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石藥集團(01093.HK):首款基於mRNA-LNP的CAR-T細胞注射液(SYS6020)獲臨牀試驗批准
格隆匯 06-25 17:42

格隆匯6月25日丨石藥集團(01093.HK)宣佈,集團開發的首款基於mRNA-LNP的嵌合抗原受體(CAR)-T細胞注射液(SYS6020)("該產品")已獲中華人民共和國國家藥品監督管理局批准,可在中國開展臨牀試驗。

該產品為全球首款獲批臨牀試驗的基mRNA-LNP的細胞治療產品。通過表達可特異性識別BCMA抗原的CAR,進而靶向識別患者體內BCMA陽性的細胞並對其進行殺滅,從而達到治療目的。與傳統的CAR-T產品相比,該產品具有細胞活率高、CAR陽性率高、無基因組整合引起的致瘤風險,以及細胞因子風暴(CRS)等副作用低的優點。臨牀前研究顯示,該產品可顯著殺傷BCMA抗原陽性的骨髓瘤細胞,並具有良好的安全性和有效性。

本次獲批的臨牀適應症為多發性骨髓瘤(MM)。此外,該產品潛在可用治療系統性紅斑狼瘡(SLE)、重症肌無力(MG)等自身免疫疾病,極具臨牀開發價值。該產品臨牀試驗的獲批,是集團在細胞治療領域佈局的首個重要成果,為其他細胞治療產品,如體內生成CAR-T的開發奠定了良好基礎。

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