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科倫藥業(002422.SZ):創新藥物KL340399注射液(STING激動劑)獲批臨牀
格隆匯 01-11 15:58

格隆匯1月11日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司開發的新一代小分子STING激動劑(KL340399注射液)獲得國家藥品監督管理局(NMPA)臨牀試驗通知書。

KL340399注射液是公司開發的具有自主知識產權、非環二核苷酸(CDN)類新一代小分子STING激動劑。其分子結構穩定、可系統給藥,並在體內外藥效活性方面有突出表現。非臨牀研究結果顯示,KL340399能與人STING蛋白結合,激活STING信號通路,誘導Ⅰ型干擾素和抗腫瘤細胞因子表達,在多個荷瘤小鼠模型中表現出呈劑量依賴性顯著抑制腫瘤生長,且具有與PD-1/PD-L1抗體聯用增效的潛質。在安全性評價中,動物耐受性整體良好。

STING全稱干擾素基因刺激蛋白(stimulator of interferon genes),是一種跨膜蛋白,是固有免疫信號通路中重要的接頭蛋白,具有識別病毒和細菌感染以及啟動機體固有防禦和免疫反應的作用。激活STING通路可誘導I型干擾素和其他促炎因子的表達和分泌,激活固有免疫應答,促進抗腫瘤免疫響應,達到治療腫瘤的目的。

截至公吿披露日,暫無同靶點藥物獲批上市,均在早期臨牀研究階段。

截至2021年11月,公司在KL340399注射液整體項目已投入3372.8萬元人民幣研發費用。

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