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今日（6月30日），中国国家药品监督管理局（NMPA）官网最新公示，科笛集团申报的非那雄胺喷雾剂新药上市申请（NDA）已获得批准。公开资料显示，这是科笛集团授权引进的一款外用非那雄胺产品（研发代号为CU-40102）。该产品本次获批的适应症为治疗雄激素性脱发。截图来源：NMPA官网雄激素性脱发（AGA）是常见的脱发类型，严重影响患者的心理健康和生活质量。该疾病一般认为与遗传因素及雄激素——二氢睾酮有关，但脱发的详细机制尚不十分清楚。非那雄胺作为特异性II型5α-还原酶竞争抑制剂，通过抑制头皮中睾酮转化为双氢睾酮，可治疗男性患者的雄激素性脱发。CU-40102是一款外用非那雄胺产品。科笛集团于2020年11月获Almirall的附属公司Polichem授予独家许可，以在大中华区开发、使用、分销等方式将CU-40102商业化用于治疗雄激素性脱发。根据科笛集团新闻稿介绍，与口服非那雄胺不同，CU-40102的外用制剂便于患者将药物直接精确地涂抹在头皮表面，在用药部位保持高浓度，减少药物的全身暴露，从而可减少口服药常会引起的副作用。CU-40102的中国3期注册性临床试验是一项多中心、随机、双盲、安慰剂对照的试验，评估了该产品对中国成年男性雄激素性脱发患者的疗效及安全性。该临床试验共入组270名中国成年男性雄激素性脱发受试者。受试者在24周的持续治疗期内每天在头皮局部外用给药一次。该临床试验结果显示，在疗效方面，受试者在治疗24周后，CU-40102组受试者的顶部秃发目标区域内的总毛发计数及终毛计数改善均显著优于安慰剂组，差异具有统计学意义，达到主要终点指标和主要的次要终点指标，且疗效从第12周起开始展现。此外，基于研究者评估的顶部毛发评分的有效率，24周治疗后CU-40102组显著优于安慰剂组，且差异具有统计学意义。安全性方面，CU-40102受试者对给药部位局部耐受性良好，CU-40102组与安慰剂组不良事件的总体发生率相似，没有发生严重不良事件，及没有导致死亡的不良事件。与此同时，同期进行的一项CU-40102在中国成年男性雄激素性脱发患者中的1期药代动力学研究显示，非那雄胺喷雾剂给药后，中国雄激素性脱发患者群体全身吸收量极少。参考资料：[1] 2025年06月30日药品批准证明文件送达信息.From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250630161536179.html[2]CU-40102（外用非那雄胺喷雾剂）新药上市申请获得国家药品监督管理局受理. Retrieved Jan 31 , 2024, from https://mp.weixin.qq.com/s/ctoKV8jXKDy-zKi7qP4Sag[3]CU-40102（外用非那雄胺喷雾剂）及CU-10201（外用4%米诺环素泡沫剂）III期临床试验结果在第18届CDA年会发布. Retrieved Dec 11, 2023, from https://mp.weixin.qq.com/s/LXPrI2Ndepnz9YN7SND4Lw[4] 科笛集团招股书 . Retrieved May 30，2023，from https://pdf.dfcfw.com/pdf/H2_AN202305311587373749_1.pdf?1685517434000.pdf免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。