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药品监管科学全国重点实验室课题研讨会暨细胞制剂质量评价创新中心揭牌仪式成功举行
Yang Zi Wan Bao Wang· 2025-08-28 05:17
近日,江苏省药监局党组成员、药品安全总监于萌率队赴江苏启创细胞基因研究院参加"药品监管科学 全国重点实验室课题"研讨会暨"细胞制剂质量评价创新中心"揭牌仪式。 三是坚守质量底线,筑牢高质量发展根基。将技术能力建设作为核心抓手,在全力推进创新的同时,打 造覆盖药品全生命周期的检验检测体系,让质量底线有"技"可依,严守安全底线和质量高线。 今年3月,由江苏省药品监督检验研究院牵头,与南京大学、江苏启创细胞基因工程研究院等单位联合 申报,成功获批药品监管科学全国重点实验室第三批课题"干细胞制备终点AI动态快检创新质控方法研 究"。该课题基于自研人工智能DeepSearch引擎和显微细胞功能分析仪,构建形态-功能映射模型,旨在 建立高效、低成本的干细胞质控方法,为监管与企业提供精准过程控制方案。5月,江苏省药品监督检 验研究院与南京九川科学技术有限公司、江苏启创细胞基因工程研究院等多家单位联合申报的"无透镜 数字芯片显微成像技术及生物医疗应用"项目,获评江苏省科协"2024年度江苏省行业领域十大科技进展 (生物医药领域)"。 下一步,江苏省药品监督检验研究院将以本次合作为抓手,聚焦干细胞、T细胞、细胞外囊泡等制剂的 ...
大消息!江苏:支持生物医药创新企业上市
Zheng Quan Shi Bao· 2025-08-27 14:01
8月27日,商务部、江苏省人民政府联合发布了《中国(江苏)自由贸易试验区生物医药全产业链开放创 新发展方案》(下称《方案》)。 业内人士指出,这实际上就是要发挥江苏自贸试验区生物医药创新能力强、上下游产业链完整的特色优 势,通过放宽市场准入,提升医用物品、研发物品的通关便利度等举措,为企业提供更加顺畅的研发和 生产环境。 支持生物医药创新企业在创业板、科创板、北交所上市 记者了解到,本次《方案》有利于发挥自贸试验区改革开放综合试验平台作用,因地制宜开展全产业链 集成创新,也为全国生物医药产业高质量发展探索路径、积累经验。 公开数据显示,2024年,江苏省生物医药集群实现营业收入4543.9亿元、利润总额730.4亿元,分别占全 国15.1%、17.9%,均居全国第一。其中,江苏自贸试验区生物医药产业产值占全省一半左右。 《方案》涵盖研发创新、审批服务、生产流通、产品采购使用等全产业链。在研发创新层面,《方案》 紧扣产业发展趋势,围绕江苏自贸试验区近年来在免疫细胞、干细胞、基因治疗等先进治疗手段,以及 体外诊断试剂等创新医疗器械研发创新等方面的需求,从搭建创新平台、支持临床研究等方面,提出系 列举措。 例如,《 ...
南华生物的保壳危途:业绩暴雷现金流不足2亿元 押注收购CRO明星能否化解退市危机 | 创新药观察
Hua Xia Shi Bao· 2025-08-21 09:47
被实施退市风险警示(*ST)的南华生物医药股份有限公司(下称"南华生物")近日紧急抛出"自救方案":公司正 式公告筹划收购动作,目标直指湖南慧泽生物医药科技有限公司(下称"慧泽医药")51%股权,交易完成后标的 公司将成为其控股子公司并纳入合并报表。 此次收购被市场普遍解读为南华生物应对退市风险的关键举措。据公司财报数据,南华生物已面临净利润连续为 负、营收规模不足的困境,2024年归母净利润亏损1984.6万元,全年营收仅1.34亿元,核心指标触及退市警示标 准,若2025年业绩仍无明显起色,退市压力迫在眉睫。 在此背景下,收购背后的潜在问题也成为资本市场关注焦点:南华生物当前现金流状况能否支撑现金交易,收购 后两家公司在业务、管理上的整合能否顺利推进,这些疑问将直接影响此次"保壳"动作的最终效果,也让这场退 市危机下的主业突围充满不确定性。 并购抢跑退市倒计时 南华生物公告披露内容,此次收购采用"纯现金交易+分阶段推进"模式,意图快速获取标的公司控制权以改善报表 表现。 从交易流程看,南华生物已于8月11日与慧泽医药股东签署《股权收购意向协议》,首先锁定90天排他期(截至 2025年11月9日),期间转让 ...
这家公司宣布重大资产重组,股价跌停……
IPO日报· 2025-08-13 00:33
Core Viewpoint - The company *ST Bio plans to acquire 51% of Hunan Huize Biomedical Technology Co., Ltd. in a cash transaction, which is expected to enhance its core business and improve profitability, while also addressing its ongoing delisting risk [1][6][9]. Group 1: Acquisition Details - The acquisition is expected to constitute a significant asset restructuring but will not involve issuing new shares or changing control of the company [2]. - The acquisition agreement has been signed, and the specific terms will be finalized after due diligence and negotiations [6]. - Huize Biomedical, established in 2014, specializes in drug research and clinical evaluation, with over 85% of its revenue coming from clinical evaluation services [7]. Group 2: Financial Performance and Risks - The company has faced continuous losses, leading to multiple delisting warnings since 2016, with its stock currently labeled as *ST Bio due to negative net profits in recent years [10][11]. - In 2024, *ST Bio reported revenues of 134 million yuan and a net loss of 19.85 million yuan, with expectations of further declines in revenue for the first half of 2025 [11]. - The company previously attempted to improve its financial situation through the acquisition of Yuan Tai Bio in 2017, but ultimately sold it due to high R&D costs and financial strain [14][15]. Group 3: Strategic Intent - The acquisition of Huize Biomedical is aimed at extending the company's biopharmaceutical business and enhancing its profitability and risk resilience [7]. - The integration of drug research and clinical evaluation services is expected to create strong synergies and improve operational efficiency [7].
000504,重大资产重组!股价已2连板
中国基金报· 2025-08-12 01:12
Core Viewpoint - The company *ST Bio is planning to acquire a 51% stake in Hunan Huize Biomedical Technology Co., Ltd. for cash, which will result in Huize becoming a subsidiary of *ST Bio, indicating a significant asset restructuring [2][6]. Group 1: Acquisition Details - The acquisition of Huize Medical, a professional CRO company focused on drug research and clinical evaluation, is expected to enhance *ST Bio's capabilities in the biopharmaceutical sector [5][6]. - Huize Medical generates over 85% of its revenue from clinical evaluation services and has established long-term partnerships with over 300 pharmaceutical companies and research institutions [5]. Group 2: Strategic Benefits - The acquisition is anticipated to extend *ST Bio's biopharmaceutical business, improving its profitability and risk resilience [6]. - The integration of drug research and clinical evaluation services is expected to enhance operational efficiency and create strong synergies [6]. Group 3: Financial Performance - *ST Bio has projected a revenue of 49 million to 52 million yuan for the first half of 2025, representing a year-on-year decline of 7.68% to 13% [7]. - The company expects a net loss attributable to shareholders of 3.5 million to 5 million yuan, an improvement from a loss of 8.39 million yuan in the same period last year [7]. Group 4: Stock Performance - Following a period of stock price decline, *ST Bio's shares were subject to delisting risk warnings starting April 30, 2025, with the stock price dropping to a low of 5.43 yuan per share on April 28 [9]. - Recently, the stock price has rebounded, closing at 12.54 yuan per share as of August 11 [10].
*ST生物(000504.SZ)筹划收购慧泽医药51%股权 预计构成重大资产重组情形
智通财经网· 2025-08-11 14:45
Core Viewpoint - *ST生物 is planning to acquire a 51% stake in Hunan Huize Biomedical Technology Co., Ltd. for cash, which will make Huize a subsidiary and included in the consolidated financial statements. This transaction is expected to constitute a significant asset restructuring as per the regulations [1] Group 1: Company Overview - Huize Biomedical is a professional CRO company focused on drug research and clinical evaluation, providing services such as pharmaceutical research, clinical trials, and data management statistical analysis [1] - Prior to the acquisition, *ST生物 primarily engaged in two business segments: "biomedical" and "energy conservation and environmental protection," along with the production and sales of other biomedical-related products [1] Group 2: Strategic Intent - The acquisition aims to extend the biomedical segment of *ST生物, enhancing the profitability of its main business and improving its risk resistance capabilities [1] - There is a strong correlation between cell clinical transformation research and drug development, and the asset integration is expected to improve operational efficiency and create significant synergies [1]
*ST生物筹划购买慧泽医药51%股权 预计构成重大资产重组
Zheng Quan Shi Bao Wang· 2025-08-11 13:56
Group 1 - The core point of the article is that *ST Bio is planning to acquire a 51% stake in Hunan Huize Biomedical Technology Co., Ltd., which will become a subsidiary after the transaction, indicating a significant asset restructuring [1] - Huize Biomedical is a specialized CRO company focused on drug research and clinical evaluation, with over 85% of its revenue coming from clinical evaluation services and established partnerships with over 300 pharmaceutical companies and research institutions [1] - The acquisition is expected to enhance *ST Bio's profitability and risk resistance by extending its biopharmaceutical business and improving operational efficiency through asset integration [1] Group 2 - The transaction is anticipated to strengthen the overall growth and profitability of *ST Bio, fostering core competitiveness in the new production capacity system and supporting long-term sustainable development [2] - Following the acquisition, *ST Bio's biopharmaceutical segment will include drug research and clinical evaluation services, which will enhance the company's competitive edge and align with shareholder interests [2] - *ST Bio previously forecasted a revenue of 49 million to 52 million yuan for the first half of 2025, representing a year-on-year decline of 7.68% to 13%, with a projected net loss of 3.5 million to 5 million yuan [2]
医疗整形美容和生活美容有何不同?专家解答
Ren Min Wang· 2025-07-04 09:09
Core Viewpoint - The National Health Commission emphasizes the importance of distinguishing between medical and non-medical beauty services, highlighting the risks associated with non-professional practices in medical aesthetics [1][2][3] Group 1: Medical vs. Non-Medical Aesthetics - Medical aesthetics involves invasive techniques such as surgeries and injections aimed at repairing or reshaping appearance, while non-medical beauty services are non-invasive, like applying face masks [1] - Medical institutions must meet strict regulatory requirements to ensure safety and quality in medical aesthetic services, which can be verified through the National Health Commission's official website [1] Group 2: Risks of Non-Medical Aesthetic Practices - Increased risk of infection due to non-sterile environments and improper handling in non-medical settings, potentially leading to severe complications like sepsis [2] - Higher likelihood of adverse reactions from unregulated injection materials, which may cause serious allergic reactions or other health issues [2] - Greater risk of embolism from injections performed by non-professionals, which can result in severe consequences such as skin necrosis, blindness, or stroke [2][3] - Non-medical institutions lack effective emergency response measures, making it difficult to address complications like allergies or embolisms promptly [3]
又一A股宣布:“摘帽”!
Zhong Guo Ji Jin Bao· 2025-04-30 16:11
Core Viewpoint - ST Jiuzhitang announced the suspension of its stock trading for one day on May 6, 2025, with the resumption of trading on May 7, 2025, and the removal of other risk warnings, changing its stock name from "ST Jiuzhitang" to "Jiuzhitang" [4][6]. Company Announcement - The company has completed the rectification of internal control deficiencies, with non-operating fund occupation balance reduced to zero, and all income from non-company bank accounts transferred to the company's bank account [6]. - The company has strengthened risk compliance awareness and internal control management, implementing various rectification measures [6]. Financial Performance - In 2024, ST Jiuzhitang reported total revenue of 2.371 billion yuan, a year-on-year decrease of 19.91%, and a net profit attributable to shareholders of 216 million yuan, down 27.31% [8]. - For Q1 2025, the company achieved revenue of 806 million yuan, a decline of 25.36%, and a net profit of 117 million yuan, down 19.40% [10]. - The decline in performance is attributed to changes in medical insurance policies, market demand fluctuations, and rising raw material costs [10]. Market Context - The company operates in the traditional Chinese medicine sector, focusing on research, production, and sales, while also exploring innovative businesses such as stem cells and health services [8]. - The pharmaceutical market is experiencing intensified competition due to ongoing reforms in the medical and pharmaceutical management systems, impacting the company's traditional business model [10].