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“零缺陷”通过美国FDA审计,华熙生物全球信赖持续升级
Huan Qiu Wang· 2025-07-10 04:39
Core Viewpoint - Huaxi Biological Technology Co., Ltd. has received a "zero defect" result from the FDA, indicating the highest level of compliance in its quality management system, which will enhance its global market competitiveness and facilitate overseas business expansion [1][2]. Group 1: FDA Audit and Certification - The FDA audit lasted five days and was conducted according to ICH Q7 guidelines, covering six major systems including quality systems and laboratory systems, confirming the company's meticulous management and commitment to quality [2]. - This is not the first time Huaxi Biological has received a "zero defect" recognition; it previously passed a similar audit by the Korean MFDS in February 2025 [2]. - The company has successfully passed five FDA audits, one PMDA audit in Japan, and two MFDS audits in Korea for its sodium hyaluronate raw materials [2]. Group 2: Global Market Position - Huaxi Biological has established a significant presence in the global market, holding 34 registration qualifications across various countries, including the EU, the US, Japan, and Korea, making it one of the suppliers with the most comprehensive registrations for pharmaceutical-grade sodium hyaluronate [2][4]. - The company has a marketing and supply chain network spanning over 70 countries and regions, with overseas subsidiaries in key markets such as the US, France, Japan, and South Korea [4]. Group 3: Product Development and Recognition - In addition to raw materials, Huaxi Biological has received global recognition in skin science innovation and medical devices, recently obtaining a medical device registration certificate from Brazil's ANVISA, known for its stringent regulatory standards [4]. - The company has accumulated over 70 medical device and skincare product registrations across more than 15 countries or regions [4]. Group 4: Long-term Strategy and Investment - Huaxi Biological emphasizes long-term research and development investment, maintaining high standards and a stable supply chain to build a strong foundation for quality products and brand development [5]. - The company follows a "technology breakthrough—quality control—global compliance—standard leadership" model, focusing on international standards and resource allocation to enhance its industrial capabilities and product standards [5].
净利润下降70.59%!华熙生物最新2024年财报
思宇MedTech· 2025-07-02 09:44
招商通知 第三届全球手术机器人大会 第二届全球医疗科技大会 2025年7月1日, 华熙生物 发布 2024年年度报告(修订版) 。 # 具体财报数据 | 主要会计数据 | 2024 年 | 2023 年 | 本期比上年同 | 2022 年 | | --- | --- | --- | --- | --- | | | | | 期增减(%) | | | 营业收入 | 5,370,770,254.64 | 6,075,923,853.74 | -11.61 | 6,359,191,975.49 | | 归属于上市公司股东的净利润 | 174,267,399.74 | 592,555,911.37 | -70.59 | 970,918,593.78 | | 归属于上市公司股东的扣除非 经常性损益的净利润 | 107,271,950.81 | 490,482,932.05 | -78.13 | 852,144,424.61 | | 经营活动产生的现金流量净额 | 564,505,133.92 | 699,648,201.22 | -19.32 | 635,188,642.10 | | | 2024 年末 | 2023 年 ...
华熙生物: 华熙生物2024年年度报告(修订版)
Zheng Quan Zhi Xing· 2025-06-30 16:44
Core Viewpoint - The annual report of Bloomage Biotechnology Corporation Limited for 2024 highlights a significant decline in revenue and net profit, attributed to management changes, increased operational costs, and a decrease in income from skin science innovation transformation business [1][3][6]. Company Overview and Financial Indicators - The company reported a total revenue of approximately 5.37 billion yuan, a decrease of 11.61% compared to the previous year [3]. - The net profit attributable to shareholders was approximately 174 million yuan, reflecting a 70.59% decline year-on-year [3]. - The net profit after deducting non-recurring gains and losses was about 107 million yuan, down 78.13% from the previous year [3]. - The basic earnings per share decreased to 0.36 yuan, a drop of 70.73% [3]. Business Performance and Strategic Initiatives - The company is undergoing a strategic upgrade, focusing on synthetic biology and cell biology to enhance its product offerings and operational efficiency [6][12]. - Management changes and restructuring efforts have incurred costs exceeding 70 million yuan, impacting short-term profitability but aimed at long-term growth [6][12]. - The company has initiated over 30 transformation projects to improve operational management and efficiency [16][20]. Revenue Breakdown - The raw materials business generated approximately 1.24 billion yuan, a year-on-year increase of 9.47%, accounting for 23.06% of total revenue [7]. - The skin science innovation transformation business reported revenue of approximately 2.57 billion yuan, a decline of 31.62%, making up 47.92% of total revenue [11][12]. - The medical terminal business achieved revenue of approximately 1.07 billion yuan, a growth of 43.57% [10]. Research and Development - The company invested 8.68% of its revenue in R&D, up from 7.35% the previous year, focusing on innovative products in the fields of regenerative medicine and nutritional science [3][5]. - New product launches included several innovative raw materials and medical products, enhancing the company's product portfolio [18][19]. ESG and Sustainability Efforts - The company has committed to sustainable development practices, becoming a member of the UN Global Compact and improving its ESG ratings [22]. - Initiatives include optimizing the ESG management system and focusing on green, low-carbon production [22].
海正生材: 浙江海正生物材料股份有限公司股东减持股份结果公告
Zheng Quan Zhi Xing· 2025-06-20 11:12
证券代码:688203 证券简称:海正生材 公告编号:2025-34 浙江海正生物材料股份有限公司 股东减持股份结果公告 重要内容提示: ? 大股东持股的基本情况 本次减持计划实施前,湖南中启洞鉴私募股权投资合伙企业(有限合伙) (以 下简称"中启洞鉴")持有公司股份 10,457,516 股,占公司总股本的 5.16%。 上述股份为公司首次公开发行前取得的股份,并已于 2024 年 2 月 19 日起上市流 通。详见公司于 2024 年 2 月 2 日在上海证券交易所网站(www.sse.com.cn)披 露的《浙江海正生物材料股份有限公司首次公开发行部分限售股上市流通公告》 (2024-03)。 公司于 2025 年 3 月 7 日在上海证券交易所网站(www.sse.com.cn)披露了 《浙江海正生物材料股份有限公司持股 5%以上股东集中竞价减持股份计划公 告》(公告编号:2025-05)。因经营发展资金需求,中启洞鉴拟自该公告披露 之日起十五个交易日后的三个月内,通过集中竞价交易方式减持不超过 本公司董事会、全体董事及相关股东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 ...
凯赛生物: 2024年年度股东大会会议资料
Zheng Quan Zhi Xing· 2025-06-17 10:17
Core Points - The annual general meeting of Shanghai Cathay Biotech Co., Ltd. is scheduled for June 27, 2025, at 14:00, combining on-site and online voting methods [3][4] - The company reported a significant increase in revenue and net profit for 2024, with total revenue reaching CNY 2,957.91 million, a 39.91% increase year-on-year, and net profit attributable to shareholders amounting to CNY 488.96 million, a 33.41% increase [16][32] - The company plans to distribute a cash dividend of CNY 4.00 per 10 shares, totaling CNY 287.58 million, based on the audited net profit for 2024 [8][9] Meeting Procedures - Attendees must register and confirm their attendance before the meeting starts, and they are required to present their shareholder certificates to enter the venue [2][3] - The meeting will include the election of monitors and counters, the presentation of the independent directors' report, and the discussion of various proposals [4][6][11] Financial Performance - The company achieved a net profit of CNY 488.96 million in 2024, with a significant increase in net profit excluding non-recurring gains and losses, which rose by 51.60% to CNY 464.73 million [16][32] - The total assets of the company reached CNY 19.02 billion, reflecting a stable financial position [32] Strategic Developments - The company has successfully introduced CNY 5.915 billion in funding through a directed issuance of shares to enhance its business development [18] - A strategic cooperation agreement was signed with Hefei Municipal Government and China Merchants Innovation Technology Group to establish a synthetic biological materials industry cluster [18][28] Governance and Compliance - The board of directors and the supervisory board have actively fulfilled their responsibilities, ensuring compliance with relevant laws and regulations [19][25] - The company has maintained a high standard of information disclosure, achieving an A-level rating for its disclosure practices in the Shanghai Stock Exchange [23][26]
A股公司沉痛公告:80岁创始人逝世,生前曾任清华大学教授
21世纪经济报道· 2025-06-16 09:40
作 者丨尹华禄 编 辑丨刘巷 6月16日盘后,奥精医疗(688613.SH)董事会沉痛公告,公司收到公司创始人、实际控制人 之一崔福斋家属通知,崔福斋于近日因病不幸逝世,享年80岁。 据奥精医疗介绍,崔福斋为公司的发展倾注了毕生心血,带领公司逐步发展壮大成为生物材 料行业领先企业、科创板上市公司,作出了巨大贡献。 奥精医疗官网显示,该公司是是一家致力于组织再生修复植入医疗器械的研发、生产和销售 的技术企业。2011年率先在国际上研制出成分和结构均与天然人体骨组织高度相似的矿化胶 原仿生骨材料,并实现了产品的临床转化和产业化。使得我国在这一医疗器械领域处于国际 地位。目前矿化胶原仿生骨系列产品广泛应用于骨科、口腔科、神经外科等领域的骨缺损修 复,现已在临床使用超百万例。 截至公告披露之日,崔福斋直接持有奥精医疗633.48万股,占总股本的4.62%,通过北京银河 九天信息咨询中心(有限合伙)间接持有35.41万股,占总股本的0.26%。崔福斋所持有的公 司股份将按法律法规办理继承手续,奥精医疗将根据后续事项进展情况及时履行信息披露义 务。 "崔福斋在公司担任首席科学家职务,不属于公司管理层,不会引起公司管理层变 ...
创投月报 | 深创投:50亿赛米产业基金落地 三成获投项目为先进制造公司
Xin Lang Zheng Quan· 2025-06-06 03:05
Group 1 - In May 2025, the number of newly registered private equity and venture capital fund managers in China dropped to 2, a decrease of 83.3% compared to April and a 60% decline year-on-year [1] - A total of 339 new private equity and venture capital funds were registered, marking a year-on-year increase of 55.5% but a month-on-month decrease of 18.7% [1] - The domestic primary equity investment market recorded 428 financing events, representing a year-on-year decrease of 13.6% and a month-on-month decrease of 18.0% [1] Group 2 - Shenzhen Innovation Investment Group (Deep Venture) has registered a new fund, the Shenzhen Hongtu Seed Fund, with a total capital contribution of 300 million yuan, focusing on advanced technology sectors [2] - The Shenzhen Semiconductor and Integrated Circuit Industry Investment Fund aims for a total scale of 5 billion yuan, with 3.6 billion yuan already contributed by various local government funds [3] Group 3 - Deep Venture disclosed 10 equity investment events in the reporting period, a fivefold increase compared to May 2024 and a 66.7% increase from April [3] - In the first five months of 2025, Deep Venture made 43 investments, which is 58.1% of its total investments in 2024 [3] Group 4 - 60% of Deep Venture's projects in May were in the angel and A-round early stages, with a focus on advanced manufacturing, particularly in integrated circuits and aerospace [6] - The company invested in "Sailu Medical," which completed an A+ round of financing, with funds aimed at expanding its sequencing platform and global market outreach [11][12]
华熙生物: 华熙生物2024年年度股东大会资料
Zheng Quan Zhi Xing· 2025-05-29 12:12
证券代码:688363 证券简称:华熙生物 华熙生物科技股份有限公司 2024 年年度股东大会会议资料 华熙生物科技股份有限公司 2024 年年度股东大会会议资料 华熙生物科技股份有限公司 2024 年年度股东大会会议资料 华熙生物科技股份有限公司 为保障华熙生物科技股份有限公司(以下简称"公司")全体股东的合法权 益,维护股东大会的正常秩序,保证股东大会的议事效率,确保本次股东大会如 期、顺利召开,根据《中华人民共和国公司法》《华熙生物科技股份有限公司章 程》《华熙生物科技股份有限公司股东大会议事规则》等相关规定,特制定公司 一、为保证股东大会的有序进行,切实维护股东的合法权益,现场出席会议 的股东及股东代理人需进行会议登记,以核实股东资格。会议开始后,现场会议 登记将终止,会议主持人将宣布现场出席会议的股东和代理人人数及所持有表决 权的股份总数。为了顺利参加股东大会,建议股东提前半小时到达会议现场,并 按规定出示会议登记所需资料办理会议登记。 二、为保证股东大会的正常秩序,除出席会议的股东及股东代理人、公司董 事、监事、高级管理人员、公司聘请的律师及董事会邀请的其他人员外,公司有 权拒绝其他无关人员进入会 ...
ST宁科: ST宁科关于重整及预重整事项的进展公告
Zheng Quan Zhi Xing· 2025-05-28 14:14
证券代码:600165 股票简称:ST 宁科 公告编号:临 2025-068 宁夏中科生物科技股份有限公司 关于重整及预重整事项的进展公告 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。 重要内容及风险提示: ● 截至本公告披露日,宁夏中科生物科技股份有限公司(以下简称:公司 或宁科生物)除已披露的被申请重整及预重整、子公司宁夏中科生物新材料有 限公司(以下简称:中科新材)被法院裁定进行重整的事项外,未发生该事项 相关进展。 ● 中科新材进入重整程序,重整能否成功存在不确定性,如法院最终裁定 中科新材重整不成功,将存在被法院宣告破产的风险,公司将可能失去对中科 新材的控制权,存在失去对子公司的持股的风险,届时公司将无法再将中科新 材纳入合并报表,对公司资产、本期及期后利润产生一定的影响。但目前公司 仍为中科新材控股股东,对其后续重整过程及重整计划草案表决拥有表决权及 一定的决策权。此外,中科新材重整是基于公司及子公司整体协同重整、按统 一方案同时完成重整的整体计划及整体安排的基础上进行,并非孤立事件。如 按公司原定计划,公司能 ...
海正生材: 中信建投证券股份有限公司关于浙江海正生物材料股份有限公司差异化分红事项的核查意见
Zheng Quan Zhi Xing· 2025-05-28 10:39
中信建投证券股份有限公司 关于浙江海正生物材料股份有限公司 差异化分红事项的核查意见 中信建投证券股份有限公司(以下简称"保荐机构"、"中信建投证券")作为 浙江海正生物材料股份有限公司(以下简称"公司"或"海正生材")首次公开发行 股票并在科创板上市及进行持续督导的保荐机构,根据《上海证券交易所科创板 股票上市规则》《证券发行上市保荐业务管理办法》《上海证券交易所上市公司 自律监管指引第7号——回购股份》等有关法律法规和规范性文件的要求,对海 正生材2024年度利润分配涉及的差异化分红事项进行了核查,并发表核查意见如 下: 一、本次实施差异化权益分派的原因 集中竞价交易方式回购公司股份方案的议案》,同意公司使用自有资金通过集中 竞价交易方式回购公司股份。回购股份用于公司股权激励或员工持股计划,回购 价格不超过人民币12.00元/股(含),回购资金总额不低于人民币2,000万元(含), 不超过人民币3,000万元(含),具体回购股份的数量以回购期满时实际回购的 股份数量为准。回购期限自董事会审议通过本次回购方案之日起12个月内。 根据《上海证券交易所上市公司自律监管指引第7号——回购股份》第二十 二条规定"上 ...