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眾生藥業(002317.SZ):子公司一類創新藥ZSP1273片獲得Ⅲ期臨牀試驗倫理批件
格隆匯 10-15 20:38

格隆匯 10 月 15日丨眾生藥業(002317.SZ)公佈,近日,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”)組織開展的一類創新藥物ZSP1273片,其用於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期臨牀研究試驗已獲得組長單位廣州醫科大學附屬第一醫院醫學倫理委員會臨牀試驗快速審查批件,批准項目開展。

藥物名稱:ZSP1273片;劑型:片劑;規格:50mg,200mg;註冊分類:化學藥品第1類;適應症:預防和治療甲型流感及人禽流感;臨牀研究階段:Ⅲ期;臨牀研究負責人:鍾南山院士。

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。目前ZSP1273片已完成Ⅱ期臨牀試驗,獲得了積極結果,是國內首個完成Ⅱ期臨牀試驗的治療甲型流感的小分子RNA聚合酶抑制劑。

廣州醫科大學附屬第一醫院鍾南山院士作為ZSP1273片Ⅱ期臨牀研究的總項目負責人(PI),將繼續作為Ⅲ期臨牀研究的總項目負責人,負責主導ZSP1273的臨牀研究工作。Ⅲ期臨牀研究方案已於近日通過組長單位廣州醫科大學附屬第一醫院醫學倫理委員會審評和批准,Ⅲ期臨牀研究計劃在全國70~80家臨牀研究中心開展。

ZSP1273片Ⅲ期臨牀試驗組長單位臨牀倫理批件的獲得,標誌着ZSP1273片Ⅲ期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。經查詢中國藥物臨牀試驗登記和信息公示平台,截止公告日,國內尚未有同類一類創新藥物正在開展用於治療成人單純性甲型流感的Ⅲ期臨牀研究登記,在同類藥物臨牀研究中進展最快。

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