ADC药物研发再结硕果！乐普生物-B(02157)MRG004A纳入突破性治疗

智通财经2025-08-11

智通财经APP获悉，8月11日，据国家药品监督管理局药品审评中心披露，乐普生物-B(02157)自主研发的TF ADC药物MRG004A被纳入突破性治疗药物，这一重要进展标志着乐普生物在ADC药物研发领域取得又一重大突破。据悉，MRG004A是针对差异化靶点、采用创新偶联技术的靶向组织因子（tissue factor，TF）的ADC药物，通过Glyco Connect™定点偶联及Hydra ...

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/2558562106?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-08-11 18:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2558562106","market":"hk","top_or_hot":-1,"title":"ADC药物研发再结硕果！乐普生物-B(02157)MRG004A纳入突破性治疗","media":"智通财经","content":"<div>\n<p>智通财经APP获悉，8月11日，据国家药品监督管理局药品审评中心披露，乐普生物-B(02157)自主研发的TF ADC药物MRG004A被纳入突破性治疗药物，这一重要进展标志着乐普生物在ADC药物研发领域取得又一重大突破。据悉，MRG004A是针对差异化靶点、采用创新偶联技术的靶向组织因子（tissue factor，TF）的ADC药物，通过Glyco Connect™定点偶联及Hydra ...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1328060.html\">网页链接</a>\n\n</div>\n","source":"stock_zhitongcaijing","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>ADC药物研发再结硕果！乐普生物-B(02157)MRG004A纳入突破性治疗</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\">\nADC药物研发再结硕果！乐普生物-B(02157)MRG004A纳入突破性治疗\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-08-11 18:00 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1328060.html><strong>智通财经</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP获悉，8月11日，据国家药品监督管理局药品审评中心披露，乐普生物-B(02157)自主研发的TF ADC药物MRG004A被纳入突破性治疗药物，这一重要进展标志着乐普生物在ADC药物研发领域取得又一重大突破。据悉，MRG004A是针对差异化靶点、采用创新偶联技术的靶向组织因子（tissue factor，TF）的ADC药物，通过Glyco Connect™定点偶联及Hydra ...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1328060.html\">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":"ADC","symbol_name":"艾格里房产","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1328060.html","article_id":"2558562106","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2558562106","pubTimestamp":1754906400,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP获悉，8月11日，据国家药品监督管理局药品审评中心披露，乐普生物-B自主研发的TF ADC药物MRG004A被纳入突破性治疗药物，这一重要进展标志着乐普生物在ADC药物研发领域取得又一重大突破。MRG004A为生物制品，适应症为晚期胰腺癌。MRG004A已分别在中、美取得IND批准，并获FDA授予孤儿药资格认定和快速通道资格，用于治疗胰腺癌。今年8月1日，乐普生物已启动MRG004A治疗胰腺癌的III期临床试验，期待MRG004A未来有望成为胰腺癌患者的全新治疗选择。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"ADC":"艾格里房产","BK4231":"零售房地产信托","02157":"乐普生物-B","BK4080":"零售业房地产投资信托","BK1161":"生物科技"},"translate_title":"ADC drug research and development bears fruitful results again! Lepu Bio-B (02157) MRG004A included in breakthrough therapy","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02157":1,"ADC":1},"content_text":"智通财经APP获悉，8月11日，据国家药品监督管理局药品审评中心披露，乐普生物-B(02157)自主研发的TF ADC药物MRG004A被纳入突破性治疗药物，这一重要进展标志着乐普生物在ADC药物研发领域取得又一重大突破。据悉，MRG004A是针对差异化靶点、采用创新偶联技术的靶向组织因子（tissue factor，TF）的ADC药物，通过Glyco Connect™定点偶联及Hydra Space™极性间隔技术连接TF靶向单抗与高效抗微管剂 MMAE，也是国内首款进入临床的TF ADC药物。MRG004A为生物制品，适应症为晚期胰腺癌。胰腺癌是发生于胰腺的恶性肿瘤，早期症状不明显，中晚期可出现腹痛、黄疸、消瘦等症状。诊断依靠影像学检查和病理活检，晚期胰腺癌预后较差。MRG004A已分别在中、美取得IND批准，并获FDA授予孤儿药资格认定和快速通道资格，用于治疗胰腺癌。此前在美国及中国进行I期临床研究时已在胰腺癌、三阴乳腺癌及宫颈癌癌等适应症中观察到抗肿瘤活性信号。在2024年ASCO大会上，乐普生物首次披露了MRG004A在实体瘤患者中I/II期MRG004A-001的初步疗效和安全性数据。其中在接受2.0mg/kg剂量治疗的12例可评估的胰腺癌患者中，MRG004A显示出令人鼓舞的抗肿瘤活性。这些患者的既往中位治疗线数为3线，其中4例达到部分缓解（PR），6例疾病稳定（SD），ORR为33.3%（4/12），DCR高达83.3%（10/12）。5例TF表达≥50%、染色强度为3+且既往治疗线数不超过三线的胰腺癌患者，在接受2mg/kg的MRG004A治疗后，其中4例达到PR，1例达到SD。今年8月1日，乐普生物已启动MRG004A治疗胰腺癌的III期临床试验，期待MRG004A未来有望成为胰腺癌患者的全新治疗选择。","kind":"news","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,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"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,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.42.4","shortVersion":"4.42.4","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/2558562106","isCrawlerRequest":true}