前沿生物(688221.SH):新冠小分子藥物FB2001獲批開展Ⅱ/Ⅲ期國際多中心臨牀試驗
格隆匯4月27日丨前沿生物(688221.SH)公佈,國家藥品監督管理局藥品審評中心同意公司按照提交的臨牀方案開展抗新冠病毒3CL蛋白酶抑制劑FB2001的關鍵性臨牀試驗,這是一項在新冠肺炎住院患者中評價FB2001的有效性和安全性的國際多中心、隨機、雙盲、安慰劑對照的Ⅱ/Ⅲ期臨牀研究。
FB2001 為注射用新冠肺炎病毒(SARS-CoV-2)蛋白酶抑制劑,擬用於治療新冠肺炎住院患者。公司擁有FB2001在全球範圍內的臨牀開發、生產、製造及商業化權利
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