康方生物-B(09926.HK):新型腫瘤免疫治療新藥Cadonilimab在中國治療復發或轉移性宮頸癌的註冊性II期臨試提前完成患者篩選入組
格隆匯 12 月 2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新藥Cadonilimab(PD-1/CTLA-4雙特異性抗體,研發代號:AK104)在中國用於經標準治療後復發或轉移性宮頸癌的註冊性II期臨牀試驗完成患者篩選入組。公司後續將根據主要終點分析結果與中國國家藥品監督管理局藥品審評中心(“CDE”)進行新藥上市申請前(Pre-NDA)溝通。如後續程序進展順利,Cadonilimab將有望成為全球首款獲批上市的基於PD-1的雙特異性抗體新藥。
Cadonilimab用於經標準治療後的復發或轉移性宮頸癌的註冊性II期臨牀試驗於2020年3月在中國啟動。於2020年4月,Cadonilimab的用於經標準治療後的復發或轉移性宮頸癌的註冊性II期臨牀試驗獲得美國食品藥品監督管理局(“FDA”)批准啟動,目前該臨牀試驗的入組工作同時推進中。
基於良好的臨牀數據,2020年8月,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)。2020年10月,Cadonilimab用於經標準治療後的復發或轉移性宮頸癌獲得CDE審核同意,納入“突破性治療藥物品種”。
目前,Cadonilimab也同步正在澳大利亞及紐西蘭開展治療復發或轉移性宮頸癌的註冊性臨牀試驗。Cadonilimab佈局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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