癌症治疗新突破，复星医药新药拟纳入突破性治疗、再生元BCMAxCD3欧盟获批

医药经济报2025-05-06

1.潜在“First-in-Class”LAG-3组合疗法显著延长癌症患者生命5月5日，专注与LAG3疗法开发的Immutep更新了一项LAG-3融合蛋白eftilagimod alpha，联合PD-1抗体Pembrolizumab用于一线头颈部鳞状细胞癌治疗的 IIb 临床TACTI-003 （KEYNOTE-C34）期试验的队列 B积极结果。结果显示，中位总生存期（OS）达17.6个月。该队列...

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/2533293525?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-05-06 13:38","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2533293525","market":"sh","top_or_hot":-1,"title":"癌症治疗新突破，复星医药新药拟纳入突破性治疗、再生元BCMAxCD3欧盟获批","media":"医药经济报","content":"<div>\n<p>1.潜在“First-in-Class”LAG-3组合疗法显著延长癌症患者生命5月5日，专注与LAG3疗法开发的Immutep更新了一项LAG-3融合蛋白eftilagimod alpha，联合PD-1抗体Pembrolizumab用于一线头颈部鳞状细胞癌治疗的 IIb 临床TACTI-003 （KEYNOTE-C34）期试验的队列 B积极结果。结果显示，中位总生存期（OS）达17.6个月。该队列...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250506145329a6d4a390&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>癌症治疗新突破，复星医药新药拟纳入突破性治疗、再生元BCMAxCD3欧盟获批</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癌症治疗新突破，复星医药新药拟纳入突破性治疗、再生元BCMAxCD3欧盟获批\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-05-06 13:38 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250506145329a6d4a390&s=b><strong>医药经济报</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>1.潜在“First-in-Class”LAG-3组合疗法显著延长癌症患者生命5月5日，专注与LAG3疗法开发的Immutep更新了一项LAG-3融合蛋白eftilagimod alpha，联合PD-1抗体Pembrolizumab用于一线头颈部鳞状细胞癌治疗的 IIb 临床TACTI-003 （KEYNOTE-C34）期试验的队列 B积极结果。结果显示，中位总生存期（OS）达17.6个月。该队列...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250506145329a6d4a390&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":"BK0060","symbol_name":"抗癌","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250506145329a6d4a390&s=b","article_id":"2533293525","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250506145329a6d4a390&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=2533293525","pubTimestamp":1746509934,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"公开资料显示，这是复星医药研发的创新型小分子化学药物芦沃美替尼。欧盟的批准是基于关键临床LINKER-MM1试验结果。这项试验纳入了117名接受200mg剂量 Lynozyfic 的复发/难治性多发性骨髓瘤患者结果显示，总缓解率ORR达到了71%。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"600196":"复星医药","BK0060":"抗癌","BK0187":"一线龙头","BK0028":"国家队","BK0239":"医药制造","BK0183":"MSCI概念","BK0096":"民营医院","BK0188":"融资融券","BK0012":"证金概念","02196":"复星医药","BK0196":"行业龙头","BK0175":"白马股"},"translate_title":"New breakthrough in cancer treatment, Fosun Pharma's new drug is planned to be included in breakthrough therapy, Regeneron BCMAxCD3 is approved in the EU","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"600196":1,"02196":0.9},"content_text":"1.潜在“First-in-Class”LAG-3组合疗法显著延长癌症患者生命5月5日，专注与LAG3疗法开发的Immutep更新了一项LAG-3融合蛋白eftilagimod alpha，联合PD-1抗体Pembrolizumab用于一线头颈部鳞状细胞癌治疗的 IIb 临床TACTI-003 （KEYNOTE-C34）期试验的队列 B积极结果。结果显示，中位总生存期（OS）达17.6个月。该队列旨在评估eftilagimod alfa联合默沙东的抗PD-1疗法Keytruda（pembrolizumab）作为复发/转移性头颈部鳞状细胞癌（HNSCC）患者一线治疗方案的效果，受试者为PD-L1表达综合阳性评分（CPS）低于1的人群。数据截止日期为2025年3 月 31 日，该队列在PD-L1表达低于1（CPS<1）的可评估患者（N=31）患者中，实现了17.6个月的中位总生存期 （OS），和抗 PD-1治疗+化疗11.3个月，以及抗 PD-1 单药治疗7.9个月的历史数据2.复星医药MEK1/2抑制剂拟纳入突破性治疗品种4月29日，CDE官网最新公示，复星医药申报的FCN-159片拟纳入突破性治疗品种，针对适应症为儿童朗格汉斯组织细胞增生症（LCH）。公开资料显示，这是复星医药研发的创新型小分子化学药物芦沃美替尼（曾用名：复迈替尼）。该产品此前已经有两项适应症的上市申请先后被CDE受理，并纳入优先审评，分别用于治疗成人树突状细胞和组织细胞肿瘤，以及治疗2岁及2岁以上儿童1型神经纤维瘤病（NF1）相关的丛状神经纤维瘤（PN）。3. 再生元BCMAxCD3双抗在欧盟获批上市4月28日，再生元宣布了一项重要进展：Lynozyfic™ (linvoseltamab)已获得欧洲委员会 (EC) 的有条件市场批准，用于治疗复发和难治性多发性骨髓瘤成人患者。具体适应症是针对那些已接受至少三种既往疗法，包括蛋白酶体抑制剂、免疫调节剂和抗 CD38 单克隆抗体，并且在最近一次治疗后疾病出现进展的患者。欧盟的批准是基于关键临床LINKER-MM1试验结果。这项试验纳入了117名接受200mg剂量 Lynozyfic™ 的复发/难治性多发性骨髓瘤患者结果显示，总缓解率ORR达到了71%。其中，50%的患者实现了完全缓解CR或更好。在达到CR或严谨CR的患者中，微小残留病MRD阴性率为 41% (58 名患者中的 24 名)。中位缓解持续时间DOR为29个月。编辑：陈丽娜、张洁莹版式编辑：陈淑文审校：马飞、张松瞄准艾伯维25亿美元大药！百济、亚盛、诺诚健华竞逐国产桂冠直击第137届广交会 | 健康赋能生活，乐享全球风尚透视FDA拟减少临床前研究动物使用的逻辑www.yyjjb.com.cn洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店","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":"4.43.1","shortVersion":"4.43.1","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/2533293525","isCrawlerRequest":true}