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開拓藥業(09939.HK)普克魯胺治療住院新冠患者III期臨床試驗完成首例患者給藥
阿思達克 10-04 12:28
開拓藥業(09939.HK)公布,10月1日,普克魯胺治療住院新冠患者的III期全球多中心臨床試驗已在美國的臨床中心完成首例患者入組及給藥。 美國III期臨床試驗是一項隨機、雙盲、安慰劑對照、全球多中心的III期關鍵性臨床試驗,旨在探索普克魯胺治療住院新冠患者的有效性和安全性。這項關鍵性臨床試驗已獲得美國食品和藥物管理局、國家藥監局、菲律賓食品和藥物管理局及巴西國家衛生監督局的批准,並正在尋求歐洲和亞洲更多監管機構的批准。
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