眾生藥業(002317.SZ):用於治療成人單純性甲型流感的一類創新藥ZSP1273片完成Ⅲ期臨牀試驗全部病例數入組
格隆匯3月16日丨眾生藥業(002317.SZ)公佈,截至2023年3月15日,公司控股子公司廣東眾生睿創生物科技有限公司(“眾生睿創”)組織開展的用於治療成人單純性甲型流感的一類創新藥物ZSP1273片Ⅲ期臨牀研究,已經按臨牀方案要求,完成全部病例數入組。
ZSP1273片是具有明確作用機制和全球自主知識產權的一類創新藥物,臨牀上擬用於甲型流感及人禽流感的預防和治療,是國內首個獲批臨牀試驗的治療甲型流感的小分子RNA聚合酶抑制劑。臨牀前研究結果表明,ZSP1273對多種甲型流感病毒的抑制能力明顯優於同靶點化合物以及神經氨酸酶抑制劑奧司他韋,並且對於奧司他韋耐藥的病毒株、巴洛沙韋耐藥的病毒株和高致病性禽流感病毒株均具有很強的抑制作用,已完成的Ⅱ期臨牀研究結果提示,ZSP1273 600 mg QD較安慰劑組能夠顯著縮短流感七項症狀緩解時間和縮短髮熱時間,並能快速降低和清除體內流感病毒,且安全性耐受性良好,有望為解決重大公共衞生事件提供新的治療選擇。
ZSP1273片治療成人單純性甲型流感的隨機、雙盲、安慰劑或奧司他韋對照的Ⅲ期臨牀研究,試驗設ZSP1273片600 mg QD組、奧司他韋膠囊75 mg BID和安慰劑組,共給藥5天,觀察21天,在全國80餘家中心開展。自項目啟動以來,眾生睿創在組長單位廣州醫科大學附屬第一醫院和主要研究者的帶領和指導下,積極推進臨牀開發進程。研究擬入組744例,實際入組750例。
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