康哲药业(00867)：创新药GnRH受体拮抗剂CMS-D002获得子宫肌瘤适应症药物临床试验批准通知书

智通财经09-26

智通财经APP讯，康哲药业(00867)发布公告，集团自主研发的创新药CMS-D002胶囊(CMS-D002)于2025年9月25日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9月26日收到药物临床试验批准通知书。NMPA同意开展临床试验以评价 CMS-D002治疗子宫肌瘤的安全性和有效性。CMS-D002是小分子促性腺激素释放激素(GnRH)受体拮抗剂。GnRH是由...

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UFs)由子宫平滑肌组织增生而形成，是女性最常见的一种良性肿瘤，其病因尚不明确，可能与遗传易感性和性激素水准有关，高危因素包括年龄、种族、肥胖和饮食等。UFs发病年龄在15至59岁之间，以30至44岁的女性最为常见，发病率整体呈逐年升高趋势，育龄期妇女的患病率可达25%。子宫肌瘤目前治疗手段包括手术治疗和药物治疗，手术治疗虽可明显改善子宫肌瘤患者症状，但存在失血及尿失禁等安全性问题;药物治疗包括对症治疗及内分泌治疗，对症治疗药物仅能改善子宫肌瘤疼痛或贫血等症状，无法缩小肌瘤体积;内分泌治疗如GnRH受体激动剂及孕激素受体调节剂虽可通过降低患者雌孕激素水准显著缩小肌瘤体积，但GnRH受体激动剂可能存在治疗初期患者症状加重(即点火效应);孕激素受体调节剂存在肝损及抗糖皮质激素效应等不良反应。因此，目前子宫肌瘤的药物治疗仍面临巨大的未被满足的临床需求。与GnRH受体激动剂相比，GnRH受体拮抗剂无“点火效应”，可以快速竞争性结合GnRH 受体并阻断其启动，快速抑制FSH和LH的释放，进而抑制下游雌激素的分泌，缓解子宫肌瘤的进展，在较低的剂量下可实现部分抑制，在更高的剂量下则达到完全抑制。此外，由于拮抗剂的作用可逆，在停药一段时间后，当内源性GnRH重新结合受体时，患者的性腺功能有望恢复正常。CMS-D002作为一款口服非肽类小分子GnRH受体拮抗剂，结合其优异的临床前表现，有望为患者提供更优的治疗选择。CMS-D002将进一步丰富集团产品矩阵，为中国患者提供差异化用药选择，满足兼具良好疗效、安全性与良好患者依从性药物的临床需求，使患者受益。CMS-D002将有效增强集团在妇科治疗领域的实力，依托现有专家网络与市场资源，提升该领域的竞争力与市场地位。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":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; 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