中國自主研發口服新冠藥料下半年進入臨牀
全球健康藥物研發中心公佈,其自主研發的以新型冠狀病毒3CL蛋白(酉每)爲靶標的臨牀前候選特效藥物分子GDI-4405加速推進多項臨牀試驗申報研究和藥物生產,預計2022年下半年進入臨牀。
全球健康藥物研發中心主任、清華大學藥學院院長丁勝表示,臨牀候選藥物分子GDI-4405在對重組新冠病毒3CL蛋白的(酉每)活性抑制、人源呼吸道上皮細胞感染的新冠活病毒的抑制,以及針對Delta變異病毒等一系列體外實驗中,表現出比輝瑞(PFE.US)獲批藥物Paxlovid更強的抗病毒活性。
丁勝指出,在大鼠以及食蟹猴動物實驗中,GDI-4405也表現出更優異的生物利用度和暴露量。在動物毒理評價實驗中,GDI-4405展現出良好的安全性。其生產成本也優於輝瑞新冠藥物Paxlovid,這將進一步促進全球小分子口服新冠藥物的研發進程,作爲疫苗的有效補充。
全球健康藥物研發中心於2016年在北京成立,是由蓋茨基金會、清華大學和北京市政府聯合創辦的一所獨立運營、非營利性質的創新藥物研發機構,也是政府與社會資本合作(PPP)模式在內地科技領域的首次實踐。
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