Core Viewpoint - The recent EU IVDR certification of the new combined antigen detection kit for COVID-19, influenza A and B, respiratory syncytial virus, and adenovirus by Dongfang Bio signifies a major advancement in the company's capabilities in respiratory virus detection and enhances its international recognition in the field [1][2] Group 1: Product Development and Certification - Dongfang Bio's newly developed antigen detection kit has received EU IVDR certification, indicating a higher regulatory standard compared to the previous IVDD certification, which enhances the product's legal status and compliance requirements [1] - The detection kit allows for the qualitative and differential detection of five viruses from a single nasal swab sample within 15 minutes, meeting the rapid testing needs during high incidence periods of respiratory diseases [1] Group 2: Market Position and Global Expansion - Dongfang Bio has established a strong presence in the respiratory infectious disease detection market, having previously obtained various IVDR and FDA certifications for its products in Europe and the United States [2] - The company's COVID-19 and influenza combination detection product has been recognized as one of the "Top 5 Medical Breakthroughs of 2024" by ABC News and is currently available in major retail pharmacies like Walgreens [2] - Dongfang Bio is accelerating its global expansion with local production bases in the US, UK, and Canada, which supports scalable production and aligns with the demand for efficient diagnostic solutions in the post-pandemic era [2]

最新一期业绩显示，2024年三季报，公司实现营业收入6.58亿元，同比0.83%；净利润-262156256.43 元，同比-262.17%，销售毛利率34.69%。 序号股票简称PE(TTM)PE(静)市净率总市值(元)25东方生物-8.98-8.980.6745.92亿行业平均 45.9448.384.71101.41亿行业中值29.6428.792.3545.52亿1天益医疗-2672.56-2672.561.6719.88亿2硕世生 物-1835.15-1835.151.1537.91亿3诺唯赞-549.11-549.112.5299.35亿4博晖创新-335.30-206.443.6951.46亿5康 泰医学-262.5830.812.6851.07亿6华大基因-197.28215.792.04200.47亿7奥精医疗-108.26-108.261.3819.61亿 8睿昂基因-79.59-79.591.2411.51亿9热景生物-60.65-60.653.33108.69亿10华大智造-52.74-52.743.96315.97 亿11中红医疗-48.32-32.870.7743.02亿 来源：金 ...

证券代码：688298 证券简称：东方生物 公告编号：2025-009 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 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"） 近日取得以下产品的境外医疗器械注册证，相关公告如下： 一、境外医疗器械注册证的具体情况 | 产品名称 | 证书编号 | 预期用途 | 有效期 | | --- | --- | --- | --- | | | | 本产品用于定性检测鼻拭子中新 | | | COVID-19/Flu A&B/RSV/Adeno Ag | | 冠病毒、甲型流感、乙型流感、 | 2025/4/15 | | Combo Rapid Test Cassette (Swab) | 6188440TD01 | 合胞病毒和腺病毒标本，旨在帮 | - | | 新冠/甲乙流/合胞病毒/腺病毒抗原联 | | 助快速鉴别诊断呼吸系统新冠病 | | | 合检测试剂（胶体金法） | | 毒、甲乙型流感、合胞病毒或腺 ...

证券代码：688298 证券简称：东方生物 公告编号：2025-008 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 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，相关公告如下： 三、对上市公司的影响 上述产品在国内外市场取证，丰富了公司产品布局，有利于整体市场拓展。 四、风险提示 上述产品的实际销售业绩取决于产品的实际竞争力和市场销售能力，目前尚 无法预测对公司未来经营业绩的影响，敬请投资者注意投资风险。 特此公告。 浙江东方基因生物制品股份有限公司 董 事 会 一、境内医疗器械注册证的具体情况 | 产品名称 | 证书编号 | 预期用途 | 持证人 | 有效期 | | --- | --- | --- | --- | --- | | 游离/总前列腺特异性 | 国械注准 ...

Core Viewpoint - FS Medical Supplies, LLC has filed a lawsuit against Zhejiang Oriental Gene Biological Products Co., Ltd. and its subsidiary, claiming breach of contract regarding a "no circumvention" clause related to COVID-19 testing kits [2][4]. Group 1: Lawsuit Details - The lawsuit was filed in the U.S. District Court for the Southern District of Texas, with the case number 4:25-CV-1332, and the cause of action is a contract dispute [4][6]. - The plaintiff alleges that the defendants violated the "no circumvention" clause by directly providing COVID-19 testing kits to FS Medical Supplies' customers, resulting in economic losses for the plaintiff [4][5]. - The plaintiff is seeking damages that include a penalty of no less than $1 billion, along with compensatory damages of at least $250 million, and other legal costs [6][7]. Group 2: Company Response and Impact - The company has engaged U.S. legal counsel to analyze the lawsuit's validity and intends to actively respond to the claims, asserting that the plaintiff's breach of contract claims are unfounded [7]. - The company has also initiated legal action against FS Medical Supplies in China, claiming that the framework agreement is invalid due to the plaintiff's lack of medical device operating licenses and false representations [7]. - Currently, the company's operations remain normal, and there are no frozen or restricted assets, indicating that the lawsuit will not impact the company's financial results for 2024, although future impacts remain uncertain [2][7].

证券代码：688298 证券简称：东方生物 公告编号：2025-007 浙江东方基因生物制品股份有限公司 关于有关事项的公告 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。 重要内容提示： "FS Medical Supplies, LLC"认为公司违反合同约定的"禁止规避"条 款，向美国德克萨斯州南区联邦地区法院提起诉讼，目前尚未开庭审理。 上市公司所处的当事人地位：被告。 影响：公司目前生产经营正常，不存在资产被冻结或受限的情况，本案不 会对公司 2024 年度损益产生影响，但目前无法预判对期后损益的影响。 被告1：浙江东方基因生物制品股份有限公司 被告2：美国衡健生物科技有限公司，系被告1美国全资子公司 （五）诉讼机构名称和所在地：美国德克萨斯州南区联邦地区法院 （六）案件主要事由（以下内容参考原告提交的起诉状中的所述信息） 2020年5月，被告1、被告2与原告签订了《FRAMEWORK PURCHASE AGREEMENT》 （《新冠抗体框架采购协议》），约定东方生物作为生产商与子公司美国衡健共 同作为该合同的制造 ...

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]