康方生物(09926.HK):國家藥監局受理開坦尼®(卡度尼利,PD-1/CTLA-4)用於一線治療宮頸癌的新適應症上市申請
格隆匯4月24日丨康方生物(09926.HK)發佈公吿,國家藥品監督管理局(“NMPA”)已於近期正式受理由公司自主研發的全球首創雙特異性抗體開坦尼®(卡度尼利,PD-1/CTLA-4)聯合含鉑化療聯合或不聯合貝伐珠單抗一線治療持續、復發或轉移性宮頸癌的新適應症上市申請(“sNDA”)。
開坦尼®已於2022年6月獲得NMPA批准用於治療既往接受過含鉑化療治療失敗的復發或轉移性二/三線宮頸癌患者。本次sNDA是基於AK104–303研究,該研究顯示,開坦尼®對於全人羣(無論PD-L1表達水平)患者均獲益顯著。本次sNDA意味着開坦尼®將推進至宮頸癌一線治療領域,為晚期宮頸癌全人羣患者帶來廣泛的獲益。
這是開坦尼®第三個適應症的上市申請。於2024年1月,開坦尼®聯合化療用於一線治療胃或胃食管結合部(G/GEJ)腺癌的sNDA獲得NMPA受理,將為胃癌全人羣患者(無論PD-L1表達水平)帶來更優效安全的治療選擇。
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