Article(id=1321425700372992926, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425686888305517, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.11.004, 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=1761148800000, acceptedDateStr=2025-10-23, onlineDate=1792982037871, onlineDateStr=2026-10-26, pubDate=1781452800000, pubDateStr=2026-06-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982037871, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982037871, creator=13701087609, updateTime=1792982037871, updator=13701087609, issue=Issue{id=1321425686888305517, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='11', pageStart='1121', pageEnd='1232', issueExtLink='null', onlineDate='null', pubDate='1781452800000', pubDateStr='2026-06-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982034656, creator='13701087609', updateTime=1792983035368, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429884228977462, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425686888305517, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429884228977463, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425686888305517, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1145, endPage=1151, ext={EN=ArticleExt(id=1321425700557542303, articleId=1321425700372992926, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=General considerations for the CMC research of immune cell therapy products during the investigational new drug, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Immune cell therapy products have demonstrated favorable therapeutic outcomes in the treatment of certain tumors. This article briefly descibes the application status of immune cell therapy products in China. By combining the pharmaceutical issues in investigational new drug (IND) applications and the common issues in regulatory communications for such products, and with reference to relevant domestic and international regulations as well as technical guidelines, it exemplifies the general considerations for pharmaceutical research in IND applicaitons of immune cell therapy products, focusing mainly on raw materials for production (cells for production, in vitro modification systems, and other raw materials for production), manufacturing processes, and quality research and control, in order to provide a reference for the research, development, and application of such products and to promote their clinical translation.

, authors=Chao CHEN, Hui-nan XU, Jing PAN, Bo SHEN^*, authorsList=Chao CHEN, Hui-nan XU, Jing PAN, Bo SHEN, authorCompany=null, correspAuthors=Bo SHEN, 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=1321425701148939168, articleId=1321425700372992926, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=免疫细胞治疗产品新药临床试验申请药学研究的一般考虑, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

免疫细胞治疗产品已在部分肿瘤治疗中取得了良好的疗效。本文简述了我国免疫细胞治疗产品申报情况，并结合此类产品在临床试验申报资料中的药学问题和在沟通交流中的常见问题，参考国内外相关法规和技术指导原则等，重点从生产用原材料（生产用细胞、体外修饰系统、其他生产用原材料）、生产工艺、质量研究与控制方面举例说明了免疫细胞治疗产品新药临床试验申请药学研究的一般考虑，以期为此类产品的研发和申报提供一定参考，促进其临床转化。

, authors=陈超, 徐慧楠, 潘静, 沈波^*, authorsList=陈超, 徐慧楠, 潘静, 沈波, authorCompany=null, correspAuthors=沈波, authorNote=, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=R+51jdf7aM+ecW4hHHORxQ==, magXml=f5gKedt2qcxHxFKpn9abkg==, pdfUrl=null, pdf=lqiea9VdaJ/4cexjHxjbTg==, pdfFileSize=1437583, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=jpfA5BMjwProAvqVeUVZhA==, mapNumber=null, fund=null)}, authors=[Author(id=1321425701463511973, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425700372992926, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=chenchao@gbacdei.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1321425701564175271, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425700372992926, authorId=1321425701463511973, language=EN, stringName=Chao CHEN, firstName=Chao, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Greater Bay Area Center for Drug Evaluation and Inspection of National Medical Products Administration, Shenzhen 518017, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1321425701660644264, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1321425700372992926, authorId=1321425701463511973, language=CN, stringName=陈超, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评检查大湾区分中心，深圳 518017, bio={"content":"

陈超，男，中级工程师，主要从事生物制品药学审评工作。E-mail: chenchao@gbacdei.org.cn。

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陈超，男，中级工程师，主要从事生物制品药学审评工作。E-mail: chenchao@gbacdei.org.cn。

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