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澤璟製藥(688266.SH):注射用鹽酸ZG0895臨牀試驗申請獲得受理
格隆匯 02-14 18:55

格隆匯2月14日丨澤璟製藥(688266.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的《受理通知書》,公司自主研發的注射用鹽酸ZG0895用於治療晚期實體瘤的臨牀試驗申請獲得受理。

ZG0895是公司自主研發的一種新型的高活性、高選擇性的Toll樣受體8(TLR8)激動劑,屬於1類小分子新藥,適應症為晚期實體瘤。另外,基於TLR8激動劑可激活機體的先天性免疫系統,由此TLR8激動劑也有望用於抗乙肝病毒感染等抗病毒治療。根據公開查詢,目前全球範圍內尚未有高選擇性TLR8激動劑類藥物獲批上市。

ZG0895在體內外藥理藥效研究實驗中均展現出優異的TLR8激動活性作用,既可以高選擇性地激動TLR8,刺激TLR8相關細胞因子分泌,進而激活髓系免疫細胞,逆轉調節性T細胞(Treg)的免疫抑制功能,從而強烈抑制腫瘤生長,又可以誘導骨髓來源的抑制性細胞(MDSCs)的凋亡,激活和增強對腫瘤的免疫反應。

ZG0895在多種體內模型中具有優異的抗腫瘤活性,可以導致腫瘤消退。皮下注射後ZG0895展現出獨特的藥代動力學特性,可以降低藥物進入循環系統後可能帶來的全身性免疫系統持續激活的風險,具備良好的安全性。同時,基於人體免疫防禦的互補性,針對先天性免疫類藥物和現有腫瘤免疫類藥物聯合應用有望產生更好的協同抗腫瘤效應,使無免疫應答的“冷”腫瘤轉變為有免疫應答的“熱”腫瘤。ZG0895有望成為一個全新的晚期實體瘤治療新藥,並可與腫瘤免疫治療藥物等其它藥物聯合增強抗腫瘤藥效,從而改善患者的生活質量和延長壽命。

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