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12月21日公告，公司控股子公司丽珠医药集团股份有限公司的控股子公司丽珠集团丽珠制药厂收 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。 ...

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 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].

| 恒生医疗保健业指数 | 港股创新药ETF | | --- | --- | | (513120) | (HSCICH) | | 周内涨跌 -2.26% | 周内涨跌 - 2.18% | | - A股当周涨跌幅 - | | | 昭衍新药 | 退市苏吴 | | 周内涨跌 ↑23.38% 周内涨跌 -66.94% | | | - 港股当周涨跌幅 - | | | 金斯瑞生物科技 | 复星医药 | | 周内涨跌) ↑ 4.84% | 周内涨跌 - 10.49% | | 聚焦前沿 | | | 热门赛道 | 又一款国产流感药物获批,不可用于 | | 流感并发症 | | | 一周热股 | 退市苏吴下跌跌幅近7成 钱氏姐弟如 | | 何"掏空"上市公司 | | | 前沿动向 | 全球首个 CDK2/4/6 抑制剂获批上市, | | 用于乳腺癌治疗 | | | 《捉令创新药》栏目中每日经济新闻推出 | 氧国一期 | 氧周一期 每经记者｜金喆 每经编辑｜魏官红 | 8 | | --- | | 解读新药研发进展与趋势 剖析产品竞争力与市场前景 | | 洞察医药资本脉络 见证医药产业高质量发展 | | 数据来源：东方财富App、富途 ...

Core Viewpoint - Health元 announced the approval of its innovative drug, Marpasisavir Capsules (Yilikan®), for domestic market, offering a new experience in flu treatment with a single oral dose for complete therapy [2] Group 1: Drug Development and Approval - The drug was developed in just two years, significantly shorter than the typical 6-8 years for global flu drug development [2] - The rapid development was facilitated by the company's AI-assisted drug design platform, which optimized structure, predicted enzyme activity, and ensured cross-strain coverage [2] - Health元 has built a strong CMC (Chemistry, Manufacturing, and Control) capability over ten years, enabling a streamlined process from small-scale trials to large-scale production in less than half the industry average time [2] Group 2: Clinical Efficacy and Safety - In phase III clinical trials, the median time for symptom relief in the Yilikan® group was significantly shorter than that of the placebo group, with a difference of -27.0 hours (P<0.0001) [3] - Particularly in patients with type B influenza, the Yilikan® group showed a statistically significant improvement with a symptom relief time difference of -31.0 hours (p<0.05) [3] - The drug demonstrated good efficacy in adolescents, with no serious adverse events reported, indicating stable safety performance [3] - Yilikan® maintains clear efficacy against both type A and type B influenza, requiring only a single oral dose and unaffected by food intake, enhancing treatment convenience and compliance [3]

Group 1 - The core point of the article is that Health元 (600380) has received domestic approval for its innovative drug, Marpacisavir Capsules (壹立康®), which offers a new treatment experience for influenza, allowing for "one-time oral administration to complete treatment" [1] - The drug's development cycle was significantly shorter than the global average for new influenza treatments, taking only two years to reach Phase III clinical trials, compared to the typical 6-8 years [1] - The company attributes this rapid development to its early investment in an AI-assisted drug design platform, which enabled quick results in key areas such as structural optimization and enzyme activity prediction [1] Group 2 - In Phase III clinical trials, the Marpacisavir group showed a statistically significant reduction in median time to symptom relief compared to the placebo group, with a difference of -27.0 hours (P<0.0001) [2] - The drug demonstrated particularly effective results in patients with type B influenza, with a symptom relief time difference of -31.0 hours (P<0.05) [2] - Marpacisavir also exhibited good efficacy in the adolescent population, with no serious adverse events reported, indicating stable safety performance [2]

Group 1 - The core point of the article is that Health元 has successfully launched its innovative drug, Marpasisavir capsules (Yilikan), for flu treatment in China, which allows for "one-time oral treatment" [1] - The drug's development cycle was significantly shortened to two years, compared to the typical 6-8 years for flu drugs, due to the company's early investment in an AI-assisted drug design platform [1] - Health元 has built a strong CMC (Chemistry, Manufacturing, and Control) capability over ten years, enabling a rapid internal process for drug development and production, achieving scale in less than half the industry average time [1] Group 2 - In Phase III clinical trials, the median time for symptom relief in the Yilikan group was significantly shorter by 27.0 hours compared to the placebo group (P<0.0001) [2] - The drug showed particularly strong efficacy in patients with type B influenza, with a symptom relief time reduced by 31.0 hours compared to the placebo (P<0.05) [2] - Yilikan demonstrated good efficacy in adolescents with no serious adverse events reported, maintaining clear effectiveness against both type A and type B influenza, and enhancing treatment convenience and compliance with a single oral dose [2]

一、药品注册证书主要内容 药品名称：玛帕西沙韦胶囊 英文名/拉丁名：PixavirMarboxil Capsules 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，健康元药业集团股份有限公司（以下简称：本公司）收到国家药品监督管理局核准签发的《药品 注册证书》，现将有关详情公告如下： 规格：20mg 申请事项：药品注册（境内生产） 剂型：胶囊剂 注册分类：化学药品1类 上市许可持有人：健康元药业集团股份有限公司 生产企业：凯莱英生命科学技术(天津)有限公司 药品批准文号：国药准字H20250070 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准注册，发给药品注册证书。 二、药品研发及相关情况 玛帕西沙韦胶囊（壹立康?）（以下简称：本品）为公司创新抗流感1类新药，适用于既往健康的12岁及 以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患者。 该适应症获批是基于一项III期、多中心、随机、双盲研究，旨在评价单次口服本品对比安慰剂在既往健 康 ...

Group 1: Company Announcements - 蓝盾光电 announced the termination of the equity transfer agreement with Shanghai Xingsi Semiconductor, with no payment made for the equity transfer [1] - 兆新股份 plans to acquire 70% of Youde New Energy for a maximum price of 220 million yuan, enhancing its capabilities in the renewable energy operation sector [2] - 南都电源 is in the process of planning a change in control and has suspended its stock trading, with the suspension expected to last no more than two trading days [3] - 万科A reported a guarantee balance of 84.476 billion yuan as of October 31, with no overdue guarantee matters [4] - 国晟科技's stock price has increased significantly, with a cumulative rise of 206.62%, indicating potential irrational speculation and risks of a rapid price drop [5] - 中威电子 announced a change in its actual controller to Fu Yingbo, with stock trading set to resume [6] Group 2: Mergers and Acquisitions - 新兴铸管's subsidiary plans to acquire 100% of China Resources Steel for 1.244 billion yuan [7] Group 3: Share Transfers and Investments - 太龙药业's shareholder plans to transfer 50.1 million shares to Jiangyao Holdings [8] - 医药 approvals include 常山药业 receiving a drug registration certificate for heparin sodium injection in Turkmenistan [9] - 真兰仪表's shareholder intends to increase holdings by 10 to 20 million yuan [9] - 海南瑞泽's vice president plans to reduce holdings by 231,000 shares [9] - 金陵体育's director has reduced holdings by 0.0276% [9] - 佰仁医疗's subsidiary has received approval for a collagen implant product [9]