【摘要】：隨著生物技術(shù)的快速發(fā)展,雙特異性抗體已經(jīng)成為新藥研發(fā)的熱點(diǎn)。最引人注目的作用是通過雙靶向T細(xì)胞和腫瘤細(xì)胞,激發(fā)免疫反應(yīng)將腫瘤細(xì)胞殺死。雙特異性抗體的結(jié)構(gòu)多樣,作用復(fù)雜,與一般抗體相比,雙特異性抗體的研發(fā)具有更大的挑戰(zhàn)。雙特異性抗體的非臨床研究除了參考一般生物制品的指導(dǎo)原則外,更需要考慮如何選擇相關(guān)動(dòng)物種屬、關(guān)注免疫相關(guān)的毒性反應(yīng)如細(xì)胞因子釋放綜合征,同時(shí)在非臨床研究向臨床試驗(yàn)轉(zhuǎn)化中更為謹(jǐn)慎地?cái)M定首次臨床試驗(yàn)起始劑量等。本文匯總分析了雙特異性抗體藥物非臨床研究需特別關(guān)注的問題。
[Abstract]:With the rapid development of biotechnology, bispecific antibody has become a hot spot in the research and development of new drugs. The most striking effect is to kill tumor cells by stimulating immune responses to both target T cells and tumor cells. The development of bispecific antibodies is more challenging than that of general antibodies because of its diverse structure and complex functions. In addition to referring to the guiding principles of general biological products, non-clinical studies of bispecific antibodies need to consider how to select related animal species and focus on immune-related toxic reactions such as cytokine release syndrome. At the same time, the initial dose of the first clinical trial should be determined more carefully in the transition from non-clinical research to clinical trial. This article summarized and analyzed the non-clinical research of anti-specific antibody drugs.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評(píng)中心;
【分類號(hào)】：R95

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