体外诊断试剂
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上海发布若干措施 全面深化药品医疗器械监管改革
Yang Shi Xin Wen· 2025-11-26 09:37
记者从11月26日举行的上海市政府新闻通气会上了解到,日前,《上海市全面深化药品医疗器械监管改 革促进医药产业高质量发展的若干措施》正式印发,从支持研发创新、深化国家改革试点、提升审评审 批质效、扩大高水平开放合作、构建全生命周期监管、强化监管能力建设6方面,提出22条举措。 上海市药品监督管理局相关负责人介绍,《若干措施》一方面积极承接好国家改革试点,主动做好地方 事权范围改革;另一方面,针对上海生物医药新技术、新企业"两多"的特点,强化对企业的前置服务, 推动监管从事后管控向跨前服务、提前指导转变。 《若干措施》明确的承接国家改革试点任务包括:争取境外生产药品补充申请审评审批和仿制药立卷审 查试点,加快首仿品种上市;遴选符合条件的品种开展生物制品分段生产试点,推进重大外资项目跨境 分段生产试点,并提供通关便利;鼓励医疗机构加快开展自行研制使用体外诊断试剂试点工作等。 上海主动创新改革举措包括:开展药品连续制造试点,推进医疗器械生产企业可共享实验室等;完善已 上市药品变更流程及指南;开展化学药品等补充申请审评审批程序改革;支持医疗器械产业聚集度高的 园区内共享共用检验检测、工艺用水用气等设施设备,打造专业化 ...
浩欧博股价连续3天上涨累计涨幅6.66%,招商基金旗下1只基金持1.07万股,浮盈赚取12.31万元
Xin Lang Cai Jing· 2025-11-25 09:09
数据显示,招商基金旗下1只基金重仓浩欧博。招商成长先导股票A(014589)三季度减持603股,持有 股数1.07万股,占基金净值比例为4.31%,位居第九大重仓股。根据测算,今日浮盈赚取约2.11万元。 连续3天上涨期间浮盈赚取12.31万元。 11月25日,浩欧博涨1.08%,截至发稿,报184.68元/股,成交1.35亿元,换手率1.15%,总市值117.23亿 元。浩欧博股价已经连续3天上涨,区间累计涨幅6.66%。 资料显示,江苏浩欧博生物医药股份有限公司位于苏州工业园区东堰里路9号,成立日期2009年6月8 日,上市日期2021年1月13日,公司主营业务涉及从事体外诊断试剂的研发、生产和销售。主营业务收 入构成为:试剂销售89.46%,其他销售5.86%,仪器销售3.84%,租赁销售0.85%。 从基金十大重仓股角度 招商成长先导股票A(014589)基金经理为梅梅。 截至发稿,梅梅累计任职时间306天,现任基金资产总规模3924.71万元,任职期间最佳基金回报 36.29%, 任职期间最差基金回报-3.25%。 风险提示:市场有风险,投资需谨慎。本文为AI大模型自动发布,任何在本文出现的信息(包 ...
浩欧博股价涨5.1%,兴业基金旗下1只基金重仓,持有9.69万股浮盈赚取86.43万元
Xin Lang Cai Jing· 2025-11-24 06:04
11月24日,浩欧博涨5.1%,截至发稿,报183.80元/股,成交1.46亿元,换手率1.30%,总市值116.68亿 元。 资料显示,江苏浩欧博生物医药股份有限公司位于苏州工业园区东堰里路9号,成立日期2009年6月8 日,上市日期2021年1月13日,公司主营业务涉及从事体外诊断试剂的研发、生产和销售。主营业务收 入构成为:试剂销售89.46%,其他销售5.86%,仪器销售3.84%,租赁销售0.85%。 从基金十大重仓股角度 数据显示,兴业基金旗下1只基金重仓浩欧博。兴业医疗保健A(011466)三季度持有股数9.69万股,占 基金净值比例为3.8%,位居第十大重仓股。根据测算,今日浮盈赚取约86.43万元。 兴业医疗保健A(011466)成立日期2021年3月8日,最新规模2.61亿。今年以来收益19.11%,同类排名 3578/8209;近一年收益11.73%,同类排名4678/8129;成立以来亏损22.64%。 兴业医疗保健A(011466)基金经理为陈旭。 截至发稿,陈旭累计任职时间4年263天,现任基金资产总规模4.04亿元,任职期间最佳基金回 报-22.64%, 任职期间最差基金回报-2 ...
乐普医疗涨2.06%,成交额1.53亿元,主力资金净流出1117.39万元
Xin Lang Cai Jing· 2025-11-24 05:51
Core Viewpoint - Lepu Medical's stock price has shown a year-to-date increase of 43.28%, but has recently experienced declines over various trading periods, indicating potential volatility in the market [1][2]. Group 1: Stock Performance - On November 24, Lepu Medical's stock rose by 2.06%, reaching a price of 15.83 CNY per share, with a trading volume of 1.53 billion CNY and a turnover rate of 0.62%, resulting in a total market capitalization of 29.181 billion CNY [1]. - The stock has seen a net outflow of 11.1739 million CNY from major funds, with significant selling pressure observed [1]. - Year-to-date, the stock has increased by 43.28%, but has declined by 3.00% over the last five trading days, 11.02% over the last 20 days, and 12.06% over the last 60 days [1]. Group 2: Company Overview - Lepu Medical, established on June 11, 1999, and listed on October 30, 2009, is based in Changping District, Beijing, and operates in the medical device sector, including cardiac treatment products, in vitro diagnostic reagents, and medical services [2]. - The company's revenue composition includes 52.72% from medical devices, 33.16% from pharmaceuticals, and 14.11% from medical services and health management [2]. - Lepu Medical is categorized under the pharmaceutical and biological industry, specifically in medical devices and consumables, and is involved in various innovative sectors such as brain-machine interfaces and smart healthcare [2]. Group 3: Financial Performance - For the period from January to September 2025, Lepu Medical reported a revenue of 4.939 billion CNY, reflecting a year-on-year growth of 3.20%, while the net profit attributable to shareholders was 982 million CNY, marking a 22.35% increase [2]. - The company has distributed a total of 4.957 billion CNY in dividends since its A-share listing, with 2.058 billion CNY distributed over the past three years [3]. - As of September 30, 2025, Lepu Medical had 82,900 shareholders, a decrease of 17.13% from the previous period, with an average of 19,490 circulating shares per shareholder, an increase of 20.67% [2].
利德曼跌2.12%,成交额7349.64万元,主力资金净流出746.68万元
Xin Lang Zheng Quan· 2025-11-24 05:11
11月24日,利德曼盘中下跌2.12%,截至13:04,报7.38元/股,成交7349.64万元,换手率1.80%,总市值 40.15亿元。 资金流向方面,主力资金净流出746.68万元,特大单买入106.78万元,占比1.45%,卖出114.30万元,占 比1.56%;大单买入752.37万元,占比10.24%,卖出1491.53万元,占比20.29%。 利德曼今年以来股价涨50.61%,近5个交易日跌20.22%,近20日跌4.28%,近60日跌19.78%。 今年以来利德曼已经4次登上龙虎榜,最近一次登上龙虎榜为8月8日。 分红方面,利德曼A股上市后累计派现1.43亿元。近三年,累计派现544.01万元。 机构持仓方面,截止2025年9月30日,利德曼十大流通股东中,医疗器械ETF(159883)位居第五大流 通股东,持股201.13万股,为新进股东。金元顺安元启灵活配置混合(004685)、华夏中证500指数增 强A(007994)退出十大流通股东之列。 责任编辑:小浪快报 资料显示,北京利德曼生化股份有限公司位于北京市北京经济技术开发区兴海路5号,成立日期1997年 11月5日,上市日期2012年2 ...
利德曼拟17.33亿收购先声祥瑞70%股份 切入生物制品行业推进“双主业”转型
Chang Jiang Shang Bao· 2025-11-18 00:14
长江商报消息 ●长江商报记者 江楚雅 利德曼计划通过并购寻求新的增长曲线,推动企业转型。 近日,利德曼(300289.SZ)发布公告称,计划以17.33亿元现金收购北京先声祥瑞生物制品股份有限公 司(下称"先声祥瑞")70%股份。 本次交易完成后,先声祥瑞将成为利德曼控股子公司,利德曼也将借此切入生物制品领域,构建"生物 制品+体外诊断"双主业模式。 业内认为,通过本次交易,上市公司的业绩将得到提升,财务状况将得到进一步改善,有利于维护上市 公司股东的利益。 标的近年业绩表现稳定 对应高溢价,交易对手方作出了明确的业绩承诺。先声祥瑞2025年、2026年、2027年扣非归母净利润分 别不低于1.66亿元(若剔除2025年mRNA平台费用1035.57万元,则为1.76亿元)、1.86亿元、2.08亿 元,三年累计扣非归母净利润不低于5.58亿元。 先声祥瑞的业务布局是此次收购的核心吸引力之一。作为拥有疫苗生产许可证的企业,其管线覆盖尚未 满足临床需求的人用创新疫苗,其中应用于脑膜炎领域的Xs03项目已提交pre-IND,另有多个创新项目 处于临床前阶段。此外,先声祥瑞在体外诊断试剂的研发、生产和销售领域也具备 ...
利德曼股价涨5.5%,永赢基金旗下1只基金位居十大流通股东,持有201.13万股浮盈赚取100.56万元
Xin Lang Cai Jing· 2025-11-17 02:18
Group 1 - Lidman shares increased by 5.5% on November 17, reaching 9.59 CNY per share, with a trading volume of 263 million CNY and a turnover rate of 5.36%, resulting in a total market capitalization of 5.217 billion CNY [1] - The stock price of Lidman has risen for six consecutive days, with a cumulative increase of 18.98% during this period [1] - Lidman, established on November 5, 1997, and listed on February 16, 2012, specializes in in vitro diagnostic reagents, diagnostic instruments, and biochemical raw materials, with the revenue composition being 67.84% from in vitro diagnostic reagents, 14.17% from diagnostic instruments, 13.21% from other sources (such as property leasing/management), and 4.78% from biochemical raw materials [1] Group 2 - Among Lidman's top ten circulating shareholders, a fund under Yongying Fund is included, and the Medical Device ETF (159883) entered the top ten shareholders in the third quarter, holding 2.0113 million shares, which is 0.37% of the circulating shares [2] - The Medical Device ETF (159883) has generated a floating profit of approximately 1.0056 million CNY today and a total floating profit of 2.9164 million CNY during the six-day increase [2] - The Medical Device ETF was established on April 22, 2021, with a current scale of 4.73 billion CNY, yielding 9.67% year-to-date, ranking 3702 out of 4216 in its category, and 1.7% over the past year, ranking 3689 out of 3956, while it has incurred a loss of 46.82% since inception [2] Group 3 - The fund manager of the Medical Device ETF (159883) is Shu Kefa, who has been in the position for 2 years and 97 days, managing a total fund size of 6.282 billion CNY [3] - During Shu Kefa's tenure, the best fund return was 103.17%, while the worst return was -30.27% [3]
冲高回落!利德曼重大资产重组
Shang Hai Zheng Quan Bao· 2025-11-14 08:06
Core Viewpoint - Lideman plans to acquire 70% of Xiansheng Xiangrui Biotech for 1.733 billion yuan, marking a significant asset restructuring move [1][4][7] Group 1: Transaction Details - The acquisition price for 70% of Xiansheng Xiangrui is set at 1.733 billion yuan, with an estimated value increase of 162.23% based on the income approach [4][6][7] - The transaction involves three parties: Shanghai Baijiahui Investment Management Co., Hainan Xiansheng Baijiahui Technology Development Co., and Nanjing Baijia Rui Enterprise Management Consulting Partnership [4][5] - The deal is expected to create approximately 1.019 billion yuan in goodwill on Lideman's consolidated balance sheet post-transaction [8] Group 2: Financial Performance - Xiansheng Xiangrui's projected net profits for 2025, 2026, and 2027 are 166 million yuan, 186 million yuan, and 208 million yuan respectively, totaling a commitment of at least 560 million yuan [8] - Prior to the acquisition, Lideman's revenue for 2024 and the first seven months of 2025 were 370 million yuan and 184 million yuan, with net losses of 75.1 million yuan and 6.2 million yuan [11] - Post-acquisition, Lideman's revenue is expected to rise to 953 million yuan and 412 million yuan for the same periods, with net profits of 57.8 million yuan and 36.6 million yuan [11] Group 3: Industry Positioning - The acquisition allows Lideman to enter the high-barrier, high-potential bioproducts industry, extending its main business into internal diagnostics and innovative vaccines [9][10] - Xiansheng Xiangrui specializes in bioproducts, focusing on tuberculosis screening and diagnosis, and is one of the few companies in China with a vaccine production license [10][11] - The transaction aims to enhance Lideman's financial status and operational scale, particularly in the field of tuberculosis diagnostics [11]
重大资产重组草案出炉!利德曼拟17.33亿元购买先声祥瑞70%股权
Zhong Guo Zheng Quan Bao· 2025-11-14 00:31
Core Viewpoint - Lideman plans to acquire 70% of Xiansheng Xiangrui for 1.733 billion yuan, marking a significant asset restructuring that will enhance its financial position and market presence in the biopharmaceutical industry [1][4]. Group 1: Acquisition Details - The transaction involves cash payment to Shanghai Baijiahui Investment Management Co., Nanjing Baijiarui Enterprise Management Consulting Partnership, and Hainan Xiansheng Baijiahui Technology Development Co. for 70% of Xiansheng Xiangrui [1]. - The acquisition will allow Lideman to consolidate Xiansheng Xiangrui into its financial statements, as the asset totals exceed 50% of Lideman's assets, revenue, and net assets [1]. Group 2: Company Overview - Lideman specializes in the research, production, and sales of in vitro diagnostic reagents, diagnostic instruments, and biochemical raw materials, with products widely used in clinical diagnostics across various healthcare institutions [2]. - Xiansheng Xiangrui, a member of Xiansheng Investment Group, focuses on biopharmaceuticals, particularly in vitro diagnostic reagents and vaccines, with a strong market position in tuberculosis screening [2][3]. Group 3: Financial Impact - Lideman's revenue for 2023, 2024, and the first three quarters of 2025 is projected at 462 million yuan, 370 million yuan, and 252 million yuan, respectively, with net profits showing a decline in 2024 and 2025 [4]. - Post-acquisition, Lideman expects to improve its financial metrics significantly, with Xiansheng Xiangrui projected to generate revenues of 653 million yuan, 582 million yuan, and 228 million yuan for the same periods, despite a downward trend [4]. - Xiansheng Xiangrui has committed to achieving a minimum net profit of 166 million yuan, 186 million yuan, and 208 million yuan for 2025, 2026, and 2027, respectively, totaling at least 560 million yuan over three years [4].
东方生物股价涨5.11%,融通基金旗下1只基金重仓,持有280万股浮盈赚取389.2万元
Xin Lang Cai Jing· 2025-11-12 02:53
Core Viewpoint - Oriental Bio has experienced a stock price increase of 5.11% on November 12, reaching 28.57 CNY per share, with a total market capitalization of 5.76 billion CNY, indicating a cumulative increase of 4.34% over three consecutive days [1] Company Overview - Zhejiang Oriental Gene Biological Products Co., Ltd. was established on December 1, 2005, and went public on February 5, 2020. The company specializes in the research, production, and sales of in vitro diagnostic products, with 97.99% of its revenue coming from diagnostic reagents and 2.01% from other supplementary sources [1] Shareholder Analysis - The top circulating shareholder of Oriental Bio includes a fund from Rongtong Fund, which reduced its holdings by 1.7 million shares in the third quarter, now holding 2.8 million shares, representing 1.39% of the circulating shares. The fund has gained approximately 3.89 million CNY in floating profit today and 3.16 million CNY during the three-day increase [2] Fund Performance - The Rongtong Health Industry Flexible Allocation Mixed A/B Fund (000727) has a total scale of 1.816 billion CNY and has achieved a year-to-date return of 15.36%, ranking 5146 out of 8147 in its category. Over the past year, it has returned 1.86%, ranking 7321 out of 8056, and since inception, it has returned 178.7% [2] Fund Holdings - The Rongtong Health Industry Flexible Allocation Mixed A/B Fund (000727) has Oriental Bio as its tenth largest holding, with 2.98% of the fund's net value allocated to this stock. The fund manager, Wan Minyuan, has been in position for 9 years and 81 days, with the best return during his tenure being 143.42% and the worst being -21.5% [3]