Current registration status and pharmaceutical review considerations of bispecific antibody drug in China
10.13200/j.cnki.cjb.004222
- VernacularTitle:我国双特异性抗体药物注册申报现状及药学审评思考
- Author:
KAN Hongjin
- Publication Type:Journal Article
- Keywords:
Bispecific antibody;
Investigational New Drug(IND);
New drug application;
Pharmaceutical review
- From:
Chinese Journal of Biologicals
2024;37(5):634-639
- CountryChina
- Language:Chinese
-
Abstract:
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.
