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眾生藥業(002317.SZ):新冠藥RAY1216片臨牀試驗獲國家藥監局批准
格隆匯 05-15 17:58

格隆匯5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口服抗新型冠狀病毒3CL蛋白酶抑制劑 RAY1216 片的藥物臨牀試驗獲得國家藥品監督管理局批准,並收到《藥物臨牀試驗批准通知書》,同意 RAY1216 片進行臨牀試驗。

眾生睿創收到藥物臨牀試驗批准通知書,其主要內容為:根據《中華人民共和國藥品管理法》及有關規定,經審查,2022 年 5 月 11 日受理的 RAY1216 片符合藥品註冊的有關要求,同意本品開展臨牀試驗。

RAY1216是眾生睿創研發的、具有全球自主知識產權的強效、廣譜抗新冠病毒3CL蛋白酶抑制劑,通過作用於新型冠狀病毒主蛋白酶(main protease,Mpro,3CLpro),抑制病毒前體蛋白質的切割,進而阻斷病毒複製,達到抗新冠病毒的作用。RAY1216片獲得國家藥品監督管理局批准,同意進行臨牀試驗,是公司在該項目研發的實質進展。眾生睿創將按照相關要求高質量、快速度推進臨牀研究。

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