证券代码：688468 证券简称：科美诊断 公告编号：2023-058 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。 科美诊断技术股份有限公司（以下简称"公司"或"科美诊断"）及全资 子公司科美博阳诊断技术（上海）有限公司（以下简称"科美博阳"）于近日 收到了 2 项国家知识产权局颁发的发明专利证书，现将具体情况公告如下： 一、发明证书的基本情况 | 发明专利名称 | 专利号 | 专利申请日 | 授权公告日 | 专利权人 | 专利期限 | | --- | --- | --- | --- | --- | --- | | 一种白介素 6 的均相 | ZL201911420131.4 | 2019 年 12 月 31 日 | 2023 年 08 月 08 日 | 科美博阳 | 二十年 | | 检测试剂盒及其应用 | | | | 科美诊断 | | | 一种肌酸激酶同工酶 的均相检测试剂盒及 | ZL201911411233.X | 2019 年 12 月 31 日 | 2023 年 08 月 08 日 | 科美博阳 | 二十年 ...

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。 科美诊断技术股份有限公司（以下简称"公司"）全资子公司科美诊断技 术（苏州）有限公司（以下简称"苏州科美"）于近日收到了2项国家知识产权 局颁发的发明专利证书，现将具体情况公告如下： 上述专利保护的技术方案均系公司自主研发，应用于公司全自动化学发光 免疫分析系统和配套检测试剂中。 1.一种肌红蛋白的均相检测试剂盒及其应用专利（ZL201911421896.X）， 属于均相检测技术领域，具体涉及一种肌红蛋白的均相检测试剂盒及其制备方 法和应用。现有化学发光检测试剂盒的特异性不理想，容易出现假阳性现象， 尤其难以兼顾灵敏度和检测量程，不能满足临床诊断的需求。本发明对试剂盒 中 R1 试剂的受体颗粒粒径分布变异系数 C.V 值上下限进行了限定，且每毫克质 量的所述受体颗粒中的糖含量也限定了下限，使得本发明的试剂盒既有较合适 的灵敏度，又有很宽的检测量程。公司使用了该专利保护的技术制备的肌红蛋 白检测试剂盒(光激化学发光法)产品，用于体外诊断主体是否患有心肌损伤， 利用本发明提供的试 ...

证券代码：688468 证券简称：科美诊断 公告编号：2023-056 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： 一、诉讼基本情况 科美博阳认为成都爱兴销售的以"肌钙蛋白Ⅰ测定试剂盒（均相化学发光 免疫分析法）"为代表的系列体外诊断试剂盒产品侵犯科美博阳的技术秘密， 科美博阳向上海知识产权法院提交《民事起诉书》，请求判令：1）程敏卓和成 都爱兴立即停止侵害科美博阳秘密的不正当竞争行为；2）程敏卓与成都爱兴赔 偿因技术秘密侵权行为而给科美博阳造成的经济损失 6,800 万元，以及科美博阳 为调查、制止不正当竞争行为所支出的合理费用 100 万元；3）程敏卓和成都爱 兴在国家级官方媒体上向科美博阳赔礼道歉并消除影响。 2020年 9 月 22日，上海知识产权法院作出"（2019）沪 73知民初 429号" 《民事判决书》，判决：1）被告程敏卓、成都爱兴于判决生效之日立即停止侵 1 案件所处的诉讼阶段：再审判决； 公司所处的当事人地位：科美诊断技术股份有限公司（以下简称"公 司"）之全资子公司科美博阳诊断技 ...

证券代码：688468 证券简称：科美诊断 公告编号：2023-036 科美诊断技术股份有限公司 关于召开 2022 年度暨 2023 年第一季度 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、准确性和完整性依法承担法律责任。 重要内容提示： 会议召开时间：2023年6月9日（星期五）下午 13:00-14:00 会议召开地点：上海证券交易所上证路演中心 （网址：http://roadshow.sseinfo.com/） （二）会议召开地点：上证路演中心（网址：http://roadshow.sseinfo.com/） （三）会议召开方式：上证路演中心网络互动 三、参加人员 董事长、总经理：李临先生 会议召开方式：上证路演中心网络互动 投资者可于2023年6月2日（星期五）至6月8日（星期四）16:00前登录上证 路演中心网站首页点击"提问预征集"栏目或通过科美诊断技术股份有限公司（ 以下简称"公司"）邮箱ir@chemclin.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。 公司于 2023 年 4 月 28 日在 ...

Financial Performance - The company's operating revenue for 2022 was ¥465,270,072.25, a decrease of 1.17% compared to ¥470,774,575.26 in 2021[22]. - The net profit attributable to shareholders for 2022 was ¥152,625,664.32, representing an increase of 6.91% from ¥142,757,221.17 in 2021[22]. - The net cash flow from operating activities increased by 29.49% to ¥244,559,713.21 in 2022, up from ¥188,856,812.25 in 2021[22]. - The total assets at the end of 2022 were ¥1,591,166,426.71, an increase of 11.20% from ¥1,430,906,695.48 at the end of 2021[22]. - The basic earnings per share for 2022 was ¥0.38, a 2.70% increase from ¥0.37 in 2021[23]. - The net profit after deducting non-recurring gains and losses was ¥120,116,898.62, a decrease of 3.90% from ¥124,991,122.27 in 2021[22]. - The net assets attributable to shareholders at the end of 2022 were ¥1,380,575,252.76, an increase of 7.97% from ¥1,278,672,724.44 at the end of 2021[22]. - The company's comprehensive gross margin remained stable at 74.37%, but there are risks of decline due to rising labor costs and market competition[91]. - The company reported a significant decrease in financing cash flow by 133.04%, amounting to 79.95 million RMB, mainly due to cash dividends and previous IPO fundraising[114]. Research and Development - The R&D expenditure as a percentage of operating revenue increased to 17.97% in 2022, up from 14.30% in 2021, marking an increase of 3.67 percentage points[23]. - Total R&D investment increased by 24.21% year-on-year to approximately ¥83.62 million, with R&D expenses accounting for 17.97% of operating income, an increase of 3.67 percentage points[65]. - The company has developed a comprehensive core technology system covering reagents, instruments, basic materials, and biological raw materials for in vitro diagnostics[37]. - The company is focusing on enhancing its competitive advantage through technology and product innovation, particularly in the field of chemiluminescence immunodiagnostics[34]. - The company has established a proprietary chemiluminescence technology platform, which has been recognized for its clinical immunodiagnostic system based on light-activated chemiluminescence technology[56]. - The company has developed 70 products in the LiCA® series, covering common clinical detection projects in infectious diseases, tumor markers, thyroid hormones, reproductive endocrine hormones, cardiac markers, and inflammation, achieving performance levels that meet or exceed international first-tier brands[57]. - The company has established a metrological traceability system for small molecule projects, enhancing the reliability of test results[76]. - The company is focusing on the development of innovative technologies to ensure the stability and quality of biological raw materials, which is crucial for cost reduction and efficiency improvement[68]. Market Position and Strategy - The company is positioned to benefit from domestic policies encouraging the procurement of domestic medical devices, accelerating the process of import substitution in the in vitro diagnostic market[60]. - The company aims to transition from a follower to a leader by exploring new biomarkers with clear clinical significance[38]. - The company is focusing on developing diagnostic products that match or exceed the performance of imported brands, targeting a market where imported brands currently hold an 80% share[125]. - The company is actively pursuing opportunities for mergers and acquisitions to drive growth[144]. - The company plans to expand its market presence and enhance product offerings, although specific strategies were not detailed in the report[104]. - The company is committed to attracting and retaining high-quality talent through training and development programs, enhancing its competitive advantage[130]. - The company is expanding its production capacity at the Suzhou base, focusing on automation and smart production methods to enhance efficiency and product quality[130]. Governance and Compliance - The company emphasizes strict quality control in production, adhering to multiple international quality management standards[49]. - The company has established a comprehensive corporate governance structure, including a board of directors and various committees, ensuring clear responsibilities and effective operations[186]. - The company has implemented a stock incentive plan, which was approved in the first extraordinary general meeting of 2022[136]. - The company has no significant differences in governance compared to regulations set by the China Securities Regulatory Commission[135]. - The company has established a governance structure that ensures effective operation and decision-making, safeguarding the interests of shareholders[134]. - The company strictly adhered to information disclosure regulations, ensuring timely and accurate reporting to protect investor interests[135]. - The company has maintained a consistent presence in the biotechnology sector, with several key personnel holding significant positions across various firms[148][149][150]. Environmental Responsibility - The company emphasizes environmental protection and complies with relevant laws and regulations, integrating green practices into its operations[185]. - The company invested approximately 29.85 million yuan in environmental protection during the reporting period[187]. - The company is not classified as a key pollutant discharging unit by environmental protection authorities[188]. - No administrative penalties were incurred due to environmental issues during the reporting period[189]. Product Development and Innovation - The company has successfully launched the LiCA® photochemical luminescence instruments, which include models such as LiCA® 500 and LiCA® 800, demonstrating high sensitivity and specificity in testing[68]. - The company has developed 8 biochemical reagents, with one product already registered and others in progressive development[22]. - The company’s LiCA® series products include 70 registered medical device certificates, covering major clinical testing projects in China[44]. - The company has obtained 49 new patents during the reporting period, including 14 invention patents and 30 utility model patents, bringing the total number of effective patents to 626[63]. - The company has established a first-level traceability system for the LiCA® small molecule project in accordance with the latest international standards, enhancing product reliability[41]. Risk Management - The company has detailed various operational risks in the report, which can be found in the "Management Discussion and Analysis" section[3]. - The company faces risks related to dealer management, product quality, and intensified market competition from both domestic and international players[89]. - The company is subject to risks from national healthcare reforms, which may impact operational performance if not addressed timely[93]. - The company faces risks related to new product development, including a typical 3-5 year timeline for obtaining registration certificates[83].

Financial Performance - The company's operating revenue for Q1 2023 was ¥100,933,657.63, representing a decrease of 16.50% compared to the same period last year[4] - The net profit attributable to shareholders was ¥34,836,760.84, down by 10.92% year-on-year[4] - The net profit after deducting non-recurring gains and losses was ¥30,632,434.37, a decrease of 12.54% compared to the previous year[4] - The basic earnings per share for the period was ¥0.09, a decrease of 10.00% compared to the same period last year[4] - The weighted average return on equity was 2.49%, a decrease of 0.52 percentage points[4] - The total comprehensive income for Q1 2023 was ¥34,836,760.84, compared to ¥39,107,317.86 in Q1 2022[22] - The net profit for Q1 2023 was ¥34,836,760.84, a decline of 10.0% from ¥39,107,317.86 in Q1 2022[21] - The net profit for Q1 2023 was -3,612,514.55 RMB, an improvement from -6,052,137.88 RMB in Q1 2022, indicating a reduction in losses by approximately 40%[30] - Total comprehensive income for Q1 2023 was -3,612,514.55 RMB, compared to -6,052,137.88 RMB in Q1 2022, reflecting a significant improvement in overall financial performance[30] Cash Flow - The net cash flow from operating activities was ¥18,271,622.63, reflecting a significant decline of 68.99% due to reduced sales collections and increased tax and procurement expenses[6] - Cash inflow from operating activities in Q1 2023 was ¥123,823,308.66, down from ¥143,862,718.38 in Q1 2022[22] - The net cash flow from operating activities was CNY 18,271,622.63, down 69.0% from CNY 58,921,042.84 in the previous year[23] - The total cash outflow from operating activities was 33,286,323.62 RMB, compared to 28,125,115.24 RMB in Q1 2022, marking an increase of approximately 18%[34] - The company incurred a tax expense of -2,231,800.27 RMB in Q1 2023, compared to -1,537,773.85 RMB in Q1 2022, reflecting an increase in tax liabilities[30] - The company's cash flow from financing activities resulted in a net outflow of -2,217,334.84 RMB, compared to -12,353,360.41 RMB in Q1 2022, indicating a significant reduction in financing costs[34] Assets and Liabilities - The total assets at the end of the reporting period were ¥1,577,016,660.57, a decrease of 0.89% from the end of the previous year[5] - The total assets as of March 31, 2023, amounted to CNY 1,116,991,175.71, a decrease from CNY 1,131,638,710.08 at the end of 2022[26] - Total liabilities as of Q1 2023 were ¥161,604,646.97, a decrease from ¥210,591,173.95 in the previous period[17] - The company's total liabilities as of March 31, 2023, were CNY 16,347,849.35, down from CNY 27,382,869.17 at the end of 2022[27] Research and Development - Research and development expenses totaled ¥21,574,900.89, which is an increase of 16.60% year-on-year, accounting for 21.38% of operating revenue, up by 6.07 percentage points[4] - The company reported a decrease in research and development expenses to ¥17,088,512.72 in Q1 2023 from ¥18,502,792.33 in Q1 2022[19] - Research and development expenses for Q1 2023 were CNY 10,909,511.00, slightly up from CNY 10,877,795.20 in Q1 2022[29] - The company has 15 products in the research pipeline, with 4 entering clinical stages and 1 obtaining domestic Class III medical device registration during the reporting period[11] - The company secured 8 domestic invention patents during the reporting period, indicating ongoing innovation efforts[12] Inventory and Current Assets - The company reported a total current assets of CNY 1,137,751,671.82 as of March 31, 2023, a decrease from CNY 1,165,252,004.65 at the end of 2022, reflecting a decline of approximately 2.5%[14] - The cash and cash equivalents decreased to CNY 247,051,012.53 from CNY 342,139,661.72, representing a decline of about 27.8%[14] - The accounts receivable decreased to CNY 31,492,953.67 from CNY 34,062,994.04, a decline of about 8.3%[14] - The company’s inventory increased to CNY 113,377,180.33 from CNY 112,560,499.21, reflecting a slight increase of about 0.7%[15] - The company’s inventory increased slightly to CNY 31,153,709.50 from CNY 30,966,985.10 at the end of 2022[26] Investment Activities - Investment activities resulted in a net cash outflow of CNY 120,379,638.70, compared to a smaller outflow of CNY 38,824,910.50 in the previous year[23] - The cash flow from investing activities showed a net outflow of -126,392,250.78 RMB, compared to -152,610,099.14 RMB in Q1 2022, indicating a reduction in cash outflow by approximately 17%[34]

证券代码：688468 证券简称：科美诊断 编号：2022-002 科美诊断技术股份有限公司 投资者关系活动记录表 | --- | --- | --- | |-------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

Financial Performance - The company's operating revenue for Q3 2022 was ¥136,387,666.48, representing a year-over-year increase of 15.06%[2] - The net profit attributable to shareholders for Q3 2022 was ¥48,730,176.59, up 28.96% compared to the same period last year[2] - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥39,021,176.07, reflecting a 31.81% increase year-over-year[2] - Basic earnings per share for Q3 2022 was ¥0.12, an increase of 33.33% from the previous year[3] - Total operating revenue for the first three quarters of 2022 reached ¥359,915,767.68, a slight increase of 1.3% compared to ¥355,463,272.78 in the same period of 2021[21] - Net profit for the third quarter of 2022 was ¥118,250,804.17, compared to ¥107,803,052.25 in the same quarter of 2021, representing an increase of 9.5%[23] - The total comprehensive income attributable to the parent company for Q3 2022 was ¥118,250,804.17, an increase from ¥107,803,052.25 in Q3 2021, representing a growth of approximately 13.4%[24] - Basic and diluted earnings per share for Q3 2022 were both ¥0.29, compared to ¥0.28 in Q3 2021, indicating a year-over-year increase of 3.6%[24] - The net profit for the first three quarters of 2022 was CNY 19,117,201.98, down 41.2% from CNY 32,622,695.40 in the previous year[30] - The company's total profit for the first three quarters was CNY 14,911,622.59, a decrease of 47.9% from CNY 28,651,680.77 in the same period of 2021[30] Research and Development - The total R&D investment for Q3 2022 was ¥23,890,313.89, which is 42.55% higher than the same period last year[3] - The R&D investment accounted for 17.52% of operating revenue, an increase of 3.38 percentage points year-over-year[3] - Research and development expenses for the third quarter of 2022 amounted to ¥51,337,884.31, an increase from ¥48,243,992.75 in the previous year, indicating a focus on innovation[22] - Research and development expenses increased to CNY 33,055,264.49, representing a rise of 26.6% compared to CNY 26,105,672.85 in the first three quarters of 2021[29] - The company obtained 14 authorized patents during the reporting period, including 1 domestic invention patent and 13 utility model patents[14] Cash Flow and Investments - The net cash flow from operating activities for the year-to-date period was ¥198,363,572.85, showing a 32.67% increase compared to the previous year[2] - The company's cash flow from operating activities remains strong, supporting ongoing investments in new product development and market expansion strategies[22] - Net cash flow from operating activities for the first three quarters of 2022 was ¥198,363,572.85, up from ¥149,520,066.42 in the same period of 2021, reflecting a growth of 32.6%[25] - Cash inflow from investment activities in the first three quarters of 2022 was ¥2,520,291,030.32, significantly higher than ¥1,496,493,979.06 in the same period of 2021, marking an increase of 68.4%[25] - The net cash flow from investment activities for the first three quarters of 2022 was -¥61,664,292.63, an improvement from -¥429,708,669.36 in the same period of 2021[25] - The company reported a net cash outflow from investing activities of CNY -33,466,720.20, an improvement from CNY -255,793,401.36 in the previous year[32] Assets and Liabilities - Total assets at the end of Q3 2022 were ¥1,518,753,584.76, a 6.14% increase from the end of the previous year[3] - Total assets as of the end of the third quarter of 2022 were ¥1,518,753,584.76, up from ¥1,430,906,695.48 at the end of the third quarter of 2021, marking a growth of 6.2%[19] - The company's equity attributable to shareholders reached ¥1,342,194,110.43, up from ¥1,278,672,724.44 in the previous year, showing an increase of 4.9%[19] - Total liabilities increased to ¥176,559,474.33 in the third quarter of 2022, compared to ¥152,233,971.04 in the same quarter of 2021, reflecting a rise of 16.0%[19] - The total liabilities as of September 30, 2022, were ¥28,525,537.88, a decrease from ¥47,669,901.28 as of December 31, 2021, indicating a reduction of approximately 40.2%[28] Shareholder Information - The company implemented a stock incentive plan, recognizing share-based payment expenses of ¥13,440,600, which impacted the net profit attributable to shareholders[4] - The company’s major shareholders include Shanghai Peixi Investment Management with 40,791,545 shares, representing a significant stake in the company[12] Inventory and Receivables - Accounts receivable decreased to ¥32,175,450.16 from ¥35,127,292.63, indicating a reduction of approximately 5.5%[17] - Inventory stood at ¥121,249,941.15, slightly down from ¥122,362,493.25 in the previous year[17] - The company’s fixed assets decreased to ¥113,671,670.15 from ¥125,905,381.60, reflecting a decline of about 9.7%[17] - The company’s long-term construction projects increased to ¥30,462,365.85 from ¥7,569,424.11, showing significant growth[17]

Financial Performance - The company reported a total revenue of RMB 100 million for the first half of 2022, representing a year-on-year increase of 15%[13]. - The gross profit margin for the first half of 2022 was 45%, compared to 40% in the same period last year, indicating improved cost management[13]. - The company's operating revenue for the first half of the year was ¥223,528,101.20, a decrease of 5.66% compared to the same period last year[19]. - The net profit attributable to shareholders was ¥69,520,627.58, reflecting a slight decrease of 0.71% year-on-year[19]. - The net profit after deducting non-recurring gains and losses was ¥58,187,233.01, down 11.28% from the previous year[19]. - The net cash flow from operating activities increased by 42.80% to ¥116,249,202.01, primarily due to a reduction in cash paid for goods and services[21]. - The basic earnings per share decreased by 10.53% to ¥0.17, while the diluted earnings per share also fell by the same percentage[21]. - The management provided a revenue guidance of RMB 220 million for the full year 2022, representing a growth of 18% compared to 2021[13]. Market Expansion and Strategy - The company has outlined a market expansion strategy targeting Southeast Asia, with an expected revenue contribution of RMB 30 million by the end of 2023[13]. - The company plans to launch two new product lines in Q3 2022, aiming to capture an additional 10% market share in the diagnostic sector[13]. - The company has established partnerships with three new distributors to enhance market reach and improve sales channels[13]. - Over 97% of the company's sales revenue is generated through a distribution model, with direct sales primarily targeting independent medical laboratories[36]. Research and Development - Research and development expenses increased by 25% to RMB 15 million, reflecting the company's commitment to innovation and new technology[13]. - Research and development expenses accounted for 16.37% of operating revenue, an increase of 3.08 percentage points compared to the previous year[21]. - Total R&D investment reached ¥36,594,113.80, an increase of 16.23% compared to the previous year, with R&D expenses accounting for 16.37% of operating income, up by 3.08 percentage points[59]. - The company emphasizes R&D innovation, with significant resources allocated to developing new technologies and products[46]. Product Development and Technology - The company has established a proprietary chemiluminescence technology platform, leading to the development of the LiCA® series products[29]. - The company is focused on expanding its product offerings in the fields of infectious diseases, tumor markers, and other clinical testing areas[30]. - The company has developed a total of 20 product registrations for infectious disease markers, including those for hepatitis B, hepatitis C, HIV, and syphilis[31]. - The LiCA® series includes models capable of processing up to 600 tests per hour, with the ability to load 200 samples at once, while the CC series can process 380 tests per hour with a capacity for 240 samples[31]. - The company has developed leading core technologies in biomarker detection, specifically for infectious diseases, including the next-generation HIV antigen/antibody detection technology and HCV antigen-antibody combined detection technology[54]. Competitive Landscape - The global in vitro diagnostics market was valued at approximately $83.4 billion in 2020, accounting for 17% of the total medical device market, and is projected to reach around $96.2 billion by 2025, growing at a CAGR of 5%[38]. - The Chinese in vitro diagnostics market reached approximately ¥89 billion in 2020, with a year-on-year growth of 24.3%[39]. - The infectious disease testing market accounts for approximately 40% of the total chemiluminescence detection market, driven by a high prevalence of diseases like viral hepatitis in China[41]. - The company is positioned as a leading player in the domestic infectious disease chemiluminescence detection market, with a strong competitive edge[48]. Risks and Challenges - The company highlighted potential risks including regulatory changes and market competition, which could impact future performance[5]. - The company faces risks from national healthcare reforms, including "two-invoice system" and "volume-based procurement," which may impact sales performance if not adapted to[102]. - The in vitro diagnostic market is experiencing increased competition from both domestic and international companies, which may impact the company's market share and profitability[98]. - Environmental compliance is critical, as improper waste management could lead to penalties or operational disruptions[98]. Legal Matters - The company is involved in a significant lawsuit regarding the infringement of trade secrets, with a claim for economic damages amounting to RMB 68 million and additional reasonable expenses of RMB 1 million[169]. - The first-instance judgment on the trade secret infringement case ordered the defendants to cease infringement and pay RMB 1 million in damages and RMB 300,000 in reasonable expenses[169]. - The company is also facing a commercial defamation lawsuit, with the plaintiff seeking a total compensation of RMB 10 million and reasonable expenses of RMB 53,500[170]. - The first-instance judgment in the defamation case dismissed all claims from the plaintiff, with the plaintiff responsible for the litigation costs of RMB 82,100[170]. Shareholder Commitments and Governance - The company reported a commitment to lock up shares for 36 months from the date of IPO, ensuring stability in share price[130]. - The actual controller and major shareholders have made commitments regarding share reduction arrangements, which are being adhered to as per the stipulated timelines[131]. - The company has a long-term commitment to repurchase shares if any fraudulent issuance is confirmed, ensuring investor protection[132]. - The company has committed to measures to compensate for the dilution of immediate returns, as detailed in the prospectus[133]. - The company will comply with all relevant laws and regulations regarding share trading and disclosure obligations[137].

Financial Performance - The company's operating revenue for 2021 was ¥470,774,575.26, representing a year-on-year increase of 12.57% compared to ¥418,200,080.02 in 2020[21]. - The net profit attributable to shareholders for 2021 was ¥142,757,221.17, which is a 21.99% increase from ¥117,020,020.48 in 2020[21]. - The net cash flow from operating activities increased by 24.29% to ¥188,856,812.25 in 2021, up from ¥151,953,266.37 in 2020[21]. - The total assets of the company reached ¥1,430,906,695.48 at the end of 2021, a 42.12% increase from ¥1,006,822,552.60 at the end of 2020[21]. - The net assets attributable to shareholders increased by 44.10% to ¥1,278,672,724.44 at the end of 2021, compared to ¥887,358,555.26 at the end of 2020[21]. - The basic earnings per share for 2021 was ¥0.37, reflecting a 12.12% increase from ¥0.33 in 2020[22]. - The company's comprehensive gross margin for the reporting period was 74.85%, remaining stable[101]. - The gross margin for the in vitro diagnostic reagents was 74.85%, an increase of 2.40 percentage points compared to the previous year[109]. - The company achieved operating revenue of 470.77 million yuan, a year-on-year increase of 12.57%[104]. - The net profit attributable to the parent company was 142.76 million yuan, reflecting a year-on-year growth of 21.99%[104]. Research and Development - The R&D expenditure as a percentage of operating revenue was 14.30% in 2021, up from 13.49% in 2020, indicating a focus on innovation[22]. - Total R&D investment for the year was approximately ¥67.32 million, representing a 19.33% increase from the previous year, and accounting for 14.30% of total revenue[73]. - The company has developed over 60 products in various categories, including infectious diseases, tumors, thyroid hormones, and cardiac markers, which have received registration certificates and successfully launched for sale[76]. - The company has established a technical platform for the development of latex immunoassays, with products achieving advanced domestic levels in terms of performance stability and anti-interference capabilities[78]. - The company has developed a proprietary chemiluminescence technology platform, leading to the creation of the LiCA® series products, which utilize a unique "no-wash" homogeneous immunoassay method[44]. - The company has obtained 33 new patents during the reporting period, including 11 domestic invention patents and 2 overseas invention patents[72]. - The company has established a robust supplier management system to ensure the quality of raw materials and components used in its diagnostic products[49]. - The company has developed 144 international and domestic patents in various fields, establishing a proprietary technology platform for clinical diagnostics[190]. Market Position and Strategy - The company is focusing on technological innovation to meet unmet medical needs and accelerate import substitution[32]. - The company successfully participated in the centralized procurement of chemical luminescence infectious disease products in Anhui Province, replacing over ten imported brand products in major hospitals shortly after the policy implementation[33]. - The company aims to create long-term value for employees and shareholders by solidifying its position as a leading and exemplary listed company in China's in vitro diagnostics industry[42]. - The company is actively pursuing diversification in its product lines and expanding into next-generation technologies to build a comprehensive in vitro diagnostic ecosystem[134]. - The company is focused on expanding its market presence and developing new technologies to drive future growth[149]. - The company is committed to maintaining transparency in its shareholding structure and governance practices[149]. - The company is developing the LiCA® series products based on a proprietary chemiluminescence technology, which is relatively new in the market[97]. - The company is at risk of technological obsolescence if it fails to keep pace with industry advancements in in vitro diagnostics[96]. Corporate Governance - The company has established a comprehensive corporate governance structure, including a board of directors and various committees, ensuring clear responsibilities and effective operations[182]. - The company has established a governance structure that ensures effective operation of the shareholders' meeting, board of directors, and supervisory board, maintaining investor interests[139]. - The company has not faced any issues regarding independence or operational autonomy from its controlling shareholders[140]. - The company has not reported any significant adverse effects from competitive activities with its controlling shareholders[140]. - The company has maintained compliance with all relevant laws and regulations regarding corporate governance[140]. - The company held one shareholders' meeting during the reporting period, with all proposed resolutions approved without any being rejected[143]. - The company has implemented various internal management systems to ensure accurate and timely information disclosure to investors[200]. Operational Risks - The company has detailed various operational risks in the "Management Discussion and Analysis" section of the report[3]. - The company faces risks related to new product development and registration, which typically takes 3-5 years, and any failure in this process could impact future profitability[94]. - The company faces risks of declining gross margin due to rising labor costs and increased operational costs related to environmental protection[101]. - The company is at risk of product registration renewals, which could adversely affect its operational and financial status if not managed properly[102]. - The company is developing the LiCA® AT 5000 model according to plan, which aims to enhance its competitive edge in the market[76]. Employee and Management - The company has a strong leadership team with diverse expertise, including clinical research and financial management[149]. - The company has established a dual-channel career model for employee development, with nearly 70 management personnel participating in the training program[169]. - The company has implemented a performance evaluation system for senior management, linking compensation to performance to enhance motivation[176]. - The company employs a total of 632 staff members, with 220 in the parent company and 412 in major subsidiaries[167]. - The workforce includes 162 production personnel, 254 sales personnel, 138 technical personnel, and 19 financial personnel[167]. Environmental and Social Responsibility - The company emphasizes environmental protection and complies with relevant laws and regulations, integrating green practices into its operations[181]. - The company has adopted clean energy and renewable energy technologies to reduce carbon emissions and improve energy efficiency[188]. - The company emphasizes employee health and safety, providing a supportive environment for career development and social responsibility awareness[194]. Product Development and Innovation - The company has established a comprehensive core technology system for in vitro diagnostics, achieving self-sufficiency in key biological raw materials and core technologies, addressing critical supply chain issues[34]. - The LiCA® Smart fully automated chemiluminescence immunoassay analyzer was successfully launched, meeting the needs of large hospitals and small to medium-sized hospitals for emergency and routine clinical immunodiagnosis[36]. - The company has developed 62 items in the LiCA® series, covering common clinical testing projects in infectious diseases, tumor markers, and other areas, with performance meeting or exceeding international brands[62]. - The company is committed to continuous investment in R&D, targeting international market leaders in each segment to enhance product performance and surpass imported brands[135].