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華海藥業(600521.SH):銀屑病治療抗體獲新藥臨牀試驗許可
格隆匯 03-05 17:14

格隆匯3月5日丨華海藥業(600521.SH)公佈,近日,公司的下屬子公司華博生物醫藥技術(上海)有限公司(以下簡稱“華博生物”)收到美國食品藥品監督管理局(以下簡稱“美國FDA”)的通知,華博生物向美國FDA申報的HB0017項目的Investigational New Drug Application(IND)(即研究性新藥)獲得臨牀試驗批准。

HB0017是一種以白介素-17(IL-17)為靶點的單克隆抗體,擬用於治療銀屑病、銀屑病關節炎和強制性脊柱炎。IL-17是一種重要的促炎症因子,在包括銀屑病、銀屑病關節炎和強制性脊柱炎在內的多種自身免疫疾病的病理進程中發揮重要作用,是此類疾病的一個重要治療靶點。國外已上市同靶點(IL-17/IL-17受體)藥物包括Cosentyx(商品名:可善挺)、Taltz(商品名:拓諮)和Siliq,國內除Cosentyx、Taltz已於2019年獲批上市外尚無其他同靶點藥物上市。根據Novartis International AG(諾華公司)和Eli Lilly and Company(禮來公司)的財報顯示,Cosentyx 2019年、Taltz 2018年全球銷售額分別為35.51億美元和9.375億美元。與同靶點藥物相比,HB0017與IL-17的親和力更高或相當,臨牀前安全性相似。

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