全球首创IL-4Rα/ST2双抗，康方生物“AK139”又获批2项适应症临床_老虎社区_美港股上老虎

全球首创IL-4Rα/ST2双抗，康方生物“AK139”又获批2项适应症临床

新药社02-04

今日，CDE官网显示，中山康方生物医药有限公司开发的AK139注射液又获批2项适应症临床：慢性鼻窦炎伴鼻息肉、中重度特应性皮炎。该药最早于2025年4月获CDE临床试验批准，截止至目前，已获批开展5项适应症临床。（图片来源：CDE）关注新药社，每日为你介绍全球新药信息AK139注射液是康方生物自主研发的1类创新生物药，为全球首创人白介素4受体（IL-4Rα）/致瘤性抑制蛋白2（ST2）双特异性重组...

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。

暂无评论

热议股票

7x24

全部

{"i18n":{"language":"zh_CN"},"data":{"share":"https://www.laohu8.com/m/news/2609310947?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2026-02-04 16:44","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2609310947","market":"hk","top_or_hot":-1,"title":"全球首创IL-4Rα/ST2双抗，康方生物“AK139”又获批2项适应症临床","media":"新药社","content":"<div>\n<p>今日，CDE官网显示，中山康方生物医药有限公司开发的AK139注射液又获批2项适应症临床：慢性鼻窦炎伴鼻息肉、中重度特应性皮炎。该药最早于2025年4月获CDE临床试验批准，截止至目前，已获批开展5项适应症临床。（图片来源：CDE）关注新药社，每日为你介绍全球新药信息AK139注射液是康方生物自主研发的1类创新生物药，为全球首创人白介素4受体（IL-4Rα）/致瘤性抑制蛋白2（ST2）双特异性重组...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260204164726a47b1b1b&s=b\">网页链接</a>\n\n</div>\n","source":"tencent","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>全球首创IL-4Rα/ST2双抗，康方生物“AK139”又获批2项适应症临床</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全球首创IL-4Rα/ST2双抗，康方生物“AK139”又获批2项适应症临床\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-02-04 16:44 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260204164726a47b1b1b&s=b><strong>新药社</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>今日，CDE官网显示，中山康方生物医药有限公司开发的AK139注射液又获批2项适应症临床：慢性鼻窦炎伴鼻息肉、中重度特应性皮炎。该药最早于2025年4月获CDE临床试验批准，截止至目前，已获批开展5项适应症临床。（图片来源：CDE）关注新药社，每日为你介绍全球新药信息AK139注射液是康方生物自主研发的1类创新生物药，为全球首创人白介素4受体（IL-4Rα）/致瘤性抑制蛋白2（ST2）双特异性重组...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260204164726a47b1b1b&s=b\">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":"LU0561508036.HKD","symbol_name":"ALLIANZ CHINA EQUITY \"A\" (HKD) INC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260204164726a47b1b1b&s=b","article_id":"2609310947","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260204164726a47b1b1b&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2609310947","pubTimestamp":1770194665,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"今日，CDE官网显示，中山康方生物医药有限公司开发的AK139注射液又获批2项适应症临床：慢性鼻窦炎伴鼻息肉、中重度特应性皮炎。该药最早于2025年4月获CDE临床试验批准，截止至目前，已获批开展5项适应症临床。在抑制炎症因子释放、组织炎症细胞浸润等指标中展现出显著优于IL-4或ST2单靶点抗体的协同效应，临床前毒理学研究显示AK139具有良好的安全性。目前，AK139注射液正在开展I期临床研究，是是康方生物第7个进入临床阶段的双抗新药。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0561508036.HKD":"ALLIANZ CHINA EQUITY \"A\" (HKD) INC","IE00B5MMRT66.SGD":"NEUBERGER BERMAN CHINA EQUITY \"A\" (SGDHDG) ACC","LU2476274720.SGD":"ALLIANZ CHINA FUTURE TECHNOLOGIES \"AT\" (SGDHDG) ACC","LU0348766576.USD":"ALLIANZ LITTLE DRAGONS \"A\" (USD) INC","LU0417516571.SGD":"Allianz Oriental Income Cl AT Acc SGD","LU2399975544.HKD":"ALLIANZ ALL CHINA EQUITY \"AT\" (HKD) ACC","LU0348767384.USD":"ALLIANZLITTLE DRAGONS \"A\" (USD) ACC","09926":"康方生物","IE00BPRC5H50.USD":"NEUBERGER BERMAN CHINA EQUITY \"A\" (USD) INC","LU0348827113.USD":"ALLIANZ RCM CHINA \"AT\" ACC","LU0417516738.SGD":"Allianz Hong Kong Equity AT Acc SGD","LU0348735423.USD":"ALLIANZ HONG KONG EQUITY \"A\" (USD) INC","BK1161":"生物科技","LU0540923850.HKD":"ALLIANZ HONG KONG EQUITY \"A\" (HKD) INC","LU1720050803.USD":"安联全方位中国股票基金","IE00B543WZ88.USD":"NEUBERGER BERMAN CHINA EQUITY \"A\" (USD) ACC","LU0634319403.HKD":"ALLIANZ HONG KONG EQUITY \"AT\" (HKD) ACC","LU1961090484.USD":"ALLIANZ ALL CHINA EQUITY \"A\" (USD) INC","LU0417516902.SGD":"Allianz China Equity Cl AT Acc SGD","BK1574":"生物医药B类股","LU2488822045.USD":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) ACC","LU0348825331.USD":"ALLIANZ CHINA EQUITY \"A\" (USD) INC","LU2476274308.USD":"ALLIANZ CHINA FUTURE TECHNOLOGIES \"AT\" (USD) ACC","LU0348783233.USD":"安联东方收入型 CI A Dis美元","LU0348784397.USD":"ALLIANZ ORIENTAL INCOME \"A\" (USD) ACC","LU1794554557.SGD":"Allianz All China Equity AT Acc H2-SGD","LU2778985437.USD":"ALLIANZ CHINA FUTURE TECHNOLOGIES \"A\" (USD) INC"},"translate_title":"The world's first IL-4Rα/ST2 double antibody, Kangfang Biotech's \"AK139\" was approved for 2 clinical indications","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"09926":1.5},"content_text":"今日，CDE官网显示，中山康方生物医药有限公司开发的AK139注射液又获批2项适应症临床：慢性鼻窦炎伴鼻息肉、中重度特应性皮炎。该药最早于2025年4月获CDE临床试验批准，截止至目前，已获批开展5项适应症临床。（图片来源：CDE）关注新药社，每日为你介绍全球新药信息AK139注射液是康方生物自主研发的1类创新生物药，为全球首创人白介素4受体（IL-4Rα）/致瘤性抑制蛋白2（ST2）双特异性重组人源化IgG1 κ亚型单克隆抗体，采用皮下注射给药方式。该药的核心优势在于可通过同时高亲和力结合IL-4Rα与ST2靶点，双重阻断IL-4/IL-13和IL-33/ST2两条核心炎症通路，协同抗炎效果优于单靶点抗体。临床前研究显示，AK139具有良好的双特异性抗原结合活性，以及良好的体内外药理学活性。在抑制炎症因子释放、组织炎症细胞浸润等指标中展现出显著优于IL-4或ST2单靶点抗体的协同效应，临床前毒理学研究显示AK139具有良好的安全性。（信息来源康方生物新闻稿）目前，AK139注射液正在开展I期临床研究，是是康方生物第7个进入临床阶段的双抗新药。在全球范围内，慢性阻塞性肺疾病（COPD）、支气管哮喘、特应性皮炎等慢性炎症性疾病构成了巨大的健康负担，患者群体极为庞大。这类疾病通常由复杂的多通路炎症网络（如IL-4、IL-13、TSLP等）共同驱动，然而，现有主流的单一靶点治疗方案在实践中呈现出显著的局限性：临疗效不足、症状控制不理想等问题。正是这一“多通路驱动”与“单通路阻断”之间的不匹配性，驱动了医药研发向更前沿的双靶点甚至多靶点策略进化。除康方的AK139注射液外，赛诺菲的Lunsekimig (TSLP/IL-13)、辉瑞的PF-07275315（TSLP/IL-4/IL-13）等也已进入临床中后阶段。这一领域新药研发的蓬勃发展吸引了巨额资本布局，但该领域也面临严格的临床验证挑战，已有项目因疗效未达预期而终止（强生，JNJ-5939靶向IL-4Rα和IL-31，终止中重度特应性皮炎的全球临床试验），整体处于从概念验证走向成熟的关键阶段。加入新药社交流群，每日获取全球新药动态声明：本公众号发布的关于新药研发进展、临床研究动态及药品获批信息等内容，仅为分享医药领域前沿资讯、提供行业信息参考。不构成任何投资建议！不构成任何形式的医疗建议、疾病诊断依据或用药指导！","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":[],"hasMoreComments":false,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"isCrawlerRequest":true}