得優先審評資格A
格隆匯 08-23 18:53

格隆匯8月23日丨康方生物-B(09926.HK)宣佈,公司已經獲得中國國家藥品監督管理局("NMPA")藥品審評中心("CDE")同意,提交其自主研發的全球首創新型腫瘤免疫治療新藥Cadonilimab(PD-1/CTLA-4雙特異性抗體,研發代號:AK104)用於治療復發或轉移性宮頸癌的註冊性II期臨牀研究的新藥上市申請("NDA"),並且獲得優先審評資格。該臨牀研究已經達到主要終點,並獲得顯着的積極結果。Cadonilimab因此將有望成為第一個獲得批准上市的基於PD-1的雙特異性抗體藥物。

該註冊性II期臨牀研究數據分析顯示,Cadonilimab治療經含鉑化療失敗的復發或轉移性宮頸癌患者的療效顯着,且安全性良好。在目標適應症人羣中,Cadonilimab與已上市PD-1單抗的公開數據相比,顯示了更優療效的潛力。相關臨牀數據將在相關的醫學國際會議或醫學期刊上發表。

基於良好的臨牀數據,Cadonilimab用於經標準治療後的復發或轉移性宮頸癌的臨牀研究於2020年10月獲得CDE審核同意納入"突破性治療藥物品種"。另外,Cadonilimab的臨牀研究同樣獲得美國食品藥品監督管理局("FDA")的認可。Cadonilimab用於經含鉑化療治療失敗的復發或轉移性宮頸癌於2020年7月獲得FDA授予快速審批通道資格,並於2021年2月獲得FDA授予Cadonilimab治療宮頸癌的孤兒藥資格。Cadonilimab聯合化療一線治療晚期宮頸癌的III期臨牀研究亦已於2021年7月啟動。

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