Key considerations for the CMC research of antibody-drug conjugates during the investigational new drug stage
DAI Yi-fei
XIE Yu-jia
YANG Jiao
CHEN Ai-ping
REN Feng
LI Qian
HE Wu
Abstract：Antibody-drug conjugates (ADCs) are leading a new revolution in cancer treatment. By combining the high specificity of antibodies with the potent cytotoxicity of chemotherapy drugs,they offer a precise and effective therapeutic approach for cancer treatment. This article reviews the development history of ADCs,the market status both in China and aboard,current clinical trial status,and regulatory policies,with a particular focus on the key considerations for chemistry,manufacture,and control ( CMC) research on ADCs during the investigational new drug ( IND) stage. This article aims to provide a reference for the CMC research and review of ADCs,and to promote the clinical translation and application of such products.
Keywords：antibody-drug conjugateinvestigational new drugCMC researchpayload
Publication Date：2025-01-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 35-42 )