丽珠医药(01513)：莱康奇塔单抗注射液上市许可申请获国家药品监督管理局受理

智通财经06-01

智通财经APP讯，丽珠医药(01513)发布公告，近日，丽珠医药集团股份有限公司的控股子公司珠海市丽珠单抗生物技术有限公司收到国家药品监督管理局核准签发的《受理通知书》(受理号：CXSS2600087)，丽珠单抗与北京鑫康合生物医药科技有限公司联合开发的“莱康奇塔单抗注射液”的境内生产药品注册上市许可申请获国家药监局受理。强直性脊柱炎为慢性炎症性风湿免疫疾病，国内患者规模约400万人，IL-17...

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/2640895713?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2026-06-01 22:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2640895713","market":"us","top_or_hot":-1,"title":"丽珠医药(01513)：莱康奇塔单抗注射液上市许可申请获国家药品监督管理局受理","media":"智通财经","content":"<div>\n<p>智通财经APP讯，丽珠医药(01513)发布公告，近日，丽珠医药集团股份有限公司的控股子公司珠海市丽珠单抗生物技术有限公司收到国家药品监督管理局核准签发的《受理通知书》(受理号：CXSS2600087)，丽珠单抗与北京鑫康合生物医药科技有限公司联合开发的“莱康奇塔单抗注射液”的境内生产药品注册上市许可申请获国家药监局受理。强直性脊柱炎为慢性炎症性风湿免疫疾病，国内患者规模约400万人，IL-17...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1448777.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>丽珠医药(01513)：莱康奇塔单抗注射液上市许可申请获国家药品监督管理局受理</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丽珠医药(01513)：莱康奇塔单抗注射液上市许可申请获国家药品监督管理局受理\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-06-01 22:00 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1448777.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，丽珠医药(01513)发布公告，近日，丽珠医药集团股份有限公司的控股子公司珠海市丽珠单抗生物技术有限公司收到国家药品监督管理局核准签发的《受理通知书》(受理号：CXSS2600087)，丽珠单抗与北京鑫康合生物医药科技有限公司联合开发的“莱康奇塔单抗注射液”的境内生产药品注册上市许可申请获国家药监局受理。强直性脊柱炎为慢性炎症性风湿免疫疾病，国内患者规模约400万人，IL-17...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1448777.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":"IPOS","symbol_name":"Renaissance International IPO ETF","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1448777.html","article_id":"2640895713","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2640895713","pubTimestamp":1780322419,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"莱康奇塔单抗注射液此次用于治疗强直性脊柱炎的上市申请已获国家药监局正式受理，是本品继银屑病适应症申请获受理并纳入优先审评后，第二项获受理的适应症。本品上市申请基于关键注册性III期临床研究，采用多中心、随机、双盲、安慰剂对照试验。截至本公告披露日，莱康奇塔单抗注射液累计直接投入的研发费用约为人民币21,693万元。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"IPOS":"Renaissance International IPO ETF","01513":"丽珠医药","BK1191":"制药"},"translate_title":"Livzon Pharmaceuticals (01513): The application for marketing authorization of lekoncitazumab injection was accepted by the National Medical Products Administration","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IPOS":1.5,"01513":1.5},"content_text":"智通财经APP讯，丽珠医药(01513)发布公告，近日，丽珠医药集团股份有限公司的控股子公司珠海市丽珠单抗生物技术有限公司收到国家药品监督管理局核准签发的《受理通知书》(受理号：CXSS2600087)，丽珠单抗与北京鑫康合生物医药科技有限公司联合开发的“莱康奇塔单抗注射液”的境内生产药品注册上市许可申请获国家药监局受理。强直性脊柱炎为慢性炎症性风湿免疫疾病，国内患者规模约400万人，IL-17通路为该领域重要治疗靶点。莱康奇塔单抗注射液此次用于治疗强直性脊柱炎的上市申请已获国家药监局正式受理，是本品继银屑病适应症申请获受理并纳入优先审评后，第二项获受理的适应症。本品上市申请基于关键注册性III期临床研究，采用多中心、随机、双盲、安慰剂对照试验。研究结果显示，本品疗效明确稳健，兼具多重优势：起效迅速，首周即显现疗效差异，可快速改善患者炎症指标;第16周临床应答率显着优于安慰剂组，可实现症状深度缓解;随访至 52 周疗效持续稳固，转药患者亦可明显获益，并改善患者生活质量。本品采用每4周皮下注射方案，给药便捷、利于提升依从性;本品安全性与耐受性良好，不良事件发生率与安慰剂组相近，无新增安全信号。同时，本品可覆盖 TNFi 初治及经治人群，无论患者既往是否接受过TNFi治疗，均可获得稳定且一致的治疗获益。 本品由丽珠单抗与北京鑫康合联合开发。截至本公告披露日，莱康奇塔单抗注射液累计直接投入的研发费用约为人民币21,693万元。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"1","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,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.44.1","shortVersion":"4.44.1","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/2640895713","isCrawlerRequest":true}