ORR高达89.5%！智翔金泰BCMA/CD3双抗申报上市

医药魔方01-08

1月8日，智翔金泰宣布双抗药物GR1803（纬利妥米单抗，velinotamig）的附条件上市申请已获得国家药监局受理，用于治疗既往至少接受过三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤（R/R MM）成人患者。GR1803是智翔金泰自主研发的一款BCMA/CD3双抗药物，其结合BCMA的亲和力（10-10M）较结合CD3的亲和力（10-...

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}\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\">\nORR高达89.5%！智翔金泰BCMA/CD3双抗申报上市\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-01-08 19:01 北京时间&nbsp;&nbsp;&nbsp;<a href=https://finance.sina.com.cn/stock/relnews/cn/2026-01-08/doc-inhfqyhi5239845.shtml><strong>医药魔方</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>1月8日，智翔金泰宣布双抗药物GR1803（纬利妥米单抗，velinotamig）的附条件上市申请已获得国家药监局受理，用于治疗既往至少接受过三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤（R/R MM）成人患者。GR1803是智翔金泰自主研发的一款BCMA/CD3双抗药物，其结合BCMA的亲和力（10-10M）较结合CD3的亲和力（10-...</p>\n\n<a href=\"https://finance.sina.com.cn/stock/relnews/cn/2026-01-08/doc-inhfqyhi5239845.shtml\">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":"BK0239","symbol_name":"医药制造","start_time":0,"source_url":"https://finance.sina.com.cn/stock/relnews/cn/2026-01-08/doc-inhfqyhi5239845.shtml","article_id":"2601490365","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601490365","pubTimestamp":1767870060,"columns":[],"sourceInfo":{"source_id":"sina","name":"sina"},"weMediaInfo":null,"summary":"1月8日，智翔金泰宣布双抗药物GR1803的附条件上市申请已获得国家药监局受理，用于治疗既往至少接受过三线治疗的复发或难治性多发性骨髓瘤成人患者。GR1803是智翔金泰自主研发的一款BCMA/CD3双抗药物，其结合BCMA的亲和力较结合CD3的亲和力高两个数量级。2025年11月，智翔金泰在ASH 2025年会上公布了GR1803治疗R/R MM的I期研究数据。结果显示，在至少接受了一次疗效评估的57例患者中，客观缓解率为89.5%。","collect":0,"end_time":0,"defaultTopTitle":"sina.com.cn","property":[],"viewcount":null,"language":"zh","relate_stocks":{"688443":"智翔金泰","BK0239":"医药制造","ORR":"Militia Long/Short Equity ETF"},"translate_title":"The ORR is up to 89.5%! Zhixiang Jintai BCMA/CD3 dual antibody applies for listing","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"688443":1.5,"ORR":1.5},"content_text":"1月8日，智翔金泰宣布双抗药物GR1803（纬利妥米单抗，velinotamig）的附条件上市申请已获得国家药监局受理，用于治疗既往至少接受过三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤（R/R MM）成人患者。GR1803是智翔金泰自主研发的一款BCMA/CD3双抗药物，其结合BCMA的亲和力（10-10M）较结合CD3的亲和力（10-8M）高两个数量级。这种非对称的亲和力设计在保证此双特异性抗体分子募集并激活T细胞杀伤肿瘤细胞的同时，可以有效减少因CD3抗体导致的T细胞非特异性激活，从而降低GR1803注射液在体内的毒副作用。2025年11月，智翔金泰在ASH 2025年会上公布了GR1803治疗R/R MM的I期研究数据。截至2025年7月1日，共60例患者入组接受治疗，其中48例患者接受180µg/kg剂量（II期推荐剂量，RP2D）治疗。结果显示，在至少接受了一次疗效评估的57例患者中，客观缓解率（ORR）为89.5%（51/57）。RP2D队列患者的ORR达到了87.5%（42/48），实现至少非常好的部分缓解（≥VGPR）的比例为70.8%（34/48），实现至少完全缓解（≥CR）的比例为37.5%（18/48），实现微小残留病变（MRD）阴性的比例为54.2%（26/48）。Copyright © 2025 PHARMCUBE. All Rights Reserved. 免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。\n\n\n海量资讯、精准解读，尽在新浪财经APP","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":"4.37.0","shortVersion":"4.37.0","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/2601490365","isCrawlerRequest":true}