华昊中天医药-B(02563)：优替德隆治疗乳腺癌脑转移美国关键临床研究首例患者用药

智通财经2025-12-17

智通财经APP讯，华昊中天医药-B(02563)发布公告,本公司全资美国子公司Biostar Pharma, Inc.(US-Biostar)已完成其一项重要海外临床研究的首例患者给药：UTD1联合卡培他滨治疗HER2阴性乳腺癌脑转移(BCBM)美国关键注册临床研究(NCT06764940)。该研究采用两阶段设计，共拟入组约120例受试者，主要研究终点为中枢神经系统客观缓解率(CNS-ORR)。由...

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/2592691845?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-12-17 21:29","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2592691845","market":"sh","top_or_hot":-1,"title":"华昊中天医药-B(02563)：优替德隆治疗乳腺癌脑转移美国关键临床研究首例患者用药","media":"智通财经","content":"<div>\n<p>智通财经APP讯，华昊中天医药-B(02563)发布公告,本公司全资美国子公司Biostar Pharma, Inc.(US-Biostar)已完成其一项重要海外临床研究的首例患者给药：UTD1联合卡培他滨治疗HER2阴性乳腺癌脑转移(BCBM)美国关键注册临床研究(NCT06764940)。该研究采用两阶段设计，共拟入组约120例受试者，主要研究终点为中枢神经系统客观缓解率(CNS-ORR)。由...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1382804.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>华昊中天医药-B(02563)：优替德隆治疗乳腺癌脑转移美国关键临床研究首例患者用药</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华昊中天医药-B(02563)：优替德隆治疗乳腺癌脑转移美国关键临床研究首例患者用药\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-12-17 21:29 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1382804.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讯，华昊中天医药-B(02563)发布公告,本公司全资美国子公司Biostar Pharma, Inc.(US-Biostar)已完成其一项重要海外临床研究的首例患者给药：UTD1联合卡培他滨治疗HER2阴性乳腺癌脑转移(BCBM)美国关键注册临床研究(NCT06764940)。该研究采用两阶段设计，共拟入组约120例受试者，主要研究终点为中枢神经系统客观缓解率(CNS-ORR)。由...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1382804.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":"BK1574","symbol_name":"生物医药B类股","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1382804.html","article_id":"2592691845","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2592691845","pubTimestamp":1765978175,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，华昊中天医药-B 发布公告,本公司全资美国子公司Biostar Pharma, Inc.已完成其一项重要海外临床研究的首例患者给药：UTD1联合卡培他滨治疗HER2阴性乳腺癌脑转移美国关键注册临床研究。优替德隆也被美国FDA授予治疗乳腺癌脑转移的孤儿药资格。晚期乳腺癌患者约20–50%会发生脑部转移。优替德隆有望改变现状，为这类患者带来新的治疗手段和生存希望。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"159938":"医药","BK1574":"生物医药B类股","02563":"华昊中天医药-B","BK1161":"生物科技","BK1515":"抗疫概念","09939":"开拓药业-B"},"translate_title":"Huahao Zhongtian Pharmaceutical-B (02563): The first patient in a key clinical study in the United States of Utidron for the treatment of breast cancer brain metastases","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"159938":1.5,"02563":1.5,"09939":1.5},"content_text":"智通财经APP讯，华昊中天医药-B(02563)发布公告,本公司全资美国子公司Biostar Pharma, Inc.(US-Biostar)已完成其一项重要海外临床研究的首例患者给药：UTD1联合卡培他滨治疗HER2阴性乳腺癌脑转移(BCBM)美国关键注册临床研究(NCT06764940)。该研究采用两阶段设计，共拟入组约120例受试者，主要研究终点为中枢神经系统客观缓解率(CNS-ORR)。由MD安德森癌症中心(MD Anderson Cancer Center)、约翰‧霍普金斯癌症中心(John Hopkins Sidney Kimmel Comprehensive Cancer Center)、希望之城癌症中心(City of Hope-Duarte)、西北大学癌症中心(Robert H. Lurie Comprehensive Cancer Center of Northwestern University)、科罗拉多大学医院(University of Colorado Hospital)、奥古斯塔大学(Augusta University)、加利福尼亚大学洛杉矶分校(University of California Los Angeles)等全美近20家头部研究中心共同参与。优替德隆独特的理化性质以及对P-糖蛋白介导的外排不敏感等优势，使其拥有穿透血脑屏障(BBB)、防治实体瘤脑转移的能力，与同为微管稳定剂的紫杉类药物形成鲜明对比。2025年ASCO大会口头报告的一项优替德隆联合贝伐珠单抗和化疗治疗HER2阴性BCBM临床II期研究共入组34例患者，结果显示CNS-ORR为67.6%，中枢神经系统临床获益率(CNS-CBR)为88.2%，中位中枢神经系统无进展生存期(CNS-PFS)为15个月;另一项发表于2025年JAMA Oncology杂志的优替德隆联合贝伐珠单抗治疗HER2阴性BCBM临床II期研究共纳入47例患者，结果显示CNS-ORR为42.6%，中位CNS-PFS为10.6个月，中位总生存期为15.1个月。两项研究中治疗相关不良事件(TRAE)大多为1–2级，且可控可逆。优替德隆也被美国FDA授予治疗乳腺癌脑转移的孤儿药资格。晚期乳腺癌患者约20–50%会发生脑部转移。由于BBB的存在，许多乳腺癌治疗药物在颅内很难达到有效的浓度，使得BCBM患者普遍预后较差，尤其HER2阴性BCBM患者预后更差，中位无进展生存期仅2–6个月。然而，HER2阴性BCBM尚缺乏明确有效的药物治疗方案，全球范围无任何药物被批准用于HER2阴性BCBM，存在明显且迫切的未被满足的临床需求。优替德隆有望改变现状，为这类患者带来新的治疗手段和生存希望。","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":"dataReport","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/2592691845","isCrawlerRequest":true}