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。 ...

Policy Developments - The National Health Commission issued a work plan for the integration of medical and elderly care services, promoting the establishment of national demonstration counties and institutions [2] - The criteria for creating demonstration institutions include operating for over 5 years, a bed occupancy rate of at least 65% in the last 2 years, and over 65% of residents being elderly individuals with disabilities or dementia [2] - The plan emphasizes comprehensive health assessments for the elderly, early intervention for age-related diseases, and the use of traditional Chinese medicine and information technology to enhance service quality [2] Drug and Device Approvals - Humanwell Healthcare announced that its subsidiary received a drug registration certificate for the transdermal patch for treating mild to moderate Alzheimer's disease, with a total R&D investment of approximately RMB 19 million [4] - Kehua Bio received medical device registration certificates for two nucleic acid testing kits, valid until July 16, 2030 [5] Financial Reports - Wohua Pharmaceutical reported a 303.16% year-on-year increase in net profit for the first half of the year, with revenue of RMB 425 million, a 7.64% increase [7] Capital Market Activities - Xiangsheng Medical signed an agreement with the Gates Foundation for the joint development and promotion of innovative obstetric and breast ultrasound screening devices, receiving project funding of USD 2.1 million [9] - Sanofi announced a deal to acquire Vicebio for up to USD 1.6 billion, including an upfront payment of USD 1.15 billion and milestone payments of USD 450 million [11] Industry Developments - The National Medical Insurance Administration reported that from January to June 2025, there were 200 million instances of personal account pooling in employee medical insurance, amounting to RMB 26.177 billion [13]

近日，上海科华生物工程股份有限公司（以下简称"公司"）控股子公司苏 州天隆生物科技有限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： | 证券代码：002022 | 证券简称：科华生物 | | | --- | --- | --- | | 债券代码：128124 | 债券简称：科华转债 | 公告编号：2025-034 | 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 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。 | 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 | | --- | --- | --- | --- | --- | | 1 | 呼吸道合胞病毒 核酸检测试剂盒 | 国械注准 | 2025年07月17日 至 | 本试剂盒适用于体 外定性检测人口咽 | | | | 20253401379 | | 拭子样本中呼吸道 | | | （荧光PCR法） | | 2030年07月16日 | 合胞病毒核酸。 | | 2 | 呼吸道腺病毒 | 国械注准 | 2025年07月17日 | 本 ...

Core Viewpoint - The company announces the payment of the fifth-year interest for its convertible bonds, "Kehua Convertible Bonds," scheduled for July 28, 2025, with a face value interest payment of 15.00 RMB per 10 bonds [1][2][4]. Summary by Sections Basic Information of "Kehua Convertible Bonds" - The fifth-year interest payment period is from July 28, 2024, to July 27, 2025, with a coupon rate of 1.50% [2][4]. - The total number of convertible bonds issued is 7.38 million, with a face value of 1,000 RMB each [1][2]. Interest Payment Calculation - The annual interest is calculated using the formula: I = B × i, where I is the annual interest amount, B is the total face value of the bonds held, and i is the coupon rate for the year [2][3]. - The interest payment method is annual, with the first interest payment starting from the bond issuance date [2][3]. Payment Dates and Taxation - The bondholder registration date for interest payment is July 25, 2025, and the interest will be paid within five trading days after the payment date [3][4]. - Individual bondholders are subject to a 20% withholding tax on interest income, which will be deducted by the payment agency [4][5]. Payment Method - The company will entrust China Securities Depository and Clearing Corporation Limited (Shenzhen Branch) to handle the interest payment, which will be distributed to the designated securities firms or recognized institutions [5][6]. Tax Exemption for Non-Resident Enterprises - Non-resident enterprises (including QFII and RQFII) are temporarily exempt from corporate income tax on the interest earned from these bonds, effective from November 7, 2021, until 2025 [6].

| 证券代码：002022 | 证券简称：科华生物 | | | --- | --- | --- | | 债券代码：128124 | 债券简称：科华转债 | 公告编号：2025-033 | 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。 特别提示： 1、"科华转债"将于 2025 年 7 月 28 日按面值支付第五年利息，每 10 张"科 华转债"（面值 1,000 元）利息为 15.00 元（含税）； 2、债权登记日：2025 年 7 月 25 日； 上海科华生物工程股份有限公司 关于可转换公司债券 2025 年付息公告 3、除息日：2025 年 7 月 28 日； 4、付息日：2025 年 7 月 28 日； 5、"科华转债"票面利率：第一年 0.30%、第二年 0.50%、第三年 0.80%、 第四年 1.20%、第五年 1.50%、第六年 2.00%。 6、"科华转债"本次付息的债权登记日为 2025 年 7 月 25 日，凡在 2025 年 7 月 25 日（含）前买入并持有本期债券的投资者享有本次派发的利息；2025 年 7 月 25 日卖出本期债券 ...

[Estimated Performance for the Current Period](index=1&type=section&id=Estimated%20Performance%20for%20the%20Current%20Period) The company projects a net loss for H1 2025, ranging from CNY 120 million to CNY 170 million, significantly wider than the prior year, with basic EPS also in deficit Estimated Financial Performance | Item | Current Reporting Period (Jan 1 - Jun 30, 2025) | Prior Year Period | | :--- | :--- | :--- | | **Net Profit Attributable to Shareholders of Listed Company** | Loss: CNY 120 million – CNY 170 million | Loss: CNY 52.4641 million | | **Net Profit After Deducting Non-Recurring Gains and Losses** | Loss: CNY 130 million – CNY 180 million | Loss: CNY 74.5405 million | | **Basic Earnings Per Share** | Loss: CNY 0.2333/share – CNY 0.3305/share | Loss: CNY 0.1035/share | [Communication with Accounting Firm](index=1&type=section&id=Communication%20with%20Accounting%20Firm) This performance forecast has not been audited by a certified public accountant - This performance forecast represents preliminary estimates by the company's finance department and has not been audited by a certified public accountant[2](index=2&type=chunk) [Explanation of Performance Changes](index=1&type=section&id=Explanation%20of%20Performance%20Changes) The company's year-on-year performance decline is primarily due to intensified market competition from policy changes impacting revenue and gross profit, and asset impairment provisions made under prudence principles, despite maintaining R&D and marketing investments [Market Competition and Operational Impact](index=1&type=section&id=Market%20Competition%20and%20Operational%20Impact) Intensified market competition from industry-wide procurement, DRG implementation, and testing price adjustments led to declines in product demand, pricing, revenue, and gross profit, yet the company maintained R&D and marketing investments - Policy reforms including centralized procurement, DRG implementation, mutual recognition of test results, and price adjustments intensified market competition, leading to a year-on-year decline in the company's operating revenue and product gross profit[3](index=3&type=chunk) - Despite revenue decline, the company maintained R&D expense ratios and marketing resource investments at the same level as the prior year to solidify its development foundation[3](index=3&type=chunk) [Impact of Asset Impairment Provisions](index=1&type=section&id=Impact%20of%20Asset%20Impairment%20Provisions) Under the principle of prudence and considering industry and company specifics, the company recognized impairment provisions for accounts receivable, inventory, and fixed assets with potential impairment risks, negatively impacting current period profit - Based on the principle of prudence, the company recognized impairment provisions for accounts receivable, inventory, and fixed assets with potential impairment risks, adversely affecting profit[3](index=3&type=chunk) [Future Outlook and Response Strategies](index=2&type=section&id=Future%20Outlook%20and%20Response%20Strategies) Facing challenges, the company will pursue a 'comprehensive and refined' and 'integrated innovation' strategy, focusing on R&D, market expansion, lean management, and AI-driven digital transformation to foster new growth and enhance competitiveness - The company's strategic positioning is “comprehensive and refined” and “integrated innovation”, focusing on continuous R&D and marketing efforts to establish comprehensive multi-methodology solutions[4](index=4&type=chunk) - The company plans to accelerate its overseas market expansion and improve domestic and international sales and service channels to enhance product international competitiveness[4](index=4&type=chunk) - The company will enhance operational efficiency through lean management, cost reduction, efficiency improvement, and AI-driven digital transformation[4](index=4&type=chunk) [Other Relevant Information](index=2&type=section&id=Other%20Relevant%20Information) The company emphasizes that this performance forecast is a preliminary estimate, with final financial data to be disclosed in the 2025 semi-annual report, urging investors to exercise caution - This performance forecast is a preliminary estimate, and specific financial data will be subject to the 2025 semi-annual report[5](index=5&type=chunk) - The company advises investors to make cautious decisions and be aware of investment risks[5](index=5&type=chunk)

科华生物（002022）公告，预计2025年上半年净利润亏损1.2亿元–1.7亿元，上年同期亏损5246.41万 元。 ...

| 证券代码：002022 | 证券简称：科华生物 | | | --- | --- | --- | | | | 公告编号：2025-031 | | 债券代码：128124 | 债券简称：科华转债 | | 上海科华生物工程股份有限公司 关于2025年第二季度可转债转股情况的公告 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。 特别提示： | 证券代码：002022 | 证券简称：科华生物 | | --- | --- | | 债券代码：128124 | 债券简称：科华转债 | | 转股价格：人民币20.64元/股 | | | 转股期限：2021年2月3日至2026年7月27日 | | 根据《深圳证券交易所股票上市规则》、《深圳证券交易所上市公司自律监管 指引第15号——可转换公司债券》的有关规定，上海科华生物工程股份有限公司 （以下简称"公司"）现将2025年第二季度可转换公司债券（以下简称"可转债"） 转股及公司股份变动情况公告如下： 一、可转债发行上市基本情况 1、 可转债发行情况 经中国证监会"证监许可[2020]970号文"批准，公司于2020年7月28日 ...

Core Viewpoint - Shanghai Kehua Bio-engineering Co., Ltd. maintains a stable long-term credit rating of A+ for both the company and its convertible bonds, despite facing challenges in revenue and profitability due to policy impacts on the in vitro diagnostic industry [4][5]. Company Overview - The company specializes in the research, development, production, and sales of in vitro diagnostic reagents and instruments, maintaining competitive advantages in product coverage, research and development, and sales channels [4][6]. - As of the end of 2024, the company had a total asset of 52.36 billion yuan and equity of 39.82 billion yuan, with a revenue of 17.59 billion yuan and a net loss of 7.35 billion yuan [12][13]. Financial Performance - The company experienced a significant decline in revenue in 2024, with total revenue dropping to 17.59 billion yuan from 24.28 billion yuan in 2023, and a worsening profit loss [7][12]. - As of March 2025, the company reported cash assets of 8.08 billion yuan, with a cash-to-short-term debt ratio of 3.86 times, indicating a relatively light debt burden [11][13]. - The company’s EBITDA was negative at -4.33 billion yuan for 2024, reflecting weakened profitability indicators [7][12]. Industry Environment - The in vitro diagnostic industry is currently under pressure from policies such as centralized procurement and medical insurance cost control, which have led to significant price reductions for diagnostic products [6][19]. - Despite short-term challenges, the industry is expected to maintain long-term growth resilience driven by factors such as domestic substitution, aging population, and technological upgrades [5][19]. Competitive Position - The company holds a strong competitive position in the in vitro diagnostic market, with a product range covering biochemical, immunological, molecular diagnostics, and point-of-care testing (POCT) [6][19]. - The company has a sales network that covers approximately 60% of domestic tertiary hospitals and exports products to over 100 countries [6][22]. Future Outlook - The company’s credit outlook is stable, with potential for improvement in debt servicing indicators as it integrates its business and expands into overseas markets [5][19]. - The long-term growth of the in vitro diagnostic market is projected to exceed 190 billion yuan by 2029, with a compound annual growth rate of 8.2% from 2023 [19][20].

上海科华生物工程股份有限公司 公开发行可转换公司债券 2025 年跟踪评级报告 1 www.lhratings.com 联合〔2025〕4555 号 联合资信评估股份有限公司通过对上海科华生物工程股份有限 公司主体及其相关债券的信用状况进行跟踪分析和评估，确定维持 上海科华生物工程股份有限公司主体长期信用等级为 A+，维持"科 华转债"信用等级为 A+，评级展望为稳定。 特此公告 联合资信评估股份有限公司 评级总监： 二〇二五年六月二十六日 声 明 一、本报告是联合资信基于评级方法和评级程序得出的截至发表之日的 独立意见陈述，未受任何机构或个人影响。评级结论及相关分析为联合资信 基于相关信息和资料对评级对象所发表的前瞻性观点，而非对评级对象的事 实陈述或鉴证意见。联合资信有充分理由保证所出具的评级报告遵循了真 实、客观、公正的原则。鉴于信用评级工作特性及受客观条件影响，本报告 在资料信息获取、评级方法与模型、未来事项预测评估等方面存在局限性。 二、本报告系联合资信接受上海科华生物工程股份有限公司（以下简称 "该公司"）委托所出具，除因本次评级事项联合资信与该公司构成评级委 托关系外，联合资信、评级人员与该公司 ...