康哲药业自研减重新药CMS-D008获批临床，创新机制开辟减重新路径

药研界面03-09

近日，康哲药业控股有限公司（简称“康哲药业”）正式宣布，其自主研发的靶向INHBE的小干扰RNA（siRNA）药物CMS-D008注射液，成功获得国家药品监督管理局药品审评中心（CDE）签发的新药临床试验（IND）批件，获批开展用于治疗超重或肥胖人群的临床试验。CMS-D008注射液是一款皮下注射的siRNA药物，核心机制是通过RNA干扰技术（RNAi）精准抑制肝脏表达的INHBE基因（编码激活素...

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E-ALK7脂肪代谢通路的活化，达到“减脂不减肌”的效果。CMS-D005注射液是一款GLP-1R（胰高血糖素样肽-1受体）和GCGR（胰高血糖素受体）双重激动剂。其机制不同于传统的GLP-1受体激动剂（如司美格鲁肽），在抑制食欲和延缓胃排空的基础上，额外激活胰高血糖素途径，以增强脂肪分解代谢，特别是针对肝脏脂肪的减少。协同机制：两者的联合使用理论上可实现“中枢食欲控制”与“外周脂肪代谢优化”的双重打击。国际同类研究（如Wave Life Sciences开发的INHBE靶向siRNA药物WVE-007）的早期数据也显示，INHBE抑制剂与GLP-1类药物联用，可能产生优于单药的减重效果，并有助于减缓停药后的体重反弹。这种“高效减重获益”与“长期成果维持”相结合的策略，有望为患者提供更全面、更持久的治疗选择。本次CMS-D008获批的临床试验，主要针对超重或肥胖人群，这一群体规模庞大，据预测，全球超重和肥胖成年人比例预计到2030年将达到50%，中国超重或肥胖成人数量也将在2030年突破5亿，市场需求旺盛。除了超重或肥胖这一核心适应症，康哲药业明确表示，未来CMS-D008还将进一步拓展适应症范围，有望覆盖腹型肥胖以及相关代谢性疾病，包括非酒精性脂肪性肝病、2型糖尿病等。这一拓展方向与INHBE基因的作用机制高度契合，相关研究已证实，INHBE功能异常与腹型肥胖、代谢综合征、2型糖尿病等疾病密切相关，靶向抑制INHBE有望为这些疾病提供新的治疗思路，从而覆盖更广泛的患者群体，满足未被满足的临床需求。目前，康哲药业正积极推进CMS-D008的临床试验筹备工作，力争推动该产品尽快完成临床研究、实现上市，同时持续推进CMS-D005的临床开发，依托两款药物的协同优势，进一步巩固公司在代谢性疾病领域的研发实力，为全球肥胖及相关代谢性疾病患者提供更创新、更全面的治疗选择。","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 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