华润双鹤利民药业被罚100万 近日，华润双鹤（600062）利民药业（济南）有限公司与辰欣药业（603367）股份有限公司，分别领走100万元与300万元罚单。它们生产的同一种药品 ——碳酸氢钠注射液——被检出"可见异物""pH值"两项关键指标不达标，直接触犯了《药品管理法》第九十八条第一款的"高压线"。 | mpa.shandong.gov.cn | 山东省药品监督管理局 | | | 简体 繁体 无障碍 智能问答 进入关怀版 ○ 请输入关键字 搜索 | | --- | --- | --- | --- | --- | | | | | | ● 本站信息 ○ 政务服务 | | 首页 机构职能 政务公开 政务服务 | | | 互动交流 | 数据查询 药品 医疗器械 化妆品 | | .. 首页 > 政务公开 > 重点领域 > 行政执法公示 > 事后公示 > 执法结果 | | | | | | 索引号: 11370000MB284723XW/2026-02637 | | | | 公开方式:主动公开 | | 发布机构: | | | | 组配分类: 执法结果 | | 发文日期: 2026-01-08 | | | | 文件编号 ...

湘乡市卫生健康局工作人员向智通财经表示，因当事人明确表示要追究医疗机构的责任，已将此线索移 交至执法部门查处。 视频编辑：张兆亿(01:57) 智通财经记者 史凭 "我现在只想曝光此事，不需要医院赔偿。"1月26日，周先生气愤地告诉智通财经，2025年12月，他在 湖南湘乡曙光医院做完包皮术后输液时，发现所输碳酸氢钠注射液已过期，双方多次协商及卫健部门行 政调解均未果。 们协商，我院也只能按之前卫健部门协商的方案，予以八千块钱的人道主义一次性补偿；如果对我院的 处理态度不满意，可通过医学鉴定和法律途径解决。" 针对院方的方案，周先生当即回复，提出两项诉求：一是院方必须带他前往上级医院做全面检查；二是 院方需就此事在媒体上公开向他道歉。 1月26日上午，院方工作人员再次向周先生发送信息称："如果您坚持要求赔偿五万元，请提供相应的依 据，您也可以通过医学鉴定和法律途径来维护您的合法权益。"同时告知周先生，由于卫健部门和其多 次进行行政调解均未达成一致，目前卫健部门已中止调解，并将相关线索移交至卫健行政执法部门。 对于"要求赔偿五万元"这一说法，周先生表示，第一次院方通知他前往调解时，并非自己主动提出要五 万元赔偿 ...

Group 1: Regulatory Developments - The National Healthcare Security Administration (NHSA) is soliciting public opinions on the "Guidelines for Real-World Comprehensive Value Assessment of Drugs" to establish a unified national evaluation system [1] - Huadong Medicine's subsidiary received FDA approval for clinical trials of DR10624, a novel drug targeting metabolic-associated fatty liver disease [1] - Fosun Pharma's subsidiary has had its drug registration application for erythromycin lactobionate injection accepted by the National Medical Products Administration [2] - Stone Pharmaceutical's new drug for hypertension has received FDA approval for clinical trials in the U.S. [3] - Zhi Mei Ru Kang's siRNA therapy for ALS has entered Phase 2 clinical trials [4] Group 2: Market and Corporate Developments - Cap Bio's major shareholders have increased their stake from 31.52% to 33.05% following capital changes and share buybacks [5] - Bluestar Medical's product is expected to be selected for national centralized procurement of drug-coated balloons, which could enhance its market presence [7] - NVIDIA and Eli Lilly have announced a $1 billion collaboration to establish an AI innovation lab focused on drug discovery and development [8] - Dr. Wang Qiang has transitioned from Xiansheng Pharmaceutical to Ganli Pharmaceutical as Senior Vice President and Chief Strategy Officer [9] Group 3: Quality Control and Safety - China Resources Double Crane has addressed recent quality issues with sodium bicarbonate injection products, clarifying that non-compliance was due to packaging issues during transport [10]

证券日报网讯 1月14日，华润双鹤（600062）在互动平台回答投资者提问时表示，关于近期碳酸氢钠注 射液产品质量相关事宜，公司高度重视，并已第一时间成立专项小组深入复盘。根据调查了解，抽检产 品为在库抽检，未上市销售，未对公众造成伤害，本次抽检不合格系个别产品在运输过程中外阻隔袋漏 气所致。经对涉事子公司所有在库、在产批次产品开展自查及第三方检验，其他批次产品无问题。公司 始终视产品质量为生命线，后续将制订并落实整改措施，持续完善产品质量抽检、安全生产监督检查等 机制，切实保障产品安全。 ...

人民财讯1月14日电，华润双鹤（600062）1月14日在互动平台表示，关于近期碳酸氢钠注射液产品质量 相关事宜，公司高度重视，并已第一时间成立专项小组深入复盘。根据调查了解，抽检产品为在库抽 检，未上市销售，未对公众造成伤害，本次抽检不合格系个别产品在运输过程中外阻隔袋漏气所致。经 对涉事子公司所有在库、在产批次产品开展自查及第三方检验，其他批次产品无问题。公司始终视产品 质量为生命线，后续将制订并落实整改措施，持续完善产品质量抽检、安全生产监督检查等机制，切实 保障产品安全。 ...

Core Viewpoint - The Shandong Provincial Drug Administration has imposed an administrative penalty on Chanshin Pharmaceutical Co., Ltd. for producing and selling sodium bicarbonate injection that does not meet national drug standards, resulting in a total fine of 3,125,018.20 yuan [1] Group 1: Regulatory Actions - Chanshin Pharmaceutical was fined 3,031,700 yuan and had 30,464 bottles of the non-compliant sodium bicarbonate injection confiscated due to violations of the Drug Administration Law [1] - The company was found to have produced a batch of sodium bicarbonate injection that failed to meet the required standards, specifically regarding visible foreign substances, and was included in a list of 28 batches of non-compliant drugs [1] Group 2: Company Overview - Chanshin Pharmaceutical, established in 1970 and listed on the Shanghai Stock Exchange in September 2017, is a large comprehensive pharmaceutical company located in Jining, Shandong Province [3] - The company operates five industrial parks covering nearly 2,000 acres, employs over 3,000 people, including more than 1,000 technical professionals, and has total assets of 7.5 billion yuan [3] - Chanshin Pharmaceutical offers over 400 specifications of various drug forms, including large-volume injections, small-volume injections, and raw materials, with a sales network spanning across China and over 50 countries and regions [3]

Group 1 - The National Medical Products Administration of China announced on January 6 that 28 batches of non-compliant drugs were identified, including sodium bicarbonate injection produced by China Resources Double Crane Pharmaceutical Co., Ltd. [1] - The specific non-compliance issue for the sodium bicarbonate injection (batch number: 24120602) was related to its pH value, which indicates the concentration of hydrogen ions and measures acidity or alkalinity [1]. - China Resources Double Crane Pharmaceutical Co., Ltd. was established in 2001 and is a member of China Resources Pharmaceutical Group, primarily engaged in the pharmaceutical manufacturing industry [2].

Group 1 - The National Medical Products Administration of China announced on January 6 that 28 batches of non-compliant drugs were identified, including sodium bicarbonate injection produced by Chenshin Pharmaceutical Co., Ltd., which failed due to visible foreign substances [1] - The visible foreign substances refer to insoluble materials that can be observed under specified visual conditions in injectable and ophthalmic solutions, typically with a particle size or length greater than 50 micrometers [2] Group 2 - Chenshin Pharmaceutical Co., Ltd. is a large comprehensive pharmaceutical enterprise engaged in research and development, production, and sales, listed on the Shanghai Stock Exchange main board in September 2017 [3] - The company is recognized as a national technology innovation demonstration enterprise and a national high-tech enterprise, and it serves as the vice president unit of the China Chemical Pharmaceutical Industry Association [3]

Core Viewpoint - China Resources Double Crane (华润双鹤) is facing declining performance, with its subsidiary, Shuanghe Limin, recently listed for producing non-compliant products, raising concerns about quality control and operational challenges [1][4][15]. Financial Performance - In 2023, China Resources Double Crane achieved a revenue of 11.31 billion yuan, marking a 17.50% increase, and a net profit of 1.67 billion yuan, up 41.55% [15]. - However, in 2024, the company reported a revenue of 11.21 billion yuan, a decrease of 0.87%, and a net profit of 1.63 billion yuan, down 2.55% [15]. - For the first three quarters of 2025, revenue further declined to 8.28 billion yuan, a drop of 3.10%, with net profit at 1.35 billion yuan, down 3.40% [15][16]. Research and Development - The company's R&D expenses have decreased significantly, with 2024 and 2025 first three quarters showing expenditures of 555 million yuan and 371 million yuan, representing year-on-year declines of 11.57% and 21.47% respectively [3][18]. - The R&D expense ratio was approximately 5% in 2024 and 4.5% in 2025 [3][18]. Product Quality Issues - On January 6, 2025, the National Medical Products Administration announced that a batch of sodium bicarbonate injection produced by Shuanghe Limin was non-compliant due to visible foreign matter and pH value issues [1][4]. - The company has been ordered to recall the problematic product and conduct investigations into the non-compliance [4]. Strategic Developments - In response to declining core business performance, China Resources Double Crane is exploring new growth avenues, including the establishment of a 500 million yuan biopharmaceutical industry fund focused on synthetic biology and related technologies [19][20]. - This fund is part of a broader strategy to diversify and create a second growth curve for the company [20].

Summary of Key Points Core Viewpoint - A total of 28 batches of drugs produced by 24 companies were found to be non-compliant with regulations as per inspections conducted by various drug testing institutions in China [2][3][4]. Group 1: Non-compliant Drugs and Companies - Four batches of Coenzyme Q10 injection produced by Liaoning Zhonghai Kangsheng Biopharmaceutical Co., Ltd., Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd., and Kangpu Pharmaceutical Co., Ltd. were found non-compliant due to issues related to appearance, insoluble particles, visible foreign matter, and content measurement [2][3]. - Two batches of sodium bicarbonate injection produced by Chenxin Pharmaceutical Co., Ltd. and China Resources Sanjiu Li Min Pharmaceutical (Jinan) Co., Ltd. were non-compliant due to visible foreign matter and pH value [2][3]. - Two batches of Twenty-Five Flavor Coral Pills produced by Tibet Changdu Guangyu Limin Pharmaceutical Co., Ltd. tested positive for 808 scarlet [2][3]. - One batch of mulberry bark produced by Chengdu Tiansheng Traditional Chinese Medicine Co., Ltd. was non-compliant due to appearance issues [2][3]. - Seven batches of Pueraria lobata produced by Zhejiang Dade Hall National Medicine Co., Ltd., Hunan Taoyuan Traditional Chinese Medicine Co., Ltd., Sichuan Jinke Pharmaceutical Co., Ltd., Sichuan Shengshi Jinrong Pharmaceutical Co., Ltd., and Sichuan Yifang Traditional Chinese Medicine Co., Ltd. were found non-compliant due to appearance issues [2][3]. Group 2: Regulatory Actions - The drug supervision management departments have mandated the relevant companies to take risk control measures such as suspending sales, recalling products, and conducting investigations into the causes of non-compliance [3][4]. - The National Medical Products Administration has instructed provincial drug supervision departments to investigate suspected illegal activities by the companies involved and to publicly disclose the results of the investigations as per the Drug Administration Law of the People's Republic of China [3][4].