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科倫藥業(002422.SZ):創新藥物SKB378/HBM9378注射液獲批臨牀

格隆匯2月21日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司與和鉑醫藥-B(02142.HK)共同開發的SKB378/HBM9378注射液獲得國家藥品監督管理局(NMPA)臨牀試驗通知書。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年12月13日受理的HBM9378(SKB378)注射液符合藥品註冊的有關要求,同意該藥品開展中重度哮喘適應症的臨牀試驗。

截至目前,全球範圍內同靶點單克隆抗體研發進度最領先的為阿斯利康/安進的Tezepelumab,該單抗於2021年12月17日在美國獲批上市,在中國正在進行III期臨牀試驗。國內康諾亞、恆瑞等創新藥企均在該靶點有佈局,目前尚無同類產品在中國境內獲批上市。

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