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丽珠医药(01513.HK):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
Ge Long Hui· 2025-12-21 10:46
Core Viewpoint - Lijun Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression, expanding its indications beyond epilepsy [1] Group 1: Company Developments - Lijun Pharmaceutical's wholly-owned subsidiary, Lijun Group Lijun Pharmaceutical Factory, has been granted a clinical trial approval notice for NS-041 tablets, specifically for the treatment of depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, making it the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] - The clinical trial for the epilepsy indication of NS-041 was approved on December 27, 2023, and is currently undergoing Phase II clinical research [1] Group 2: Drug Mechanism and Efficacy - Research indicates that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms related to depression [1] - In preclinical studies for the depression indication, NS-041 demonstrated significant antidepressant effects in classical acute and chronic depression models in mice [1] - The selectivity of NS-041 is higher than that of other drugs targeting the same pathway currently under investigation, and no potential ocular toxicity risks have been identified [1]
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
智通财经网· 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, marking a significant advancement in its drug development pipeline [1] Group 1: Clinical Trial Approval - Lijun Pharmaceutical's subsidiary, Lijun Group Lijun Pharmaceutical Factory, 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 aimed at treating neurological and psychiatric disorders, currently the only KCNQ2/3 agonist in China approved for both epilepsy and depression clinical studies [1] - The clinical trial for the epilepsy indication was approved on December 27, 2023, and is currently in Phase II [1] Group 2: Mechanism and Efficacy - Research indicates that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms of depression [1] - Preclinical studies of NS-041 in classic acute and chronic depression models in mice have shown promising antidepressant effects, with higher target selectivity compared to other investigational drugs targeting the same pathway [1] - No potential ocular toxicity risks have been identified in the studies conducted [1] Group 3: Financial Investment - As of the announcement date, the total direct investment in the research and development of NS-041 tablets amounts to approximately RMB 58.54 million [2] - The drug was introduced through a licensing agreement signed in 2024 with Neuron Pharma (Shanghai) Co., Ltd., granting Lijun Pharmaceutical exclusive rights in the Greater China region [2]
丽珠集团(000513.SZ):NS-041片获得药物临床试验批准通知书
Xin Lang Cai Jing· 2025-12-21 09:21
Core Viewpoint - LIZHU Group's subsidiary has received approval for clinical trials of NS-041 tablets for the treatment of depression, marking a significant development in the company's product pipeline [1] Group 1: Company Developments - LIZHU Group's wholly-owned subsidiary, LIZHU Pharmaceutical Factory, has been granted a clinical trial approval notice by the National Medical Products Administration for NS-041 tablets to include a new indication for the treatment of depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, specifically epilepsy and depression [1] - NS-041 is currently the only KCNQ2/3 agonist in China approved to conduct clinical research for both epilepsy and depression [1] Group 2: Clinical Trial Status - As of December 27, 2023, NS-041 has also been approved to initiate clinical trials for the epilepsy indication, which is currently undergoing Phase II clinical research [1]