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健康元:子公司通过马来西亚药监局GMP认证
南财智讯12月30日电,健康元公告,全资子公司健康元海滨药业有限公司吸入混悬液(激素)与吸入溶液 生产线通过了马来西亚药监局(NPRA)PIC/SGMP符合性检查,并于2025年11月20日获得GMP证书。 本次认证标志着健康元海滨的生产和质量管理体系符合PIC/SGMP标准,将有助于推进公司吸入制剂产 品在马来西亚及其他PIC/S成员国药品注册上市的工作,对子公司相关产品的海外市场拓展带来积极影 响。 ...
健康元:拟将毛孩子动物保健(广东)有限公司49%股权转让给心有毛孩
Xin Lang Cai Jing· 2025-12-30 10:36
健康元公告,2025年12月30日,公司召开董事会,审议通过了《关于出售资产暨关联交易的议案》。公 司拟将持有的毛孩子动物保健(广东)有限公司49%股权转让给关联方深圳市心有毛孩投资合伙企业 (有限合伙),交易价格为5145万元。同时,心有毛孩拟认购毛孩子1500万元新增注册资本,增资价款 为1500万元。交易完成后,心有毛孩将持有毛孩子52.56%的股权,公司控股子公司丽珠集团将持有毛 孩子47.44%的股权,公司将不再直接持有毛孩子股权,毛孩子不再纳入公司合并报表范围内。 ...
西部证券晨会纪要-20251225
Western Securities· 2025-12-25 03:00
晨会纪要 证券研究报告 2025 年 12 月 25 日 核心结论 分析师 【医疗器械】IVD 体外诊断相关医疗器械行业报告:IVD 国内短期承压,头 部企业积极出海 建议关注公司:迈瑞医疗(300760.SZ,已覆盖)、新产业(300832.SZ)、 安图生物(603658.SH,已覆盖)、亚辉龙(688575.SH)、迪瑞医疗 (300396.SZ)、艾德生物(300685.SZ)等 风险提示:行业政策变化风险、新产品研发注册风险、技术替代风险、行业 竞争加剧风险、地缘政治等风险 【医药生物】健康元(600380.SH)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 盈利预测与评级:预计 2025-2027 年公司实现营收 158.11/170.17/182.73 亿元,同比增长 1.2%/7.6%/7.4%,归母净利润 14.66/15.72/17.09 亿元,同 比增长 5.7%/7.3%/8.7%。基于公司主业集采影响出清、创新管线即将步入 收获期,首次覆盖给予"买入"评级。 风险提示:市场竞争加剧,产品销售不及预期;新药研发进度不及预期;产 品集采降价超预期。 【北交所】北交所市场点评 ...
海光信息目标价涨幅达52% 24股获推荐丨券商评级观察
Core Insights - On December 24, 2023, brokerage firms provided target prices for listed companies, with notable increases for Haiguang Information, Xingfu Electronics, and Dashang Co., with target price increases of 52.80%, 39.48%, and 33.19% respectively, belonging to the semiconductor, electronic chemicals, and general retail industries [1][2]. Group 1: Target Price Increases - Haiguang Information received a target price of 336.00 yuan, representing a 52.80% increase [2]. - Xingfu Electronics has a target price of 52.00 yuan, indicating a 39.48% increase [2]. - Dashang Co. has a target price of 24.60 yuan, reflecting a 33.19% increase [2]. Group 2: Brokerage Recommendations - A total of 24 listed companies received brokerage recommendations on December 24, with companies like Jiankangyuan, Yanjing Beer, and Bomai Ke receiving one recommendation each [2]. - Haiguang Information's rating was upgraded from "Recommended" to "Strong Buy" by Huachuang Securities [4]. Group 3: First-Time Coverage - On December 24, 12 companies received first-time coverage, including Jiankangyuan with a "Buy" rating from Western Securities, Yanjing Beer with a "Buy" rating from Aijian Securities, and Sailun Tire with a "Buy" rating from Bank of China International [4][5]. - Other companies receiving first-time ratings include Xibu Mining with an "Increase" rating from Bohai Securities and Data Port with a "Buy" rating from Northeast Securities [5].
海光信息目标价涨幅达52%;24股获推荐丨券商评级观察
Core Viewpoint - On December 24, several brokerage firms provided target prices for listed companies, with notable increases in target prices for companies in the semiconductor, electronic chemicals, and general retail sectors. Group 1: Target Price Increases - Haiguang Information, Xingfu Electronics, and Dashang Co. have the highest target price increases of 52.80%, 39.48%, and 33.19% respectively, based on the latest closing prices [1] - The target prices for Haiguang Information, Xingfu Electronics, and Dashang Co. are set at 336.00 yuan, 52.00 yuan, and 24.60 yuan respectively [2] Group 2: Brokerage Recommendations - A total of 24 listed companies received brokerage recommendations on December 24, with companies like Jiankangyuan, Yanjing Beer, and Bomai Co. receiving one recommendation each [2] - Haiguang Information's rating was upgraded from "Recommended" to "Strongly Recommended" by Huachuang Securities [4] Group 3: First-Time Coverage - On December 24, 12 companies received first-time coverage from brokerages, including Jiankangyuan with a "Buy" rating from Western Securities and Yanjing Beer with a "Buy" rating from Aijian Securities [4][5] - Other companies receiving first-time ratings include Sailun Tire, Xibu Mining, and Data Port, with ratings of "Buy" or "Increase" from various brokerages [5]
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: ...