丽珠医药(01513)：NS-041 片新增治疗抑郁症适应症获得药物临床试验批准通知书

智通财经

Dec 21, 2025

智通财经APP讯，丽珠医药(01513)公布，公司全资控股子公司丽珠集团丽珠制药厂(丽珠制药厂)收到国家药品监督管理局核准签发的关于 NS-041 片新增针对治疗抑郁症适应症的《药物临床试验批准通知书》(通知书编号： 2025LP03436、2025LP03437)，同意 NS-041 片新增适应症开展临床试验。

NS-041 片是一款新型高选择性 KCNQ2/3 激动剂，目标用于癫痫和抑郁症等神经精神类疾病的治疗，系目前国内唯一获批同时开展癫痫和抑郁症临床研究的 KCNQ2/3 激动剂。2023 年 12 月 27 日，NS-041 片获批开展癫痫适应症的临床试验，目前该适应症正在进行 II 期临床研究。

本次 NS-041 片新增获批的临床试验适应症为治疗抑郁症，研究表明，KCNQ2/3 通道激活剂能够调节中脑腹侧被盖区多巴胺神经元的兴奋性，从而改善相关抑郁症状。在该适应症的临床前研究中，NS-041 片在小鼠经典急性和慢性抑郁模型中，均表现出良好的抗抑郁效果;靶点选择性高于同靶点在研药物，且未发现潜在眼毒性风险。

NS-041 片系由丽珠制药厂与纽欧申医药(上海)有限公司于 2024 年签署许可协议引进，丽珠制药厂独家享有该药物在大中华区的所有权益。截至本公告日期，NS-041 片累计直接投入的研发费用约为人民币 5,853.94 万元。

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