The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and Development of Bispecific Antibody Antitumor Drugs.” These guidelines provide recommendations on critical issues in the clinical research and development (R&D) of bispecific antibodies (BsAbs), focusing on general principles rather than specific types. The guidelines are also applicable for the development of multi-specific antibody drugs targeting more than two antigen epitopes.
Distinguishing Features of Bispecific Antibodies
The guidelines highlight that bispecific antibodies (BsAbs) differ significantly from single-targeted monoclonal antibodies (mAbs). BsAbs can perform unique biological functions by binding to different epitopes, stimulating targeted immune responses, and addressing treatment challenges that cannot be resolved by mAbs. This capability allows BsAbs to deliver clinical benefits that are unattainable with traditional mAbs. Therefore, during the clinical R&D process, in addition to adhering to the general rules of anti-tumor drug development, R&D themes should be determined based on clinical value, structural characteristics, and mechanism of action, with a focus on in-depth exploration, analysis, and confirmation of the clinical advantages of BsAbs.
Key Considerations in Clinical Development
The guidelines emphasize that, while following the general principles and laws of drug R&D, special attention should be paid to several critical factors during the development process. These include risk control in clinical trials, optimal drug administration strategies, clinical trial design, immunogenicity, and biomarker development. By addressing these factors, the guidelines aim to ensure the safety and efficacy of bispecific antibody antitumor drugs and guide their successful clinical development.-Fineline Info & Tech
