Article(id=1242137592657949237, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1242137589919068720, articleNumber=null, orderNo=3, doi=10.3981/j.issn.1000-7857.2019.11.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1548604800000, receivedDateStr=2019-01-28, revisedDate=1549296000000, revisedDateStr=2019-02-05, acceptedDate=null, acceptedDateStr=null, onlineDate=1561025569627, onlineDateStr=2019-06-20, pubDate=1560355200000, pubDateStr=2019-06-13, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1561025569627, onlineIssueDateStr=2019-06-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1774078279885, creator=sys-migrate, updateTime=1774078279886, updator=sys-migrate, issue=Issue{id=1242137589919068720, tenantId=1146029695717560320, journalId=1146031591421210625, year='2019', volume='37', issue='11', pageStart='1', pageEnd='108', issueExtLink='null', onlineDate='null', pubDate='1560355200000', pubDateStr='2019-06-13', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=null, issueType=-1, specialIssue=null, createTime=1774078279233, creator='sys-migrate', updateTime=1774078279233, updator='sys-migrate', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=6, endPage=8, ext={EN=ArticleExt(id=1242137596030165695, articleId=1242137592657949237, tenantId=1146029695717560320, journalId=1146031591421210625, language=EN, title=Why did FDA grant Zanubrutinib breakthrough designation for mantle cell lymphoma?, columnId=1242136927416168874, journalTitle=Science & Technology Review, columnName=Scientific Comments, runingTitle=null, highlight=null, articleAbstract=The U.S. Food and Drug Administration (FDA) has granted the investigational BTK inhibitor Zanubrutinib (BGB-3111) a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least 1 prior therapy, on Jan. 15th 2019. This paper introduced the definition of the breakthrough therapy designation, the breakthrough achievements of Zanubrutinib, the significance of this event to Chinese pharmaceutical R&D enterprises., authors=ZHANG Hongtao, authorsList=ZHANG Hongtao, authorCompany=Pathology and Laboratory Medicine, Perelman School of Medicine, Philadelphia 19104, USA, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=TbHw0mDjHfuOO0hYz5E0Jg==, pdfFileSize=843477, 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=1242137595245834809, articleId=1242137592657949237, tenantId=1146029695717560320, journalId=1146031591421210625, language=CN, title=中国第一个获得美国FDA“突破性疗法”认证的抗癌新药,到底好在哪?, columnId=1150494642043760854, journalTitle=科技导报, columnName=科技评论, runingTitle=null, highlight=null, articleAbstract=2019年1月15日,美国食品和药物管理局(FDA)授予了一款在研的布鲁顿氏酪氨酸激酶(BTK)抑制剂泽布替尼(Zanubrutinib)突破性疗法认证,用于治疗先前接受至少一次疗法的成年套细胞淋巴瘤(MCL)患者,这也成为首个在FDA获得突破性疗法认定的中国自主研发抗癌新药。介绍了突破性疗法认证的定义,讲述了新型布鲁顿氏酪氨酸激酶抑制剂泽布替尼的特点,阐述了其对中国医药研发企业的意义。, authors=张洪涛, authorsList=张洪涛, authorCompany=宾夕法尼亚大学医学院病理及实验医学系, 美国费城 19104, correspAuthors=null, authorNote=张洪涛,副教授,研究方向为癌症靶向治疗、免疫治疗,电子信箱:zhanghon@mail.upenn.edu, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=PftQ4MKyj2qhd05WRDoxlQ==, pdfFileSize=843477, 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)}, authors=null, keywords=[Keyword(id=1242137593521975862, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242137592657949237, language=CN, orderNo=1, keyword=突破性疗法认证), Keyword(id=1242137593614250551, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242137592657949237, language=CN, orderNo=1, keyword=抗癌药), Keyword(id=1242137595107422776, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242137592657949237, language=CN, orderNo=1, keyword=泽布替尼), Keyword(id=1242137595703009980, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242137592657949237, language=EN, orderNo=1, keyword=breakthrough designation), Keyword(id=1242137595791090365, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242137592657949237, language=EN, orderNo=1, keyword=anticancer drugs), Keyword(id=1242137595870782142, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242137592657949237, language=EN, orderNo=1, keyword=Zanubrutinib)], refs=null, funds=null, companyList=null, figs=null, attaches=null, journal=Journal(id=1125356956822126595, delFlag=0, nameCn=科技导报, nameEn=Science & Technology Review, nameHistory1=null, nameHistory2=null, issn=1000-7857, eissn=, cn=11-1421/N, coden=null, periodic=3, language=CN, oaType=0, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=wfghvu3bhh/dKxuZ+ucVHA==, journalPrice=null, startedYear=null, abbrevIsoEn=Sci Technol Rev, journalRemark=null, publicationField=null, createdTime=null, updatedTime=1774230116083, createdBy=null, updatedBy=13041195026, firstLetterCn=S, firstLetterEn=S, subjectCode=Natural Sciences, subjectName=自然科学, subjectCodeEn=Natural Sciences, subjectNameEn=null, picCn=wfghvu3bhh/dKxuZ+ucVHA==, picEn=yjSfclmpNm7ihn9NbTZ69g==, jcr=null, cjcr=null, exts=[JournalExt(id=1242774439910290156, language=CN, name=科技导报, nameHistory1=null, nameHistory2=null, managedBy=中国科学技术协会, sponsoredBy=中国科学技术协会, publishedBy=科技导报社, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=http://www.kjdb.org/CN/home, createdTime=1774230116107, updatedTime=1774230116107, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=http://www.kjdb.org/CN/column/column7.shtml, submissionAuthorUrl=https://kjdbauthor.cast.org.cn/webm, submissionEditorUrl=https://kjdbeditor.cast.org.cn/webm/, submissionReviewUrl=https://kjdbauthor.cast.org.cn/webm, submissionCeEditorUrl=https://kjdbeditor.cast.org.cn/webm/, submissionAeEditorUrl=https://kjdbeditor.cast.org.cn/webm/, option={"copyright":""}), JournalExt(id=1242774439960621805, language=EN, name=Science & Technology Review, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=http://www.kjdb.org/EN/home, createdTime=1774230116119, updatedTime=1774230116119, createdBy=13041195026, updatedBy=13041195026, submissionGuidelinesUrl=http://www.kjdb.org/EN/column/column7.shtml, submissionAuthorUrl=https://kjdbauthor.manuscriptcloud.com/login, submissionEditorUrl=https://kjdbeditor.manuscriptcloud.com/login, submissionReviewUrl=https://kjdbauthor.manuscriptcloud.com/login, submissionCeEditorUrl=https://kjdbeditor.manuscriptcloud.com/login, submissionAeEditorUrl=https://kjdbeditor.manuscriptcloud.com/login, option={"copyright":""})], databaseList=null, tenantJournalId=1146031591421210625, websiteList=[Website(id=1146104741081231361, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1146031591421210625, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/kjdb/CN, language=CN, createTime=1751182263881, createBy=18614031015, updateTime=1751778001962, updateBy=18614031015, name=科技导报, tplId=1146099689490845704, title=科技导报, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1148021146403992296, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=articleTextType, value=kx, createTime=1751639170504, updateTime=1751639170504, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146378826469, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=banner, value=null, createTime=1751639170498, updateTime=1751639170498, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146366243556, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=logo, value=https://castjournals.cast.org.cn/joweb/kjdb/CN/file/pic?fileId=9GHSf7eGlIPH0Tv/OOdstA==, createTime=1751639170495, updateTime=1751639170495, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146395603687, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/kjdb/CN/file/pic, createTime=1751639170502, updateTime=1751639170502, creator=18614031015, updator=18614031015), WebsiteProps(id=1148021146387215078, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146104741081231361, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1751639170500, updateTime=1751639170500, creator=18614031015, updator=18614031015)]), Website(id=1146105254833139715, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1146031591421210625, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/kjdb/EN, language=EN, createTime=1751182386363, createBy=18614031015, updateTime=1753500121937, updateBy=18614031015, name=科技导报, tplId=1146101810881728533, title=Science & Technology Review, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1155838567709528217, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=articleTextType, value=kx, createTime=1753502988984, updateTime=1753502988984, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567692750998, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=banner, value=null, createTime=1753502988980, updateTime=1753502988980, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567688556693, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=logo, value=https://castjournals.cast.org.cn/joweb/kjdb/EN/file/pic?fileId=9GHSf7eGlIPH0Tv/OOdstA==, createTime=1753502988979, updateTime=1753502988979, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567705333912, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/kjdb/EN/file/pic, createTime=1753502988983, updateTime=1753502988983, creator=18614031015, updator=18614031015), WebsiteProps(id=1155838567701139607, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1146105254833139715, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1753502988982, updateTime=1753502988982, creator=18614031015, updator=18614031015)])], journalTitle=科技导报, weixinUrl=null, journalUrl=null, iacademicId=null, status=1, seqNo=null, journalTitleEn=Science & Technology Review, journalPhotoCn=wfghvu3bhh/dKxuZ+ucVHA==, journalPhotoEn=yjSfclmpNm7ihn9NbTZ69g==, journalFirstLetter=S, journalRecommend=null, journalNew=null, journalCollection=1, jcrJf=null, cjcrJf=0.91, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false, interPubPlatform=null, interPubPlatformUrl=null), detailUrlCn=https://castjournals.cast.org.cn/joweb/kjdb/CN/10.3981/j.issn.1000-7857.2019.11.001, detailUrlEn=https://castjournals.cast.org.cn/joweb/kjdb/EN/10.3981/j.issn.1000-7857.2019.11.001, pdfUrlCn=https://castjournals.cast.org.cn/joweb/kjdb/CN/PDF/10.3981/j.issn.1000-7857.2019.11.001, pdfUrlEn=https://castjournals.cast.org.cn/joweb/kjdb/EN/PDF/10.3981/j.issn.1000-7857.2019.11.001, aliStartDate=null, aliEndDate=null, collectionFlag=false, citedCount=null, citedUrl=null, previewStatus=0, delFlag=0, hasFullText=0, orderTime=1560355200000, fullTextJson=null, articleText=null, reference=null)
收藏切换
中国第一个获得美国FDA“突破性疗法”认证的抗癌新药,到底好在哪?
收藏切换
PDF下载
科技导报 | 科技评论 2019,37(11): 6-8
收起
收藏切换
科技导报 | 科技评论 2019, 37(11): 6-8
中国第一个获得美国FDA“突破性疗法”认证的抗癌新药,到底好在哪?
全屏
张洪涛
作者信息
    宾夕法尼亚大学医学院病理及实验医学系, 美国费城 19104
Why did FDA grant Zanubrutinib breakthrough designation for mantle cell lymphoma?
Affiliations
出版时间: 2019-06-13 doi: 10.3981/j.issn.1000-7857.2019.11.001
文章导航
收藏切换
2019年1月15日,美国食品和药物管理局(FDA)授予了一款在研的布鲁顿氏酪氨酸激酶(BTK)抑制剂泽布替尼(Zanubrutinib)突破性疗法认证,用于治疗先前接受至少一次疗法的成年套细胞淋巴瘤(MCL)患者,这也成为首个在FDA获得突破性疗法认定的中国自主研发抗癌新药。介绍了突破性疗法认证的定义,讲述了新型布鲁顿氏酪氨酸激酶抑制剂泽布替尼的特点,阐述了其对中国医药研发企业的意义。
突破性疗法认证  /  抗癌药  /  泽布替尼
The U.S. Food and Drug Administration (FDA) has granted the investigational BTK inhibitor Zanubrutinib (BGB-3111) a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least 1 prior therapy, on Jan. 15th 2019. This paper introduced the definition of the breakthrough therapy designation, the breakthrough achievements of Zanubrutinib, the significance of this event to Chinese pharmaceutical R&D enterprises.
breakthrough designation  /  anticancer drugs  /  Zanubrutinib
张洪涛. 中国第一个获得美国FDA“突破性疗法”认证的抗癌新药,到底好在哪?. 科技导报, 2019 , 37 (11) : 6 -8 . DOI: 10.3981/j.issn.1000-7857.2019.11.001
ZHANG Hongtao. Why did FDA grant Zanubrutinib breakthrough designation for mantle cell lymphoma?[J]. Science & Technology Review, 2019 , 37 (11) : 6 -8 . DOI: 10.3981/j.issn.1000-7857.2019.11.001
2019年第37卷第11期
PDF下载
319
86
引用本文
BibTeX
文章信息
doi: 10.3981/j.issn.1000-7857.2019.11.001
  • 接收时间:2019-01-28
  • 首发时间:2019-06-20
  • 出版时间:2019-06-13
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期:2019-01-28
  • 修回日期:2019-02-05
基金
作者信息
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/kjdb/CN/10.3981/j.issn.1000-7857.2019.11.001
分享至
全文二维码

扫描看全文

引用本文
BibTeX
本文的引用情况
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
关闭全屏