医药早参｜阿斯利康撤回Trop2 ADC非鳞状NSCLC上市申请

每日经济新闻11-14

每经记者：陈星每经编辑：魏官红｜ 2024年11月14日星期四｜NO.1 阿斯利康撤回Trop2 ADC非鳞状NSCLC的上市申请阿斯利康宣布撤回此前基于TROPION-Lung01三期临床数据递交的治疗非鳞状NSCLC的上市申请，转而递交复发性或转移性EGFR突变NSCLC的后线治疗上市申请。这一上市申请的策略调整是在FDA反馈的基础上做出的。点评：Dato-DXd目前围绕NSCLC有9项...

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/2483629358?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2024-11-14 08:22","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2483629358","market":"us","top_or_hot":-1,"title":"医药早参｜阿斯利康撤回Trop2 ADC非鳞状NSCLC上市申请","media":"每日经济新闻","content":"<div>\n<p>每经记者：陈星每经编辑：魏官红｜ 2024年11月14日 星期四 ｜NO.1 阿斯利康撤回Trop2 ADC非鳞状NSCLC的上市申请阿斯利康宣布撤回此前基于TROPION-Lung01三期临床数据递交的治疗非鳞状NSCLC的上市申请，转而递交复发性或转移性EGFR突变NSCLC的后线治疗上市申请。这一上市申请的策略调整是在FDA反馈的基础上做出的。点评：Dato-DXd目前围绕NSCLC有9项...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241114082335abbef158&s=b\">网页链接</a>\n\n</div>\n","source":"tencent","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>医药早参｜阿斯利康撤回Trop2 ADC非鳞状NSCLC上市申请</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医药早参｜阿斯利康撤回Trop2 ADC非鳞状NSCLC上市申请\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-14 08:22 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241114082335abbef158&s=b><strong>每日经济新闻</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>每经记者：陈星每经编辑：魏官红｜ 2024年11月14日 星期四 ｜NO.1 阿斯利康撤回Trop2 ADC非鳞状NSCLC的上市申请阿斯利康宣布撤回此前基于TROPION-Lung01三期临床数据递交的治疗非鳞状NSCLC的上市申请，转而递交复发性或转移性EGFR突变NSCLC的后线治疗上市申请。这一上市申请的策略调整是在FDA反馈的基础上做出的。点评：Dato-DXd目前围绕NSCLC有9项...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241114082335abbef158&s=b\">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":"LU0320765992.SGD","symbol_name":"FTIF - Franklin Biotechnology Discovery A Acc SGD","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241114082335abbef158&s=b","article_id":"2483629358","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241114082335abbef158&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2483629358","pubTimestamp":1731543747,"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"每经记者：陈星每经编辑：魏官红｜ 2024年11月14日 星期四 ｜NO.1 阿斯利康撤回Trop2 ADC非鳞状NSCLC的上市申请阿斯利康宣布撤回此前基于TROPION-Lung01三期临床数据递交的治疗非鳞状NSCLC的上市申请，转而递交复发性或转移性EGFR突变NSCLC的后线治疗上市申请。这一上市申请的策略调整是在FDA反馈的基础上做出的。NO.4 卡尔史托斯首批国产内镜影像产品获批上市全球医疗技术公司卡尔史托斯宣布其首批国产内窥镜影像产品已正式获得医疗器械注册证。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU2456880835.USD":"ALLIANZ GLOBAL INCOME \"AT\" (USD) ACC","BK4080":"零售业房地产投资信托","BK4585":"ETF&股票定投概念","LU2417539215.USD":"ALLIANZ GLOBAL INCOME \"AMF\" (USD) INC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","BK4568":"美国抗疫概念","BK4588":"碎股","BK4007":"制药","AZN":"阿斯利康","ADC":"艾格里房产","LU2462157665.USD":"ALLIANZ GLOBAL INCOME \"A\" (USD) INC","LU1829250122.USD":"高盛欧洲核心股票组合Acc","BK4231":"零售房地产信托"},"translate_title":"Pharmaceutical Early Ginseng | AstraZeneca withdraws Trop2 ADC non-squamous NSCLC marketing application","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ADC":1,"AZN":1},"content_text":"每经记者：陈星每经编辑：魏官红｜ 2024年11月14日 星期四 ｜NO.1 阿斯利康撤回Trop2 ADC非鳞状NSCLC的上市申请阿斯利康宣布撤回此前基于TROPION-Lung01三期临床数据递交的治疗非鳞状NSCLC的上市申请，转而递交复发性或转移性EGFR突变NSCLC的后线治疗上市申请。这一上市申请的策略调整是在FDA反馈的基础上做出的。点评：Dato-DXd目前围绕NSCLC有9项三期临床在推进，同时探索多种联合治疗方案，覆盖EGFR野生型NSCLC和EGFR突变NSCLC。NO.2 国家卫生健康委召开医药企业座谈会国家卫生健康委在京召开医药企业座谈会，听取对当前医药产业发展形势和下一步工作的意见建议。会议提及，支持外资企业扎根中国，加强研发创新，推进中高端产品本土化生产，支持国内企业“走出去”，促进国际交流，合作共赢。点评：国家相关部门对外资企业扎根中国，以及推动中高端产品本土化的支持力度不减。NO.3 四环医药拟分拆轩竹生物至港交所上市四环医药公告，拟将旗下创新药平台轩竹生物拆分至港交所主板上市。轩竹生物曾尝试在科创板上市，但2023年3月IPO申请被暂缓，后终止了在科创板的上市计划。点评：偏重医美业务的四环医药有意分拆创新药业务，此次决定意味着轩竹生物选择了另一条拓展资本市场的路径。NO.4 卡尔史托斯首批国产内镜影像产品获批上市全球医疗技术公司卡尔史托斯宣布其首批国产内窥镜影像产品已正式获得医疗器械注册证。本次获批的产品，全部由卡尔史托斯上海制造基地生产制造，涵盖内窥镜摄像主机、影像模块及摄像头等共8款产品，均为卡尔史托斯的核心影像产品。点评：上海制造基地是卡尔史托斯在亚太地区设立的首个制造基地，自2023年官宣建设以来，卡尔史托斯持续有序地推进本土化进程。本次产品获批成为卡尔史托斯在华发展的又一重要里程碑。NO.5 东阳光药GLP-1/FGF21授权给Apollo TherapeuticsApollo Therapeutics宣布从东阳光药引进GLP-1/FGF21双靶点药物HEC88473的中国外全球权益，东阳光药将收到1200万美元预付款，9.26亿美元里程碑金额，以及高个位数至低双位数的销售分成。点评：近年来，Akero、89bio的FGF21融合蛋白在NASH适应症取得重要突破。国内方面，东阳光药、安源医药/正大天晴、道尔生物均有产品进入临床阶段。每日经济新闻","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","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/2483629358"}