Article(id=1291707017698243493, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.00.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1760803200000, receivedDateStr=2025-10-19, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896551774, onlineDateStr=2026-08-05, pubDate=1763308800000, pubDateStr=2025-11-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896551774, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896551774, creator=13701087609, updateTime=1785896551774, updator=13701087609, issue=Issue{id=1291706987964822180, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='21', pageStart='3001', pageEnd='3150', issueExtLink='null', onlineDate='null', pubDate='1763308800000', pubDateStr='2025-11-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896544684, creator='13701087609', updateTime=1785896721343, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707729324826977, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707729324826978, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3125, endPage=3131, ext={EN=ArticleExt(id=1291707017937318822, articleId=1291707017698243493, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Reseach status of non-clinical carcinogenicity studies and evaluations of SGLTs antidiabetic drugs, columnId=1246531408630534361, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Review, runingTitle=null, highlight=null, articleAbstract=

Innovative hypoglycemic drugs generally need to undergo carcinogenicity testing and evaluation during market application to identify the potential carcinogenic efficacy and risks of the drug. This article takes sodium glucose cotransporter protein (SGLTs) inhibitors, a new type of hypoglycemic drugs that do not depend on insulin levels, as the focus of attention for the treatment of diabetes drugs, as an example. Through the drug information disclosed by the National Drug Administration (NMPA), the U.S. Food and Drug Administration (FDA) and other drug regulatory agencies, this article reviews and combs the carcinogenicity test information of SGLTs drugs that have been marketed at home and abroad, and analyzes and elaborates it, with a view to enhancing the understanding of the carcinogenicity of these drugs and providing reference for the development and evaluation of clinical trials of new drugs.

, authors=Zheng LI, Mao-shan YIN, Hua-jing YIN, Yin WANG, Shuang WU, Bing YU, Mu-zhen SUN, Shu-jun FU, authorsList=Zheng LI, Mao-shan YIN, Hua-jing YIN, Yin WANG, Shuang WU, Bing YU, Mu-zhen SUN, Shu-jun FU, authorCompany=null, correspAuthors=Shu-jun FU, 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=1291707018398692264, articleId=1291707017698243493, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=SGLTs糖尿病治疗药物的非临床致癌性研究现状, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

创新性的降糖新药在上市申请时一般需要完成致癌性试验评估,以识别药物的潜在致癌疗效与风险。本文以治疗糖尿病药物的关注焦点钠-葡萄糖共转运蛋白(SGLTs)抑制剂这类不依赖胰岛素水平的新型降糖药为案例,通过国家药品监督管理局(NMPA)和美国食品药品监督局(FDA)等药品监管机构公开的药品信息,回顾及梳理了国内外已上市的SGLTs药物的致癌性试验信息,并进行分析与阐述,以期增强对该类药物致癌性评价的了解,为新药临床试验的研发和评价提供参考。

, authors=李峥, 尹茂山, 尹华静, 王寅, 吴爽, 于冰, 孙沐禛, 付淑军, authorsList=李峥, 尹茂山, 尹华静, 王寅, 吴爽, 于冰, 孙沐禛, 付淑军, authorCompany=null, correspAuthors=付淑军, authorNote=

李峥(1980-),女,博士,主管药师,主要从事新药药理毒理评价研究

, correspAuthorsNote=
付淑军,主任药师 Tel: (010) 80996569 E-mail:
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李峥(1980-),女,博士,主管药师,主要从事新药药理毒理评价研究

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李峥(1980-),女,博士,主管药师,主要从事新药药理毒理评价研究

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SGLTs糖尿病治疗药物的非临床致癌性研究现状
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李峥 , 尹茂山 , 尹华静 , 王寅 , 吴爽 , 于冰 , 孙沐禛 , 付淑军
中国临床药理学杂志 | 综述 2025,41(21): 3125-3131
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中国临床药理学杂志 |综述 2025 , 41 (21) : 3125 -3131
SGLTs糖尿病治疗药物的非临床致癌性研究现状
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李峥, 尹茂山, 尹华静, 王寅, 吴爽, 于冰, 孙沐禛, 付淑军
作者信息
  • 国家药品监督管理局 药品审评中心,北京 100076
通讯作者:
付淑军,主任药师 Tel: (010) 80996569 E-mail:
作者简介:

李峥(1980-),女,博士,主管药师,主要从事新药药理毒理评价研究

Reseach status of non-clinical carcinogenicity studies and evaluations of SGLTs antidiabetic drugs
Zheng LI, Mao-shan YIN, Hua-jing YIN, Yin WANG, Shuang WU, Bing YU, Mu-zhen SUN, Shu-jun FU
Affiliations
  • Centre for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
出版时间: 2025-11-17 doi: 10.13699/j.cnki.1001-6821.2025.00.021
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创新性的降糖新药在上市申请时一般需要完成致癌性试验评估,以识别药物的潜在致癌疗效与风险。本文以治疗糖尿病药物的关注焦点钠-葡萄糖共转运蛋白(SGLTs)抑制剂这类不依赖胰岛素水平的新型降糖药为案例,通过国家药品监督管理局(NMPA)和美国食品药品监督局(FDA)等药品监管机构公开的药品信息,回顾及梳理了国内外已上市的SGLTs药物的致癌性试验信息,并进行分析与阐述,以期增强对该类药物致癌性评价的了解,为新药临床试验的研发和评价提供参考。

糖尿病  /  致癌性试验  /  钠-葡萄糖共转运蛋白

Innovative hypoglycemic drugs generally need to undergo carcinogenicity testing and evaluation during market application to identify the potential carcinogenic efficacy and risks of the drug. This article takes sodium glucose cotransporter protein (SGLTs) inhibitors, a new type of hypoglycemic drugs that do not depend on insulin levels, as the focus of attention for the treatment of diabetes drugs, as an example. Through the drug information disclosed by the National Drug Administration (NMPA), the U.S. Food and Drug Administration (FDA) and other drug regulatory agencies, this article reviews and combs the carcinogenicity test information of SGLTs drugs that have been marketed at home and abroad, and analyzes and elaborates it, with a view to enhancing the understanding of the carcinogenicity of these drugs and providing reference for the development and evaluation of clinical trials of new drugs.

diabetes mellitus  /  carcinogenicity study  /  sodium-glucose cotransporter protein
李峥, 尹茂山, 尹华静, 王寅, 吴爽, 于冰, 孙沐禛, 付淑军. SGLTs糖尿病治疗药物的非临床致癌性研究现状. 中国临床药理学杂志, 2025 , 41 (21) : 3125 -3131 . DOI: 10.13699/j.cnki.1001-6821.2025.00.021
Zheng LI, Mao-shan YIN, Hua-jing YIN, Yin WANG, Shuang WU, Bing YU, Mu-zhen SUN, Shu-jun FU. Reseach status of non-clinical carcinogenicity studies and evaluations of SGLTs antidiabetic drugs[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (21) : 3125 -3131 . DOI: 10.13699/j.cnki.1001-6821.2025.00.021

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doi: 10.13699/j.cnki.1001-6821.2025.00.021
  • 接收时间:2025-10-19
  • 首发时间:2026-08-05
  • 出版时间:2025-11-17
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  • 收稿日期:2025-10-19
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    国家药品监督管理局 药品审评中心,北京 100076

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付淑军,主任药师 Tel: (010) 80996569 E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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