In recent years,domestic and foreign bispecific antibody(BsAb,referred to as bis-antibody)has been developing rapidly,and as of December 2023,nearly 200 bis-antibodies have been in clinical research,and more than a dozen bisantibody drugs have been approved for marketing. This paper reviews the domestic and foreign registration status of bis-antibody,and discusses the common technical problems in the pharmaceutical development of such products in combination with the experience of pharmaceutical review and related literature,in order to provide a basis for the pharmaceutical development and evaluation of bis-antibody drugs.