浙江东方基因生物制品股份有限公司 2025 年第二次临时股东会 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 2025 年第二次临时股东会会议资料 2025 年 11 月 1 浙江东方基因生物制品股份有限公司 2025 年第二次临时股东会 浙江东方基因生物制品股份有限公司 2025 年第二次临时股东会会议须知 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，确保股东会的正常秩序和议事效率，保证股东会如期、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》《上市公司股东会规 则》《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 有限公司股东会议事规则》等相关规定，特制定本股东会会议须知。 一、为保证本次股东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），列席会议的公司董事、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，并按股东会通知的相关要求，出示 ...

Core Viewpoint - The announcement highlights the recent achievements of Oriental Bio in obtaining multiple medical device registrations for its products, enhancing its product portfolio and international market presence [1][2]. Group 1: Product Registrations - Oriental Bio's subsidiary, Shanghai Wanzijian Bio, and Healgen Scientific LLC have recently obtained medical device registrations in China, Australia, and Singapore [1]. - The domestic registrations include the Gastrin-17 test kit and the N-terminal pro B-type natriuretic peptide test kit, which assist in diagnosing atrophic gastritis and heart failure, respectively [1]. - The international registration includes Healgen's rapid test for COVID-19 and Influenza A/B antigens, suitable for individuals aged 14 and above, to be conducted within 7 days of symptom onset [1]. Group 2: Technological Advancements - The respiratory triple test kit has a sensitivity of over 90% and specificity of over 99%, marking it as a core component of Oriental Bio's global respiratory detection product matrix [1]. - Research from Emory University indicates that Healgen's triple test kit demonstrates 2 to 20 times higher sensitivity compared to other LFA products used in similar studies, with detection limits approaching molecular testing levels [1]. Group 3: Regulatory Milestones - The triple test kit is the first product to receive FDA De Novo certification in the U.S. and is also the first over-the-counter (OTC) testing product to achieve this certification [2]. - This product does not require emergency use authorization and can be self-administered by non-professional users at home [2]. - The FDA has created a new regulatory classification for this test kit, which has been recognized as one of the "Top 5 Breakthroughs in U.S. Medicine for 2024" by ABC News [2]. Group 4: Market Penetration - Healgen's triple test kit has successfully entered over 13,000 stores under Walmart, CVS, and Walgreens, as well as on Amazon and other professional channels [3]. - The product has received high praise from customers, contributing to steady market sales growth [3].

Core Points - The company has elected Chen Junze as an independent director and adjusted the specialized committees within the board [1][2][3] - Chen Junze's qualifications and independence have been verified and approved by the Shanghai Stock Exchange [2][3] - The company has recently obtained medical device registration certificates for several products, enhancing its product offerings [3][5] Group 1: Board Changes - Independent director Li Bo resigned due to personal work reasons [1] - Chen Junze has been nominated as an independent director candidate and will serve on various committees upon shareholder approval [1][2] - The specialized committee members have been updated, with Chen Junze taking key roles [4] Group 2: Medical Device Registration - The company’s subsidiary has received medical device registration certificates in China, Australia, and Singapore [3][5] - The new products will expand the company's market reach and enhance its product variety [5] Group 3: Upcoming Shareholder Meeting - The second extraordinary general meeting of shareholders is scheduled for November 20, 2025 [6][10] - The meeting will utilize both on-site and online voting methods [6][8] - Shareholders must register in advance and provide necessary documentation to attend [9][10]

Group 1: Medical Device Registration - The company announced that its subsidiary, Shanghai Wanzijian Biotechnology Co., Ltd., and Healgen Scientific LLC have recently obtained medical device registration certificates in China, Australia, and Singapore [1] - The registration of these products enhances the variety of the company's flow cytometry technology platform and expands the market for respiratory triple detection products internationally [1] Group 2: Board of Directors Changes - The company reported the resignation of independent director Li Bo due to personal work reasons and has proposed Chen Junze as a candidate for the independent director position [4][5] - Chen Junze's qualifications and independence have been verified and will be submitted for shareholder approval [5][6] Group 3: Shareholder Meeting Notification - The company will hold its second extraordinary general meeting of 2025 on November 20, 2025, with both on-site and online voting options available [7][9] - The meeting will discuss various proposals that have been approved by the board and disclosed in previous announcements [12]

Core Points - The company, Dongfang Biological, announced on the evening of November 4 that its board of directors has agreed to nominate Mr. Chen Junze as a candidate for the independent director of the third board of directors [1] Summary by Category - **Company Announcement** - Dongfang Biological's board has approved the nomination of Mr. Chen Junze as an independent director candidate for the third board [1]

Group 1 - Jilin Chemical Fiber's controlling shareholder, Jilin Chemical Fiber Group, completed a capital increase and share expansion, raising registered capital from 809 million to 2.508 billion yuan, with the State-owned Assets Supervision and Administration Commission's shareholding increasing to 67.09% [2] - Lepu Medical's subsidiary received NMPA registration approval for a rechargeable implantable deep brain stimulation system, aimed at assisting patients with advanced Parkinson's disease [3] - Zhenai Home announced a potential change in control, leading to a stock suspension starting November 5, 2025, due to ongoing negotiations [4] Group 2 - Yutong Bus reported a 5.62% year-on-year decline in October sales, with total sales for the year increasing by 5.87% [11] - Qianli Technology's October sales surged by 111.44%, with significant growth in both new energy and other vehicle categories [12] - Sike Xide's major shareholder completed a reduction of 825,195 shares, raising a total of approximately 22.84 million yuan [14] Group 3 - Far East Holdings' subsidiary secured contracts exceeding 1 billion yuan in October, which is expected to positively impact future performance [24] - Quan Yang Quan's subsidiary won a 1.48 billion yuan project for airline drinking water supply, anticipated to enhance future earnings [25] - Guoji Automobile's subsidiary won an 8.09 billion yuan project for a lightweight component factory, expected to positively influence operational performance [26]

Group 1 - Jinguang Electric won a bid for a State Grid procurement project with a total amount of 21.7976 million yuan, accounting for approximately 2.93% of the company's expected revenue for 2024 [1] - Shen Gong Co. plans to reduce its shareholding by up to 2%, equating to 340.61 million shares [2] - Guomai Culture received a government subsidy of 3.78 million yuan, representing 24.90% of its audited net profit for 2024 [2] Group 2 - Guomai Culture focuses on the development and provision of digital content operation platforms [3] - Shentong Technology's two directors plan to collectively reduce their shareholding by no more than 0.0473% [4] - Ruihua Tai intends to reduce its shareholding by up to 1%, amounting to 1.8 million shares [5] Group 3 - Guoji Automobile's wholly-owned subsidiary won a total contract project worth 809 million yuan [7] - Changcheng Technology's stock is expected to remain suspended due to potential changes in control [9] - Huabei Pharmaceutical's subsidiary received approval for a chemical raw material drug listing application [11] Group 4 - Fuyao Glass has changed its legal representative to Cao Hui [13] - Huaxi Biological plans to reduce its shareholding by up to 2%, totaling 9.6336 million shares [14] - Hopu Co. signed a procurement contract for a storage system worth 500 million yuan [15] Group 5 - ST Songfa's subsidiary plans to invest 458 million yuan in a mooring dock project [18] - Zhonghong Medical's subsidiary is expected to be selected for several centralized procurement projects [19] - Huakai Yibai's vice chairman plans to increase his shareholding by no less than 30 million yuan [20] Group 6 - Haichuang Pharmaceutical completed the first participant enrollment for a clinical trial of a drug for metabolic-associated fatty liver disease [21] - Dongfang Biological's subsidiary obtained medical device product registration certificates for multiple products [22] - Lepu Medical's rechargeable implantable deep brain stimulation system received NMPA registration approval [23] Group 7 - Changyuan Power's power generation in October decreased by 32.25% year-on-year [24] - Jinshi Yaya's diclofenac sodium sustained-release tablets passed the consistency evaluation for generic drugs [26] - Yutong Bus sold 3,040 buses in October, a decrease of 5.62% year-on-year [27] Group 8 - Far East Co. signed contracts worth 1.062 billion yuan in October [28] - Tianya Pharmaceutical's subsidiary passed the consistency evaluation for a drug [29] - Yuheng Pharmaceutical plans to resolve a debt dispute through a share transfer agreement [30] Group 9 - Hailanxin's subsidiary won a bid for a marine observation network project worth 1.097 billion yuan [31] - Huasheng Lithium plans to reduce its shareholding by up to 0.37% [33] - Maike Biological obtained product registration certificates for five new in vitro diagnostic products [34] Group 10 - Huayuan New Materials signed a strategic cooperation agreement with Taiblue New Energy [37] - Greebo's actual controller and some directors plan to collectively increase their shareholding by no less than 11.5 million yuan [39] - Yian Technology received a government subsidy of 1.1643 million yuan [41] Group 11 - Kangtai Biological's quadrivalent influenza virus vaccine has commenced Phase I clinical trials [43] - Spring Airlines received a commitment letter for a stock repurchase loan of up to 450 million yuan [45] - Foton Motor sold 8,006 new energy vehicles in October, a year-on-year increase of 98.83% [46] Group 12 - Greebo plans to transfer 100% equity of its subsidiary for 280 million yuan [48] - Siwei Liekong's director is under investigation [49] - Dingyang Technology launched a new generation of multi-channel microwave signal generator products [50] Group 13 - Jiangling Motors reported a year-on-year increase of 8.06% in vehicle sales for October [51] - Shengyi Technology plans to reduce its shareholding by up to 1.03% [52] - Dongshan Precision completed the acquisition of 100% equity of France's GMD Group for approximately 814 million yuan [53] Group 14 - Tianyang Technology plans to acquire 7.5% of Baoland's shares for 155 million yuan [54] - Alter plans to establish a joint venture company with a total investment of 672 million yuan [54] - Changchun High-tech's clinical trial application for a drug was approved [55] Group 15 - Beibu Gulf Port's cargo throughput in October increased by 22.73% year-on-year [56] - ST Zhangjiajie was ruled by the court to undergo reorganization [57] - Teda Co.'s subsidiary was selected as a supplier for an energy project in Indonesia [58]

Core Insights - Oriental Bio (688298.SH) announced that its subsidiary, Shanghai Wanzijian Biotechnology Co., Ltd., along with American Hengjian, has recently obtained medical device product registration certificates in China, Australia, and Singapore [1] Domestic Medical Device Registration - Product Name: Gastrin 17 Test Kit (Flow Cytometry Method); Certificate Number: Hu Xie Zhu Zhun 20252400429; Intended Use: For in vitro quantitative detection of Gastrin 17 (G-17) levels in human serum, primarily for assisting in the diagnosis of atrophic gastritis [1] - Product Name: N-terminal Pro B-type Natriuretic Peptide Test Kit (Magnetic Particle Chemiluminescence Method); Certificate Number: Hu Xie Zhu Zhun 20252400426; Intended Use: For in vitro quantitative detection of N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in human serum and plasma samples, primarily for assisting in the diagnosis of heart failure [1] International Medical Device Registration - Product Name: Healgen Rapid Test for COVID-19/Influenza A/B Antigen (Self-test); Certificate Number: DV-2024-MC24333-1; Intended Use: A lateral flow immunochromatographic test for qualitative detection and differentiation of Influenza A virus, Influenza B virus nucleoprotein antigens, and SARS-CoV-2 nucleocapsid antigens. This test is suitable for individuals aged 14 and above, requiring self-collected anterior nasal swab samples for testing. Specific testing conditions: SARS-CoV-2 infection must be tested within 7 days of symptom onset, while Influenza A and B infections must be tested within 4 days of symptom onset [1][2]

Core Insights - Oriental Bio (688298.SH) announced that its subsidiary, Shanghai Wanzijian Biotechnology Co., Ltd., along with American Hengjian, has recently obtained medical device product registration certificates in China, Australia, and Singapore [1] Domestic Medical Device Registration - Product Name: Gastrin 17 Test Kit (Flow Cytometry Method); Certificate Number: Hu Xie Zhu Zheng 20252400429; Intended Use: For in vitro quantitative detection of gastrin 17 (G-17) levels in human serum, primarily used for the auxiliary diagnosis of atrophic gastritis [1] - Product Name: N-terminal Pro B-type Natriuretic Peptide Test Kit (Magnetic Particle Chemiluminescence Method); Certificate Number: Hu Xie Zhu Zheng 20252400426; Intended Use: For in vitro quantitative detection of N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in human serum and plasma samples, primarily used for the auxiliary diagnosis of heart failure [1] International Medical Device Registration - Product Name: Healgen Rapid Test for COVID-19/Influenza A/B Antigen (Self-test); Certificate Number: DV-2024-MC24333-1; Intended Use: A lateral flow immunochromatographic test for qualitative detection and differentiation of Influenza A virus, Influenza B virus nucleoprotein antigens, and SARS-CoV-2 nucleocapsid antigens. This test is suitable for individuals aged 14 and above and requires self-collected anterior nasal swab samples for testing. Specific testing conditions: SARS-CoV-2 infection must be tested within 7 days of symptom onset, and Influenza A and B infections must be tested within 4 days of symptom onset [1][2]

根据《中华人民共和国公司法》（以下简称"《公司法》"）、《中华人民共和国 证券法》《上市公司独立董事管理办法》《上海证券交易所科创板股票上市规则》 以及《公司章程》等法律、法规、规范性文件的规定。浙江东方基因生物制品股 份有限公司（以下简称"公司"）第三届董事会提名委员会对独立董事候选人陈 军泽先生的任职资格进行审核并发表审核意见如下： 提名委员会对公司第三届董事会独立董事候选人陈军泽先生的个人履历等 相关背景进行资格审查，认为该独立董事候选人教育背景、专业能力、工作经历 和职业素养等方面符合拟担任职务的任职要求，具备履行独立董事职责的任职资 格。 浙江东方基因生物制品股份有限公司 关于公司第三届董事会独立董事候选人的审核意见 董事会提名委员会同意提名陈军泽先生为为公司第三届董事会独立董事候 选人。 浙江东方基因生物制品股份有限公司 董事会提名委员会 截至目前，陈军泽先生未持有公司股份，与公司控股股东、持有公司 5%以 上股份的股东、公司董事、高级管理人员不存在关联关系。陈军泽先生不存在《公 司法》规定的不得担任公司独立董事的情形，不存在被中国证监会确定为市场禁 入者且尚在禁入期的情形，未受过中国证监会及其他 ...