On November 9th, 2022, the Drug Review Center of the National Medical Products Administration issued the “Technical Guidelines for Clinical Research and Development of Bispecific Antibody Antitumor Drugs”, proposing suggestions on issues that require special attention in the clinical research and development of Bispecific Antibody Antitumor drugs, and guiding enterprises to conduct clinical research and development more scientifically.

Bispecific antibody (BsAb), abbreviated as "dual antibody", which is a "single drug" with dual functions. Effector cells or cytokines such as immune cells can be connected to tumor cells, thereby enhancing their killing effect on target cells. In recent years, the research and development enthusiasm of the pharmaceutical industry and the development of biopharmaceutical technology have driven BsAb drugs into a high-speed development stage.

CDE pointed out that for BsAb targeting multiple Epitope, due to the particularity of structure and function, it is necessary to combine the characteristics of bispecific antibodies in clinical research and development to determine a reasonable research and development agenda. The main goal should be to solve problems that cannot be solved by monoclonal antibodies, and the design approach should be guided by clinical needs. It is recommended to pay attention to the following issues in clinical research and development:

1. Risk control for the first time human clinical trial;

2. The best medication strategy;

3. Clinical trials confirm research and development issues;

4. Immunogenicity;

5. Development of biomarkers.