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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 ...
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]
丽珠集团(000513) - 关于获得药物临床试验批准通知书的公告
2025-12-21 09:15
药物名称:NS-041片 剂型:片剂 证券代码:000513、01513 证券简称:丽珠集团、丽珠医药 公告编号:2025-079 丽珠医药集团股份有限公司 关于获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露内容真实、准确、完整,没有虚假记 载、误导性陈述或重大遗漏。 近日,丽珠医药集团股份有限公司(以下简称"公司")全资控股子公司 丽珠集团丽珠制药厂(以下简称"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。现将有关情况公告如下: 一、药品基本情况 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。 截至本公告披露日,NS-041片累计直接投入的研发费用约为人民币5,853.94 万元。 三、药品的市场情况 根据国家药品监督管理局药品审评中心(CDE)网站显示,截至本公告披 露日,国内尚无新一代靶向KCNQ2/3的药物上市 ...
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(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].
趋势研判!2025年中国肥胖症药物行业发展全景分析:市场规模不断增长,超重肥胖症药物市场具有强劲增长潜力[图]
Chan Ye Xin Xi Wang· 2025-12-15 01:42
关键词:肥胖症药物行业政策措施、肥胖症药物行业产业链、肥胖症药物市场规模、肥胖症药物行业细 分结构、肥胖症药物市场竞争格局、肥胖症药物行业面临的挑战 一、肥胖症药物行业定义及类别 肥胖症是一种普遍且复杂的慢性疾病,患病群体庞大,且已被视为多种慢性代谢性疾病的重要风险因 素。肥胖症患病率的增加已经成为全球性的严重健康问题和社会问题,肥胖症的治疗较困难。肥胖症的 治疗包括行为心理干预、运动干预、临床营养治疗与药物治疗等。药物治疗是肥胖症二级预防及治疗过 程中非常重要的一环。对肥胖症及时诊断和分类,评估并发症或合并症的情况,尽早给予生活方式调 整,必要时使用减重药物治疗,定期复查随访。当充分的生活方式干预和行为治疗(包括控制饮食量、 减少脂肪摄入、增加体力活动等)仍未达到预期减重效果,或者增加运动量可能加重基础疾病时,可以 考虑减重药物治疗。 适用于药物治疗的肥胖症情况 在肥胖症的治疗策略中,药物治疗极其重要。目前,全球用于治疗肥胖症的药物主要有3类:中枢性减 重药、非中枢性减重药以及兼有减重效果的降糖药物。主流抗肥胖症药物包括中枢神经系统作用药物、 脂肪酶抑制剂和营养刺激激素受体激动剂等。 主流抗肥胖症药物类别 ...
精准医疗板块12月12日涨0.53%,华大智造领涨,主力资金净流出10.22亿元
Sou Hu Cai Jing· 2025-12-12 09:21
Core Insights - The precision medicine sector experienced a slight increase of 0.53% on December 12, with BGI Genomics leading the gains [1] - The Shanghai Composite Index closed at 3889.35, up 0.41%, while the Shenzhen Component Index closed at 13258.33, up 0.84% [1] Stock Performance - BGI Genomics (688114) saw a closing price of 64.50, with a significant increase of 7.68% and a trading volume of 86,400 shares, resulting in a transaction value of 540 million yuan [1] - Other notable performers included: - BGI (300676) with a closing price of 45.71, up 3.86% [1] - Wondfo Biotech (300685) at 21.55, up 1.41% [1] - Berry Genomics (000710) at 11.18, up 0.72% [1] - WuXi AppTec (603259) at 94.05, up 0.70% [1] Capital Flow - The precision medicine sector saw a net outflow of 1.022 billion yuan from institutional investors, while retail investors contributed a net inflow of 586 million yuan [2] - The capital flow for specific stocks included: - BGI Genomics (688114) had a net inflow of 22.93 million yuan from institutional investors [3] - Anke Bio (300009) experienced a net inflow of 3.38 million yuan from institutional investors [3] - However, ST Xiangxue (300147) faced a net outflow of 2.93 million yuan from institutional investors [3]
丽珠医药获纳入港交所科技100指数首批成份股 创新实力获资本市场认证
Group 1 - The Hong Kong Stock Exchange has launched the Hong Kong Stock Exchange Technology 100 Index, which tracks the performance of the 100 largest technology companies listed on the exchange, covering six major innovation themes: artificial intelligence, biotechnology and pharmaceuticals, electric vehicles and smart driving, information technology, internet, and robotics [1] - The index includes only stocks that qualify for the Stock Connect program, catering to both international and mainland Chinese investors [1] - Lijun Pharmaceutical Group has been selected as one of the first constituent stocks of the Hong Kong Stock Exchange Technology 100 Index, highlighting its strong performance in the biopharmaceutical sector [2] Group 2 - Lijun Pharmaceutical, listed on both the Shenzhen Stock Exchange and the Hong Kong Stock Exchange, has distinguished itself through its deep expertise in biomedicine, continuous R&D investment, and strong market performance [2] - The inclusion in the Technology 100 Index is seen as a recognition of the company's commitment to technological innovation and high-quality development, enhancing its visibility and influence in the international capital market [2] - This recognition is expected to encourage Lijun Pharmaceutical to continue its focus on R&D innovation and expedite the development of its pipeline, further solidifying its core competitiveness in the biopharmaceutical field [2]
丽珠医药(01513):选举王智瑶为独立非执行董事
智通财经网· 2025-12-10 12:13
Core Viewpoint - The company, Lijun Pharmaceutical (01513), held its first extraordinary general meeting of shareholders on December 10, 2025, where it approved the nomination of Ms. Wang Zhiyao as an independent non-executive director candidate for the 11th Board of Directors [1] Group 1: Board Appointments - Ms. Wang Zhiyao was elected as an independent non-executive director, with her term starting from the date of approval until the end of the 11th Board's term [1] - The company held its first employee representative meeting on the same day, where Ms. Ran Yongmei was democratically elected as an employee representative director for the 11th Board [1] Group 2: Committee Adjustments - The company convened the 30th meeting of the 11th Board on the same day, where it approved adjustments to the members of certain specialized committees [1] - The adjusted composition of the 11th Board committees is as follows: - Audit Committee: Mr. Bai Hua (Chairman), Mr. Luo Huiyuan, Ms. Cui Lijie - Remuneration and Assessment Committee: Ms. Cui Lijie (Chairman), Mr. Bai Hua, Mr. Tang Yanggang - Nomination Committee: Mr. Luo Huiyuan (Chairman), Ms. Cui Lijie, Mr. Tao Desheng - Environmental, Social and Governance Committee: Mr. Zhu Baoguo (Chairman), Mr. Tang Yanggang, Mr. Bai Hua, Ms. Cui Lijie, Ms. Wang Zhiyao - Strategic Committee: Mr. Zhu Baoguo (Chairman), Mr. Tang Yanggang, Mr. Tao Desheng [1]