Key Points of the Non-clinical Evaluation in the WHO's"Guidelines on the Non-Clinical and Clinical Evaluation of Monoclonal Antibodies and Related Products Intended for the Prevention or Treatment of Infectious Diseases"
10.3870/j.issn.1004-0781.2025.12.001
- VernacularTitle:WHO《针对预防和治疗感染性疾病的单抗类药物的非临床和临床评价指导原则》中非临床评价的要点介绍
- Author:
Meiling CHEN
1
;
Tao SUN
1
;
Shujun FU
1
Author Information
1. 国家药品监督管理局药品审评中心,北京 100163
- Publication Type:Journal Article
- Keywords:
Guidelines on the Non-Clinical and Clinical Evaluation of Monoclonal Antibodies and Related Products Intended for the Prevention or Treatment of Infectious Diseases;
Infectious disease;
Monoclonal antibodies;
Nonclinical evaluation
- From:
Herald of Medicine
2025;44(12):1877-1884
- CountryChina
- Language:Chinese
-
Abstract:
Monoclonal antibodies(mAbs)represent the most extensively utilized class of therapeutic proteins in clinical practice.While the majority of currently marketed mAbs are primarily employed for the treatment of non-infectious diseases,such as tumors and autoimmune disorders,the number of monoclonal antibody drugs approved globally for the prevention or treatment of infectious diseases has been progressively increasing since the onset of the COVID-19 pandemic.On March 25,2023,the World Health Organization(WHO)published the"Guidelines on the Non-Clinical and Clinical Evaluation of Monoclonal Antibodies and Related Products Intended for the Prevention or Treatment of Infectious Diseases".However,China has yet to release analogous guidelines.This article aims to elucidate the non-clinical evaluation aspects of monoclonal antibody drugs for infectious disease prevention and treatment as outlined in the WHO guidelines,with a focus on regulatory considerations,overarching principles of non-clinical evaluation,as well as pharmacodynamics,pharmacokinetics,and toxicology studies.It is intended to serve as a reference for the non-clinical research and evaluation of such novel drugs in China.
