百奥泰(688177.SH)：BAT2506获美国FDA上市批准

智通财经05-18 17:58

智通财经APP讯，百奥泰(688177.SH)发布公告，公司于近日收到美国食品药品监督管理局(简称“FDA”)签发的关于Immgolis^™/Immgolis Intri^™(BAT2506，戈利木单抗注射液)上市批准通知。

据悉，BAT2506是百奥泰根据中国国家药品监督管理局(简称“NMPA”)、FDA、欧洲药品管理局(简称“EMA”)生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。

截至本公告披露日，BAT2506(戈利木单抗注射液)已获得FDA、EMA上市批准，美国商品名为Immgolis^™/Immgolis Intri^™，欧洲注册商品名为Gotenfia^®;已向NMPA、巴西国家卫生监督局等递交上市许可申请，目前正在评审中。BAT2506(戈利木单抗注射液)的商业化授权合作目前已覆盖118个国家和地区。

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/2636024622?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2026-05-18 17:58","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2636024622","market":"hk","top_or_hot":-1,"title":"百奥泰(688177.SH)：BAT2506获美国FDA上市批准","media":"智通财经","content":"<html><body><p>智通财经APP讯，<a href=\"https://laohu8.com/S/688177\">百奥泰</a>(688177.SH)发布公告，公司于近日收到<a href=\"https://laohu8.com/S/USFD\">美国食品</a>药品监督管理局(简称“FDA”)签发的关于Immgolis<sup>™</sup>/Immgolis Intri<sup>™</sup>(BAT2506，戈利木单抗注射液)上市批准通知。</p><p>据悉，BAT2506是百奥泰根据中国国家药品监督管理局(简称“NMPA”)、FDA、欧洲药品管理局(简称“EMA”)<a href=\"https://laohu8.com/S/000504\">生物</a>类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。</p><p>截至本公告披露日，BAT2506(戈利木单抗注射液)已获得FDA、EMA上市批准，美国商品名为Immgolis<sup>™</sup>/Immgolis Intri<sup>™</sup>，欧洲注册商品名为Gotenfia<sup>®</sup>;已向NMPA、巴西国家卫生监督局等递交上市许可申请，目前正在评审中。BAT2506(戈利木单抗注射液)的商业化授权合作目前已覆盖118个国家和地区。</p></body></html>","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>百奥泰(688177.SH)：BAT2506获美国FDA上市批准</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百奥泰(688177.SH)：BAT2506获美国FDA上市批准\n</h2>\n\n<h4 class=\"meta\">\n\n</h4>\n\n</header>\n<article>\n<html><body><p>智通财经APP讯，<a href=\"https://laohu8.com/S/688177\">百奥泰</a>(688177.SH)发布公告，公司于近日收到<a href=\"https://laohu8.com/S/USFD\">美国食品</a>药品监督管理局(简称“FDA”)签发的关于Immgolis<sup>™</sup>/Immgolis Intri<sup>™</sup>(BAT2506，戈利木单抗注射液)上市批准通知。</p><p>据悉，BAT2506是百奥泰根据中国国家药品监督管理局(简称“NMPA”)、FDA、欧洲药品管理局(简称“EMA”)<a href=\"https://laohu8.com/S/000504\">生物</a>类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。</p><p>截至本公告披露日，BAT2506(戈利木单抗注射液)已获得FDA、EMA上市批准，美国商品名为Immgolis<sup>™</sup>/Immgolis Intri<sup>™</sup>，欧洲注册商品名为Gotenfia<sup>®</sup>;已向NMPA、巴西国家卫生监督局等递交上市许可申请，目前正在评审中。BAT2506(戈利木单抗注射液)的商业化授权合作目前已覆盖118个国家和地区。</p></body></html>\n\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"http://www.zhitongcaijing.com/content/detail/1442972.html\">智通财经</a> </p>\n\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n</div>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1442972.html","article_id":"2636024622","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2636024622","pubTimestamp":1779098337,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，百奥泰 发布公告，公司于近日收到美国食品药品监督管理局签发的关于Immgolis/Immgolis Intri上市批准通知。据悉，BAT2506是百奥泰根据中国国家药品监督管理局、FDA、欧洲药品管理局生物类似药相关指导原则开发的戈利木单抗生物类似药。截至本公告披露日，BAT2506已获得FDA、EMA上市批准，美国商品名为Immgolis/Immgolis Intri，欧洲注册商品名为Gotenfia;已向NMPA、巴西国家卫生监督局等递交上市许可申请，目前正在评审中。BAT2506的商业化授权合作目前已覆盖118个国家和地区。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"688177":"百奥泰","BK4588":"碎股","BK4585":"ETF&股票定投概念","IPOS":"Renaissance International IPO ETF","LABU":"三倍做多标普生物-Direxion","BK0239":"医药制造"},"translate_title":"Biotech (688177.SH): BAT2506 received marketing approval from the US FDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"688177":1.5,"IPOS":1.5,"LABU":1.5},"content_text":"智通财经APP讯，百奥泰(688177.SH)发布公告，公司于近日收到美国食品药品监督管理局(简称“FDA”)签发的关于Immgolis™/Immgolis Intri™(BAT2506，戈利木单抗注射液)上市批准通知。据悉，BAT2506是百奥泰根据中国国家药品监督管理局(简称“NMPA”)、FDA、欧洲药品管理局(简称“EMA”)生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。截至本公告披露日，BAT2506(戈利木单抗注射液)已获得FDA、EMA上市批准，美国商品名为Immgolis™/Immgolis Intri™，欧洲注册商品名为Gotenfia®;已向NMPA、巴西国家卫生监督局等递交上市许可申请，目前正在评审中。BAT2506(戈利木单抗注射液)的商业化授权合作目前已覆盖118个国家和地区。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"productRelease","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":"4.42.2","shortVersion":"4.42.2","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/2636024622","isCrawlerRequest":true}