康諾亞-B(02162.HK)皮炎藥上市許可申請獲國家藥監局受理
康諾亞-B(02162.HK)公布,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,已於今日(7日)國家藥品監督管理局受理,並已納入優先審評審批程序。
該藥物擬定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)。結果顯示,有關試驗在第16周達到共同主要終點,長期治療可獲得持續性臨床獲益,安全性良好。
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