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健康元药业集团股份有限公司 关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告
Drug Information - The drug "Lai Kang Qi Ta" monoclonal antibody injection has received acceptance for domestic production registration from the National Medical Products Administration (NMPA) [1] - It is classified as a Class 1 therapeutic biological product and is intended for adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy [1] - The drug is a self-developed innovative IL-17A/F dual-target inhibitor, which is the first of its kind in China and the second globally [1][2] Clinical Development - A clinical trial for the drug is set to achieve primary and secondary efficacy endpoints by July 2025, demonstrating superior efficacy compared to the control group [1] - The trial results indicate faster onset, better short-term efficacy, long-lasting effects, and less frequent dosing compared to the control drug [1] - The cumulative R&D investment for the drug is approximately RMB 204.03 million [2] Market Situation - As of the announcement date, there are no approved products in China for psoriasis indications targeting the IL-17A/F dual-target [3] - There are three imported and two domestic products approved for IL-17A and IL-17RA single-target indications [3] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [3]
12月24日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-24 10:12
Group 1 - Jizhi Co., Ltd. plans to acquire at least 51% equity in Pumai Technology through cash payment, aiming to gain control over the company, which is a leading enterprise in the field of robot performance testing and calibration in China [1] - Yaxing Chemical's subsidiary intends to transfer 7.14% equity for 60 million yuan to another fund under the same control, indicating strategic investment movements within the same management group [2] - Weigao Bio's application for clinical trials of subcutaneous human immunoglobulin has been accepted by the National Medical Products Administration, targeting primary immunodeficiency diseases [3] Group 2 - Sentai Co., Ltd.'s controlling shareholder plans to increase shareholding by at least 100 million yuan within 12 months, aiming to enhance confidence in the company's future [4] - Health元's subsidiary has received acceptance for the marketing authorization application of Lecanemab injection, which is intended for moderate to severe plaque psoriasis patients [5][11] - Sunshine Nuohuo has signed a technical development contract for the STC008 injection project, with a total payment of 500 million yuan, indicating significant investment in cancer treatment [6] Group 3 - Hunan YN has been designated as a delivery warehouse for lithium carbonate by the Guangzhou Futures Exchange, enhancing its position in the lithium market [7] - Tianji Co., Ltd. is pushing for the industrialization of lithium sulfide material preparation, although it faces risks in commercialization [8] - Yuandong Bio has received FDA approval for Methylene Blue injection, expanding its product portfolio in the U.S. market [10] Group 4 - Nanshan Aluminum has established a wholly-owned subsidiary in Hainan with an investment of 5 million yuan, focusing on high-end aluminum products [13] - ST Xifa plans to acquire 50% equity in Lhasa Beer, aiming for full ownership, with the transaction currently in the planning stage [14] - Hengrui Medicine's SHR-A1904 injection has been included in the list of breakthrough therapy products, indicating its potential in treating advanced gastric cancer [12] Group 5 - Chengdu Gas is planning to merge three subsidiaries, streamlining operations and enhancing efficiency [26] - Baoli Electric intends to invest 50 million yuan to establish a wholly-owned subsidiary focused on key equipment and solutions in energy storage [27] - Huadian International has successfully put the second unit of its Longkou Phase IV project into commercial operation, marking a significant milestone in its energy production capacity [34]
健康元(600380.SH):莱康奇塔单抗注射液上市许可申请获受理
Ge Long Hui· 2025-12-24 09:48
Core Viewpoint - The company Health元 (600380.SH) announced that its subsidiary Zhuhai Lizhu Antibody Biotechnology Co., Ltd. has received the acceptance notice from the National Medical Products Administration for the domestic production registration application of "Lai Kang Qi Ta Antibody Injection" [1] Group 1 - The acceptance number for the registration application is CXSS2500144 [1]
健康元(600380) - 健康元药业集团股份有限公司关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告
2025-12-24 09:15
健康元药业集团 关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告 证券代码:600380 证券简称: 健康元 公告编号:临 2025-083 健康元药业集团股份有限公司 关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告 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)控股子公司珠海市 丽珠单抗生物技术有限公司(以下简称:丽珠单抗)收到国家药品监督管理局(以 下简称:国家药监局)核准签发的《受理通知书》(受理号:CXSS2500144),丽 珠单抗"莱康奇塔单抗注射液"的境内生产药品注册上市许可申请获国家药监局受 理。现将相关情况公告如下: 一、药品基本情况 药物名称:莱康奇塔单抗注射液 剂型:注射剂 规格:160mg(1.6mL)/瓶 受理通知书审批结论:根据《中华人民共和国行政许可法》第三十二条的规定, 经审查,决定予以受理。 二、药品研发及相关情况 银屑病是一种由遗传、免疫和环境因素共同诱发的慢性炎症性皮肤病,全球患 者群体约 1 亿。莱康奇塔单抗注射液(以下简称 ...
健康元(600380):首次覆盖报告:呼吸龙头再起航,创新+国际化开启成长新篇章
Western Securities· 2025-12-24 05:15
公司深度研究 | 健康元 呼吸龙头再起航,创新+国际化开启成长新篇章 健康元(600380.SH)首次覆盖报告 大型综合医药集团,创新+国际化开启新篇章。公司始创于 1992 年,保健品 业务起家,通过收并购不断开拓商业版图,经过 30 余年逐步发展为大型综 合医药集团。近年来,公司加快布局国际化及创新转型,一方面推动海外生 产基地建设,同时通过合作引进等方式快速丰富研发管线,聚焦呼吸常见疾 病,同时拓展镇痛、抗感染等领域布局。 制剂集采压力出清,新品放量助力主业拐点向上。近年来受艾普拉唑系列产 品、盐酸左沙丁胺醇吸入溶液等大单品降价影响,公司主业短暂承压,目前 核心产品降价压力基本出清,后续随着妥布霉素吸入溶液、玛帕西沙韦等新 品陆续放量,公司主业有望拐点向上。 加快创新管线布局,聚焦呼吸大适应症。多年深耕呼吸领域,近年来随着公 司创新转型进程加速推进,公司通过合作引进快速扩充在研管线,覆盖支气 管扩张、流感、COPD 等呼吸常见适应症。目前改良新药妥布霉素吸入溶液 以及流感新药玛帕西沙韦胶囊已获批,另外 TSLP 单抗、MABA 双靶点吸入 溶液、PREP 抑制剂等核心药物已进入 2 期临床。 丽珠集团: ...
A股头条:我国科学家实现新一代光计算芯片研究新突破;首块L3级自动驾驶牌照诞生;摩尔线程发布新一代GPU架构
Jin Rong Jie· 2025-12-22 10:12
Group 1 - The State Council emphasizes the need for all departments to align their actions with the central government's economic work requirements for the upcoming year, enhancing responsibility and urgency in implementing tasks [1] - The Ministry of Commerce highlights the importance of high-quality business development and international trade coordination, aiming to boost domestic and international economic cycles [2] - Researchers at Shanghai Jiao Tong University have achieved a breakthrough in all-optical computing chips, which could significantly enhance computational efficiency for AI and large-scale data processing [3] Group 2 - The National Internet Information Office and the China Securities Regulatory Commission have taken action against 17 accounts spreading rumors and illegal stock recommendations, emphasizing the need for accurate financial information dissemination [4] - Fujian Province has introduced a comprehensive financial support plan for technology innovation, aiming for a 10% annual growth in loans to technology-related industries by 2025-2027 [5] - The world's first commercial supercritical carbon dioxide power generation unit has successfully commenced operations, marking a significant advancement in energy technology [6] Group 3 - Moore Threads has launched a new GPU architecture, "Huagang," which boasts a 50% increase in computing density and a tenfold improvement in energy efficiency [7][8] - The first L3-level autonomous driving license has been issued to Changan Automobile, marking a significant milestone in the development of autonomous driving technology [9] - Nine U.S. pharmaceutical companies have reached agreements with the government to lower drug prices, indicating a shift towards more affordable healthcare solutions [10] Group 4 - The market has shown signs of recovery with a three-day rebound, although caution is advised as the overall trend has not yet confirmed a sustained upward movement [11] - Samsung has unveiled the world's first 2nm smartphone chip, which is expected to enhance performance significantly, indicating advancements in semiconductor technology [12]
全球大公司要闻 | 摩尔线程首次披露GPU路线图
Wind万得· 2025-12-21 22:35
Group 1 - ByteDance announced the release of the Doubao large model 1.8 and the Seedance 1.5 Pro video generation model, entering the "multimodal agent" field, with enterprise users able to access it via Volcano Engine API starting December 23 [2] - Changan Automobile received the first L3-level autonomous driving license in China, marking the country's advancement in commercializing autonomous driving [2] - Moore Threads unveiled its new GPU architecture "Huagang" at the MUSA Developer Conference, boasting a 50% increase in computing power density and a 10-fold efficiency improvement [3] Group 2 - SoftBank Group is working to finalize a $22.5 billion investment in OpenAI by year-end, potentially using its stake in Arm as collateral [3] - Guizhou Bailing faced penalties totaling 25.6 million yuan due to false records in multiple annual reports, with its stock being suspended and then marked as ST [5] - Alibaba's DingTalk initiated a secret project "D Plan" to enter the AI hardware market, speculated to launch smart hardware products [5] Group 3 - OpenAI improved its "compute margin" to 70% as of October, significantly up from 52% at the end of 2024 [8] - Nike projected a low single-digit revenue decline for Q3, reflecting weak consumer demand and increased market competition [8] - Tesla's CEO Elon Musk had a legal victory restoring his $55-56 billion compensation plan, which may impact the company's governance structure [8] Group 4 - Samsung Electronics launched the world's first 2nm mobile application processor Exynos 2600, with AI computing power increased by 113% compared to the previous generation [10] - Toyota launched the new Levin L and Corolla models, with prices starting at 129,800 yuan and 99,000 yuan respectively, while also expanding its hydrogen network in California [10] - Mitsubishi UFJ Financial Group acquired a 20% stake in Shriram Finance, part of a broader trend of mergers and acquisitions in Japan [10] Group 5 - BMW Group opened a battery recycling center in Bavaria, capable of processing several tons annually, utilizing innovative direct recycling technology [14] - LVMH continued to invest in high-end beauty brands to strengthen its competitive position in the beauty market [14] - Swedish Stegra's green steel plant project has surpassed 50% installation progress of its electrolyzers, aiming for production in 2026 [14]
健康元NS-041片新增适应症临床试验获批
Bei Jing Shang Bao· 2025-12-21 09:21
Core Viewpoint - The announcement highlights that Health元's subsidiary, Lijun Pharmaceutical Group, 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 - Health元's subsidiary, Lijun Pharmaceutical Group, has received a clinical trial approval notice from the National Medical Products Administration for NS-041 tablets to include a new indication for the 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] - NS-041 is currently the only KCNQ2/3 targeted drug 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 tablets have also been approved to conduct clinical trials for the indication of epilepsy, which is currently undergoing Phase II clinical research [1]
健康元(600380) - 健康元药业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
2025-12-21 08:00
证券代码:600380 证券简称:健康元 公告编号:临 2025-082 健康元药业集团股份有限公司 关于获得药物临床试验批准通知书的公告 健康元药业集团 关于获得药物临床试验批准通知书的公告 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)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(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。现将有关详情公告如下: 一、药品基本情况 药物名称:NS-041 片 剂型:片剂 注册分类:化学药品 1 类 申请适应症:抑郁症 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,2025 年 10 月 13 日受理的 NS-041 片符合药品注册的有关要求,同意开展抑郁症的临床 试验。 二、药品研发及相关情况 NS ...
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]