Interpretation of guidance on CMC study and evaluation of antibody-drug conjugates
LI Qian
WU Yong-kai
WEI Wei
HE Wu
Abstract：In recent years,with the iteration and maturation of technology,the proportion of antibody-drug conjugates(ADCs)in anti-tumor drugs has become increasingly prominent,and the number of applications has been growing steadily.As of December 2024,16 ADC products have been approved for marketing worldwide,and 2 domestic innovative ADC products have been approved for marketing in China,with over a hundred ADC products approved for clinical research.To standardize and guide the research and development and application of such products,the Guidance on CMC study and evaluation of antibody-drug conjugates was issued by the Center for Drug Evaluation,National Medical Products Administration,in February 2024.This article interprets the main contents of the guidance based on the drafting ideas,to facilitate the industry's better understanding and promote the marketing application of such products.
Keywords：antibody-drug conjugateCMC researchguidance
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 561-565 )