Article(id=1291707079639724277, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707004800750583, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.22.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1757865600000, receivedDateStr=2025-09-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896566542, onlineDateStr=2026-08-05, pubDate=1764259200000, pubDateStr=2025-11-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896566542, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896566542, creator=13701087609, updateTime=1785896566542, updator=13701087609, issue=Issue{id=1291707004800750583, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='22', pageStart='3151', pageEnd='3300', issueExtLink='null', onlineDate='null', pubDate='1764259200000', pubDateStr='2025-11-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896548700, creator='13701087609', updateTime=1785896693213, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707610999316815, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707004800750583, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707610999316816, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707004800750583, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3284, endPage=3289, ext={EN=ArticleExt(id=1291707081636212982, articleId=1291707079639724277, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial design considerations for advanced therapy medicinal products in dystrophic epidermolysis bullosa, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Dystrophic epidermolysis bullosa (DEB) is a mechanobullous disorder caused by mutations in the COL7A1 gene encoding type VII collagen. It has been included in China’s Rare Disease List, with clinical management primarily focused on preventing mechanical trauma and infections. In recent years, significant progress has been made in the development of advanced therapy medicinal products (ATMPs) for DEB, with two products already approved for marketing and multiple others undergoing clinical trials. This article reviews the fundamental characteristics of both approved and investigational ATMPs for DEB and discusses key considerations in clinical trial design, aiming to provide valuable insights for the clinical development of advanced therapies for this condition.

, authors=Chen-yang ZHAO, Shuang LU, authorsList=Chen-yang ZHAO, Shuang LU, authorCompany=null, correspAuthors=Shuang LU, 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=1291707082013700343, articleId=1291707079639724277, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=营养不良型大疱性表皮松解症先进治疗药品临床试验设计考量, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

营养不良型大疱性表皮松解症（DEB）是由编码Ⅶ型胶原α1链的COL7A1基因发生突变所引起的机械性大疱性疾病，已纳入我国罕见病目录，临床治疗上以防止机械性损伤和感染为主。近年来，先进治疗药品研发进展迅速，2个产品获批上市用于该疾病的治疗，另有多个产品开展临床试验。本文基于治疗DEB的已上市和处于研发阶段的先进治疗药品的基本情况，探讨临床试验设计的关键要素，旨在为DEB先进治疗药品的临床研发提供有益参考。

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赵晨阳（1990-），女，副研究员，主要从事细胞和基因治疗药品审评与监管科学研究

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赵晨阳（1990-），女，副研究员，主要从事细胞和基因治疗药品审评与监管科学研究

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