Article(id=1236366099567144961, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, articleNumber=null, orderNo=null, doi=null, 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=1671638400000, acceptedDateStr=2022-12-22, onlineDate=1772702248708, onlineDateStr=2026-03-05, pubDate=1675008000000, pubDateStr=2023-01-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772702248708, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772702248708, creator=13701087609, updateTime=1772702248708, updator=13701087609, issue=Issue{id=1236366095871955240, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='2', pageStart='113', pageEnd='216', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772702247826, creator=13701087609, updateTime=1772702896580, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236368817010561584, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236368817010561585, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236366095871955240, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=118, endPage=122, ext={EN=ArticleExt(id=1236366101135814679, articleId=1236366099567144961, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Interpretation of guidance on CMC study and evaluation of ex vivo genetic manipulation system, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

A large number of investigational new drug (IND) applications of cellular products have been submitted in recent years. Up to October 2022, two cellular products have been approved to be marketed in China, which provide effective therapeutic approach to treat serious diseases. Genetic manipulation systems are used to modify or edit genes in various types of cellular products, including lentivirus, γ-retrovirus, adenovirus, sendaivirus or other viral vectors, as well as DNA, RNA, protein, protein-RNA complex or other non-viral vector systems. A guidance on CMC study and evaluation of ex vivo genetic manipulation systems was issued by CDE, NMPA on May 2022, in order to illustrate criterions on CMC research and evaluation of such systems. This paper provides a detailed interpretation of the guidance, combined with the guidance drafting logic, to help readers better understand the content of the guidance.

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近年来，大量细胞治疗产品申报临床试验，截至2022年10月，我国已有2个细胞治疗产品批准上市，为严重疾病治疗提供了有效的手段。基因修饰系统包括慢病毒、γ-逆转录病毒、腺病毒、仙台病毒等病毒载体系统，以及DNA、RNA、蛋白质和蛋白质-RNA复合物等非病毒载体类系统，目前已应用于多种细胞产品的基因修饰或编辑。为规范基因修饰系统的药学研究和评价，国家药品监督管理局药品审评中心于2022年5月发布了《体外基因修饰系统药学研究与评价技术指导原则（试行）》。本文结合该指南的起草思路，对指南进行解读，以方便读者更好地理解指南内容。

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卢加琪，女，审评员，主要从事生物制品药学研究。联系电话：(010)85243055，E-mail: lujq@cde.org.cn。

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卢加琪，女，审评员，主要从事生物制品药学研究。联系电话：(010)85243055，E-mail: lujq@cde.org.cn。

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李倩，女，审评员，主要从事生物制品药学研究。联系电话：(010)85242986，E-mail: liqian@cde.org.cn。

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李倩，女，审评员，主要从事生物制品药学研究。联系电话：(010)85242986，E-mail: liqian@cde.org.cn。

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