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眾生藥業(002317.SZ):甲型流感及人禽流感預防治療藥物首例受試者入組
格隆匯 12-08 18:55

格隆匯12月8日丨眾生藥業(002317.SZ)發佈公告,近日,公司控股子公司廣東眾生睿創生物科技有限公司(以下簡稱“眾生睿創”)組織開展的用於預防和治療甲型流感及人禽流感的一類創新藥物ZSP1273片的臨牀試驗,已在全國二十五家臨牀研究中心開展Ⅱ期臨牀試驗,目前首例受試者已入組。

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、首個完成Ⅰ期臨牀試驗的治療甲型流感的小分子RNA聚合酶抑制劑。

“ZSP1273片治療成人單純性甲型流感的隨機、雙盲、安慰劑對照Ⅱ期臨牀研究”已獲得組長單位廣州醫科大學附屬第一醫院Ⅱ期臨牀試驗倫理批件,鍾南山院士作為ZSP1273項目Ⅱ/Ⅲ期臨牀試驗的總項目負責人(PI),負責主導 ZSP1273的臨牀研究工作。ZSP1273項目在全國二十五家臨牀研究中心開展Ⅱ期臨牀研究,目前首例受試者已入組。本試驗主要研究目的是初步評估ZSP1273片治療成人甲型流感患者的安全性和療效,確定Ⅲ期臨牀試驗的擬用劑量及給藥方案。

ZSP1273片Ⅱ期臨牀試驗的首例受試者入組,標誌着ZSP1273片臨牀研究進一步取得了實質性進展,併為其成功上市邁出了堅實的一步。

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