National Medical Products Administration issued the Technical Guiding Principles for Clinical Research and Development of Bispecific Antibody Antitumor Drugs.

CCTV News:National Medical Products Administration website reported on November 14th that recently, National Medical Products Administration Drug Administration Center issued the "Guiding Principles for Clinical Research and Development of bispecific antibody Antitumor Drugs", which pointed out that Bispecific Antibody (BsAb) is an artificial antibody prepared by cell fusion, recombinant DNA, protein engineering and other technologies, which can specifically bind two antigens or two different epitopes of the same antigen at the same time or successively. According to the Guiding Principles, BsAb is different from the single targeting of monoclonal antibodies, and it can play a special biological function such as stimulating directed immune response by combining different epitopes, solve the treatment problems that monoclonal antibodies can’t solve, and bring patients clinical benefits that monoclonal antibodies don’t have. Therefore, in the process of clinical research and development, in addition to following the general research and development rules of anti-tumor drugs, we should also pay attention to clinical value-oriented, based on structural and mechanism characteristics, reasonably determine the research and development topics, and deeply explore, analyze and clarify the clinical advantages of BsAb during the research and development process.