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

梁携儿; 高沿航; 牛俊奇; 侯金林

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—— 《〈慢性乙型肝炎病毒感染治疗药物临床试验技术指导原则〉问答文件》解读

DOI: 10.12449/JCH260807

1.
南方医科大学南方医院感染内科，广州 510515
2.
吉林大学第一医院肝胆胰内科，传染病与病原生物学中心，长春 130061

基金项目:

国家科技重大专项课题 (2025ZD1803701)

利益冲突声明：本文不存在任何利益冲突。

作者贡献声明：侯金林负责课题设计，撰写论文；梁携儿、牛俊奇和高沿航参与拟定写作思路，修改论文；侯金林、梁携儿、牛俊奇和高沿航收集数据，分析资料，指导撰写文章并最后定稿。

详细信息

通信作者:
侯金林， jlhousmu@163.com （ORCID： 0000-0001-8230-8583）

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出版历程
- 收稿日期: 2026-07-08
- 录用日期: 2026-07-20
- 出版日期: 2026-08-25

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

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

Research funding:

National Science and Technology Major Project (2025ZD1803701)

More Information

Corresponding author: Hou Jinlin， jlhousmu@163.com （ORCID： 0000-0001-8230-8583）

摘要

摘要: 实现乙型肝炎功能性治愈（临床治愈）是当前肝病临床与新药研发的核心目标。2023 年国家药品监督管理局药品审评中心发布《慢性乙型肝炎病毒感染治疗药物临床试验技术指导原则》搭建顶层框架；2026年7月配套征求意见问答文件，为乙型肝炎新药研发提供切实的政策指导，对临床研究者、创新药企和肝病学科发展具有多重深远价值。
- 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
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.
- Hepatitis B Virus /
- Functional Cure /
- Drugs， Investigational /
- Clinical Trial /
- Technical Guideline

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参考文献(8)

[1]	Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Infectious Diseases, Chinese Medical Association. Guidelines for the prevention and treatment of chronic hepatitis B(version 2022)[J]. Chin J Clin Infect Dis, 2022, 15( 6): 401- 427. DOI: 10.3760/cma.j.issn.1674-2397.2022.06.001. 中华医学会肝病学分会, 中华医学会感染病学分会. 慢性乙型肝炎防治指南(2022年版)[J]. 中华临床感染病杂志, 2022, 15( 6): 401- 427. DOI: 10.3760/cma.j.issn.1674-2397.2022.06.001.
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