Article(id=1321425754202689760, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425746170597545, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.13.005, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1760457600000, acceptedDateStr=2025-10-15, onlineDate=1792982050705, onlineDateStr=2026-10-26, pubDate=1784044800000, pubDateStr=2026-07-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982050705, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982050705, creator=13701087609, updateTime=1792982050705, updator=13701087609, issue=Issue{id=1321425746170597545, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='13', pageStart='1345', pageEnd='1456', issueExtLink='null', onlineDate='null', pubDate='1784044800000', pubDateStr='2026-07-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982048790, creator='13701087609', updateTime=1792982953102, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429539205534609, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425746170597545, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429539205534610, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425746170597545, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1372, endPage=1377, ext={EN=ArticleExt(id=1321425754362073313, articleId=1321425754202689760, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Progress in the implementation of conditional approval process for drugs in China: a pooled analysis from 2020 to 2024, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To conduct a comprehensive analysis of drugs marketed through the conditional approval process in China from 2020 to 2024, along with recommendations for improving this process.
Methods: Drugs conditionally approved during the study period were identified through the National Medical Products Administration public data, the Center for Drug Evaluation public data, and the Yaozhi Database. The basic information, pre-market clinical trial studies, and post-marketing study requirements and progress were collected and analyzed.
Results: A total of 143 approved matters were marketed through the conditional approval process. Key characteristics included: R&D resources were highly concentrated on antineoplastic drugs, a high percentage of applications in pre-market pivotal clinical trials were based on surrogate endpoints, and the conversion rate of drugs from conditional approval to full approval was low.
Conclusion: It is necessary to strengthen the guidance provided by drug regulatory and relevant departments, establish a system for recognizing surrogate endpoints, and improve the flexibility of the conditional approval process.
, authors=Li WANG, Xiang-qi ZHAO, Gui-yu LIAN
*, Zhe HUANG
*, authorsList=Li WANG, Xiang-qi ZHAO, Gui-yu LIAN, Zhe HUANG, authorCompany=null, correspAuthors=Gui-yu LIAN, Zhe HUANG, 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=1321425754609537250, articleId=1321425754202689760, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=我国药品附条件批准程序实施进展：2020—2024年汇总分析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=
目的： 对2020—2024年我国附条件批准药物进行系统分析，为完善我国药品附条件批准程序提供建议和参考。
方法： 通过国家药品监督管理局公开数据库、国家药品监督管理局药品审评中心公开数据库和药智数据库确定研究期间附条件批准的所有药品，收集并分析其基本信息、上市前临床试验研究和上市后研究要求与进展。
结果： 共有143个获批事项经由附条件批准程序上市，其特点包括：研发资源高度集中于抗肿瘤药物、替代终点在上市前关键临床试验中的应用占比较高、附条件批准药品转常规批准的转换率较低。
结论： 需加强药品监管等相关部门的导向作用，建立替代终点认定制度，提高附条件批准程序的灵活性。
, authors=王莉, 赵祥琦, 连桂玉
*, 黄哲
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