Financial Performance - The company's operating revenue for 2022 was ¥6,969,862,627.72, representing a 43.58% increase compared to ¥4,268,011,808.72 in 2021[20] - The net profit attributable to shareholders for 2022 was ¥970,845,080.02, which is a 14.16% increase from ¥721,016,662.06 in 2021[20] - The net cash flow from operating activities reached ¥2,153,632,187.55, marking a significant increase of 99.55% compared to ¥775,342,174.21 in the previous year[20] - Basic earnings per share for 2022 were ¥1.8878, up 14.09% from ¥1.4026 in 2021[20] - The net profit after deducting non-recurring gains and losses was ¥952,357,688.19, reflecting a 13.88% increase from ¥704,501,000.58 in 2021[20] - Total assets increased to ¥8,813,157,013.32, up 26.71% from ¥6,955,215,549.19[21] - Net assets attributable to shareholders rose to ¥4,814,922,149.78, reflecting a 24.34% increase from ¥3,872,397,866.89[21] Dividend and Shareholder Information - The company plans to distribute a cash dividend of ¥6 per 10 shares to all shareholders, with no bonus shares or capital reserve conversion[4] - The proposed cash dividend for the 2022 fiscal year is ¥6 per 10 shares, with no stock dividends or capital reserve transfers planned[152] Market and Industry Insights - The company operates in the in vitro diagnostic market, which is rapidly growing due to factors like aging population and increased healthcare spending[33][34] - The global in vitro diagnostics (IVD) market size was $67.11 billion in 2019 and is projected to reach $91.09 billion by 2027, with a CAGR of 4.8% from 2020 to 2027[35] - China's IVD market grew from approximately RMB 42.75 billion in 2015 to about RMB 80.57 billion in 2019, with a CAGR of 17.2%[36] - By 2030, China's IVD market is expected to reach RMB 288.15 billion, capturing 33.2% of the global market share[36] Product Development and R&D - The company has over 100 projects in different stages of research and development, with more than 260 approved reagents and instruments by the National Medical Products Administration[44] - The company emphasizes R&D investment, having undertaken over 30 major national science and technology projects[44] - The company continues to invest in R&D, focusing on new product development across multiple product lines, including biochemical and molecular diagnostics[48] - Research and development expenses increased by 68.71% to ¥250,493,757.83 in 2022, up from ¥148,472,181.49 in 2021, reflecting a significant increase in R&D investment[64] Sales and Revenue Breakdown - The company's self-produced products accounted for 77.34% of total revenue, with a significant growth of 62.19% year-on-year[53] - Domestic sales contributed 90.48% of total revenue, showing a substantial increase of 68.62% compared to 2021[53] - The total sales volume of self-produced diagnostic reagents reached 13,996,293 boxes in 2022, a year-on-year increase of 58.49% compared to 8,830,845 boxes in 2021[56] - The sales volume of self-produced medical instruments surged to 52,157 units, marking a 159.59% increase from 20,092 units in 2021[56] Corporate Governance and Management - The company has established a transparent performance evaluation and incentive mechanism for directors, supervisors, and senior management to ensure the achievement of development strategies and operational goals[103] - The board of directors consists of seven members, including four independent directors, ensuring compliance with legal and regulatory requirements[102] - The company has implemented a performance evaluation system for senior management, with a new assessment method established for 2022[141] - The company has maintained a stable management structure with no significant changes in senior management during the reporting period[112] Risk Management and Compliance - The company has identified potential risks in its future operations, which are detailed in the management discussion section of the report[4] - The company faces risks from regulatory changes in the in vitro diagnostics industry, which could adversely affect its operations[95] - The company acknowledges the long development cycle for new products, which typically takes 3-5 years, and is implementing measures to mitigate R&D risks[96] - The company has established departments to ensure timely registration of products in domestic and international markets, reducing registration risks[97] Financial Audit and Reporting - The company’s financial statements have been audited by Da Hua Certified Public Accountants[19] - The company has appointed Dahua Accounting Firm for the 2022 annual audit, with an audit fee of ¥2,120,000, marking the first year of service[183] - The internal control audit report for Kehua Bio-engineering Co., Ltd. indicates effective financial reporting internal controls as of December 31, 2022, with a standard unqualified opinion[164] Employee and Compensation Information - The total number of employees at the end of the reporting period is 2,709, with 921 in the parent company and 1,788 in major subsidiaries[143] - Total pre-tax compensation for the company's directors, supervisors, and senior management during the reporting period amounted to CNY 552.03 million[129] - The company has implemented a performance-oriented compensation management system to enhance employee development and satisfaction[169] Strategic Initiatives and Future Plans - The company plans to focus on cardiovascular health, liver disease, kidney disease, infectious diseases, tumors, reproductive health, and maternal and child health, aiming for comprehensive disease management[91] - The company aims to expand into the in vitro diagnostic reagent raw material market, ensuring strategic safety for product development and production[92] - The company is expanding its drug metabolism and genetic disease application areas through the development of new drug gene testing kits, with several products expected to be registered in 2023 and 2024[68] Legal Matters - The company reported a total litigation amount of approximately ¥1,050,433,000 related to arbitration with Tianlong Technology Co., Ltd. and Suzhou Tianlong Biotechnology Co., Ltd.[187] - The company has not faced any significant penalties or rectification measures during the reporting period[189]

Financial Performance - The company's operating revenue for 2021 was ¥4,854,310,523.68, representing a 16.82% increase compared to ¥4,155,428,846.74 in 2020[19] - The net profit attributable to shareholders for 2021 was ¥850,413,412.99, which is a 25.92% increase from ¥675,356,413.28 in 2020[19] - The net profit after deducting non-recurring gains and losses was ¥836,316,794.92, up 26.92% from ¥658,928,540.60 in the previous year[19] - The basic earnings per share for 2021 was ¥1.6546, an increase of 23.99% from ¥1.3345 in 2020[19] - The total assets at the end of 2021 were ¥6,955,215,549.19, reflecting a 16.36% increase from ¥5,977,153,474.43 at the end of 2020[20] - The net assets attributable to shareholders increased by 23.29% to ¥3,872,397,866.89 from ¥3,140,958,791.90 in 2020[20] - The net cash flow from operating activities decreased by 21.06% to ¥1,079,220,264.86 from ¥1,367,198,250.32 in 2020[19] - The weighted average return on net assets for 2021 was 24.17%, slightly down from 24.76% in 2020[19] Revenue Breakdown - The company's total revenue for Q1 was approximately CNY 1.45 billion, with a net profit attributable to shareholders of CNY 342.23 million[23] - In Q2, the revenue decreased to approximately CNY 946.76 million, while the net profit attributable to shareholders was CNY 136.82 million[23] - For Q3, the revenue rebounded to approximately CNY 1.33 billion, with a net profit of CNY 250.04 million[23] - The revenue from self-produced products amounted to ¥3,323,377,102.02, accounting for 68.46% of total revenue, with a year-on-year growth of 23.94%[52] - The company's domestic revenue was ¥3,740,078,291.44, which is 77.05% of total revenue, showing a 13.20% increase from the previous year[53] Market and Product Development - The global in vitro diagnostic market size exceeded USD 111.7 billion in 2021, with a projected CAGR of 6.1% from 2017 to 2024[31] - The domestic in vitro diagnostic industry is experiencing rapid growth, particularly in biochemical, immunological, and molecular diagnostics[32] - The company has over 80 CE-certified products through its Italian subsidiary, TGS, and exports to over 30 countries[33] - The company has a competitive advantage in product lines within the domestic in vitro clinical diagnostic industry[33] - The company is focused on developing new technologies and expanding its market presence in the in vitro diagnostic sector[32] - The company’s immunodiagnostic products include enzyme-linked immunosorbent assay (ELISA) and chemiluminescent immunoassay (CLIA), with a focus on high throughput and rapid detection[35] - The company’s products cover 30 provinces and municipalities in China, serving over 12,000 hospitals and more than 500 high-barrier disease control centers and blood stations[35] - The company has established a professional marketing team with a strong background in biology and medicine, enhancing its brand influence and market share[38] Research and Development - The company has over 100 ongoing research projects and has obtained 260 CFDA registration certificates and more than 50 invention patents[37] - The company is focusing on R&D, with approximately 100 projects at various stages of development, including new products for infectious disease detection and automated laboratory systems[47] - The company aims to enhance its core competitiveness through increased R&D efforts and the continuous launch of new products, aligning with industry trends[91] - The company will continue to invest in R&D, focusing on molecular and immunological fields, and aims to improve product quality and registration efficiency[93] Risk Management - The company has outlined potential risks in its future development outlook, which investors should be aware of[5] - The company faces risks related to the ongoing COVID-19 pandemic, which may impact sales of routine diagnostic products[94] - Regulatory changes in the in vitro diagnostics industry pose a risk, necessitating close monitoring and adjustments to comply with new policies[95] - New product development involves significant risks, including high costs and lengthy approval processes, which could affect the company's competitive position[96] - The company has established departments to ensure timely product registration and compliance with quality management systems in both domestic and international markets[96] Corporate Governance - The company has established a governance structure that includes a board of directors, supervisory board, and various committees to ensure compliance and protect shareholder rights[101] - The company has implemented a transparent performance evaluation and incentive mechanism for its directors and senior management to ensure alignment with long-term strategic goals[103] - The company emphasizes the importance of information disclosure and has committed to improving its transparency in financial reporting and communication with stakeholders[103] - The company maintains complete independence from its major shareholders in terms of business, personnel, assets, institutions, and finance[105] Employee and Management Structure - The total number of employees at the end of the reporting period was 2,257, with 926 in the parent company and 1,331 in major subsidiaries[132] - The company had a total of 669 technical personnel, 591 sales personnel, and 534 production personnel[132] - The company has implemented a performance-oriented compensation system to align employee contributions with rewards[134] - The management team includes experienced professionals with backgrounds in finance, pharmaceuticals, and engineering, indicating a strong leadership structure[113][114] Financial Liabilities and Investments - The company’s financial liabilities remained at zero, indicating no outstanding debts[72] - The company raised a total of ¥738,000,000.00 from the issuance of convertible bonds, with a net amount of ¥718,529,590.53 after deducting issuance costs[81] - The company has not reported any penalties from securities regulatory agencies for its directors, supervisors, and senior management in the past three years[120] Legal and Compliance Issues - The company reported that its 2021 annual audit was not completed due to disputes with minority shareholders, leading to a warning of delisting risk[98] - The company temporarily excluded Tianlong Company from its consolidated financial statements starting October 1, 2021, due to loss of control, but has since regained control and included it back in the financial reports[98] - The company is actively monitoring arbitration cases related to its investments and is seeking to resolve disputes amicably[97] Community Engagement - A team of 22 volunteers was formed to assist in COVID-19 testing efforts, contributing to public health initiatives[161] - The company emphasizes employee rights protection and has developed a comprehensive training and development system[160]

编号：2015004 证券代码：002022 证券简称：科华生物 上海科华生物工程股份有限公司 投资者关系活动记录表 | --- | --- | --- | |----------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

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