全球首款！映恩生物HER3-ADC治疗HR+/HER2-乳腺癌获FDA授予FTD

药渡Daily2025-12-18

今日，映恩生物在其官网宣布，公司开发的新型HER3ADC药物DB-1310获FDA授予快速通道资格认定（Fast Track Designation，FTD），适应症为既往接受过内分泌治疗、CDK4/6抑制剂治疗，且在不可切除或转移性疾病阶段接受或未接受过化疗，或在完成辅助化疗期间或结束后6个月内出现疾病复发的成人晚期/不可切除或转移性激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（...

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/2592571081?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-12-18 17:20","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2592571081","market":"hk","top_or_hot":-1,"title":"全球首款！映恩生物HER3-ADC治疗HR+/HER2-乳腺癌获FDA授予FTD","media":"药渡Daily","content":"<div>\n<p>今日，映恩生物在其官网宣布，公司开发的新型HER3ADC药物DB-1310获FDA授予快速通道资格认定（Fast Track Designation，FTD），适应症为既往接受过内分泌治疗、CDK4/6抑制剂治疗，且在不可切除或转移性疾病阶段接受或未接受过化疗，或在完成辅助化疗期间或结束后6个月内出现疾病复发的成人晚期/不可切除或转移性激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251218174009a45aed31&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>全球首款！映恩生物HER3-ADC治疗HR+/HER2-乳腺癌获FDA授予FTD</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全球首款！映恩生物HER3-ADC治疗HR+/HER2-乳腺癌获FDA授予FTD\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-12-18 17:20 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251218174009a45aed31&s=b><strong>药渡Daily</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>今日，映恩生物在其官网宣布，公司开发的新型HER3ADC药物DB-1310获FDA授予快速通道资格认定（Fast Track Designation，FTD），适应症为既往接受过内分泌治疗、CDK4/6抑制剂治疗，且在不可切除或转移性疾病阶段接受或未接受过化疗，或在完成辅助化疗期间或结束后6个月内出现疾病复发的成人晚期/不可切除或转移性激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251218174009a45aed31&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":"HK0000500386.USD","symbol_name":"易方达 (香港) 中国股票股息基金A 类 (累积) 美元","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251218174009a45aed31&s=b","article_id":"2592571081","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251218174009a45aed31&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=2592571081","pubTimestamp":1766049621,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"今日，映恩生物在其官网宣布，公司开发的新型HER3ADC药物DB-1310获FDA授予快速通道资格认定，适应症为既往接受过内分泌治疗、CDK4/6抑制剂治疗，且在不可切除或转移性疾病阶段接受或未接受过化疗，或在完成辅助化疗期间或结束后6个月内出现疾病复发的成人晚期/不可切除或转移性激素受体阳性、人表皮生长因子受体2阴性乳腺癌患者。根据映恩生物官网显示，DB-1310是全球首款在此适应症上获FTD的HER3-ADC药物。研究治疗相关停药率低参考文献映恩生物官网","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"HK0000500386.USD":"易方达 (香港) 中国股票股息基金A 类 (累积) 美元","09606":"映恩生物-B","HK0000252152.HKD":"易方达 (香港) 中国股票股息基金A 类 (累积) 港元","HK0000252160.HKD":"易方达 (香港) 中国股票股息基金A 类 (分派) 港元","LU2543165471.USD":"E FUND (HK) GLOBAL QUALITY GROWTH \"A\" (USD) ACC","BK1161":"生物科技"},"translate_title":"The first in the world! Yingen Biotech's HER3-ADC treatment of HR+/HER2-breast cancer was granted FTD by the FDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"09606":0.9},"content_text":"今日，映恩生物在其官网宣布，公司开发的新型HER3ADC药物DB-1310获FDA授予快速通道资格认定（Fast Track Designation，FTD），适应症为既往接受过内分泌治疗、CDK4/6抑制剂治疗，且在不可切除或转移性疾病阶段接受或未接受过化疗，或在完成辅助化疗期间或结束后6个月内出现疾病复发的成人晚期/不可切除或转移性激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（免疫组化0、1+或2+/原位杂交阴性）乳腺癌患者。根据映恩生物官网显示，DB-1310是全球首款在此适应症上获FTD的HER3-ADC药物。DB-1310由一种新型人源化抗HER3单克隆抗体与一种专有的DNA拓扑异构酶I抑制剂有效载荷（P1021）共价偶联而成，DAR值为8。2025年ASCO年会上首次公开了DB-1310在标准治疗失败的晚期实体瘤患者中临床I/IIa期研究（NCT05785741）数据，研究结果显示在123例疗效可评估的患者中，未经确认的客观缓解率（uORR）为31%，疾病控制率（DCR）为84%。亚组分析中，在EGFR突变非小细胞肺癌（NSCLC）亚组，46例患者中：uORR达44%，DCR高达91%，中位无进展生存期（mPFS）为7.0个月，中位总生存期（mOS）为18.9个月，且在5.5mg/kg剂量组（n=12），uORR高达66.7%。从安全性上来看，最常见的治疗相关不良事件（TRAEs）为1-2级血液学及胃肠道事件。研究治疗相关停药率低（3.5%）参考文献映恩生物官网","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":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,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","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/2592571081","isCrawlerRequest":true}