信立泰(002294.SZ)：SAL0133片獲批開展治療成人輕型/普通型COVID-19適應症I期臨牀試驗
格隆匯1月3日丨信立泰(002294.SZ)公佈，近日，公司收到國家藥品監督管理局核准簽發的《臨牀試驗批准通知書》，同意SAL0133片開展治療成人輕型/普通型新型冠狀病毒肺炎(COVID-19)適應症I期臨牀試驗。
SAL0133系公司自主創新研發、具有自主知識產權的強效、廣譜抗新型冠狀病毒的3CL蛋白酶(3C-like protease ，3CLpro)抑制劑。
3CLpro在新型冠狀病毒的RNA複製中具有重要作用，主要作用於病毒進入宿主細胞後的初始複製階段，抑制3CLpro蛋白酶的活性，可有效阻斷病毒複製，達到抗新型冠狀病毒的作用。此外，3CLpro在Beta冠狀病毒中保守性高，SARS-CoV-2與SARS-CoV的3CLpro同源性大於96%，兩者結構基本一致，已報道的很多3CLpro抑制劑具有廣譜抗冠狀病毒能力。由於人體內沒有與3CLpro類似切割位點的蛋白酶，可篩選高特異性的抑制劑，且安全性較好。
臨牀前研究數據顯示，SAL0133在酶水平活性顯示出對3CLpro的強力抑制活性，對野生型新冠病毒及Alpha (B.1)、Beta、Delta、Omicron (BA.2、BA.5)五種新冠變異株均有較強的抗病毒活性，對當前流行株Omicron BA.5株的抗病毒活性EC90值是奈瑪特韋的10倍。在新冠病毒感染的動物模型體內，SAL0133可顯著降低肺部組織病毒載量，並明顯改善肺部炎症，其顯著降低病毒載量的劑量低於奈瑪特韋。非臨牀藥代動力學研究證實，SAL0133表現出良好的口服吸收特性，滲透性好，口服生物利用度高，半衰期長，代謝穩定性好，口服暴露量高。GLP毒理學研究證明SAL0133具有良好的安全性。綜上表明SAL0133作用機制明確，具有強力、廣譜的抗新冠病毒作用，預期不需要聯合CYP3A4抑制劑利托那韋，藥物相互作用的潛在風險較低；有望實現臨牀單藥用藥、每日一次，改善患者用藥順應性。若能研發成功並獲批上市，將為患者提供新的用藥選擇，滿足未被滿足的臨牀需求。
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