Article(id=1236331164001169688, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, 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=1678636800000, acceptedDateStr=2023-03-13, onlineDate=1772693919420, onlineDateStr=2026-03-05, pubDate=1698595200000, pubDateStr=2023-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772693919420, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772693919420, creator=13701087609, updateTime=1772693919420, updator=13701087609, issue=Issue{id=1236331158678597790, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='20', pageStart='2009', pageEnd='2120', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772693918151, creator=13701087609, updateTime=1772694963216, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335542061814375, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335542061814376, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2022, endPage=2028, ext={EN=ArticleExt(id=1236331164215079196, articleId=1236331164001169688, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of drugs marketed under the U.S. breakthrough therapy designation program and their innovation points, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To understand the innovation points of drugs marketed after the implementation of the U.S. breakthrough therapy designation (BTD) program, and provide a reference basis for the development of innovative drugs and the review of breakthrough therapy drugs in China.
Methods: As of 2021, all BTD drugs approved by the U.S. FDA for marketing were collected, and the characteristics of these drugs in terms of innovative therapeutic modalities, treatment mechanisms, and technological breakthroughs were categorized and statistically analyzed.
Results: The US FDA received 1 192 BTD drug applications and approved 242 for marketing. Among the marketed drugs, 42 (17%) were new drugs to fill clinical treatment gaps, 99 (41%) were drugs for expanded indications and new applicable populations, 27 (21%) were drug combinations for combination therapy, 16 (7%) were new drugs with more clinical treatment advantages, 31 (12.8%) were drugs with new mechanisms of action, and 12 (5%) were drugs prepared in new dosage forms or processes.
Conclusion: The substantial improvement of the clinical efficacy of BTD drugs is reflected in the innovation of drugs and advancement of treatment.
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目的： 了解美国突破性治疗认定（BTD）程序实施后上市药品的创新点，为我国BTD药品的研发以及审评工作提供可借鉴的依据。
方法： 收集截至2021年美国FDA批准上市的BTD药品，对这些药品创新性的治疗模式、治疗机制和技术突破等方面的特点进行分类统计分析。
结果： 美国FDA获得1 192个BTD药品申请，审批上市242个。上市药品中有42个（17%）为填补临床治疗空白的新药，有99个（41%）为扩大适应证或新适用人群的药品，有27个（21%）为联合治疗的药品组合，有16个（7%）为更具临床治疗优势的新药，有31个（12.8%）为新作用机制药品，有12个（5%）为新的剂型或工艺制备的药品。
结论： 突破性治疗药品临床治疗功效的实质性提高，体现在药品的创新性和治疗的进步性两方面。
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王亚星，女，本科生在读，主要从事药品研发政策评估研究。E-mail: yaxingwang@hust.edu.cn。
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王亚星，女，本科生在读，主要从事药品研发政策评估研究。E-mail: yaxingwang@hust.edu.cn。
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