康方生物-B(09926.HK)：Cadonilimab獲批開展一線治療晚期宮頸癌全球III期臨牀研究
格隆匯 4 月 28日丨康方生物-B(09926.HK)發佈公吿，中國國家藥品監督管理局藥品審評中心(“CDE”)同意開啟評價公司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)加含鉑化療聯合╱不聯合貝伐珠單抗，用於一線治療持續、復發或轉移性宮頸癌的隨機、雙盲、安慰劑對照的全球性III期臨牀研究。這是中國首個一線宮頸癌雙免疫療法的III期臨牀研究。
近日，公司成功舉辦了該全球性III期臨牀研究的專家研討會，來自包括中國、美國、歐洲和澳大利亞等全球知名婦科腫瘤研究機構的眾多專家學者出席。研討會回顧了中國、美國、歐洲和澳大利亞治療宮頸癌的現狀，總結了 Cadonilimab在前期多個腫瘤適應症臨牀研究的成果，並就Cadonilimab開展全球性III期臨牀試驗的框架方案進行了詳細討論。
啟動Cadonilimab治療宮頸癌III期的臨牀研究，彰顯了公司高效的臨牀運營效率。Cadonilimab在前期開展的宮頸癌臨牀研究中已經顯示出優越的臨牀療效，公司在此基礎上進一步開展全球性的III期臨牀研究用於一線治療宮頸癌，這將有助於公司在全球範圍幫助更多的宮頸癌患者。公司認為Cadonilimab將有望成為全球首款獲批上市的PD-1/CTLA-4雙特異性抗體新藥。
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美國食品藥品監督管理局(FDA)授予快速審批通道資格。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“突破性治療品種”名單。2021年1月，Cadonilimab完成了中國治療復發或轉移性宮頸癌的註冊性II期臨牀試驗患者入組。
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