关键词: 转基因小鼠, 专利保护, 抗体药物, 人源化

Abstract: This paper reviewed the evolution of therapeutic antibody drugs from mouse antibody, chimeric antibody, humanized antibody to full human antibody, as well as the development process of humanized antibody transgenic animals used for full human monoclonal antibody discovery. The characteristics and core patent protection of human antibody transgenic animal platform commonly used in the world were mainly summarized. Since human antibody transgenic animals use genetic engineering technology to replace animal immunoglobulin gene with human antibody immunoglobulin gene, it can directly express human antibody protein, so it has been widely used in the development of whole human antibody drugs. However, in order to solve the matching problem between the human immunoglobulin gene and animal B cell development, obtain the candidate antibodies with richer diversity and higher affinity, it is necessary to conduct more in-depth basic research on the mechanism of animal antibody production. At the same time, in the face of sudden biosafety incidents, how to rapidly and massively produce full human antibodies is also a key issue to be considered in the future cultivation of humanized antibody transgenic animals.

Key words: transgenic mice, patent protection, antibody drugs, humanization