康方生物(09926.HK)卡度尼利治療宮頸癌聯合療法申請獲批
康方生物(09926.HK)宣布,國家藥監局已正式批准開坦尼(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,為卡度尼利的第三項全人群獲批的適應症。
公司預期,今次適應症獲批將填補國內一線宮頸癌患者中免疫治療的空白。開坦尼是康方生物自主研發的全球首創PD-1/CTLA-4雙特異性腫瘤免疫治療藥物,已於2022年6月獲得國家藥監局批准上市,成為全球首個獲批的PD-1/CTLA-4雙特異性抗體。
目前康方生物正在通過卡度尼利聯合療法開展覆蓋約20項適應症的超過28個臨床試驗,包括胃癌、肝癌、肺癌等。
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