康哲药业(00867)：创新药高选择性TYK2抑制剂CMS-D001获得溃疡性结肠炎适应症和克罗恩病适应症药物临床试验批准通知书

智通财经05-26

智通财经APP讯，康哲药业(00867)发布公告，于2026年5月22日，创新药CMS-D001片(CMS-D001或产品)获得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，于5月25日收到药物临床试验批准通知书。NMPA同意本集团开展临床试验以评价CMS-D001治疗溃疡性结肠炎适应症和克罗恩病适应症的安全性和有效性。CMS-D001是高选择性TYK2(酪氨酸激酶2)抑制剂。...

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disease，CD)是一种可累及全消化道的慢性肉芽肿性炎症性疾病，常见临床表现包括腹痛、腹泻、体重下降、肠瘘及肠梗阻等。CD多为年轻起病，病程迁延，致残率高，无法治愈，严重影响患者的生存质量及预后。根据《我国炎症性肠病流行病学研究进展》，近年来，CD的发病率在全球范围内呈上升趋势。在中国，CD患病率约为1.4/10万-3.0/10万，年发病率约0.5/10万-1.0/10万，推算全国现存患者约2万至4.5万人。因存在漏诊、误诊情况，实际患病人数可能更高。UC和CD为炎症性肠病(Inflammatory Bowel Disease，IBD)的主要亚型。目前，临床治疗轻中度IBD的药物以氨基水杨酸和糖皮质激素为主。中重度IBD的药物主要包括生物制剂和小分子靶向药物等，临床上JAK抑制剂治疗疗效最优，但临床缓解率最高仅能达到30-40%，仍急需开发新型IBD治疗药物。CMS-D001通过特异性抑制TYK2的激活，可更精准作用于IBD的关键致病环节，同时减少对其他JAK激酶介导的信号通路的影响，安全性较其他JAK抑制剂更佳。因此，TYK2抑制剂已成为IBD的新兴靶点，有望开发成为新型IBD口服药物。如若获批上市，CMS-D001可与本集团在售产品莎尔福(美沙拉秦，适用于溃疡性结肠炎和克罗恩病)、独家药亿活(布拉氏酵母菌散，用于治疗成人和儿童腹泻)等品种形成协同，强化对肠道疾病患者全周期、全病程管理，有效增强本集团在消化治疗领域的实力，并在团队、专家网络与市场资源方面形成协同效应，共同提升集团在该领域的竞争力与市场地位。CMS-D001由本集团旗下德镁医药有限公司及其附属公司(德镁医药)自主研发，已于2024年1月18日及2025年7月11日分别获批开展关于银屑病适应症与特应性皮炎适应症的药物临床试验。目前，CMS-D001健康受试者I期研究已完成，银屑病和特应性皮炎的Ⅱ期临床试验正在开展中，首例受试者已入组。该产品可与德镁医药的皮肤健康领域产品(如在研创新药长效抗IL-4Rα单抗MG-K10以及在售创新药磷酸芦可替尼乳膏、皮肤学级护肤品禾零舒缓产品)形成管线协同。德镁医药已将关于IBD的相关权利独家许可予本集团(除德镁医药)。CMS-D001未来还拟开发用于治疗系统性红斑狼疮等自身免疫病。本集团正积极准备开展相关临床试验工作，力争该产品尽快上市。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"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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