临床肝胆病杂志2026，Vol.42Issue(8)：1778-1781,4.DOI:10.12449/JCH260807
锚定乙型肝炎功能性治愈,构建中国特色乙型肝炎新药审评标尺
摘要
Abstract
Achieving the functional cure(clinical cure)of hepatitis B is the primary goal of current clinical hepatology and novel drug research and development.In 2023,the Center for Drug Evaluation,National Medical Products Administration,issued Technical guidance for clinical trials of therapeutic drugs for chronic hepatitis B virus infection to establish a top-level regulatory framework.Supporting Q&A documents for public consultation were released in July 2026 to provide practical policy guidance for the research and development of novel hepatitis B drugs,which has far-reaching implications for clinical investigators,innovative pharmaceutical enterprises,and the development of hepatology.关键词
乙型肝炎病毒/功能性治愈/药物,临床试用/临床试验/技术指导原则Key words
Hepatitis B Virus/Functional Cure/Drugs,Investigational/Clinical Trial/Technical Guideline引用本文复制引用
梁携儿,高沿航,牛俊奇,侯金林..锚定乙型肝炎功能性治愈,构建中国特色乙型肝炎新药审评标尺[J].临床肝胆病杂志,2026,42(8):1778-1781,4.基金项目
国家科技重大专项课题(2025ZD1803701) National Science and Technology Major Project(2025ZD1803701) （2025ZD1803701）
