双特异性抗体药物非临床研究的考虑要点

发布时间：2018-07-26 19:47

【摘要】：随着生物技术的快速发展,双特异性抗体已经成为新药研发的热点。最引人注目的作用是通过双靶向T细胞和肿瘤细胞,激发免疫反应将肿瘤细胞杀死。双特异性抗体的结构多样,作用复杂,与一般抗体相比,双特异性抗体的研发具有更大的挑战。双特异性抗体的非临床研究除了参考一般生物制品的指导原则外,更需要考虑如何选择相关动物种属、关注免疫相关的毒性反应如细胞因子释放综合征,同时在非临床研究向临床试验转化中更为谨慎地拟定首次临床试验起始剂量等。本文汇总分析了双特异性抗体药物非临床研究需特别关注的问题。
[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.
【作者单位】：国家食品药品监督管理总局药品审评中心;
【分类号】：R95

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