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]

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]

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]

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 ...

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]

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 ...

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]

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].

Core Insights - Obesity is a prevalent and complex chronic disease, recognized as a significant risk factor for various chronic metabolic diseases, leading to a growing demand for weight loss treatments [1][2] - The global market for obesity drugs is expanding rapidly, with the overweight obesity drug market projected to reach $17 billion in 2024 and $20.6 billion in 2025, indicating strong growth potential [6][8] Industry Definition and Categories - Obesity is classified as a chronic, multifactorial disease requiring long-term treatment to mitigate obesity-related health risks, with drug therapy being a crucial component of treatment strategies [2][3] - Current obesity treatment drugs fall into three main categories: central weight loss drugs, non-central weight loss drugs, and anti-diabetic drugs with weight loss effects [3] Market Size and Growth - The global overweight obesity drug market is expected to grow from $17 billion in 2024 to $20.6 billion in 2025, with GLP-1 obesity drugs projected to account for $14.7 billion (86.47%) of the market in 2024 and $18.2 billion (88.35%) in 2025 [6][8] Industry Chain - The obesity drug industry chain consists of upstream raw materials (high-grade pharmaceutical intermediates, APIs), midstream production (obesity drug manufacturing), and downstream distribution channels (hospitals, specialty pharmacies, online pharmacies) [8] Policy Environment - The increasing prevalence of obesity is expected to lead to significant healthcare costs, prompting the need for effective interventions and policies to manage obesity, with a focus on drug treatments [8][9] Competitive Landscape - Key players in the obesity drug market include Novo Nordisk, Hanyu Pharmaceutical, East China Pharmaceutical, and others, with a growing emphasis on the development of effective weight loss medications [10][11] - Novo Nordisk's semaglutide has become a leading product in the market, contributing significantly to the company's revenue [11][12] Challenges in the Industry - The obesity drug market faces challenges such as limited drug options available in domestic markets, insufficient clinical research on long-term safety and efficacy, and lack of insurance coverage for obesity treatments [14][15] - There is a need for a multi-modal treatment approach, combining lifestyle interventions with pharmacological and surgical options to effectively manage obesity [15]

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]