Article(id=1317885695637701319, tenantId=1146029695717560320, journalId=1316781422847033486, issueId=1317885672153797495, articleNumber=null, orderNo=null, doi=10.12449/JCH260807, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1783440000000, receivedDateStr=2026-07-08, revisedDate=null, revisedDateStr=null, acceptedDate=1784476800000, acceptedDateStr=2026-07-20, onlineDate=1792138034971, onlineDateStr=2026-10-16, pubDate=1787587200000, pubDateStr=2026-08-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792138034971, onlineIssueDateStr=2026-10-16, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792138034971, creator=13701087609, updateTime=1792138034971, updator=13701087609, issue=Issue{id=1317885672153797495, tenantId=1146029695717560320, journalId=1316781422847033486, year='2026', volume='42', issue='8', pageStart='1745', pageEnd='2000', issueExtLink='null', onlineDate='null', pubDate='1787587200000', pubDateStr='2026-08-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1792138029373, creator='13701087609', updateTime=1792138608261, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1317888100290900262, tenantId=1146029695717560320, journalId=1316781422847033486, issueId=1317885672153797495, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1317888100290900263, tenantId=1146029695717560320, journalId=1316781422847033486, issueId=1317885672153797495, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1778, endPage=1781, ext={EN=ArticleExt(id=1317885695935496905, articleId=1317885695637701319, tenantId=1146029695717560320, journalId=1316781422847033486, language=EN, title=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, columnId=1317885695859999432, journalTitle=Journal of Clinical Hepatology, columnName=Hotspot·Perspective·Viewpoint, runingTitle=null, highlight=null, articleAbstract=

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.

, authors=Xie’er Liang¹, Yanhang Gao², Junqi Niu², Jinlin Hou¹, authorsList=Xie’er Liang, Yanhang Gao, Junqi Niu, Jinlin Hou, authorCompany=null, correspAuthors=Jinlin Hou, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1317885696744997579, articleId=1317885695637701319, tenantId=1146029695717560320, journalId=1316781422847033486, language=CN, title=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, columnId=1317885696044548810, journalTitle=临床肝胆病杂志, columnName=热点·视点·观点, runingTitle=null, highlight=null, articleAbstract=

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。

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DOI: 10.3760/cma.j.issn.1674-2397.2022.06.001., articleTitle=慢性乙型肝炎防治指南(2022年版), refAbstract=null), Reference(id=1317885699123167986, tenantId=1146029695717560320, journalId=1316781422847033486, articleId=1317885695637701319, doi=null, pmid=null, pmcid=null, year=2022, volume=15, issue=6, pageStart=401, pageEnd=427, url=null, language=null, rfNumber=1, rfOrder=1, authorNames=Chinese Society of Hepatology, Chinese Medical Association, Chinese Society of Infectious Diseases, Chinese Medical Association, journalName=Chin J Clin Infect Dis, refType=null, unstructuredReference=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., articleTitle=Guidelines for the prevention and treatment of chronic hepatitis B (version 2022), refAbstract=null), Reference(id=1317885699198665459, tenantId=1146029695717560320, journalId=1316781422847033486, articleId=1317885695637701319, doi=null, pmid=null, pmcid=null, year=2026, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=2, rfOrder=2, authorNames=You H, Maiwall R, Chen J, journalName=Hepatol Int, refType=null, unstructuredReference=You H, Maiwall R, Chen J, et al. APASL clinical practice guidelines on the management of chronic hepatitis B infection: A 2026 update[J]. Hepatol Int, 2026. DOI: 10.1007/s12072-026-11108-1. [Epub ahead of print], articleTitle=APASL clinical practice guidelines on the management of chronic hepatitis B infection: A 2026 update, refAbstract=null), Reference(id=1317885699265774324, tenantId=1146029695717560320, journalId=1316781422847033486, articleId=1317885695637701319, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=3, rfOrder=3, authorNames=国家药品监督管理局药品审评中心, journalName=null, refType=null, unstructuredReference=国家药品监督管理局药品审评中心. 慢性乙型肝炎病毒感染治疗药物临床试验技术指导原则[EB/OL]. (2023-04-25)[2026-07-16]. https://www.cde.org.cn/main/att/download/dcb4a9d069bffa935f7481f35139509b., articleTitle=慢性乙型肝炎病毒感染治疗药物临床试验技术指导原则, refAbstract=null), Reference(id=1317885699324494581, tenantId=1146029695717560320, journalId=1316781422847033486, articleId=1317885695637701319, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=3, rfOrder=4, authorNames=Center for Drug Evaluation, National Medical Products Administration, journalName=null, refType=null, unstructuredReference=Center for Drug Evaluation, National Medical Products Administration. Technical guidance for clinical trials of therapeutic drugs for chronic hepatitis B virus infection[EB/OL]. (2023-04-25)[2026-07-16]. https://www.cde.org.cn/main/att/download/dcb4a9d069bffa935f7481f35139509b., articleTitle=Technical guidance for clinical trials of therapeutic drugs for chronic hepatitis B virus infection, refAbstract=null), Reference(id=1317885699395797750, tenantId=1146029695717560320, journalId=1316781422847033486, articleId=1317885695637701319, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=4, rfOrder=5, authorNames=国家药品监督管理局药品审评中心, journalName=null, refType=null, unstructuredReference=国家药品监督管理局药品审评中心. 《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[EB/OL]. (2026-07-06)[2026-07-16]. https://www.cde.org.cn/main/att/download/b5c643fc45ce555042ba839e8d94c10f., articleTitle=《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, refAbstract=null), Reference(id=1317885699555181303, tenantId=1146029695717560320, journalId=1316781422847033486, articleId=1317885695637701319, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=4, rfOrder=6, authorNames=Center for Drug Evaluation, National Medical Products Administration, journalName=null, refType=null, unstructuredReference=Center for Drug Evaluation, National Medical Products Administration. Q&A Document for the technical guidance for clinical trials of therapeutic drugs for chronic hepatitis B virus infection[EB/OL]. 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