立信会计师事务所(特殊普通合伙) 关于浙江东方基因生物制品股份有限公司 2024年年度报告信息披露监管问询函的回复 信会师函字[2025]第 ZF171 号 上海证券交易所: 根据贵所《关于对浙江东方基因生物制品股份有限公司 2024 年年度报告的 信息披露监管问询函》(以下简称"问询函")(上证科创公函【2025】第 0152 号)的要求,立信会计师事务所(特殊普通合伙)(以下简称"会计师"或"我们") 作为浙江东方基因生物制品股份有限公司(以下简称"公司"或"东方生物")2024 年度财务报表审计机构,对问询函中与会计师相关的内容作了认真核查,现回复 如下: 问题 1、关于营业收入。公司主营业务为体外诊断试剂。2024年,公司营 业收入为 8.28 亿元,同比增长 0.95%,归母净利润为-5.29 亿元,同比增亏 33.06%。其中,境外收入 6.05 亿元,同比增长 23.14%;境内收入 2.07 亿元, 同比下滑 35.7%。公司 2024 年产品销量同比减少 16.1%。公司综合毛利率同 比减少 12 个百分点。 请公司:(1)列示 2024 年境内主要销售产品类型、用途、收入金额、收 入占比及 ...

上述证书的取得，进一步完善了公司在国内传染病检测领域的产品系列，丰 富了流式荧光（液态生物芯片）用于消化道等恶性肿瘤的疗效观察、预后判断及 复发检测、治疗监测等领域的配套检测试剂，扩展了流式荧光发光法的应用领域， 有利于国内市场的整体拓展。 三、风险提示 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"） 及子公司上海万子健生物科技有限公司近日取得以下中国医疗器械注册证（体外 诊断试剂），相关证书内容公告如下： | 产品名称 | 证书编号 | 预期用途 | 有效期 | 持证主体 | | --- | --- | --- | --- | --- | | 乙型肝炎病毒表面抗原 | 国械注准 | 本产品用于体外定性检测人全 | 2025/5/29 | | | （HBsAg）检测试剂(胶体金 | | 血/血清/血浆样本中的乙型肝 | -2030/5/2 | 东方生物 | | 法) | 20253401025 | 炎病毒表面抗原（HBsAg） | 8 | | | | | ...

Core Insights - The company has successfully developed a liquid chip platform that addresses a critical technology bottleneck in the in vitro diagnostic (IVD) field, previously dominated by foreign giants [1][2][3] - The liquid chip technology is recognized as a key area for innovation in China's "13th Five-Year" national science and technology plan, highlighting its importance for future diagnostic advancements [2] - The platform has been implemented in several renowned hospitals in Shanghai and the Southwest region, providing reliable diagnostic support for tumor markers and autoimmune diseases [1][7] Technology and Innovation - The liquid chip technology utilizes special fluorescent polymer microspheres and signal analysis, overcoming high technical barriers that have historically limited domestic capabilities [2][3] - The core breakthrough involves the use of quantum dot materials for microsphere encoding, allowing for the analysis of over 100 coding signals and enhancing the capacity to thousands with 3D encoding technology [2][4] - The company has established a comprehensive intellectual property system covering the entire supply chain from raw materials to end instruments and reagents, eliminating reliance on foreign technologies [3][4] Product Development and Market Expansion - The company has launched the Mplex-MA1600, the first dual-function immunoassay analyzer in the industry, integrating flow fluorescence and chemiluminescence technologies for efficient multi-item and rapid single-item testing [4][5] - Since July 2023, the company has received 13 NMPA registration certificates for reagents in various fields, including tumor markers and autoimmune diseases, with plans to expand the range of detectable markers [5][6] - The liquid chip technology is also being applied in animal testing and food safety, with collaborations with several research institutes to develop diagnostic kits for various pathogens in livestock [6][7] Competitive Advantage - The company has achieved a breakthrough in "higher performance and lower cost" compared to international leader Luminex, thanks to its fully controllable domestic platform [1][7] - The new detection system combines quantum dot encoding microspheres with single-laser detection technology, achieving high throughput (120 samples/hour), high sensitivity (pg/mL level), and high accuracy (CV < 5%) [7] - The compact design of the fully automated detection equipment reduces the footprint by approximately 40% and lowers overall detection costs by about 50%, facilitating widespread adoption [7]

Group 1 - The animal vaccine sector increased by 1.35%, ranking fourth among concept sectors, with 13 stocks rising, including Kexing Pharmaceutical, Kanghua Biological, and Dongfang Biological, which rose by 7.40%, 6.06%, and 5.85% respectively [1][2] - The leading stocks in terms of net inflow of main funds include Tiankang Biological with a net inflow of 17.69 million, followed by Dongfang Biological, Dabeinong, and Haizheng Pharmaceutical with net inflows of 17.19 million, 7.87 million, and 5.25 million respectively [2][3] - The main fund inflow rates for Dongfang Biological, Haili Biological, and *ST Xianfeng are 9.15%, 6.15%, and 5.51% respectively [3] Group 2 - The top gainers in the animal vaccine sector include Kexing Pharmaceutical with a rise of 7.40% and Kanghua Biological with a rise of 6.06%, while the biggest losers include Weilan Biological, Jinhai Biological, and Plai Ke, which fell by 1.82%, 1.26%, and 1.08% respectively [1][4] - The overall net outflow of main funds from the animal vaccine sector was 4.75 million, indicating a mixed sentiment among investors [2]

Group 1 - The annual general meeting of Zhejiang Oriental Gene Biological Products Co., Ltd. was held on May 28, 2025, at the company's conference room in Anji County, Huzhou City, Zhejiang Province [2] - All resolutions presented at the meeting were approved without any objections [2] - The meeting was conducted in accordance with the Company Law, Securities Law, and the company's articles of association, with a combination of on-site and online voting [2][3] Group 2 - All current directors (7) and supervisors (3) attended the meeting, along with the company secretary and senior management [3] - The following non-cumulative voting proposals were approved: 2024 Board Work Report, 2024 Supervisory Board Work Report, 2024 Financial Settlement Report, 2024 Annual Profit Distribution Plan, 2024 Annual Report and Summary, 2025 Financial Budget Report, 2025 Director Remuneration Plan, 2025 Supervisor Remuneration Plan, and the proposal to reappoint the auditing firm for 2025 [4][5] - The meeting did not involve any special resolutions, and certain proposals required abstention from related shareholders [6] Group 3 - The meeting was witnessed by lawyers from Guohao Law Firm (Hangzhou), confirming that the meeting's procedures and results were legal and valid [7] - The company will file the meeting resolutions and legal opinions as required [9]

一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 5 月 28 日 （二） 股东大会召开的地点：浙江省湖州市安吉县递铺街道阳光大道东段东方 基因会议室 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： 证券代码：688298 证券简称：东方生物 公告编号：2025-023 浙江东方基因生物制品股份有限公司 2024年年度股东大会决议公告 本公司董事会及全体董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。 重要内容提示： 本次会议是否有被否决议案：无 | 1、出席会议的股东和代理人人数 | 85 | | --- | --- | | 普通股股东人数 | 85 | | 2、出席会议的股东所持有的表决权数量 | 99,235,127 | | 普通股股东所持有表决权数量 | 99,235,127 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 51.3649% | | 例（%） | | | 普通股股东所持有表决权数量占公司表决权数量的比例（%） | 51.3649% | ...

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].