Targeting functional cure of hepatitis B and establishing a China-specific evaluation benchmark for novel hepatitis B drugs： Interpretation of Q&A Document for the technical guidance for clinical trials of therapeutic drugs for chronic hepatitis B virus infection

VernacularTitle: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
Author: Xie’er LIANG ¹ ; Yanhang GAO ² ; Junqi NIU ² ; Jinlin HOU ¹
Author Information

1. Department of Infectious Diseases， Nanfang Hospital， Southern Medical University， Guangzhou 510515， China
2. Department of Hepatology， Center of Infectious Diseases and Pathogen Biology， The First Hospital of Jilin University， Changchun 130061， China
Publication Type:News
Keywords: Hepatitis B Virus; Functional Cure; Drugs， Investigational; Clinical Trial; Technical Guideline
From: Journal of Clinical Hepatology 2026;42(8):1778-1781
CountryChina
Language:Chinese
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.