Article(id=1291404829000200406, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.11.018, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1733760000000, receivedDateStr=2024-12-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824504375, onlineDateStr=2026-08-04, pubDate=1750089600000, pubDateStr=2025-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824504375, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824504375, creator=13701087609, updateTime=1785824504375, updator=13701087609, issue=Issue{id=1291404791758975909, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1750089600000', pubDateStr='2025-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824495496, creator='13701087609', updateTime=1785824495496, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1602, endPage=1607, ext={EN=ArticleExt(id=1291404829428019415, articleId=1291404829000200406, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Pharmacodynamic study of dirozalkib, columnId=1291404810335539455, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacodynamics Study, runingTitle=null, highlight=null, articleAbstract=
Objective To study the in vitro and in vivo pharmacodynamics of dirozalkib.
Methods Prepare dirozalkib solutions with concentrations ranging from 3.81×10-3 to 1 000.00 nmol·L-1. The activities of dirozalkib against kinases anaplastic lymphoma kinase (ALK), ALK-L1196M, and ALK-G1202R were evaluated using the Mobility Shift Assay and Radioisotope Filter Binding methods. The inhibitory effect of dirozalkib on cell proliferation was evaluated using the CellTiter-Glo assay in multiple Ba/F3 cell lines transfected with EML4-ALK fusion genes and drug-resistant mutants, at concentrations ranging from 1.53×10-2 to 1 000.00 nmol·L-1. Ba/F3-EML4-ALK-L1196M (crizotinib-resistant) cells were subcutaneously inoculated in NOD SCID mice. The tumor-bearing mice were randomly divided into blank group (solvent control), experimental group (50 mg·kg-1 dirozalkib), control group (50 mg·kg-1 crizotinib), each group consisted of 9 mice. The mice were gavage once a day, continuous administration over a 14-day period. BALB/c nude mice were used to establish a human lung cancer tumor tissue-derived LU-01-0319R (crizotinib-resistant) patient-derived tumor xenograft (PDX) model. The tumor-bearing mice were randomly divided into blank group (solvent control), experimental group (24 mg·kg-1 dirozalkib), control group (24 mg·kg-1 crizotinib), each group consisted of 9 mice. The mice were gavage once a day, continuous administration over a 21-day period. Human lung cancer H228-luc cells were intracranially inoculated in BALB/c nude mice. The tumor-bearing mice were randomly divided into blank group (solvent control), experimental group (100 mg·kg-1 dirozalkib), control group (100 mg·kg-1 crizotinib), each group consisted of 9 mice. The mice were gavage once a day, continuous administration over a 14-day period. Assessed the anti-tumor efficacy of dirozalkib.
Results Dirozalkib significantly inhibited the kinase activities of ALK, ALK-L1196M, and ALK-G1202R [50% inhibiting concentration (IC50) <1.0 nmol·L-1]. In cells, dirozalkib exhibited significant proliferation inhibitory activity against NCI-H3122 cells harboring EML4-ALK fusion (IC50 = 3.00 nmol·L-1). Additionally, it demonstrated potent inhibitory activity against multiple cell lines with EML4-ALK fusion and drug-resistant mutants of crizotinib and second-generation ALK inhibitors (IC50: 1.92-62.85 nmol·L-1). In the crizotinib-resistant Ba/F3-EML4-ALK-L1196M xenograft model, dirozalkib at a dose of 50 mg·kg-1 had a significant anti-tumor effect, with a relative tumor proliferation rate of 6.14%. In the LU-01-0319R human lung cancer xenograft model (crizotinib-resistant PDX model), the 24 mg·kg-1 dirozalkib also had a significant tumor inhibitory effect, with a relative tumor proliferation rate of 13.19%. For the H228-luc human lung cancer intracranial inoculation model, dirozalkib at 100 mg·kg-1 could significantly inhibit tumor growth [BLI value was (569.34±153.65) × 105 photons·s-1]and could significantly prolong the survival time of the animals.
Conclusion Dirozalkib effectively inhibits ALK and various resistance mutations associated with first- and second-generation ALK-TKIs, and shows significant antitumor activity in multiple tumor models, including intracranial implantation models.
, authors=Ben-ke JIANG, Pan ZHAO, Feng WANG, Jia-kui LI, Hui-min ZHOU, authorsList=Ben-ke JIANG, Pan ZHAO, Feng WANG, Jia-kui LI, Hui-min ZHOU, authorCompany=null, correspAuthors=Hui-min ZHOU, 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=1291404830719865048, articleId=1291404829000200406, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=地罗阿克的药效学研究, columnId=1291404810494923009, journalTitle=中国临床药理学杂志, columnName=药效学研究, runingTitle=null, highlight=null, articleAbstract=
方法 配制3.81×10-3~1 000.00 nmol·L-1地罗阿克溶液，用Mobility Shift Assay和Radioisotope Filter Binding方法评价地罗阿克对间变淋巴瘤激酶（ALK）、ALK-L1196M、ALK-G1202R的活性。用CellTiter-Glo试剂盒在多株转染EML4-ALK融合基因及耐药突变型的Ba/F3细胞上考察1.53×10-2~1 000.00 nmol·L-1地罗阿克对细胞的增殖抑制作用。在NOD SCID小鼠皮下接种Ba/F3-EML4-ALK-L1196M（克唑替尼耐药）细胞，随机分为空白组（溶剂对照）、实验组（50 mg·kg-1地罗阿克）和对照组（50 mg·kg-1克唑替尼），每组9只，每天灌胃给药1次，连续给药14 d。用BALB/c裸鼠建立人肺癌肿瘤组织来源的LU-01-0319R（克唑替尼耐药）病人来源肿瘤异种移植（PDX）模型，随机分为空白组（溶剂对照）、实验组（24 mg·kg-1地罗阿克）和对照组（24 mg·kg-1克唑替尼），每组9只，每天灌胃给药1次，连续给药21 d。在BALB/c裸鼠颅内接种人源肺癌H228-luc细胞，随机分为空白组（溶剂对照）、实验组（100 mg·kg-1地罗阿克）和对照组（100 mg·kg-1克唑替尼），每组9只，每天灌胃给药1次，连续给药14 d。评价地罗阿克的抗肿瘤作用。
结果 地罗阿克对ALK、ALK-L1196M、ALK-G1202R激酶活性均有明显抑制作用[半数抑制浓度（IC50）均小于1.0 nmol·L-1]。地罗阿克对EML4-ALK融合的细胞株（NCI-H3122）具有显著的增殖抑制活性（IC50=3.00 nmol·L-1），对于具有EML4-ALK融合的细胞株以及克唑替尼和2代酪氨酸激酶抑制药（ALK-TKI）耐药突变株均具有较强的抑制活性（IC50：1.92~62.85 nmol·L-1）。在克唑替尼耐药的Ba/F3-EML4-ALK-L1196M异种移植模型上，50 mg·kg-1地罗阿克有显著的抗肿瘤作用，相对肿瘤增殖率为6.14%；在LU-01-0319R人源肺癌异种移植模型（克唑替尼耐药PDX模型）上，24 mg·kg-1地罗阿克有显著的抑瘤作用，相对肿瘤增殖率为13.19%；对于H228-luc人源肺癌颅内接种模型，100 mg·kg-1地罗阿克能够显著抑制肿瘤生长，肿瘤部位光学信号强度（BLI）值为（569.34±153.65）× 105 photons·s-1，且能显著延长动物的存活时间。
结论 地罗阿克能够很好地抑制ALK及多种一代、二代ALK-TKI的耐药突变，在多种肿瘤模型（包括颅内接种模型）中均表现出了显著的抗肿瘤作用。
, authors=姜本科, 赵盼, 王凤, 李嘉逵, 周慧敏, authorsList=姜本科, 赵盼, 王凤, 李嘉逵, 周慧敏, authorCompany=null, correspAuthors=周慧敏, authorNote=
姜本科（1995- ），男，硕士研究生，主要从事创新药物研发的相关工作
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