丽珠医药: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
Zhi Tong Cai Jing·2025-12-21 10:35

Core Viewpoint - Lijun Pharmaceutical's subsidiary has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy [1][2] Group 1: Clinical Trial Approval - Lijun Pharmaceutical's subsidiary, Lijun Group, has been granted a clinical trial approval notice by the National Medical Products Administration for NS-041 tablets to treat depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist, currently the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] Group 2: Clinical Research and Efficacy - The clinical trial for the depression indication follows the approval for epilepsy, with the latter currently in Phase II clinical research [1] - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, improving symptoms of depression [1] - NS-041 has shown good antidepressant effects in classical acute and chronic depression models in mice, with higher target selectivity than other drugs in development and no potential ocular toxicity risks identified [1] Group 3: Financial Investment - As of the announcement date, the total direct investment in the research and development of NS-041 has reached approximately RMB 58.54 million [2]