康諾亞-B(02162.HK):司普奇拜單抗治療成人中重度特應性皮炎的藥品上市許可申請獲國家藥監局受理
格隆匯12月7日丨康諾亞-B(02162.HK)宣佈,司普奇拜單抗注射液(抗IL-4Rα單克隆抗體,研發代號:CM310)的上市申請,已於2023年12月7日獲國家藥品監督管理局("國家藥監局")受理,並已納入優先審評審批程序。現將相關情況公吿如下:
● 藥物名稱:司普奇拜單抗注射液
● 劑型:注射劑
● 申請事項:境內生產藥品註冊上市許可
● 註冊分類:治療用生物製品1類
● 申請人:成都康諾行生物醫藥科技有限公司(公司的全資附屬公司)
● 受理號:CXSS2300090
● 擬定適應症:用於治療外用藥控制不佳或不適合外用藥治療的成人中重度特應性皮炎
此次申報基於一項多中心、隨機、雙盲、安慰劑對照的 III 期研究(CM310AD005),以第16周時達到濕疹面積和嚴重程度指數較基線改善至少75%(EASI-75)及研究者整體評分法(IGA)評分達到0分或1分且較基線下降≥2分的達標率為共同主要終點。結果顯示,本試驗在第16周達到了共同主要終點,長期治療可獲得持續性臨牀獲益,安全性良好。
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