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中恒集团:关于控股孙公司获得药品补充申请批准通知书的公告
Zheng Quan Ri Bao· 2026-02-06 12:13
Group 1 - The core point of the article is that Zhongheng Group announced the approval of a supplemental application for Sodium Lactate Ringer's Injection (500ml) by its subsidiary Hunan Kangyuan Pharmaceutical Co., Ltd. from the National Medical Products Administration [2] Group 2 - The approval signifies a regulatory milestone for Hunan Kangyuan Pharmaceutical, enhancing its product portfolio in the pharmaceutical market [2] - This development may lead to increased market competitiveness and potential revenue growth for the company [2] - The product is expected to meet the growing demand for intravenous solutions in clinical settings [2]
莱美药业(300006.SZ):乳酸钠林格注射液获得药品补充申请批准通知书
Ge Long Hui A P P· 2026-02-06 10:51
Core Viewpoint - Laimei Pharmaceutical (300006.SZ) announced that its wholly-owned subsidiary, Hunan Kangyuan Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the sodium lactate Ringer's injection (specification: 500ml) [1] Group 1 - The sodium lactate Ringer's injection is used to regulate body fluids, electrolytes, and acid-base balance [1] - It is indicated for patients with metabolic acidosis or dehydration associated with metabolic acidosis [1]
莱美药业(300006) - 关于全资子公司获得药品补充申请批准通知书的公告
2026-02-06 10:31
乳酸钠林格注射液是一种调节体液、电解质及酸碱平衡药,适用于代谢性酸 证券代码:300006 证券简称:莱美药业 公告编号:2026-005 重庆莱美药业股份有限公司 关于全资子公司获得药品补充申请批准通知书的公告 本公司及董事会全体成员保证公告内容真实、准确和完整,没有虚假记载、误导性陈 述或重大遗漏。 近日,重庆莱美药业股份有限公司(以下简称"公司")全资子公司湖南康 源制药有限公司(以下简称"湖南康源")收到国家药品监督管理局核准签发的 乳酸钠林格注射液(规格:500ml)《药品补充申请批准通知书》,现将有关事 宜公告如下: | 药品名称 | 通用名称:乳酸钠林格注射液 | | --- | --- | | | 英文名/拉丁名:Sodium Lactate Ringer's Injection | | 剂型 | 注射剂 注册分类 化学药品 | | 规格 | 500ml 原药品批准文号 国药准字 H20084559 | | 包装规格 30 | 袋/箱 药品注册标准编号 YBH01872026 | | 申请内容 | 注射剂仿制药质量和疗效一致性评价,其他变更事项包括:1.变更药 | | | 品处方及生产工艺(含 ...
莱美药业(300006) - 关于控股子公司收到执行裁定的公告
2026-02-06 10:31
证券代码:300006 证券简称:莱美药业 公告编号:2026-004 重庆莱美药业股份有限公司 关于控股子公司收到执行裁定的公告 二、本次诉讼裁定的情况 上述补充协议生效后,成都金星向四川自贸试验区法院申请撤销对耀匀 医药的执行申请及解除对其的保全措施。近日,成都金星收到四川自贸试验 区法院出具的《执行裁定书》,裁定如下: 解除本案中对被保全人成都耀匀医药科技有限公司名下账号的冻结。 本裁定立即执行。 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误 导性陈述或重大遗漏。 重要内容提示: 一、前期诉讼事项的基本情况 1.案件所处的诉讼阶段:经和解后子公司申请撤销执行; 3.对公司损益产生的影响:本次执行裁定事项不会对公司本期利润产生 重大不利影响,不存在损害公司及股东利益的情形。 重庆莱美药业股份有限公司(以下简称"公司")控股子公司成都金星 健康药业有限公司(以下简称"成都金星")与成都耀匀医药科技有限公司 (以下简称"耀匀医药")的诉讼事项,因耀匀医药未履行法院生效的一审 判决,成都金星遂向四川自由贸易试验区人民法院(以下简称"四川自贸试 验区法院")申请执行。后相关各方经协商 ...
莱美药业:全资子公司乳酸钠林格注射液获药品补充申请批准
Guo Ji Jin Rong Bao· 2026-02-06 10:23
Core Viewpoint - The announcement indicates that the wholly-owned subsidiary of the company, Hunan Kangyuan Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the sodium lactate Ringer's injection (specification: 500ml) [1] Group 1: Product Approval - The sodium lactate Ringer's injection has passed the consistency evaluation of quality and efficacy for generic drugs [1] - The approval allows for changes in the drug formulation, production process, quality standards, packaging materials, and containers, along with revisions to the drug instructions [1] - The validity period for the approval is set at 18 months [1]
莱美药业(300006) - 关于控股子公司纳米炭铁混悬注射液联合放疗II期临床试验获得伦理批件的公告
2026-01-30 09:45
一、纳米炭铁临床试验进展情况 目前,纳米炭铁的 I 期临床试验已顺利完成,主要评估不同剂量的纳米炭铁 单药单次给药在晚期实体瘤患者中的安全性、耐受性、药代动力学特征和初步疗 效。纳米炭铁 IbIIa 期临床试验已完成部分受试者入组,疗效随访中,主要评估 不同剂量的纳米炭铁单药多次给药在晚期实体瘤患者中的安全性、耐受性、药代 动力学特征和初步疗效。纳米炭铁联合放疗 II 期临床试验将验证药物联合治疗 的有效性和安全性,为产品的最终上市申请提供关键数据支持。 目前,瀛瑞医药正积极筹备研究中心启动前相关工作,确保试验的顺利进行。 证券代码:300006 证券简称:莱美药业 公告编号:2026-003 重庆莱美药业股份有限公司 关于控股子公司纳米炭铁混悬注射液联合放疗II期临 床试验获得伦理批件的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误 导性陈述或重大遗漏。 重庆莱美药业股份有限公司(以下简称"公司"或"莱美药业")控股子公 司四川瀛瑞医药科技有限公司(以下简称"瀛瑞医药")自主研发的"纳米炭铁 混悬注射液"(以下简称"纳米炭铁")于近期在四川大学华西医院顺利通过了 伦理审查并 ...
莱美药业2025年净利预亏1.2亿元至1.35亿元
Bei Jing Shang Bao· 2026-01-23 13:21
Core Viewpoint - Laimei Pharmaceutical (300006) forecasts a net profit loss of between 120 million to 135 million yuan for 2025, compared to a loss of 87.8044 million yuan in the same period last year [1] Group 1: Financial Performance - The company's revenue is expected to slightly decrease year-on-year due to a decline in sales volume and prices of certain products [1] - The company plans to continue its R&D investments to enrich its product pipeline, which will impact operating profits [1] Group 2: Asset and Investment Impacts - Some intangible assets are showing signs of impairment due to centralized procurement policies, with an estimated impairment provision of about 60 million yuan [1] - The company has recognized an investment loss of approximately 23 million yuan due to increased R&D expenditures and fair value changes in certain joint ventures [1]
稳进·突破·引领——莱美药业2025年度回顾
新财富· 2026-01-23 11:15
Core Viewpoint - In 2025, Laimei Pharmaceutical achieved significant milestones in innovation and product development, enhancing its position in the pharmaceutical industry through successful clinical trials and recognition for its innovative products. Group 1: Innovation and R&D - The clinical trial for the innovative anti-cancer drug "Nano Carbon Iron Suspension Injection" was approved, allowing it to be tested in solid tumor patients [2][4] - The drug is based on the existing Nano Carbon Suspension Injection and utilizes Fe2+ as an active anti-cancer component [4] - Laimei's generic drug "Mabalaoshuwei Tablets" received ethical approval and entered the bioequivalence trial phase [5] - "Nano Carbon Suspension Injection" was selected as one of the first batch of iconic products in future industries by the Chongqing Municipal Economic and Information Technology Commission [8] - "Injection Esomeprazole Sodium" was recognized as a major industrial technology innovation product for 2024 by the Chongqing Municipal Economic and Information Technology Commission [10] Group 2: Market Expansion and Product Selection - Laimei's product "Nicorandil Tablets" was selected in the 11th batch of national drug centralized procurement, marking its entry into the mainstream medical market [12][13] - Multiple products from Laimei were selected in the Guangdong Alliance centralized procurement, enhancing accessibility to essential medications [15][16][18] Group 3: Brand Recognition and Awards - Laimei was included in the "Top 50 Comprehensive Strength List" of the 2024 China Innovative Drug Value Ranking, reflecting its commitment to innovation [22] - The company received the "Golden Information Disclosure Award" for the second consecutive year, recognizing its excellence in information disclosure and compliance [24] - Laimei was awarded the title of "Leading Enterprise in Manufacturing Innovation" by the Chongqing Economic Development Zone [26] - The company was recognized as a "Pilot Enterprise for Strong Party Building" in the Nanan District, highlighting its commitment to governance and community engagement [31]
莱美药业:预计2025年亏损1.2亿元~1.35亿元
Xin Lang Cai Jing· 2026-01-23 09:15
Core Viewpoint - The company expects a net profit loss attributable to shareholders of 120 million to 135 million yuan for the year 2025, compared to a loss of 87.8044 million yuan in the same period last year [1] Financial Performance - The net profit loss after deducting non-recurring gains and losses is anticipated to be between 124 million and 139 million yuan, compared to a loss of 119 million yuan in the previous year [1] - The performance fluctuation is primarily due to a decline in sales volume and prices of certain products, leading to a slight decrease in operating revenue year-on-year [1] Investment and Impairment - Continuous research and development investments are impacting operating profits [1] - The company has recognized an impairment provision for certain intangible assets amounting to approximately 60 million yuan [1] - An investment loss of about 23 million yuan has also been confirmed [1]
莱美药业(300006) - 2025 Q4 - 年度业绩预告
2026-01-23 09:15
证券代码:300006 证券简称:莱美药业 公告编号:2026-002 重庆莱美药业股份有限公司 2025 年度业绩预告 一、本期业绩预计情况 1.业绩预告期间:2025 年 1 月 1 日至 2025 年 12 月 31 日。 2.业绩预告情况:预计净利润为负值 | 项 目 | 本报告期 | | 上年同期 | | | --- | --- | --- | --- | --- | | 归属于上市公司 股东的净利润 | 亏损:12,000.00 | 万元~13,500.00 | 万元 亏损:8,780.44 | 万元 | | 扣除非经常性损 益后的净利润 | 亏损:12,410.00 | 万元~13,910.00 | 万元 亏损:11,886.97 | 万元 | 注:本表格中的"万元"均指"人民币万元"。 二、与会计师事务所沟通情况 重庆莱美药业股份有限公司(以下简称"公司")已就本次业绩预告有关事 项与年度审计会计师事务所进行预沟通,公司与会计师事务所在业绩预告相关 财务数据方面不存在分歧。 三、业绩变动原因说明 本报告期内,公司业绩主要影响原因如下: 1.公司部分品种销量、销售价格同比下降,导致公司营业收入同 ...