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...

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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,"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; 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