证券代码：002022 证券简称：科华生物 公告编号：2025-036 债券代码：128124 债券简称：科华转债 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 一、董事会会议召开情况 上海科华生物工程股份有限公司（以下简称"公司"）第十届董事会第十四 次会议（以下简称"本次会议"或"会议"）通知于2025年7月30日以邮件方式送 达全体董事、监事及高级管理人员，会议于2025年7月31日以通讯表决的方式召 开。本次会议应参会董事9人，实际参会董事9人（包含3名独立董事）。本次会议 由公司董事长李明先生主持，会议的召开符合《中华人民共和国公司法》、《上海 科华生物工程股份有限公司章程》和《上海科华生物工程股份有限公司董事会议 事规则》的有关规定。 二、董事会会议审议情况 （一）审议通过《关于聘任公司财务总监的议案》 经公司总裁提名，董事会提名委员会、审计委员会审核，公司董事会同意聘 任臧显峰先生为公司财务总监，任期自本次董事会审议通过之日起至第十届董事 会任期届满之日止。 具体详见公司于同日在《证券时报》、《中国证券报》、《上海证券报》及巨潮 资讯网（htt ...

Core Viewpoint - Kehua Bio (002022.SZ) does not have products or business in the assisted reproduction field, but it offers diagnostic products related to prenatal care [1] Group 1 - The company has diagnostic products in the field of prenatal care, including the Anti-Müllerian Hormone (AMH) assay kit (chemiluminescence method) [1] - The company also provides the Survival Motor Neuron 1 (SMN1) detection kit (PCR-melting curve method) [1]

Group 1 - The company does not have products or business related to assisted reproductive technology [2] - The company and its subsidiaries have diagnostic products in the field of reproductive health, such as the Anti-Müllerian Hormone (AMH) assay kit and the Survival Motor Neuron 1 (SMN1) detection kit [2]

Group 1 - The company’s subsidiary, Xi'an Tianlong, has not applied for the National Medical Products Administration (NMPA) medical device registration certificate for its Chikungunya virus RNA detection kit (fluorescent PCR method) [2] - The detection kit is currently only available as a research reagent and is suitable for testing needs in customs and disease control scenarios [2] - The company will closely monitor market demand and will formulate product registration plans based on actual business needs and development strategies to actively seize related business opportunities [2]

Core Viewpoint - The company, Kehua Bio-engineering, has stated that its subsidiary, Xi'an Tianlong, has not applied for the National Medical Products Administration's medical device registration for its chikungunya virus RNA detection kit, which is currently only available as a research reagent for customs and disease control applications [1] Group 1 - The chikungunya virus RNA detection kit is based on fluorescent PCR technology [1] - The company is monitoring market demand closely and plans to develop a product registration strategy aligned with its business needs and development strategy [1] - The company aims to actively seize related business opportunities in the future [1]

Core Viewpoint - The medical device industry experienced a slight increase of 0.47% on July 28, with a net outflow of funds amounting to 295 million [1] Group 1: Market Performance - A total of 52 stocks in the sector rose, while 68 stocks declined [1] - The top-performing stocks included: - Aidi Te (16.88%) - Kehua Bio (10.01%) - Rejing Bio (6.88%) - Zhengchuan Co. (6.68%) - David Medical (6.55%) [1][1][1] Group 2: Fund Flow - The net capital flow for the top gainers was as follows: - Aidi Te: 106 million - Kehua Bio: 12 million - Rejing Bio: 21 million - Zhengchuan Co.: -14 million (outflow) [1][1][1] - Other notable stocks with positive fund flow included: - David Medical: -6 million (outflow) - Sainuo Medical: 6 million [1][1] Group 3: Declining Stocks - The stocks with the largest declines included: - Aohua Endoscopy (-4.09%) - Tianyi Medical (-2.73%) - Mountain Outside Mountain (-2.53%) - Ruimaite (-2.42%) - Jianfan Bio (-2.32%) [1][1][1] - Additional stocks that saw declines were: - Lude Medical (-2.22%) - Nanwei Medical (-2.14%) - San Nuo Bio (-2.13%) [1][1]

Group 1 - The hepatitis concept sector experienced a short-term surge, with Kewah Bio (002022) hitting the daily limit up [1] - Other companies such as Qianyuan Pharmaceutical (300254), Hendi Pharmaceutical (301211), Da'an Gene (002030), Asia-Pacific Pharmaceutical (002370), and Kangzhi Pharmaceutical (300086) also saw significant increases in their stock prices [1]

Group 1: Overview of Chikungunya Fever - Chikungunya virus is spreading globally, with 119 countries reporting cases and approximately 5.5 million people at risk of infection [1] - In Foshan, Guangdong Province, over 4,000 confirmed cases have been reported, primarily mild cases [1] Group 2: Symptoms and Treatment - Chikungunya fever is characterized by high fever and severe joint pain, particularly affecting small joints [2] - There is currently no specific treatment or widely used vaccine; management is primarily supportive, focusing on symptom relief [3] Group 3: Market Response and Company Involvement - Investors are inquiring about companies with products related to Chikungunya fever, focusing on mosquito repellent products, testing kits, and antipyretic and analgesic medications [4] - Companies like Rainbow Group, Runben Co., and Weigao Medical have reported an increase in sales of mosquito repellent products [5][6] - Pharmaceutical companies such as Renhe Pharmaceutical and Xinhua Pharmaceutical have indicated they offer products for fever and pain relief [7] Group 4: Testing Products - Companies like Kehua Bio, YHLO Biotech, and Shuoshi Bio have developed testing kits for Chikungunya virus [8] - YHLO Biotech has a rapid screening kit for Chikungunya, currently used for research purposes [8] - The market interest in these companies has led to notable stock price increases since the news of the outbreak [8]

| 证券代码：002022 | 证券简称：科华生物 | | --- | --- | | 债券代码：128124 | 公告编号：2025-035 债券简称：科华转债 | 上海科华生物工程股份有限公司 关于产品获得医疗器械注册证的公告 上海科华生物工程股份有限公司董事会 2025年7月26日 近日，上海科华生物工程股份有限公司（以下简称"公司"）收到国家药品 监督管理局颁发的医疗器械注册证（体外诊断试剂）。具体情况如下： | 序号 | 产品名称 | 注册证编号 | 注册证有效期 | 适用范围/预期用途 | | --- | --- | --- | --- | --- | | | 丙型肝炎病 | | 2025年07月24日 | 本质控品配套本公司丙型 肝炎病毒抗体（Anti-HCV） | | 1 | 毒抗体质控 | 国械注准 20253401473 | 至 | 检测试剂盒（化学发光法） | | | 品 | | 2030年07月23日 | 使用，用于丙型肝炎病毒抗 | | | | | | 体检测项目的质量控制。 | 以上新产品医疗器械注册证的取得，丰富了公司产品线，将对公司业务发展 具有正面影响。公司目前尚无法预测上述 ...

科华生物：公司产品丙型肝炎病毒抗体质控品获得医疗器械注册证 智通财经7月25日电，科华生物(002022.SZ)公告称，公司收到国家药品监督管理局颁发的医疗器械注册 证，产品为丙型肝炎病毒抗体质控品，注册证编号为国械注准20253401473，有效期至2030年07月23 日。该产品本质控品配套公司丙型肝炎病毒抗体（Anti-HCV）检测试剂盒（化学发光法）使用，用于 丙型肝炎病毒抗体检测项目的质量控制。新产品的取得将丰富公司产品线，对业务发展具有正面影响。 但公司目前无法预测该产品对未来营业收入的影响，提醒投资者注意投资风险。 ...