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前沿生物(688221.SH):霧化吸入用FB2001獲批開展Ⅱ/Ⅲ期臨牀試驗
格隆匯 11-23 16:48

格隆匯11月23日丨前沿生物(688221.SH)公佈,近日,公司在研抗新冠病毒藥物霧化吸入用FB2001,擬用於治療輕型、普通型新型冠狀病毒(SARSCoV-2)感染患者的Ⅱ/Ⅲ臨牀試驗方案,獲得國家藥品監督管理局藥品審評中心同意。公司在研產品FB2001(通用名:Bofutrelvir),為公司與中國科學院上海藥物研究所、中國科學院武漢病毒研究所共同開發的抗新冠肺炎病毒3CL蛋白酶抑制劑,公司擁有FB2001在全球範圍內的臨牀開發、生產及商業化權利。

霧化吸入用FB2001臨牀前研究顯示,經霧化吸入給藥,FB2001在大鼠和犬具有良好的安全性,在大鼠和犬的上呼吸道和肺部有很高的藥物濃度。此外,公司委託中國科學院武漢病毒研究所評價了FB2001霧化吸入給藥和滴鼻給藥對Omicron株感染小鼠的體內藥效,研究顯示,FB2001經霧化吸入和滴鼻給藥均顯示出顯著的抗病毒作用,可以顯著降低小鼠肺部的病毒載量,相對於對照組,經霧化吸入FB2001可以降低肺部病毒載量4.6log10copies/ml,相當於99.998%的病毒被抑制,經鼻腔滴入FB2001可以降低肺部病毒載量3.6log10copies/ml,相當於99.97%的病毒被抑制。

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