眾生藥業(002317.SZ)：ZSP1273顆粒劑獲批臨牀試驗
格隆匯 3 月 11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”)一類創新藥物ZSP1273顆粒劑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ZSP1273顆粒劑進行臨牀試驗。
眾生睿創收到編號為2021LP00305、2021LP00306、2021LP00307的藥物臨牀試驗批准通知書，受理號分別為CXHL2000658、CXHL2000659、CXHL2000660。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，ZSP1273顆粒符合藥品註冊的有關要求，同意按照提交的方案開展相關臨牀研究。
ZSP1273是眾生睿創針對重大突發傳染性疾病——甲型流感及人禽流感研發的具有明確作用機制和自主知識產權的一類創新藥。臨牀前研究結果表明，ZSP1273具有強大的體外廣譜抗甲型流感病毒活性，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；體內藥效試驗也較同靶點參考化合物和奧司他韋有更佳的保護動物、降低動物肺部病毒滴度的藥效；ZSP1273對於奧司他韋耐藥的病毒株及高致病性禽流感病毒均具有很強的抑制作用，並且與奧司他韋聯合用藥展現高度協同作用；在符合藥物非臨牀研究質量管理規範下的毒理研究結果表明ZSP1273安全性良好，安全治療窗口非常高。上述試驗結果提示ZSP1273具有非常重大的臨牀應用價值。
ZSP1273片已經完成Ⅰ、Ⅱ期臨牀研究，臨牀研究結果提示ZSP1273片具有治療成人單純性甲型流感的臨牀應用潛力，且安全性良好。目前正在開展治療成人單純性甲型流感的Ⅲ期臨牀試驗，以進一步確證其療效和安全性。
為方便特殊人羣，包括兒童患者以及吞嚥困難患者的用藥，眾生睿創開發了ZSP1273顆粒劑，並獲得國家藥品監督管理局的臨牀試驗批准通知書，同意ZSP1273顆粒劑開展臨牀試驗。
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