康方生物-B(09926.HK)：凱得寧治療復發或轉移性宮頸癌新藥上市申請獲NMPA受理
格隆匯9月24日丨康方生物-B(09926.HK)發佈公吿，中國國家藥品監督管理局(“NMPA”)已經正式受理全球首創的凱得寧(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新藥上市申請，並獲得優先審評。凱得寧由公司自主研發併產業化，是全球首個提交新藥上市申請的基於PD-1的雙特異性抗體藥物。凱得寧是公司第二款提交新藥上市申請的自主研發的創新抗體藥物，亦是公司在中國和美國提交的第五個新藥上市申請。
臨牀研究數據顯示，凱得寧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著，且安全性良好。在目標適應症人羣中，凱得寧與已上市PD-1單抗公開數據相比，顯示了更優療效。相關臨牀數據將在有關國際會議及期刊上發表。
全球範圍內，雖然有治療宮頸癌適應症的PD-1單抗獲批上市，但臨牀研究結果顯示其僅在二線以上的PD-L1陽性患者中取得不超過15%的客觀緩解率。凱得寧在註冊性II期臨牀中表現出來的單藥有效性和安全性數據令人鼓舞，不僅在PD-L1陽性人羣中獲得較高的響應率，在PD-L1陰性人羣中也看到了不俗的效果，中位無進展生存期也有顯著提升，為中國晚期宮頸癌患者帶來更好的治療手段。2030年是《加速消除宮頸癌全球戰略》和《健康中國2030》綱要的共同關鍵節點，公司相信凱得寧將作為中國首個自主研發的雙特異性抗體產品，能助力宮頸癌全球和中國健康戰略的順利實現。
子宮頸癌是中國發病率最高的婦科惡性腫瘤，晚期轉移復發患者常規治療難以治癒，是婦科腫瘤醫生面臨的最大挑戰之一，存在重大臨牀需求。免疫檢查點抑制劑單藥治療臨牀療效不盡滿意，聯合應用雖然有望提高療效但毒副作用嚴重，大大限制了其臨牀應用。凱得寧經臨牀試驗證明對晚期轉移復發常規治療失敗的子宮頸癌患者有效率高、毒副反應低、安全可控、已進入快速審批程序。
公司將充分發揮在雙特異性抗體領域的先導優勢，加速推進凱得寧在其他適應症的臨牀研究。公司期待凱得寧在腫瘤雙免疫抗體治療的優勢能做福更多的腫瘤患者。
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