Core Viewpoint - The achievement of FDA's first DeNovo marketing authorization for OTC respiratory triple test kits by the subsidiary, American Hengjian Biotechnology, marks a milestone in the company's development history [1][3]. Group 1: FDA Authorization and Product Details - American Hengjian received its first OTC flu test kit marketing authorization through traditional pre-market review on October 8, eliminating reliance on emergency use authorization [1]. - The newly authorized product ranks among the top in sensitivity and specificity compared to other OTC flu and COVID-19 test kits that were launched under emergency use authorization [1]. - The FDA's announcement highlighted that this is the first OTC flu and COVID-19 combined home test kit authorized without emergency use, establishing a new regulatory category for similar devices [2]. Group 2: Company Background and Achievements - American Hengjian, a subsidiary of Oriental Bio, is located in Houston, Texas, and focuses on the research, development, production, and sales of diagnostic reagents and instruments for infectious diseases and tumor markers [2]. - The company has made significant progress in respiratory test reagents and instruments, achieving FDA authorization for various products, including the flu and COVID-19 triple test kit [2]. - Both Oriental Bio and American Hengjian have large production bases and automated assembly lines in China and Texas, with a daily production capacity exceeding 10 million tests in both locations [2]. Group 3: Team and R&D Efforts - The company emphasizes the recruitment and training of high-tech talent to build a first-class team dedicated to addressing global respiratory and COVID-19 outbreaks [3]. - The achievement of the FDA DeNovo certificate for the COVID-19/flu triple test reflects the collective efforts of the company's teams in the U.S. and China, showcasing their commitment to high-quality and reliable diagnostic reagents [3].

证券代码：688298 证券简称：东方生物 公告编号：2024-063 浙江东方基因生物制品股份有限公司 关于召开 2024 年第三季度业绩说明会的公告 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、准确性和完整性承担法律责任。 重要内容提示： 会议召开时间：2024 年 11 月 13 日(星期三)上午 11:00-12:00 会 议 召 开 地 点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2024 年 11 月 06 日(星期三)至 11 月 12 日(星期二)16:00 前 登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 zqb@orientgene.com 进行提问。公司将在说明会上对投资者普遍关注的问题进 行回答。 浙江东方基因生物制品股份有限公司（以下简称"公司"）已于 2024 年 10 月 31 日发布公司 2024 年第三季度报告，为便于广大投资者更全面深入地了解公 司 2024 年 ...

Financial Performance - Revenue for Q3 2024 reached ¥239,378,629.93, an increase of 58.92% compared to the same period last year[2] - Net profit attributable to shareholders was -¥110,548,767.87, a decrease of 3.13% year-on-year[2] - Basic earnings per share for the year-to-date were -¥1.32, a decrease of 267.98% compared to the previous year[3] - The company experienced a 262.17% decrease in net profit attributable to shareholders from the beginning of the year to the reporting period[6] - The net profit for the third quarter of 2024 was -274,227,549.60 RMB, compared to -67,266,359.19 RMB in the same period of 2023, indicating a significant increase in losses[19] - Operating profit for the third quarter was -282,546,252.62 RMB, a decline from -44,437,855.43 RMB year-over-year[19] - The company reported a total comprehensive loss of -291,781,782.68 RMB for the third quarter, compared to -42,388,332.53 RMB in the same quarter of 2023[20] Assets and Liabilities - Total assets at the end of the reporting period were ¥8,234,404,013.88, down 8.47% from the end of the previous year[3] - The company's total assets decreased to ¥8,234,404,013.88 from ¥8,995,951,150.74[17] - The total liabilities decreased to ¥1,183,176,692.28 from ¥1,446,223,002.71, indicating improved financial health[16] - The company's equity attributable to shareholders was ¥6,880,382,859.03, down 7.47% from the previous year[3] - The company's equity attributable to shareholders decreased to ¥6,880,382,859.03 from ¥7,436,071,401.35, reflecting changes in retained earnings[17] - Short-term borrowings decreased to ¥186,735,657.38 from ¥198,221,896.67, showing a reduction in reliance on debt[16] Cash Flow - Cash flow from operating activities for the year-to-date increased by 77.33% compared to the previous year[7] - The cash flow from operating activities showed a net outflow of -367,152,854.58 RMB, an improvement from -1,619,675,103.24 RMB in the previous year[21] - The company reported a financial expense of -¥45,920,433.50, a significant improvement from -¥252,109,103.42 in the previous year, indicating better financial management[18] - The net cash flow from financing activities was -374,987,236.57, a significant decrease compared to 35,322,755.53 in the previous period[22] - Cash and cash equivalents at the end of the period totaled 1,942,768,528.39, down from 4,844,939,391.44 at the beginning of the period[22] - The net decrease in cash and cash equivalents was -985,834,813.78, compared to -1,711,620,452.84 in the previous period[22] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 10[8] - The company’s major shareholders include Anji Fulanglai Import and Export Trade Co., Ltd., holding 39.31 million shares, representing 19.50% of the total shares[10] - The top ten unrestricted shareholders collectively hold a significant portion of the company's shares, with the largest shareholder controlling 39.31 million shares[10] Research and Development - R&D expenses totaled ¥63,579,055.71, accounting for 26.56% of revenue, a decrease of 16.19% compared to the previous year[3] - Research and development expenses rose to ¥209,881,229.54, compared to ¥188,135,533.21 in the previous year, indicating a focus on innovation[18] Market and Product Development - The company achieved FDA De Novo certification for its Healgen Rapid Check COVID-19/flu A&B Antigen Test on October 7, 2024, marking it as the first OTC testing product to receive this certification in the U.S.[13] - The company has established a strategic focus on expanding its market presence in the U.S. for respiratory testing products[13] - The company plans to continue monitoring the market demand for its newly certified products in the U.S. and actively promote sales[13] Share Buyback and Financial Management - The company completed a share buyback program, repurchasing 8.4036 million shares, which is 4.17% of the total share capital, with a total expenditure of approximately RMB 277 million[13] - The company’s share buyback was approved with a budget of between RMB 250 million and RMB 300 million, aimed at employee stock ownership plans or equity incentives[13] Other Financial Metrics - The company reported a total of ¥32,035,741.30 in non-recurring gains and losses for the current period[5] - Total operating revenue for the first three quarters of 2024 reached ¥657,613,863.02, a slight increase from ¥652,171,856.12 in the same period of 2023[18] - Total operating costs increased significantly to ¥1,015,757,409.45 from ¥718,719,790.87 year-on-year[18] - The company reported an increase in accounts receivable, with notes receivable rising to RMB 1.80 million from RMB 1.57 million, an increase of 14.0%[14] - Accounts receivable increased to ¥271,051,469.49 from ¥206,163,074.65, reflecting a growing customer base[15] - Inventory levels rose to ¥427,260,228.20, up from ¥346,775,187.97, suggesting increased production or stockpiling[15] - Interest income decreased to 83,735,447.92 RMB from 158,298,097.02 RMB year-over-year, reflecting a decline of approximately 47%[19] - The company reported a total of 4,996,672.21 RMB in other income, down from 8,465,436.48 RMB in the previous year, indicating a decrease of about 41%[19] - The company distributed dividends and interest payments totaling 10,939,543.43, down from 390,641,397.99 in the previous period[22] Accounting Changes - The company has adopted new accounting standards starting from 2024, which may affect the financial statements[22]

证券代码：688298 证券简称：东方生物 公告编号：2024-061 浙江东方基因生物制品股份有限公司 对外投资公告 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： 投资标的名称：东方基因全球数字化研发创新总部项目（以下简称"本 项目"） 投资金额：项目总投资 15 亿元，固定资产投资 12 亿元 相关风险提示： 1、本项目的投资和实施，以合法取得本项目选址用地，以及完成各项建设 许可/备案/批复等合法手续，作为本项目实施的前置条件，具有一定的不确定性。 2、项目建设进程、运营能力和预期经营效益存在一定的不确定性。 本议案无需提交股东大会审议，本项目投资不构成关联交易，不构成《上市 公司重大资产重组管理办法》《科创板上市公司重大资产重组特别规定》等规定 的重大资产重组。 一、对外投资概述 （一）对外投资的基本情况 浙江东方基因生物制品股份有限公司（以下简称"东方生物"、"东方基因"、 "公司"）下属全资子公司上海万山水生物科技有限公司（以下简称"上海万山 水"、"乙方"）作为"东方基因全球数字化研发创新总 ...

浙江东方基因生物制品股份有限公司 关于郑煜梓女士不再担任公司副总经理的公告 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。 证券代码：688298 证券简称：东方生物 公告编号：2024-059 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 10 月 29 日召开第三届董事会第十次会议，审议通过了《关于郑煜梓女士不再担任公 司副总经理的议案》：因公司业务调整原因，郑煜梓女士不再担任公司副总经理 职务，任期至本次董事会决议通过之日止，截至本公告披露日，郑煜梓女士未持 有公司股份。 浙江东方基因生物制品股份有限公司 董 事 会 2024 年 10 月 31 日 上述事项不会对公司正常的生产经营管理活动产生影响，公司对郑煜梓女士 在公司任职期间的工作表示感谢。 特此公告。 ...

证券代码：688298 证券简称：东方生物 公告编号：2024-062 浙江东方基因生物制品股份有限公司 第三届监事会第九次会议决议公告 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 九次会议于 2024 年 10 月 20 日以电子邮件的形式发出会议通知，于 2024 年 10 月 29 日下午 14:00 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。 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《2024 年第三季度报告》。 特此公告。 表决结果：本议案有效表决票 3 票，3 票同意，0 票反对，0 票弃权。 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《关于自愿披露购买资产的公告》。 2、审议通过《关于对外投资的议案》 表决结果：本议案有效 ...

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： 证券代码：688298 证券简称：东方生物 公告编号：2024-060 浙江东方基因生物制品股份有限公司 关于自愿披露购买资产的公告 浙江东方基因生物制品股份有限公司（以下简称"东方生物""公司"） 通过境外全资控股公司 Healgen Holding Inc.（以下简称"衡健美国控股"） 拟以 2090 万美元的对价向 Wellcom Investment LLC（以下简称"Wellcom"） 购买位于 330 Barker Cypress Rd and 330 Cypress Run, Houston Harris County, TX, 77094 的 ParkView 办公楼（以下简称"标的资产或标的房产"）。 本议案无需提交股东大会审议。本次购买资产不构成关联交易，不构成 《上市公司重大资产重组管理办法》《科创板上市公司重大资产重组特别规定》 等规定的重大资产重组。 相关风险提示：本次购买资产的实施，以依法取得中国境外投资项目所 有有权审批机构备案审 ...

| 产品名称 | 证书 | 预期 | 授权 | | --- | --- | --- | --- | | | 类型 | 用途 | 日期 | | Healgen Rapid Check COVID-19/flu A&B Antigen Test | FDA De Novo | 本产品应用横向流动免疫层析法，适 用于有呼吸道感染体征和症状的个体 | 2024/10/07 | | | | 的前鼻拭子样本中抗原检测，在约 15 | | | Healgen新冠、甲乙流抗原快速联合 检测试剂 | | 分钟内快速定性、鉴别检测新型冠状 | | | | | 病毒或甲/乙型流感病毒感染，获准可 | | | | | 由非专业用户家庭自测使用。 | | 证券代码：688298 证券简称：东方生物 公告编号：2024-058 浙江东方基因生物制品股份有限公司 关于自愿披露呼吸道三联检产品 取得美国FDA De Novo 认证的公告 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（简称"公司"）全资子公司美国衡健 生 ...

证券代码：688298 证券简称：东方生物 公告编号：2024-057 浙江东方基因生物制品股份有限公司 关于股份回购实施结果暨股份变动的公告 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、准确性和完整性承担法律责任。。 重要内容提示： | 回购方案首次披露日 | 2024/2/8，由实际控制人方剑秋先生、方炳良先生、 | | --- | --- | | | 方效良先生提议 | | 回购方案实施期限 | 2024/2/7~2025/2/6 | | 预计回购金额 | 万元~30,000 万元 25,000 | | 回购价格上限 | 39.33 元/股 | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | □用于转换公司可转债 | | | □为维护公司价值及股东权益 | | 实际回购股数 | 840.36 万股 | | 实际回购股数占总股本比例 | 4.17% | | 实际回购金额 | 亿元 2.77 | | 实际回购价格区间 | 27.26 元/股~34.50 元/股 | 一、 回购审批情况和回购方案内容 二、 回购实施情况 （一 ...

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 年第二次临时股东大会 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 2024 年第二次临时股东大会 法律意见书 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 二〇二四年九月 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 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年第二次临 时 ...