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復星醫藥(02196.HK):抗S1全人源單克隆中和抗體HLX70新藥獲美國FDA藥品臨牀試驗批准
格隆匯 10-08 16:51

格隆匯 10 月 8日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司Hengenix Biotech,Inc.(即控股子公司上海復宏漢霖生物技術股份有限公司全資子公司;以下簡稱“Hengenix”)收到美國FDA(即美國食品藥品監督管理局,下同)關於同意抗S1全人源單克隆中和抗體HLX70(以下簡稱“該新藥”)用於治療新型冠狀病毒肺炎和新型冠狀病毒引起的急性呼吸窘迫綜合徵或多重器官衰竭進行臨牀試驗的函。Hengenix擬於近期條件具備後於美國開展該新藥的I期臨牀試驗。

該新藥基於復宏漢霖於2020年5月與三優生物醫藥(上海)有限公司、上海江生物科技股份有限公司就全人源抗體藥物用於單藥或聯用治療新型冠狀病毒肺炎所達成的《合作開發協議》進行研發。

該新藥為靶向SARS-CoV-2病毒表面Spike蛋白受體結合區區域的全人源單克隆抗體,擬用於新型冠狀病毒肺炎、新型冠狀病毒引起的急性呼吸窘迫綜合徵或多重器官衰竭的治療。

截至公告日,於全球範圍內尚無用於治療新型冠狀病毒肺炎的全人源抗體藥物獲得上市批准。截至2020年8月,集團現階段針對該新藥累計研發投入約為人民幣1,520萬元(未經審計)。

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