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健康元NS-041片新增适应症临床试验获批
Bei Jing Shang Bao· 2025-12-21 09:21
Core Viewpoint - The announcement highlights that Health元's subsidiary, Lijun Pharmaceutical Group, 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 - Health元's subsidiary, Lijun Pharmaceutical Group, has received a clinical trial approval notice from the National Medical Products Administration for NS-041 tablets to include a new indication for the treatment of depression [1] - NS-041 tablets are 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 targeted drug 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 tablets have also been approved to conduct clinical trials for the indication of epilepsy, which is currently undergoing Phase II clinical research [1]
健康元(600380.SH)下属子公司获得药物临床试验批准通知书
智通财经网· 2025-12-21 07:57
Core Viewpoint - The announcement highlights that the company’s subsidiary, Lijun Pharmaceutical Group Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression, in addition to its existing indication for epilepsy [1] Group 1 - NS-041 is a novel highly selective KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders such as epilepsy and depression [1] - It is currently the only KCNQ2/3 targeted drug in China approved to conduct clinical research for both epilepsy and depression [1] - The clinical trial for the epilepsy indication was approved on December 27, 2023, and is currently in Phase II [1]
健康元:控股子公司获得NS-041片新增抑郁症临床试验批准通知书
Ge Long Hui A P P· 2025-12-21 07:52
Core Viewpoint - The announcement indicates that the company's subsidiary, Lizhu Pharmaceutical Factory, has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets, which are aimed at treating depression and epilepsy, marking a significant development in the field of neuropsychiatric disorders [1] Group 1 - The NS-041 tablet is a novel high-selectivity KCNQ2/3 agonist, targeting both epilepsy and depression, making it the only KCNQ2/3 targeted drug in China approved for clinical research in both conditions [1] - As of the announcement date, there are no new generation targeted KCNQ2/3 drugs available in the domestic market [1] - Following the approval for clinical trials, the drug must still undergo clinical testing and receive further review and approval from the National Medical Products Administration before it can be manufactured and marketed, indicating several uncertainties ahead [1]
健康元(600380.SH):NS-041片获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-12-21 07:47
Core Viewpoint - The company has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy, making it the only KCNQ2/3 targeted drug in China approved for both conditions [1][2]. Group 1: Clinical Trial Approval - The National Medical Products Administration has granted approval for NS-041 tablets to conduct clinical trials for the new indication of "treatment of depression" [1]. - NS-041 tablets are a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, specifically epilepsy and depression [1]. Group 2: Clinical Research Findings - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms of depression [2]. - In preclinical research, NS-041 tablets demonstrated significant antidepressant effects in both acute and chronic depression models in mice, with higher target selectivity compared to other investigational drugs [2]. Group 3: Licensing and Rights - NS-041 tablets were introduced through a licensing agreement signed in 2024 between the company and Neurona Therapeutics (Shanghai) Co., Ltd., granting the company exclusive rights to the drug in Greater China [2].
健康元:NS-041片获得药物临床试验批准通知书
Ge Long Hui· 2025-12-21 07:43
Core Viewpoint - The company has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy, making it the only KCNQ2/3 targeted drug in China approved for both conditions [1][2]. Group 1: Clinical Trial Approval - The National Medical Products Administration has granted approval for NS-041 tablets to conduct clinical trials for the new indication of "treatment of depression" [1]. - NS-041 tablets are a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, specifically epilepsy and depression [1]. Group 2: Clinical Research Findings - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms of depression [2]. - In preclinical research, NS-041 tablets demonstrated significant antidepressant effects in both acute and chronic depression models in mice, with higher target selectivity compared to other drugs in development [2]. Group 3: Licensing and Rights - NS-041 tablets were introduced through a licensing agreement signed in 2024 between the company and Neurona Therapeutics (Shanghai) Co., Ltd., granting the company exclusive rights to the drug in Greater China [2].