前沿生物(688221.SH):抗新冠病毒藥物注射用FB2001的藥物臨牀I期橋接試驗申請獲批
格隆匯12月10日丨前沿生物(688221.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,抗新冠病毒藥物注射用FB2001的藥物臨牀I期橋接試驗申請獲得批准。
公司與中國科學院上海藥物研究所達成合作,獲得抗新冠病毒(SARS-CoV2)候選新藥FB2001(DC系列候選藥物)在全球範圍內的臨牀開發、生產、製造及商業化權利。
FB2001為新冠肺炎病毒(SARS-CoV-2)蛋白酶抑制劑,是基於冠狀病毒主蛋白酶三維結構(3CL)設計合成的擬肽類化合物,具有高效靶向抑制冠狀病毒主蛋白酶以及體外抗新冠病毒的活性,同時在實驗動物體內展現出良好的體內藥代動力學性質和安全性,上述研究成果已發表於國際權威期刊《科學》(Science)並作為封面文章刊登。
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