康哲药业(00867)：1类新药MG-K10季节性过敏性鼻炎适应症中国上市许可申请已获受理

智通财经04-23

智通财经APP讯，康哲药业(00867)发布公告，本集团拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα人源化单抗注射液MG-K10(通用名为柯美奇拜单抗注射液，“MG-K10”或“产品”)季节性过敏性鼻炎适应症中国上市许可申请于2026年4月23日获得中国国家药品监督管理局(NMPA)受理。产品拟用于鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者...

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/2629833770?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2026-04-23 19:14","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2629833770","market":"hk","top_or_hot":-1,"title":"康哲药业(00867)：1类新药MG-K10季节性过敏性鼻炎适应症中国上市许可申请已获受理","media":"智通财经","content":"<div>\n<p>智通财经APP讯，康哲药业(00867)发布公告，本集团拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα人源化单抗注射液MG-K10(通用名为柯美奇拜单抗注射液，“MG-K10”或“产品”)季节性过敏性鼻炎适应症中国上市许可申请于2026年4月23日获得中国国家药品监督管理局(NMPA)受理。产品拟用于鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1432781.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>康哲药业(00867)：1类新药MG-K10季节性过敏性鼻炎适应症中国上市许可申请已获受理</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康哲药业(00867)：1类新药MG-K10季节性过敏性鼻炎适应症中国上市许可申请已获受理\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-04-23 19:14 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1432781.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，康哲药业(00867)发布公告，本集团拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα人源化单抗注射液MG-K10(通用名为柯美奇拜单抗注射液，“MG-K10”或“产品”)季节性过敏性鼻炎适应症中国上市许可申请于2026年4月23日获得中国国家药品监督管理局(NMPA)受理。产品拟用于鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1432781.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":"00867","symbol_name":"康哲药业","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1432781.html","article_id":"2629833770","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2629833770","pubTimestamp":1776942858,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"MG-K10已于一项成人中重度季节性过敏性鼻炎的多中心、随机、双盲、安慰剂对照的III期临床研究中达到方案设计的主要研究终点。MG-K10作为以IL-4Rα为靶点的生物制剂，可从源头阻断2型炎症通路。MG-K10季节性过敏性鼻炎适应症上市申请获NMPA受理，是本集团眼科业务公司康哲维盛将治疗领域从眼科拓展至耳鼻喉科的重要跨越，亦是本集团在2型炎症性疾病领域研发进程中的又一重要里程碑。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"00867":"康哲药业","SG9999015952.SGD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (SGD) ACC","LU2488822045.USD":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) ACC","IE00B7SZL793.SGD":"Legg Mason Royce - US Small Cap Opportunity A Acc SGD-H","IE00BVYPNQ40.USD":"GUINNESS ASIAN EQUITY INCOME \"C\" (USD) ACC","SG9999015978.USD":"利安颠覆性创新基金A","IE00BVYPNP33.GBP":"GUINNESS ASIAN EQUITY INCOME \"C\" (GBP) ACC","BK1191":"制药","BK1593":"医美概念股","MG":"Mistras Group","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","IE00B66KJ199.SGD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY  \" A\" (SGD) ACC","IE00BGHQDM52.EUR":"GUINNESS ASIAN EQUITY INCOME \"C\" (EUR) ACC","IE0031619046.USD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY \"A\" (USD) INC","SG9999004220.SGD":"Nikko AM Shenton Asia Dividend Equity Fund  SGD","BK4123":"调查和咨询服务","SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","IPOS":"Renaissance International IPO ETF","IE00BYV24P56.USD":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (USD) ACC","IE00B19Z4B17.USD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY \"A\" (USD) ACC","IE00BMCWC346.EUR":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (EUR) ACC"},"translate_title":"Kangzhe Pharmaceutical (00867): Class 1 new drug MG-K10 seasonal allergic rhinitis indication China marketing authorization application has been accepted","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00867":1.5,"IPOS":1.5,"MG":1.5},"content_text":"智通财经APP讯，康哲药业(00867)发布公告，本集团拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα人源化单抗注射液MG-K10(通用名为柯美奇拜单抗注射液，“MG-K10”或“产品”)季节性过敏性鼻炎适应症中国上市许可申请于2026年4月23日获得中国国家药品监督管理局(NMPA)受理。产品拟用于鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者。MG-K10是一种创新的长效抗IL-4Rα人源化单抗，能同时阻断关键2型炎症因子IL-4和 IL-13的信号传导从而发挥免疫调节作用，用于治疗2型炎症性疾病，包括季节性过敏性鼻炎、哮喘、特应性皮炎(AD)、结节性痒疹、慢性阻塞性肺疾病(COPD)、慢性自发性荨麻疹(CSU)、慢性鼻窦炎伴鼻息肉及嗜酸性粒细胞性食管炎等。目前已上市的抗IL-4Rα药物均需要每2周给药一次，而MG-K10凭借更长的半衰期，可实现4周一次的给药频率，有望成为全球首个上市的长效抗IL-4Rα单抗，具有成为同类最优(Best-in-Class)的潜力。MG-K10已于一项成人中重度季节性过敏性鼻炎的多中心、随机、双盲、安慰剂对照的III期临床研究中达到方案设计的主要研究终点。该III期研究结果显示，主要终点达统计学差异，疗效显著优于安慰剂组，且安全性良好。过敏性鼻炎是由IgE介导、以2型炎症为核心机制的鼻黏膜慢性炎症性疾病，易感个体在接触花粉、尘螨等环境过敏原后发病。近年来我国该病患病率已从11.1%升至17.6%，受累患者约2.5亿，其中持续性中重度患者占比达52.2%，疾病负担突出且已成为重要公共卫生问题。目前临床常用的鼻用糖皮质激素、抗组胺药等标准治疗存在明显局限， 62%的中重度患者症状仍无法有效控制，且长期使用鼻用激素易引发鼻出血，抗组胺药则常伴随嗜睡等不良反应，临床未被满足需求显著。MG-K10作为以IL-4Rα为靶点的生物制剂，可从源头阻断2型炎症通路。相较于已获批的同靶点生物制剂(每2周给药一次)，MG-K10在给药频率上实现了差异化突破——每4周一次给药的长效特性，显著延长了给药间隔，有助于提升患者的治疗依从性，减少频繁就医带来的时间与经济成本。有望为传统治疗控制不佳的中重度患者提供治疗新选择，减轻疾病带来的个人及社会经济负担。MG-K10季节性过敏性鼻炎适应症上市申请获NMPA受理，是本集团眼科业务公司康哲维盛将治疗领域从眼科拓展至耳鼻喉科的重要跨越，亦是本集团在2型炎症性疾病领域研发进程中的又一重要里程碑。若该产品成功获批上市，本集团将依托强大的学术推广、渠道网络等商业化能力，加速推进该产品商业化落地，并有望进一步提升康哲维盛在相关专科领域的学术品牌影响力，为本集团带来业务增长新动力。于2025年1月24日，本集团通过本公司附属公司与湖南麦济生物技术股份有限公司及其附属公司就MG-K10签订合作协议(协议)。根据该协议及补充约定，本集团获得了产品在中国大陆、香港特别行政区、澳门特别行政区、台湾地区及新加坡的共同开发权(除AD外)及独家商业化权利;其中旗下德镁医药有限公司通过其附属公司获得该产品在皮肤科适应症领域于中国大陆的共同开发权(除AD外)及独家商业化权利。","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":"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":"4.44.0","shortVersion":"4.44.0","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/2629833770","isCrawlerRequest":true}