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康諾亞-B(02162.HK):司普奇拜單抗注射液納入優先審評審批程序用於治療慢性鼻竇炎伴鼻息肉
格隆匯 05-23 16:32

格隆匯5月23日丨康諾亞-B(02162.HK)宣佈,近日,經國家藥品監督管理局藥品審評中心("藥審中心")審核,同意按優先審評範圍「(一)臨牀急需的短缺藥品、防治重大傳染病和罕見病等疾病的創新藥和改良型新藥」,將司普奇拜單抗注射液納入優先審評審批程序,用於治療慢性鼻竇炎伴鼻息肉。

據悉,司普奇拜單抗(研發代號CM310)是一種針對白介素4受體α亞基(IL-4Rα)的高效、人源化抗體,其為首個國產且獲得國家藥品監督管理局臨牀試驗申請批准的IL-4Rα抗體藥物。通過靶向IL-4Rα,司普奇拜單抗可雙重阻斷白介素4 (IL-4)及白介素13 (IL-13)的信號傳導。IL-4及IL-13為引發II型炎症的兩種關鍵細胞因子。司普奇拜單抗已在過往多項臨牀試驗中,顯示了良好的安全性及令人鼓舞的療效。截至公吿日期,司普奇拜單抗注射液治療成人中重度特應性皮炎以及季節性過敏性鼻炎的藥品上市許可申請已獲國家藥品監督管理局受理。

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