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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].
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]
丽珠医药(01513.HK):选举王智瑶为独立非执行董事
Ge Long Hui· 2025-12-10 12:06
格隆汇12月10日丨丽珠医药(01513.HK)公告,于2025年12月10日召开2025年第一次临时股东大会,审议 通过了《关于提名王智瑶女士为公司独立非执行董事候选人的议案》,选举王智瑶为第十一届董事会独 立非执行董事,任期自临时股东大会审议通过之日起至公司第十一届董事会任期届满之日止。公司于 2025年12月10日召开2025年第一次职工代表大会,经董事会提名委员会对候选人进行资格审查,公司职 工代表大会通过民主选举冉永梅为公司第十一届董事会职工代表董事。 ...
丽珠医药(01513) - 独立非执行董事选举完成、选举职工代表董事暨调整董事会委员会组成
2025-12-10 11:59
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。 獨立非執行董事選舉完成、選舉職工代表董事暨調整董事會委員會 組成 獨立非執行董事選舉完成的情況 麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.*(「本公司」)於2025年12 月10日召開2025年第一次臨時股東大會(「臨時股東大會」),審議通過了《關於提名王 智瑤女士為公司獨立非執行董事候選人的議案》,選舉王智瑤女士為第十一屆董事會(「董 事會」)獨立非執行董事,任期自臨時股東大會審議通過之日起至本公司第十一屆董事會 任期屆滿之日止。 本次獨立非執行董事選舉完成後,本公司獨立非執行董事佔第十一屆董事會成員的比例不 低於三分之一,符合相關法律法規的要求。 茲提述本公司日期為2025年11月10日之公告,內容有關擬議選舉獨立非執行董事。董事會 謹此就香港聯合交易所有限公司證券上市規則(「香港上市規則」)第13.51(2)(a)條規定之 資料作出如下補充披露: 王 ...