临床肝胆病杂志2026，Vol.42Issue(8)：1773-1777,5.DOI:10.12449/JCH260806
乙型肝炎功能性治愈新药临床价值评价标准的探讨
Perspectives on assessing the clinical value of novel drugs for achieving functional cure of chronic hepatitis B
左书凝 1钟钰婷 1赵建中1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100163
- 折叠
摘要
Abstract
China bears a substantial disease burden of chronic hepatitis B(CHB).Under current clinical management regimens for CHB,achieving functional cure(also termed clinical cure)is the core goal for the treatment of patients meeting treatment indications.To achieve the goal of functional cure,drug regulatory authorities in China and globally have successively issued technical criteria to provide guidance for the overall design and scientific evaluation of clinical trials for innovative drugs.However,the rapid development in scientific research,clinical practice,and new drug research and development in this field has brought new challenges,especially those concerning the assessment of the clinical value of investigational drugs.This article reviews the current status of clinical research and development of new drugs for achieving the functional cure of CHB worldwide,analyzes the characteristics of available clinical trial data,and focuses on key aspects of pivotal clinical trials for CHB functional cure drugs,including target populations(baseline HBsAg level),HBsAg seroclearance response,HBsAg seroreversion after drug withdrawal,and clinically meaningful target threshold of functional cure response rate,in order to provide a reference for further refinement of related technical criteria.关键词
乙型肝炎,慢性/功能性治愈/药物,临床试用Key words
Hepatitis B,Chronic/Functional Cure/Drugs,Investigational引用本文复制引用
左书凝,钟钰婷,赵建中..乙型肝炎功能性治愈新药临床价值评价标准的探讨[J].临床肝胆病杂志,2026,42(8):1773-1777,5.
