中国创新药掘金！一文梳理突破性疗法（BTD）品种

格隆汇2025-06-09

突破性疗法梳理：（1）突破性疗法意味着显著且可靠临床的意义。突破性疗法最初于2020年被CDE引入国内，允许创新药物与改良型新药研发企业在三期临床开展前申请突破性治疗药物程序，其要旨集中于两点：（1）用于加快治疗严重危及生命或严重影响生存质量的疾病新药落地，从而尽早满足患者的治疗需求；（2）针对适应症尚无有效治疗手段或药物，新药较现阶段治疗手段具有足够证明其临床优势。（2）突破性疗法的动态变化，...

网页链接

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

精彩评论

我们需要你的真知灼见来填补这片空白

发表看法

{"i18n":{"language":"zh_CN"},"isChannel":false,"data":{"share":"https://www.laohu8.com/m/news/2542381463?lang=zh_CN&edition=full","thumbnail":"https://img3.gelonghui.com/a2903-ed9e8418-5ef2-4a54-b766-f38f7afa9aca.jpg?guru_height=718&guru_width=1280","is_english":false,"pubTime":"2025-06-09 19:55","share_image_url":"https://static.laohu8.com/6b8fa6424aebe95f6781d04ef17a1852","id":"2542381463","market":"hk","top_or_hot":-1,"title":"中国创新药掘金！一文梳理突破性疗法（BTD）品种","media":"格隆汇","content":"<div>\n<p>突破性疗法梳理： （1）突破性疗法意味着显著且可靠临床的意义。突破性疗法最初于2020年被CDE引入国内，允许创新药物与改良型新药研发企业在三期临床开展前申请突破性治疗药物程序，其要旨集中于两点：（1）用于加快治疗严重危及生命或严重影响生存质量的疾病新药落地，从而尽早满足患者的治疗需求；（2）针对适应症尚无有效治疗手段或药物，新药较现阶段治疗手段具有足够证明其临床优势。（2）突破性疗法的动态变化，...</p>\n\n<a href=\"https://www.gelonghui.com/p/2298985\">网页链接</a>\n\n</div>\n","source":"gelonghui_highlight","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>中国创新药掘金！一文梳理突破性疗法（BTD）品种</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n中国创新药掘金！一文梳理突破性疗法（BTD）品种\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-06-09 19:55 北京时间&nbsp;&nbsp;&nbsp;<a href=https://www.gelonghui.com/p/2298985><strong>格隆汇</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>突破性疗法梳理： （1）突破性疗法意味着显著且可靠临床的意义。突破性疗法最初于2020年被CDE引入国内，允许创新药物与改良型新药研发企业在三期临床开展前申请突破性治疗药物程序，其要旨集中于两点：（1）用于加快治疗严重危及生命或严重影响生存质量的疾病新药落地，从而尽早满足患者的治疗需求；（2）针对适应症尚无有效治疗手段或药物，新药较现阶段治疗手段具有足够证明其临床优势。（2）突破性疗法的动态变化，...</p>\n\n<a href=\"https://www.gelonghui.com/p/2298985\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1008478684.HKD","symbol_name":"UBS (LUX) EQUITY FUND -  CHINA OPPORTUNITY \"P\" (HKD) ACC","start_time":0,"source_url":"https://www.gelonghui.com/p/2298985","article_id":"2542381463","we_media_id":null,"thumbnails":["https://img3.gelonghui.com/a2903-ed9e8418-5ef2-4a54-b766-f38f7afa9aca.jpg?guru_height=718&guru_width=1280"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2542381463","pubTimestamp":1749470126,"columns":[],"sourceInfo":{"source_id":"gelonghui_highlight","name":"格隆汇"},"weMediaInfo":null,"summary":"从热门靶点到全球新靶点、从老牌药企到新兴药企","collect":0,"end_time":0,"defaultTopTitle":"gelonghui.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"300204":"舒泰神","688506":"百利天恒","LU1008478684.HKD":"UBS (LUX) EQUITY FUND -  CHINA OPPORTUNITY \"P\" (HKD) ACC","IE0008368742.USD":"首域中国增长基金I Acc","LU0072913022.USD":"UBS (LUX) EQUITY FUND -  GREATER CHINA \"P\" (USD) ACC","BK1521":"挪威政府全球养老基金持仓","IE00B543WZ88.USD":"NEUBERGER BERMAN CHINA EQUITY \"A\" (USD) ACC","LU0326950275.SGD":"Schroder ISF China Opportunities A Acc SGD-H","IE00B031HY20.USD":"FSSA CHINA GROWTH \"I\" (USD) INC","LU1226288170.HKD":"UBS (LUX) KEY SEL S-CHINA ALLOCATION OPP \"P6%\"(HK D) INC","LU1226287529.USD":"UBS (LUX) KEY SELECTION SICAV - CHINA ALLOCATION  OPPORTUNITY (USD) \"P\" (USD) ACC","LU1226287875.USD":"UBS (LUX) KEY SEL S-CHINA ALLOCATION OPP \"PM\" (USD) INC","BK0046":"生物疫苗","LU0880133367.SGD":"UBS (LUX) EQUITY FUND CHINA OPPORTUNITY USD \"P\" (SGD) ACC","LU1226288253.USD":"UBS (LUX) KEY SELECTION SICAV - CHINA ALLOCATION  OPPORTUNITY (USD) \"P\" (USD) INC","06978":"永泰生物-B","LU1951186391.HKD":"UBS (LUX) KEY SEL CHINA ALLOCATION OPPORTUNITY (US \"P\" (HKD) INC","IE00B5MMRT66.SGD":"NEUBERGER BERMAN CHINA EQUITY \"A\" (SGDHDG) ACC","IE0008369823.USD":"FSSA HONG KONG GROWTH \"I\" ACC","BK0028":"国家队","LU1152091168.USD":"UBS (LUX) EQUITY FUND - CHINA OPPORTUNITY (USD) \"PM\" INC","LU1807302812.USD":"UBS (LUX) EQUITY SICAV ALL CHINA \"P\" (USD) ACC","BK1161":"生物科技","LU1993786604.SGD":"UBS (LUX) EQUITY SICAV ALL CHINA \"P\" (SGD) ACC","BK1191":"制药","BK1593":"医美概念股","LU1960683339.HKD":"UBS (LUX) EQUITY SICAV ALL CHINA \"P\" (HKD) ACC","LU1226287792.SGD":"UBS (LUX) KEY SEL S-CHINA ALLOCATION OPP \"P\" (SGDHDG) INC","LU0140636845.USD":"施罗德大中华区股票A Acc","IE00BZ08YR35.GBP":"GUINNESS BEST OF CHINA \"C\" (GBP) ACC","LU0501845795.SGD":"瑞银大中华区股票基金P Acc SGD","01530":"三生制药","LU0067412154.USD":"UBS (LUX) EQUITY FUND -  CHINA OPPORTUNITY \"P\" (USD) ACC","IE00BZ08YS42.EUR":"GUINNESS BEST OF CHINA \"C\" (EUR) ACC","BK1515":"抗疫概念","02096":"先声药业","IE00BZ08YT58.USD":"GUINNESS BEST OF CHINA \"C\" (USD) ACC","BK1574":"生物医药B类股","LU1152091754.HKD":"UBS (LUX) EQUITY FUND - CHINA OPPORTUNITY (USD) \"PM\" (HKD) INC","SG9999004220.SGD":"Nikko AM Shenton Asia Dividend Equity Fund  SGD","BK1583":"高瓴概念","BK0239":"医药制造"},"translate_title":"China's innovative drug nuggets! One article sorts out the breakthrough therapy (BTD) varieties","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"300204":0.9,"688506":0.9,"02096":0.9,"01530":0.9,"06978":1},"content_text":"突破性疗法梳理： （1）突破性疗法意味着显著且可靠临床的意义。突破性疗法最初于2020年被CDE引入国内，允许创新药物与改良型新药研发企业在三期临床开展前申请突破性治疗药物程序，其要旨集中于两点：（1）用于加快治疗严重危及生命或严重影响生存质量的疾病新药落地，从而尽早满足患者的治疗需求；（2）针对适应症尚无有效治疗手段或药物，新药较现阶段治疗手段具有足够证明其临床优势。（2）突破性疗法的动态变化，从热门靶点到新靶点、从老牌Pharma&biotech逐步扩散：Insight数据库显示，截至2025年6月4日，仅考虑国产创新药（自研），目前CDE共批准126款品种正式纳入突破性疗法；从靶点看，突破性疗法逐渐从PD-1、HER2、EGFR等靶点逐步拓展PD-1/IL-2、BCL2、B7-H4等新兴靶点，呈百花齐放的趋势。从公司看，除了恒瑞医药、信达生物等老牌Pharma&biotech以外，海南海药、舒泰神、广生堂、药捷安康等企业的突破性疗法也值得期待。（3）突破性疗法的潜在出海机会：值得注意的是，CDE突破性疗法从2020年起步，同时随着研发实力提升，国产分子也逐步具备了全球竞争力。由于取得突破性疗法，必须满足以下2个条件：（1）用于防治严重疾病或病症（危及生命或者严重影响生存质量）；（2）药品需要初步证明具有明显临床优势。这意味着纳入CDE突破性疗法的在商业化上有价值，在数据上有优势。海外和MNC BD部门在寻求国内分子时，同样对数据上有较高的要求，因此此刻梳理突破性疗法对指导国产创新药分子出海有现实意义。突破性疗法分子高出海成功率也证实了这一点。科伦博泰生物、三生制药、百利天恒、传奇生物、荣昌生物等企业在出海方面已经完成了从0到1的突破，首付款及总金额体量屡创新高，石药集团也公布了其潜在的BD可能。后续舒泰神的波米泰酶α、先声的先必新®舌下片（取得美国突破性疗法认定）等众多品种也拥有BD潜力。我们梳理了目前尚未出海目前国产创新药、以分子是否是FIC、是否取得美国BTD认证、海外临床进度为参考，挑选了当下有出海潜力的突破性疗法品种。风险提示宏观经济环境风险、药物临床研发风险、国内市场竞争风险、海外市场销售不及预期风险、第三方数据偏差风险文中报告节选自天风证券研究所已公开发布研究报告《天风证券-医药生物-行业专题研究：买全球最好的中国创新药：突破性疗法（BTD）品种梳理》，分析师：杨松     SAC执业证书编号：S1110521020001曹文清  SAC执业证书编号：S1110523120003","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.44.1","shortVersion":"4.44.1","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2542381463","isCrawlerRequest":true}