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前沿生物(688221.SH):目前正積極加速推進注射用FB2001擬治療新冠病毒感染住院患者的II/III期臨牀試驗等
格隆匯 01-02 17:31

格隆匯1月2日丨前沿生物(688221.SH)公佈,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了抗新型冠狀病毒3CL蛋白酶抑制劑FB2001(通用名:Bofutrelvir),公司擁有FB2001在全球範圍內的臨牀開發、生產及商業化權利。目前,公司正在積極加速推進注射用FB2001擬治療新冠病毒感染住院患者的II/III期臨牀試驗和霧化吸入用FB2001擬治療輕型、普通型新冠病毒感染患者的II/III期臨牀試驗。

截至2022年12月31日,注射用FB2001的國際多中心、隨機、雙盲、安慰劑對照II/III期臨牀試驗已獲得中國、澳大利亞、菲律賓等多個國家的研究批准,受試者已入組並給藥。近期隨着各城市新冠病毒感染者的增加,公司將積極推進臨牀試驗進度、加快受試者入組工作。

注射用FB2001擬用於治療新冠病毒感染住院患者。根據世衞組織統計數據,截至2022年12月23日,全球累計新冠病毒感染確診病例達651,918,402例,累計死亡病例達6,656,601例;根據美國疾病控制與預防中心數據顯示,2022年美國新冠病毒感染住院病人數累計超過202萬。近期,歐美多國、亞洲各國及我國已開始出現新型奧密克戎亞型毒株XBB.1.5,研究表明XBB.1.5是免疫逃逸能力最強的奧密克戎亞型毒株之一,傳播速度已超過BQ.1和BQ.1.1等其他奧密克戎變體。國內外專家預計,XBB.1.5將會在短時間內成為全世界的主要流行毒株,需要密切關注。感染人數的增加,預期對高效、廣譜、安全性好的抗新冠病毒藥物有持續性剛性需求,尤其是高齡、有基礎疾病、未接種疫苗及免疫缺陷的人羣,是感染新冠病毒後可能發展為危重症甚至死亡的脆弱羣體,特別需要重點保護,上述四類脆弱人羣在全球範圍的基數龐大。

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