Application of platform technology and regulatory considerations for innovative monoclonal antibody products
QIU Xiao
WANG Wen-bo
YANG Fei
ZHANG Meng-meng
GONG Xu
WEI Wei
Abstract：Technical advancements have led to greater diversity in the molecular entities of innovative recombinant monoclonal antibodies,enabling them to better meet clinical needs.A growing number of innovative monoclonal antibody products are being submitted for market approval through accelerated regulatory pathways due to their remarkable clinical efficacy.To address the challenges in chemistry,manufacturing,and controls(CMC)development during rapid drug advancement,it is necessary to introduce scientific regulatory tools.This article summarizes the definitions of platform knowledge provided by various domestic and international regulatory agencies,as well as regulations regarding the use of platform knowledge to support CMC development in accelerated programs.It also analyzes the benefits and challenges of applying platform knowledge based on the actual conditions,with the aim of providing actionable recommendations for the future use of this regulatory tool in China.
Keywords：platform technologyinnovationrecombinant monoclonal antibodyaccelerated developmentregulatory tools
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2585-2588 )