KCNQ2/3通道激活剂
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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]
丽珠医药(01513) - 自愿公告 NS-041片新增治疗抑鬱症适应症获得药物临床试验批准通知书
2025-12-21 10:14
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完整性亦 不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任 何損失承擔任何責任。 自願公告 NS-041 片新增治療抑鬱症適應症 獲得藥物臨床試驗批准通知書 近日,麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.*(「本公司」)全资控 股子公司麗珠集團麗珠制藥廠(「麗珠制藥廠」)收到國家藥品監督管理局核准簽發的關於 NS-041 片新增針對治療抑鬱症適應症的《藥物臨床試驗批准通知書》(通知書編號: 2025LP03436、2025LP03437),同意 NS-041 片新增適應症開展臨床試驗。現將有關詳情公 告如下: 藥品基本情況 藥物名稱:NS-041 片 劑型:片劑 註冊分類:化學藥品 1 類 本次 NS-041 片新增獲批的臨床試驗適應症為治療抑鬱症,研究表明,KCNQ2/3 通道激活劑 能夠調節中腦腹側被蓋區多巴胺神經元的興奮性,從而改善相關抑鬱症狀。在該適應症的臨 床前研究中,NS-041 片在小鼠經典急性和慢性抑鬱模型中,均表現出 ...