Article(id=1291404877784150573, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404807152067353, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.08.023, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1728489600000, receivedDateStr=2024-10-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824516006, onlineDateStr=2026-08-04, pubDate=1745769600000, pubDateStr=2025-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824516006, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824516006, creator=13701087609, updateTime=1785824516006, updator=13701087609, issue=Issue{id=1291404807152067353, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1745769600000', pubDateStr='2025-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824499166, creator='13701087609', updateTime=1785824499166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1180, endPage=1185, ext={EN=ArticleExt(id=1291404877985477166, articleId=1291404877784150573, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Research progress of - bireociclib - a new cyclin-dependent kinase 4 and 6 inhibitor, columnId=1246531408630534361, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Review, runingTitle=null, highlight=null, articleAbstract=

Bireociclib, a novel selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, demonstrates significant therapeutic benefits in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. As a monotherapy in later-line treatment, it substantially improves objective response rate (ORR), prolongs median progression-free survival (PFS), and extends median overall survival (OS). When combined with fulvestrant as a second-line therapy, it significantly delays disease progression and reduces mortality risk. Currently, marketing authorization applications for Bireociclib monotherapy in breast cancer and its combination with fulvestrant for advanced breast cancer have been submitted to National Medical Products Administration. The phase Ⅲ clinical trial investigating its first-line use in combination with letrozole/anastrozole is nearing completion. This article comprehensively reviews Bireociclib’s molecular structure, pharmacodynamic properties, pharmacokinetic characteristics, etc.

, authors=Pan ZHAO, Hui-min ZHOU, Bo CHEN, Feng WANG, Jia-kui LI, Xi-feng MA, authorsList=Pan ZHAO, Hui-min ZHOU, Bo CHEN, Feng WANG, Jia-kui LI, Xi-feng MA, authorCompany=null, correspAuthors=Xi-feng MA, 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=1291404878274884143, articleId=1291404877784150573, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=细胞周期蛋白依赖性激酶4/6抑制药吡洛西利的研究进展, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

吡洛西利作为新型细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制药，对于激素受体（HR）阳性/人表皮生长因子受体2（HER2）阴性的晚期或转移性乳腺癌患者，其单药后线治疗可以显著提高患者的客观缓解率（ORR）、延长中位无进展生存期（PFS）和中位总生存期（OS）；联合氟维司群二线治疗可以显著延缓疾病进展或降低死亡风险。目前，吡洛西利单药后线治疗乳腺癌患者以及吡洛西利联合氟维司群二线治疗晚期乳腺癌患者的上市申请已提交国家药品监督管理局，联合来曲唑/阿那曲唑一线治疗的Ⅲ期临床试验即将完成。本文旨在从化合物结构、药理学的特点及临床研究等方面对吡洛西利进行阐述。

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赵盼（1988-），女，硕士研究生，中级工程师，主要从事创新药物研发的相关工作

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赵盼（1988-），女，硕士研究生，中级工程师，主要从事创新药物研发的相关工作

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