康哲药业(00867)：1类新药MG-K10人源化单抗注射液新增获得慢性自发性荨麻疹适应症药物III期临床试验批准通知书

智通财经09-28

智通财经APP讯，康哲药业(00867)发布公告，旗下德镁医药有限公司(德镁医药，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市)连同其附属公司拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα MG-K10人源化单抗注射液(MG-K10)于2025年9月28日获中国国家药品监督管理局(NMPA)签发的药物临床试验批准通知书，NMPA同意...

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/2570844305?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-09-28 19:51","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2570844305","market":"fut","top_or_hot":-1,"title":"康哲药业(00867)：1类新药MG-K10人源化单抗注射液新增获得慢性自发性荨麻疹适应症药物III期临床试验批准通知书","media":"智通财经","content":"<div>\n<p>智通财经APP讯，康哲药业(00867)发布公告，旗下德镁医药有限公司(德镁医药，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市)连同其附属公司拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα MG-K10人源化单抗注射液(MG-K10)于2025年9月28日获中国国家药品监督管理局(NMPA)签发的药物临床试验批准通知书，NMPA同意...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1350344.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人源化单抗注射液新增获得慢性自发性荨麻疹适应症药物III期临床试验批准通知书</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人源化单抗注射液新增获得慢性自发性荨麻疹适应症药物III期临床试验批准通知书\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-09-28 19:51 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1350344.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，旗下德镁医药有限公司(德镁医药，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市)连同其附属公司拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα MG-K10人源化单抗注射液(MG-K10)于2025年9月28日获中国国家药品监督管理局(NMPA)签发的药物临床试验批准通知书，NMPA同意...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1350344.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":"IE00B7SZL793.SGD","symbol_name":"Legg Mason Royce - US Small Cap Opportunity A Acc SGD-H","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1350344.html","article_id":"2570844305","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2570844305","pubTimestamp":1759060312,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"产品的嗜酸性粒细胞性食管炎、慢性鼻窦炎伴鼻息肉适应症也已获得NMPA签发的药物临床试验批准通知书。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"IE00B7SZL793.SGD":"Legg Mason Royce - US Small Cap Opportunity A Acc SGD-H","BK1593":"医美概念股","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","III":"信息服务","BK4123":"调查和咨询服务","IE00BGHQDM52.EUR":"GUINNESS ASIAN EQUITY INCOME \"C\" (EUR) ACC","IE00B66KJ199.SGD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY  \" A\" (SGD) ACC","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","MG":"Mistras Group","SG9999004220.SGD":"Nikko AM Shenton Asia Dividend Equity Fund  SGD","IE0031619046.USD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY \"A\" (USD) INC","SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","IE00B19Z4B17.USD":"LEGG MASON ROYCE US SMALL CAP OPPORTUNITY \"A\" (USD) ACC","IE00BYV24P56.USD":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (USD) ACC","IE00BMCWC346.EUR":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (EUR) ACC","LU2488822045.USD":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) ACC","SG9999015952.SGD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (SGD) ACC","BK4134":"信息科技咨询与其它服务","00867":"康哲药业","BK1191":"制药"},"translate_title":"Kangzhe Pharmaceutical (00867): Class 1 new drug MG-K10 humanized monoclonal antibody injection newly obtained phase III clinical trial approval notice for chronic spontaneous urticaria indication drugs","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00867":1.5,"III":1.5,"MG":1.5},"content_text":"智通财经APP讯，康哲药业(00867)发布公告，旗下德镁医药有限公司(德镁医药，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市)连同其附属公司拥有共同开发权(除特应性皮炎(AD)外)及独家商业化权利的1类新药抗IL-4Rα MG-K10人源化单抗注射液(MG-K10)于2025年9月28日获中国国家药品监督管理局(NMPA)签发的药物临床试验批准通知书，NMPA同意开展MG-K10用于慢性自发性荨麻疹(CSU)的III期临床试验。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，用于治疗2型炎症性疾病。目前已上市的抗IL-4Rα药物均需要每2周给药一次，而MG-K10具有更长的半衰期，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。集团与湖南麦济生物技术股份有限公司(麦济生物)正积极准备开展相关临床试验工作。此外，MG-K10已在成人中重度AD的一项随机、双盲、安慰剂对照III期临床研究中取得阳性结果，达到方案设计的临床试验主要研究终点。哮喘、结节性痒疹和季节性过敏性鼻炎均已进入中国III期临床试验阶段，在此前完成的成人中重度哮喘的II期临床试验中，MG-K10也呈现良好的有效性和安全性。产品的嗜酸性粒细胞性食管炎、慢性鼻窦炎伴鼻息肉适应症也已获得NMPA签发的药物临床试验批准通知书。","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,"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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.10","shortVersion":"4.35.10","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/2570844305","isCrawlerRequest":true}