证券代码：688298 证券简称：东方生物 公告编号：2025-006 浙江东方基因生物制品股份有限公司 关于自愿披露获得医疗器械注册证的公告 上述产品在国内市场取证，丰富了公司在国内市场的产品布局，有利于整体 市场拓展。 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、准确性和完整性依法承担法律责任。 浙江东方基因生物制品股份有限公司（以下简称"东方生物"或"公司"） 下属全资子公司上海万子健生物科技有限公司（以下简称"上海万子健"）近期 取得以下产品的国内医疗器械注册证，相关公告如下： | 产品名称 | 证书编号 | 预期用途 | 持证人 | 有效期 | | --- | --- | --- | --- | --- | | 糖类抗原15-3检测试 （流式荧光发光法） | | 供医疗机构用于体外定量检测人 体血清中糖类抗原15-3的含量。临 据 | | 2025/3/6 -2030/3/5 | | 剂盒 | 沪械注准 | 床上用于乳腺癌的治疗监测，不作 | | | | | 20252400090 | 为恶性肿瘤早期诊断或确诊的依 | | | | 人附睾蛋白 ...

这一决策标志着东方生物从"人医"到"动保"的双赛道战略正式落地，公司计划通过技术迁移、产业链整 合与全球化布局，打造动物健康领域的全新增长极。 3月10日，东方生物在浙江安吉召开发布会，正式宣布进军动物保健（动保）领域。发布会上，东方生 物还宣布，其控股子公司华信农威研发的蓝耳病灭活疫苗蓝倍安和衣原体基因工程亚单位疫苗孕倍安正 式上市。 打造"人医"+"动保"双赛道战略 "此次进军动保领域，我们已做好充分准备。"方炳良透露，为实现动保领域的快速突破，东方生物采取 了"自主研发+战略并购"的组合拳。 2023年是东方生物在动保领域布局的关键一年。东方生物于当年底获得了新版《中华人民共和国兽药 GMP证书》《中华人民共和国兽药生产许可证》，可开展动宠物免疫学类诊断制品（B类）的生产。当 年，公司通过收购北京华信农威生物科技，获取涵盖猪蓝耳病灭活疫苗、猪圆环病毒灭活疫苗、猪瘟活 疫苗（细胞源）、猪支原体肺炎灭活疫苗等20余种产品的批文与成熟渠道。据悉，华信农威前身为北京 市兽医生物药品厂，借助此次收购，东方生物迅速切入动保疫苗市场，大大缩短了产品研发取证和市场 拓展周期，为布局动保领域赢得了宝贵的时间。 从IVD龙 ...

关于自愿披露获得医疗器械注册证及新兽药证书的公告 证券代码：688298 证券简称：东方生物 公告编号：2025-005 浙江东方基因生物制品股份有限公司 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、准确性和完整性依法承担法律责任。 浙江东方基因生物制品股份有限公司（以下简称"东方生物"或"公司"） 及下属全资子公司美国衡健生物科技有限公司（以下简称"美国衡健"）、上海 万子健生物科技有限公司（以下简称"上海万子健"）近期取得以下产品的国内 外医疗器械注册证；子公司美国衡健的Strep A抗原检测试剂（仅处方使用）取得 的美国CLIA证书近期生效；另外，公司参与研制一款动物检测试剂被纳入由中华 人民共和国农业农村部审查批准核发的新兽药注册目录，相关公告如下： 一、美国CLIA证书的基本情况 | 产品名称 | | 证书 | 适用范畴 | 生效 | | --- | --- | --- | --- | --- | | | | 类型 | | 日期 | | Rapid Strep A Antigen Test A族链球菌抗原快速检测试剂 | CLIA | WAI ...

Financial Performance - Total revenue for 2024 reached RMB 826.71 million, a slight increase of 0.80% compared to the previous year[4] - Operating profit was RMB -565.84 million, a decrease of 47.42% year-over-year[4] - Net profit attributable to shareholders was RMB -511.60 million, down 28.68% from the previous year[4] - Basic earnings per share decreased by 32.01% to RMB -2.60[4] Assets and Equity - Total assets at the end of 2024 were RMB 8,144.11 million, a decline of 9.47% from the beginning of the year[4] - Shareholders' equity attributable to the parent company decreased by 10.44% to RMB 6,659.97 million[4] Operational Challenges - The company faced increased operational costs due to investments in technology and asset depreciation[7] - The decline in key performance indicators was attributed to slower growth in routine testing business and increased costs from acquisitions and R&D[9] Strategic Focus - The company is focusing on enhancing product lines and technology integration through acquisitions and new projects[7] Investor Advisory - Investors are advised to be cautious as the financial data is preliminary and subject to change upon final audit[10]

Financial Performance Forecast - The company expects a net loss attributable to shareholders of the parent company for 2024 to be between -485 million and -535 million CNY, compared to a net loss of -398 million CNY in the previous year[4]. - The net profit attributable to shareholders of the parent company, after deducting non-recurring gains and losses, is projected to be between -550 million and -595 million CNY[4]. - The total profit for the previous year was -404 million CNY, with a net profit attributable to shareholders of the parent company at -398 million CNY[5]. - The financial data in the performance forecast has not been audited by registered accountants and is based on preliminary calculations by the company's financial department[9]. - The company has not identified any significant uncertainties that could affect the accuracy of the performance forecast as of the announcement date[9]. - Investors are advised to pay attention to investment risks as the forecast data is preliminary and the final audited financial data will be disclosed in the 2024 annual report[10]. Operational Costs and Investments - The company has increased investment in clinical trials and product registration to enhance competitiveness in core markets, leading to higher R&D expenses[8]. - The company is facing increased operational costs due to the construction of industrial transformation bases and depreciation of fixed and intangible assets[8]. - The company has been actively acquiring and establishing new projects to improve product line and technology layout, which has added to operational costs[8]. - The company is currently in the early investment stage of local production layout overseas to mitigate geopolitical and policy risks[8].

归属于母公司所有者扣除非经常性损益后的净利润为-5.50亿元到-5.95亿元。 主要原因包括：常规检测业务受经济大环境影响，行业竞争激烈，部分收购及新设项目短期业绩不及预 期；上市前业绩规模基数较小，重点产品的研发、临床、注册取证、市场推广及客户验证等需要时间周 期；加大对已有技术的产业转化基地建设，相关折旧摊销费用较高；持续完善产品线布局、技术路径布 局以及产业上下游整合，收购兼并新增相关运营成本；加大临床试验、产品注册等研发费用投入；项目 资金投入增加导致货币资金减少，利息收入、汇兑收益等财务贡献减少；持续加大海外本土化生产布 局，目前处于项目前期投入阶段。 以上预告数据为初步核算数据，具体准确的财务数据以正式披露的经审计后的2024年年报为准。 财联社1月16日电，东方生物公告，预计2024年年度实现归属于母公司所有者的净利润为-4.85亿元 到-5.35亿元，与上年同期相比，将出现亏损。 ...

Core Insights - In 2024, the company focused on proactive change and innovative development, achieving significant accomplishments in globalization and R&D registration [1] Globalization Strategy - The company accelerated the construction of production, sales, and research bases in various locations including Anji, Hangzhou, Nanjing, Chengdu, Hainan, Shanghai, and the United States, aiming for early production and effectiveness [2] - Acquisitions included the purchase of Confirm in the U.S. for local retail channel development, and the acquisition of Hangzhou Laihe for complementary capabilities in infectious disease and drug testing [2] - The establishment of a large-scale POCT production base in the U.S. with multiple automated production lines ensures capacity for local orders [2] - A new medical laboratory in the U.S. received CLIA certification, allowing for research and testing services [2] R&D and Product Development - The company established a North American R&D center to enhance technical capabilities and improve production efficiency [3] - Investment in a global digital R&D innovation headquarters in Shanghai aims to develop precision medical instruments and establish a comprehensive molecular diagnostic platform [3] - The company received FDA emergency use authorization for a combined rapid test for COVID-19 and influenza, marking a significant milestone in product registration [4] Regulatory Approvals and Certifications - The company’s drug testing kits received various certifications, including NMPA in China and FDA approvals in the U.S. for multiple products [4][5] - The establishment of a drug monitoring and warning center in collaboration with local authorities highlights the company's commitment to public health [4] Future Outlook - The chairman expressed optimism for 2025, emphasizing the balance of opportunities and challenges ahead, and the company's readiness to embrace the future with determination [5]

第三届监事会第十次会议决议公告 证券代码：688298 证券简称：东方生物 公告编号：2024-072 浙江东方基因生物制品股份有限公司 集资金使用效益，获得一定的投资收益。公司监事会同意公司使用额度不超过 7,500.00 万元的部分暂时闲置募集资金进行现金管理。 具体内容详见公司于同日在上海证券交易所网站(http://www.sse.com.cn) 披露的《关于使用部分暂时闲置募集资金进行现金管理的公告》。 本公司监事会及全体监事保证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、准确性和完整性依法承担法律责任。 浙江东方基因生物制品股份有限公司（以下简称"公司"）第三届监事会第 十次会议于 2024 年 12 月 24 日以电子邮件的形式发出会议通知，于 2024 年 12 月 27 日中午 12:00 在公司会议室以现场会议方式召开。会议应出席监事 3 名， 实到出席监事 3 名。会议召开符合法律法规、《中华人民共和国公司法》及《公 司章程》的相关规定。 会议由监事方晓萍女士主持召开，全体与会监事经认真审议和表决，形成以 下决议： 1、审议通过《关于部分募投项目延期的议案》 ...

证券代码：688298 证券简称：东方生物 公告编号：2024-068 浙江东方基因生物制品股份有限公司 关于部分募投项目延期的公告 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、准确性和完整性依法承担法律责任。 浙江东方基因生物制品股份有限公司（以下简称"公司"）于 2024 年 12 月 27 日召开第三届董事会第十一次会议、第三届监事会第十次会议审议通过了《关 于部分募投项目延期的议案》，同意公司对首发募集资金投资项目之"技术研发 中心建设项目""营销网络与信息化管理平台建设项目"达到预计可使用状态的 时间由原计划的 2024 年 12 月延长至 2025 年 12 月，本次延期未改变募投项目的 投资内容、投资总额、实施主体。保荐机构光大证券股份有限公司对本事项出具 了明确同意的核查意见，该事项无需提交公司股东大会审议。现将相关情况公告 如下： 一、募集资金基本情况 根据中国证券监督管理委员会于 2019 年 12 月 31 日出具的《关于同意浙江 东方基因生物制品股份有限公司首次公开发行股票注册的批复》（证监许可〔2019〕 2999 号），公司 ...