前沿生物(688221.SH)在2022年新發傳染病國際會議(ICEID)報吿抗新冠病毒藥物FB2001最新臨牀數據
格隆匯8月9日丨前沿生物(688221.SH)公佈,公司在2022年第11屆新發傳染病國際會議(ICEID)報吿在研抗新冠病毒小分子藥物注射用FB2001(通用名:Bofutrelvir)美國、中國Ⅰ期臨牀研究的最新數據。
抗新冠病毒小分子藥注射用FB2001的Ⅰ期臨牀試驗,在美國和中國開展,共有120名受試者接受了FB2001的靜脈注射給藥,單劑量為5mg-400mg/天,多劑量為30mg-400mg/天,連續給藥5天。美國、中國Ⅰ期臨牀試驗數據顯示,FB2001具有良好的臨牀安全性和耐受性,無劑量限制性毒性(DLT),未見嚴重不良事件報吿,血漿藥物濃度和模擬的肺部藥物濃度能夠達到治療的有效藥物濃度水平,藥代動力學特徵在美國和中國人羣無人種差異。
上述最新臨牀數據,於美國時間2022年8月8日在第11屆新發傳染病國際會議(ICEID)報吿。新發傳染病國際會議(ICEID)是美國疾病控制和預防中心(CDC)主辦的全球性學術會議,1998年首屆新發傳染病國際會議(ICEID)在美國亞特蘭大成功召開,大會迄今已有24年舉辦歷史。此次會議由美國疾病控制與預防中心(CDC)、美國傳染病學會、非洲疾控中心、美國微生物學會和國家傳染病基金會等來自30多個不同國家的科學協辦方共同組織,於當地時間8月8日在美國亞特蘭大順利召開,此次會議包含來自世界各地的1500多名公共衞生領域的專家參加,聚焦全球範圍內的傳染病問題並進行深入交流。
公司在研產品FB2001,為抗新冠肺炎病毒3CL蛋白酶抑制劑,其對新冠肺炎病毒3CL蛋白酶的抑制活性IC50為0.053±0.005μM,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。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。注射用FB2001已啟動國際多中心II/III期臨牀試驗,擬治療全球新冠肺炎住院患者。
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