Article(id=1322127440458138127, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, articleNumber=null, orderNo=null, doi=null, 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=1624464000000, acceptedDateStr=2021-06-24, onlineDate=1793149345745, onlineDateStr=2026-10-28, pubDate=1640793600000, pubDateStr=2021-12-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793149345745, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793149345745, creator=13701087609, updateTime=1793149345745, updator=13701087609, issue=Issue{id=1322127420036071763, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='24', pageStart='2225', pageEnd='2327', issueExtLink='null', onlineDate='null', pubDate='1640793600000', pubDateStr='2021-12-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793149340876, creator='13701087609', updateTime=1793149575427, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128403881374295, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128403881374296, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2234, endPage=2241, ext={EN=ArticleExt(id=1322127440672047632, articleId=1322127440458138127, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Reflections on patent management under the situation of accelerated approval of new drugs based on an analysis of the research and development process of osimertinib, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The research and development process of osimertinib was prompted by new drug expedited programs in the US, which resulted in the highly coincident time periods of drug registration and patent examination. Based on the review of the research and development process and patent strategy of osimertinib, the opportunities and challenges of pioneering new drugs and follow-on drugs under the global trend of accelerating approval process were analyzed. The exploration of special patent examination management such as creating a fast-track for drugs undergoing clinical trials was proposed to strengthen the protection of innovations.

, authors=Qian YANG, Chun-peng JIN, Ru ZHENG, Qiu-juan MA, authorsList=Qian YANG, Chun-peng JIN, Ru ZHENG, Qiu-juan MA, authorCompany=null, correspAuthors=Qiu-juan 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=1322127440919511569, articleId=1322127440458138127, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新药加速审批形势下对专利管理工作的思考——基于奥希替尼研发历程的分析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

奥希替尼在美国获得多种特殊审评模式激励,新药注册审批与专利审查的时间周期高度重合。本文通过回溯奥希替尼的研发历程及其专利策略的特点,分析了药品加速审评审批的全球大趋势下首创型新药和跟进型新药研发过程中的机遇与挑战,在此基础上,提出探索建立创新药专利专项审查管理工作机制,针对进入临床阶段的创新药开辟专利审查快速通道,为创制安全有效的新药保驾护航。

, authors=杨倩, 靳春鹏, 郑茹, 马秋娟, authorsList=杨倩, 靳春鹏, 郑茹, 马秋娟, authorCompany=null, correspAuthors=马秋娟, authorNote=

靳春鹏,男,硕士,副研究员,研究方向:医药领域知识产权政策。E-mail:。

杨倩,女,博士,副研究员,研究方向:医药领域知识产权政策。E-mail:。

, correspAuthorsNote=
马秋娟,女,博士,研究员,研究方向:医药领域知识产权政策。联系电话:(010)53960066,E-mail:。
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杨倩,女,博士,副研究员,研究方向:医药领域知识产权政策。E-mail:。

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杨倩,女,博士,副研究员,研究方向:医药领域知识产权政策。E-mail:。

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新药加速审批形势下对专利管理工作的思考——基于奥希替尼研发历程的分析
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杨倩 , 靳春鹏 , 郑茹 , 马秋娟
中国新药杂志 | 新药述评与论坛 2021,30(24): 2234-2241
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中国新药杂志 |新药述评与论坛 2021 , 30 (24) : 2234 -2241
新药加速审批形势下对专利管理工作的思考——基于奥希替尼研发历程的分析
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杨倩 , 靳春鹏 , 郑茹, 马秋娟
作者信息
  • 国家知识产权局专利局专利审查协作北京中心,北京 100160
通讯作者:
马秋娟,女,博士,研究员,研究方向:医药领域知识产权政策。联系电话:(010)53960066,E-mail:。
作者简介:

靳春鹏,男,硕士,副研究员,研究方向:医药领域知识产权政策。E-mail:。

杨倩,女,博士,副研究员,研究方向:医药领域知识产权政策。E-mail:。

Reflections on patent management under the situation of accelerated approval of new drugs based on an analysis of the research and development process of osimertinib
Qian YANG , Chun-peng JIN , Ru ZHENG, Qiu-juan MA
Affiliations
  • Patent Examination Corporation Center of Beijing, China National Intellectual Property Administration, Beijing 100160, China
出版时间: 2021-12-30
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奥希替尼在美国获得多种特殊审评模式激励,新药注册审批与专利审查的时间周期高度重合。本文通过回溯奥希替尼的研发历程及其专利策略的特点,分析了药品加速审评审批的全球大趋势下首创型新药和跟进型新药研发过程中的机遇与挑战,在此基础上,提出探索建立创新药专利专项审查管理工作机制,针对进入临床阶段的创新药开辟专利审查快速通道,为创制安全有效的新药保驾护航。

新药特殊审评模式  /  专利布局  /  专利管理  /  奥希替尼

The research and development process of osimertinib was prompted by new drug expedited programs in the US, which resulted in the highly coincident time periods of drug registration and patent examination. Based on the review of the research and development process and patent strategy of osimertinib, the opportunities and challenges of pioneering new drugs and follow-on drugs under the global trend of accelerating approval process were analyzed. The exploration of special patent examination management such as creating a fast-track for drugs undergoing clinical trials was proposed to strengthen the protection of innovations.

new drug expedited programs  /  patent strategy  /  patent management  /  osimertinib
杨倩, 靳春鹏, 郑茹, 马秋娟. 新药加速审批形势下对专利管理工作的思考——基于奥希替尼研发历程的分析. 中国新药杂志, 2021 , 30 (24) : 2234 -2241 .
Qian YANG, Chun-peng JIN, Ru ZHENG, Qiu-juan MA. Reflections on patent management under the situation of accelerated approval of new drugs based on an analysis of the research and development process of osimertinib[J]. Chinese Journal of New Drugs, 2021 , 30 (24) : 2234 -2241 .

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  • 首发时间:2026-10-28
  • 出版时间:2021-12-30
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  • 录用日期:2021-06-24
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    国家知识产权局专利局专利审查协作北京中心,北京 100160

通讯作者:

马秋娟,女,博士,研究员,研究方向:医药领域知识产权政策。联系电话:(010)53960066,E-mail:。
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
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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