国浩律师（杭州）事务所 关 于 浙江东方基因生物制品股份有限公司 2024 年年度股东大会 法律意见书 地址：杭州市上城区老复兴路白塔公园 B 区 2 号、15 号国浩律师楼 邮编：310008 Grandall Building, No.2＆No.15, Block B, Baita Park, Old Fuxing Road, Hangzhou, Zhejiang 310008, China 电话/Tel: (+86)(571) 8577 5888 传真/Fax: (+86)(571) 8577 5643 电子邮箱/Mail：grandallhz@grandall.com.cn 网址/Website：http://www.grandall.com.cn 二〇二五年五月 国浩律师（杭州）事务所 法律意见书 国浩律师（杭州）事务所 关 于 浙江东方基因生物制品股份有限公司 2024 年年度股东大会 法律意见书 致：浙江东方基因生物制品股份有限公司 国浩律师（杭州）事务所（以下简称"本所"）接受浙江东方基因生物制品 股份有限公司（以下简称"公司"）委托，指派律师出席公司 2024 年年度股东 大会（以下简称"本 ...

Core Insights - The company is strategically positioning itself in the respiratory testing market by leveraging its expertise in infectious disease detection and expanding its product offerings through multi-detection technology and global market channels [1][5] Group 1: Product Development and Recognition - The Healgen triple detection reagent and H5N1 diagnostic reagent have received significant recognition from Emory University, showcasing their superior performance [2] - Healgen's triple detection reagent is the first to obtain the FDA De Novo certification, marking a milestone for Chinese companies in the high-end IVD market [2] - The company has developed a five-in-one detection reagent for COVID-19, influenza A/B, respiratory syncytial virus, and adenovirus, which has received EU IVDR certification [3] Group 2: Global Market Expansion - The company has achieved FDA 510(k) certification for various detection products in the U.S. and multiple IVDR certifications in Europe, indicating a robust product matrix [4] - The company is implementing a dual-channel strategy by promoting both professional and home testing products, significantly expanding its market reach [4] Group 3: Investment and R&D - The company has invested heavily in clinical trials, with costs around $5 million in the U.S. and €200,000 in Europe, which is notable in the industry [5] - The company has obtained 126 certifications for various respiratory pathogens across multiple countries, establishing a comprehensive global testing framework [5]

一、境外医疗器械注册证的具体情况 二、境内医疗器械注册证的具体情况 | | | | | | 本产品用于体外定量检测人 | | | | --- | --- | --- | --- | --- | | | | 体血清中甲胎蛋白（AFP）的 | | | | | 国械注准 | 含量。用于对恶性肿瘤患者 | 2025/5/14 | | | 甲胎蛋白检测试剂盒 | | 进行动态监测以辅助判断疾 | | 上海万子 | | (流式荧光发光法) | 2025340093 | 病进程或治疗效果，不能作 | - | 健生物 | | | 4 | | 2030/5/13 | | | | | 为恶性肿瘤早期诊断或确诊 | | | | | | 的依据，不宜用于普通人群 | | | | | | 的肿瘤筛查。 | | | 证券代码：688298 证券简称：东方生物 公告编号：2025-022 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及获得中国合格评定国家 认可委员会（CNAS）实验室认可证书的公告 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 ...

Core Viewpoint - The animal vaccine sector has shown a significant increase, with a 4.00% rise, ranking third among concept sectors, driven by notable gains in several stocks [1][2]. Group 1: Sector Performance - As of May 20, the animal vaccine concept increased by 4.00%, with 19 stocks rising, including *ST Xianfeng, which hit the daily limit, and others like Kexing Pharmaceutical, Ruipu Biological, and Kanghua Biological, which rose by 15.56%, 8.41%, and 6.70% respectively [1][2]. - The animal vaccine sector was among the top-performing sectors, alongside cultivated diamonds and pet economy, which rose by 4.10% and 4.08% respectively [2]. Group 2: Capital Inflow - The animal vaccine sector saw a net inflow of 67 million yuan, with 13 stocks receiving net inflows, and 6 stocks attracting over 10 million yuan in net inflows [2]. - Jinhe Biological led the net inflow with 36.88 million yuan, followed by Kexing Pharmaceutical, Dabeinong, and Plk, which received net inflows of 15.38 million yuan, 13.79 million yuan, and 13.60 million yuan respectively [2][3]. Group 3: Capital Flow Ratios - Stocks such as *ST Xianfeng, Kexing Pharmaceutical, and KQ Biotech had the highest net inflow ratios, at 14.17%, 6.56%, and 5.52% respectively [3]. - The top stocks in terms of capital inflow included Jinhe Biological with a turnover rate of 18.22% and a daily increase of 4.40%, and Kexing Pharmaceutical with a turnover rate of 3.46% and a daily increase of 15.56% [3][4].

Core Viewpoint - The article discusses the significant legal challenges faced by Dongfang Biological (东方生物), including a lawsuit from American FS Company seeking at least $1 billion in damages, which has led to a notable decline in the company's stock price and raised concerns about its information disclosure practices [2][3][4]. Group 1: Legal Issues - Dongfang Biological's subsidiary, American Hengjian Biotechnology, was sued by American FS Company, with claims exceeding $1 billion [2]. - The lawsuit alleges that Dongfang Biological violated a "no circumvention" clause in a contract related to the supply of COVID-19 antibody testing reagents [3]. - The company has initiated a counter-suit against American FS Company in a Chinese court, with the hearing scheduled for May 15, 2025 [2][4]. Group 2: Financial Performance - Prior to the lawsuit disclosure, Dongfang Biological's stock price dropped over 11% [2]. - The company reported revenues of 32.65 billion yuan and 101.7 billion yuan in 2020 and 2021, respectively, with net profits of 16.77 billion yuan and 49.2 billion yuan [4]. - In 2024, the company faced a revenue of 8.28 billion yuan, a slight increase of 0.95% year-on-year, but incurred a net loss of 5.29 billion yuan [4]. Group 3: Market Strategy and Challenges - Approximately one-third of Dongfang Biological's products are exported to the U.S., and recent tariff issues may impact future growth [6]. - The company has established a localized production base in the U.S. and is focusing on expanding its domestic market presence while maintaining its position in Europe and Asia [6]. - Dongfang Biological plans to mitigate tariff impacts through cost reduction and pricing negotiations with clients [6].

浙江东方基因生物制品股份有限公司 2024 年年度股东大会 证券简称：东方生物 证券代码：688298 浙江东方基因生物制品股份有限公司 2024 年年度股东大会会议资料 2025 年 5 月 28 日 1 浙江东方基因生物制品股份有限公司 2024 年年度股东大会 浙江东方基因生物制品股份有限公司 2024 年年度股东大会会议须知 为维护浙江东方基因生物制品股份有限公司（以下简称"公司"）全体股东 的合法权益，确保股东大会的正常秩序和议事效率，保证股东大会如期、顺利召 开，根据《中华人民共和国公司法》《中华人民共和国证券法》《浙江东方基因 生物制品股份有限公司章程》《浙江东方基因生物制品股份有限公司股东大会议 事规则》等相关规定，特制定本股东大会会议须知。 一、为保证本次股东大会的严肃性和正常秩序，切实维护与会股东（或股东 代表）的合法权益，除出席会议的股东（或股东代表）、公司董事、监事、高级 管理人员、见证律师及董事会邀请的人员外，公司有权依法拒绝其他人员进入会 场。 二、出席会议的股东（或股东代表）须在会议召开前 30 分钟到会议现场办 理签到手续，并按股东大会通知的相关要求，出示自然人股东和法人股东相 ...

最新一期业绩显示，2025年一季报，公司实现营业收入1.92亿元，同比4.94%；净利润-115452483.95 元，同比-71.41%，销售毛利率27.36%。 序号股票简称PE(TTM)PE(静)市净率总市值(元)26东方生物-8.13-8.870.7246.93亿行业平均 49.8445.684.61105.51亿行业中值36.5938.052.4346.93亿1天益医疗-1742.06-2983.951.8622.20亿2澳华内 镜-602.36302.124.8363.48亿3诺唯赞-409.62-484.482.2587.66亿4爱朋医疗-362.84275.654.3729.77亿5博晖 创新-324.04514.213.4647.54亿6硕世生物-131.86-1926.851.1838.57亿7奥精医疗-125.28-183.621.6523.25亿 8睿昂基因-99.99-82.091.4212.94亿9康泰医学-84.67-71.543.0255.73亿10中红医疗-70.88-56.530.9049.26亿 11华大智造-59.73-53.004.11318.43亿 来源：金融界 5 ...

Group 1 - The core viewpoint of the news is that Dongfang Biological has shown a slight increase in stock price and has a low price-to-book ratio, indicating potential investment interest [1] - As of the first quarter of 2025, nine institutions hold shares in Dongfang Biological, with a total holding of 110.96 million shares valued at 2.87 billion yuan [1] - Dongfang Biological specializes in the research, production, and sales of in vitro diagnostic products, covering a full industry chain from raw materials to independent testing laboratories [1] Group 2 - The latest financial results for the first quarter of 2025 show that the company achieved revenue of 192 million yuan, a year-on-year increase of 4.94%, but reported a net loss of approximately 115.45 million yuan, a year-on-year decline of 71.41% [1] - The company's gross profit margin stands at 27.36% [1] - Dongfang Biological has accumulated a total of 639 authorized patents and software copyrights, with 268 domestic and 335 international patents [1]

2025年4月30日，东方生物(688298.SH)发布2025年第一季报。截至2025年4月30日，共有9个机构投资者 披露持有东方生物A股股份，合计持股量达1.11亿股，占东方生物总股本的55.04%。其中，机构投资者 包括安吉福浪莱进出口贸易有限公司、Fangs Holdings Limited Liability Company、安吉涌威创业投资合 伙企业(有限合伙)、中国工商银行股份有限公司-融通健康产业灵活配置混合型证券投资基金、招商银行 股份有限公司-广发价值核心混合型证券投资基金、香港中央结算有限公司、招商银行股份有限公司-南 方中证1000交易型开放式指数证券投资基金、汇添富基金管理股份有限公司-社保基金四二三组合、招 商银行股份有限公司-南方科创板3年定期开放混合型证券投资基金，机构投资者合计持股比例达 55.04%。相较于上一季度，机构持股比例合计下跌了0.60个百分点。 公募基金方面本期较上一季度持股减少的公募基金共计2个，包括融通健康产业灵活配置混合A/B、南 方中证1000ETF，持股减少占比达0.28%。本期较上一季未再披露的公募基金共计55个，主要包括融通 医疗保健行业混合A/ ...

Core Viewpoint - The company is facing significant challenges in its transformation efforts, as evidenced by worsening financial performance despite advancements in global expansion and R&D initiatives [1][4][7]. Financial Performance - In 2024, the company's total revenue was 828 million yuan, a year-on-year increase of 0.95% [1]. - Gross profit decreased to 263 million yuan, reflecting a decline of 25.5% compared to the previous year [1]. - The net profit attributable to shareholders was a loss of 529 million yuan, worsening by 33.06% from a loss of 398 million yuan in 2023 [1][7]. - The company's net cash flow from operations was -348 million yuan, although this represented a 78.8% improvement year-on-year, it remained negative [7]. - Total assets decreased by 10.0% to 8.095 billion yuan, and net assets attributable to shareholders fell by 10.6% to 6.645 billion yuan [7]. Global Expansion Efforts - The company accelerated its global expansion in 2024, establishing production and research bases in various locations including the U.S. and several cities in China [4]. - Acquisitions of companies such as Confirm in the U.S. and others in China were made to enhance its market presence in North America, Europe, and Southeast Asia [4]. - A large POCT production base was established in the U.S., and the company received CLIA certification, marking the official launch of its laboratory business in the U.S. [4]. R&D Investments - The company made significant strides in R&D, including the establishment of a North American R&D center and a digital innovation headquarters in Shanghai [4]. - Important certifications were obtained for products in various fields, including emergency use authorization from the FDA and IVDR registration from the EU [4]. - Despite increased R&D investments, the company reported a non-recurring net profit loss of 571 million yuan, which expanded by 32.60% year-on-year, indicating that R&D efforts have not yet translated into profit growth [5][6]. Challenges Ahead - The company’s financial deterioration and cash flow pressures highlight the need for improved commercialization of its products and effective management of its financial health [7]. - The ongoing losses and lack of immediate economic benefits from global expansion and R&D efforts pose significant challenges for the company's future profitability [1][4][7].