证券代码：688575 证券简称：亚辉龙 公告编号：2025-037 深圳市亚辉龙生物科技股份有限公司 关于自愿披露取得医疗器械注册证的公告 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。 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"或"亚辉龙"）于近日收 到了由国家药品监督管理局签发的医疗器械注册证,具体信息如下： | 序 | 产品名称 | 注册编号 | 注册证有效期 | 注册 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 号 | | | | 分类 | | | 1 | 乙型肝炎病毒 抗原测 e 定试剂盒（化学发光法） | 国 械 注 准 | 至 2030/4/28 | 三类 | 用于体外定量测定人血清和（或）血浆中乙 型肝炎病毒 抗原（HBeAg）的含量。 | | | | 20253400890 | | | e | | 2 | 乙型肝炎病毒 抗体测 e 定试剂盒（化学发光法） | 国 械 注 准 20253400885 | 至 2030/4/28 | 三类 | 本 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [2] Core Views - The company reported a revenue of 2.012 billion yuan in 2024, a decrease of 2.02% year-on-year, with a net profit attributable to shareholders of 302 million yuan, down 15.06% [6] - The company's non-COVID related self-produced revenue grew by 26.13% to 1.672 billion yuan, with overseas revenue increasing by 64.78% to 250 million yuan [7] - The self-produced chemiluminescence business achieved a revenue of 1.522 billion yuan, up 30.27% year-on-year [7] - The company added 2,662 self-produced chemiluminescence instruments in 2024, with a total installation exceeding 10,800 units by the end of the year [8] - The company expects revenues of 2.315 billion yuan in 2025, with a year-on-year growth of 15.1%, and net profits of 385 million yuan, representing a growth of 27.6% [9] Financial Summary - In 2024, the company achieved a gross margin of 65.3% and a return on equity (ROE) of 10.9% [12] - The projected earnings per share (EPS) for 2025 is 0.67 yuan, with a price-to-earnings (P/E) ratio of 21 [12] - The company anticipates a revenue growth trajectory of 15.1% in 2025, 15.9% in 2026, and 15.2% in 2027 [9][12]

Investment Rating - The investment rating for the company is "Buy" (maintained) [2] Core Views - The company reported a revenue of 2.012 billion yuan in 2024, a decrease of 2.02% year-on-year, with a net profit attributable to shareholders of 302 million yuan, down 15.06% [6] - The company's non-COVID self-produced revenue grew by 26.13% to 1.672 billion yuan, with overseas non-COVID self-produced revenue increasing by 64.78% [7] - The company achieved a revenue of 1.522 billion yuan from its self-produced chemiluminescence business, marking a growth of 30.27% [7] - The company has seen a steady increase in installed chemiluminescence instruments, with a total of over 11,340 units installed by March 31, 2025, covering over 6,090 medical institutions [8] - The company expects revenue growth of 15.1%, 15.9%, and 15.2% for the years 2025, 2026, and 2027, respectively, with net profit growth of 27.6%, 27.2%, and 21.5% for the same years [9] Summary by Sections Financial Performance - In 2024, the company achieved a total revenue of 2.012 billion yuan, with a net profit of 302 million yuan [6] - For Q1 2025, the company reported a revenue of 418 million yuan, down 3.13%, and a net profit of 10 million yuan, down 84.63% [6] Business Growth - The self-produced chemiluminescence business saw a revenue increase of 30.27% in 2024, with significant growth in both domestic and overseas markets [7] - The company installed 2,662 new chemiluminescence instruments in 2024, with a total of over 11,340 units installed by early 2025 [8] Future Projections - The company forecasts revenues of 2.315 billion yuan in 2025, 2.684 billion yuan in 2026, and 3.091 billion yuan in 2027, with corresponding net profits of 385 million yuan, 490 million yuan, and 595 million yuan [9][12]

Core Viewpoint - The company reported a decline in revenue and net profit for 2024, but showed strong growth in non-COVID self-produced luminous business, particularly in overseas markets, despite short-term pressures in Q1 2025 due to centralized procurement impacts [1][2] Financial Performance - In 2024, the company achieved revenue of 2.012 billion yuan (YoY -2.02%) and a net profit of 302 million yuan (YoY -15.06%), with a non-recurring net profit of 287 million yuan (YoY +30.84%) [1] - For Q4 2024, the company reported revenue of 618 million yuan (YoY +21.57%) and a net profit of 83 million yuan (YoY +18.43%) [1] - In Q1 2025, revenue was 418 million yuan (YoY -3.13%) and net profit was 10 million yuan (YoY -84.63%) [1] Business Segments - The non-COVID self-produced luminous revenue for 2024 was 1.672 billion yuan (+26.1%), accounting for 83% of total revenue, with self-produced luminous revenue at 1.522 billion yuan (+30.3%) [2] - Domestic market revenue was 1.724 billion yuan (-7.03%), influenced by centralized procurement execution and inventory adjustments, while overseas market revenue grew to 250 million yuan (+52.08%) [2] R&D and Product Development - The company invested 338 million yuan in R&D in 2024, representing 16.8% of revenue, and achieved significant product registrations and localizations [3] - The introduction of high-end self-developed instruments and a rich product matrix in specialty testing areas is expected to enhance market expansion and improve profit margins [3] Future Outlook - Revenue projections for 2025-2027 are 2.309 billion yuan, 2.678 billion yuan, and 3.167 billion yuan, with expected growth rates of 14.76%, 15.98%, and 18.27% respectively [4] - Net profit forecasts for the same period are 371 million yuan, 464 million yuan, and 583 million yuan, with growth rates of 23.01%, 25.14%, and 25.51% respectively [4]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative increase of over 15% compared to the CSI 300 index in the next six months [1][14]. Core Views - The company's chemical luminescence business shows strong performance, with rapid installation growth both domestically and internationally [1]. - The company reported a revenue of 2.012 billion yuan in 2024, a year-on-year decrease of 2.02%, primarily due to a significant reduction in COVID-19 related business [4]. - The non-COVID self-produced main business revenue grew by 26.13% year-on-year, reaching 1.672 billion yuan [6]. - The company achieved a gross margin of 65.28% in 2024, an increase of 8.47 percentage points year-on-year [8]. Summary by Sections Financial Performance - In 2024, the company reported a net profit of 302 million yuan, down 15.06% year-on-year, mainly due to investment income impacts [4]. - The first quarter of 2025 saw a revenue of 418 million yuan, a decline of 3.13% year-on-year, with a net profit of 10 million yuan, down 84.63% [5]. - The company’s gross margin for non-COVID self-produced business was 71.50%, up 1.50 percentage points year-on-year [6]. Business Growth - The company installed 2,662 self-produced chemical luminescence instruments in 2024, with domestic installations increasing by 2.22% and international installations rising by 80.56% [7]. - The revenue from chemical luminescence diagnostic reagents grew significantly, with specific product lines seeing increases of up to 38.21% year-on-year [7]. Profitability and Forecast - The report forecasts revenues of 2.312 billion yuan, 2.692 billion yuan, and 3.101 billion yuan for 2025, 2026, and 2027, respectively, with expected growth rates of 14.93%, 16.44%, and 15.19% [10]. - The projected diluted earnings per share (EPS) for 2025, 2026, and 2027 are 0.64 yuan, 0.80 yuan, and 0.99 yuan, respectively [10].

Investment Rating - The investment rating for the company is not explicitly stated in the provided documents, but the analysis suggests a positive outlook based on revenue growth and profitability forecasts [1][2]. Core Insights - The company's luminous business has shown strong performance, with international revenue growing rapidly. In 2024, the company achieved total revenue of 20.12 billion yuan, a year-over-year decrease of 2.02%, primarily due to a significant decline in COVID-related business. However, non-COVID self-produced business maintained rapid growth, generating revenue of 16.72 billion yuan, a year-over-year increase of 26.13% [2][3]. - The company has increased its research and development investments, leading to continuous upgrades of its instrument platform, which is expected to enhance its competitive edge in the market. The gross profit margin for 2024 was 65.28%, an increase of 8.47 percentage points year-over-year, attributed to a shift in revenue structure towards higher-margin products [2][3]. - Revenue forecasts for 2025-2027 are optimistic, with expected revenues of 23.07 billion yuan, 26.87 billion yuan, and 31.70 billion yuan, representing year-over-year growth rates of 14.7%, 16.4%, and 18.0% respectively. Corresponding net profits are projected to be 3.45 billion yuan, 4.30 billion yuan, and 5.40 billion yuan, with growth rates of 14.5%, 24.6%, and 25.4% [2][3]. Financial Summary - In 2024, the company reported total revenue of 20.12 billion yuan, with a year-over-year decrease of 2.02%. The net profit attributable to the parent company was 3.02 billion yuan, down 15.06% year-over-year. The net cash flow from operating activities was 5.30 billion yuan [1][3]. - The company’s gross profit margin is projected to improve from 65.3% in 2024 to 66.8% by 2027, indicating a positive trend in profitability [3][4]. - The earnings per share (EPS) is expected to increase from 0.61 yuan in 2025 to 0.95 yuan in 2027, reflecting the anticipated growth in net profit [3][4].

Investment Rating - The investment rating for the company is not explicitly stated in the provided documents, but the analysis suggests a positive outlook based on revenue growth projections and business performance [1][2]. Core Insights - The company's luminous business has shown strong performance, with international revenue growing rapidly. In 2024, the company achieved total revenue of 20.12 billion yuan, a year-over-year decrease of 2.02%, primarily due to a significant decline in COVID-related business. However, non-COVID self-produced business maintained rapid growth, generating revenue of 16.72 billion yuan, up 26.13% year-over-year [2][3]. - The company has increased its research and development investments, leading to continuous upgrades of its instrument platform, which is expected to enhance its competitive edge in the market. The gross profit margin for 2024 was 65.28%, an increase of 8.47 percentage points year-over-year, attributed to a shift in revenue structure towards higher-margin products [2][3]. - Revenue forecasts for 2025-2027 are optimistic, with expected revenues of 23.07 billion yuan, 26.87 billion yuan, and 31.70 billion yuan, representing year-over-year growth rates of 14.7%, 16.4%, and 18.0%, respectively. Corresponding net profits are projected to be 3.45 billion yuan, 4.30 billion yuan, and 5.40 billion yuan, with growth rates of 14.5%, 24.6%, and 25.4% [2][3]. Financial Summary - In 2024, the company reported total revenue of 20.12 billion yuan, with a year-over-year decrease of 2.02%. The net profit attributable to the parent company was 3.02 billion yuan, down 15.06% year-over-year. The net cash flow from operating activities was 5.30 billion yuan [1][3]. - The company's gross profit margin is projected to improve from 65.3% in 2024 to 66.8% by 2027, indicating a positive trend in profitability [3][4]. - The earnings per share (EPS) is expected to increase from 0.61 yuan in 2025 to 0.95 yuan in 2027, reflecting the anticipated growth in net profit [3][4].

Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests a long-term focus on domestic innovative drugs in the oncology field and AI medical investment opportunities [3][4]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.16%, outperforming the Wind All A index (1.15%) and the CSI 300 index (0.38%) [3][8]. - The upcoming ASCO conference is highlighted as a significant event for domestic innovative drug companies, with over 70 oral presentations and more than 10 major studies expected [3][4]. - The Ministry of Industry and Information Technology and six other departments issued a plan for the digital transformation of the pharmaceutical industry, aiming for significant advancements by 2027 and full coverage by 2030 [3][4]. Market Weekly Review - The pharmaceutical and biotechnology sector increased by 1.16% from April 21 to April 25, outperforming the Wind All A index and the CSI 300 index [3][8]. - Notable performers included medical research outsourcing (6.34%) and raw materials (4.72%), while blood products (-3.26%) and vaccines (-6.38%) continued to decline [3][9]. - Individual stock performances showed significant gains for Yong'an Pharmaceutical (31.4%), Shuyou Shen (28.4%), and Erkang Pharmaceutical (27.7%), while *ST Jiyuan (-43.2%), Nanhua Biological (-35.3%), and Shuangcheng Pharmaceutical (-27.7%) faced substantial losses [3][11]. Industry News and Key Company Announcements - On April 25, Kangfang Bio announced FDA approval for its drug Anike for the treatment of recurrent or metastatic nasopharyngeal carcinoma [12]. - The same day, Kangfang Bio also reported the approval of its PD-1/VEGF bispecific antibody for first-line treatment of specific lung cancer types [13]. - The digital transformation plan for the pharmaceutical industry aims to enhance competitiveness and quality management through AI and data integration by 2030 [3][4].

Summary of the Conference Call for 亚辉龙 Company Overview - **Company**: 亚辉龙 (YHLO) - **Industry**: In Vitro Diagnostics (IVD) Key Financial Performance - **2024 Total Revenue**: 1.772 billion CNY, up 26.13% YoY - **2025 Q1 Revenue**: 418 million CNY, down 3.13% YoY - **Non-COVID Related Revenue (2024)**: 1.672 billion CNY, up 24.11% YoY - **Non-COVID Related Revenue (2025 Q1)**: 345 million CNY, up 1.09% YoY - **Overseas Non-COVID Related Revenue Growth**: 64.78% in 2024, 46.53% in 2025 Q1 [2][3] Profitability Metrics - **2024 Gross Margin**: 65.15%, up 8.58 percentage points YoY - **2025 Q1 Gross Margin**: 58.87%, down 2.9 percentage points YoY - **Chemical Luminescence Reagent Gross Margin**: 81.75% in 2024, down 1.2 percentage points YoY [2][5] Expense Management - **2024 Sales Expenses**: Increased by 9.94% - **2024 R&D Expenses**: Increased by 6.16%, R&D expense ratio at 16.74% - **2025 Q1 Sales Expenses**: Increased by 52% - **2025 Q1 Management Expenses**: Increased by 176% - **2025 Q1 R&D Expenses**: Decreased by 20.78% [2][6] Product Performance - **Automated Chemical Luminescence Immunoassay Analyzer Revenue (2024)**: 1.522 billion CNY, up 30.27% - **Overseas Revenue for Analyzers**: Increased by 69.1% [2][7] Installation and Market Coverage - **2024 New Installations of Self-produced Analyzers**: 2,662 units, with overseas growth of 80.56% - **Total Installations by 2025 Q1**: Over 11,340 units - **Coverage of Medical Institutions**: Over 6,090 domestic medical institutions, with a 70% coverage rate in top-tier hospitals [3][10][8] Innovations and R&D - **AI Medical Innovations**: Development of an AI-based indirect immunofluorescence ANA interpretation system with 91.3% accuracy and a false negative rate below 0.3% [12][13] - **Diabetes Management Platform**: Collaboration with Jiangsu Provincial People's Hospital to enhance diabetes diagnosis efficiency [14] Market Challenges and Strategies - **IVD Industry Pressures**: Challenges from DRG implementation, inspection mutual recognition, and healthcare cost control policies [17] - **Response to DRG Policy**: Adjusting strategies to maintain stable growth despite reduced testing volumes [18][19] Future Outlook - **Overseas Business Growth**: Expected to maintain over 50% growth in 2025 Q1, with a focus on non-US markets [15][36] - **Long-term Goals**: Aim to become a leading domestic brand in the immunodiagnostics field within five years and a global leader in ten years [38] Regulatory and Market Dynamics - **Impact of Tariff Policies**: Potential for increased domestic brand adoption due to tariff impacts on imports [20][30] - **Drug Centralized Procurement**: Implementation across provinces, providing opportunities for domestic brands [31] Conclusion - **Strategic Focus**: Emphasis on innovation, market expansion, and maintaining competitive advantages through AI and product development in the IVD sector [21][22][24]

Core Viewpoint - The company demonstrated strong operational resilience in its 2024 annual report, achieving a revenue of 2.012 billion yuan and a net profit of 302 million yuan, with a significant year-on-year growth in its self-owned business segment [2] Group 1: Financial Performance - The company reported a revenue of 2.012 billion yuan for 2024, with a net profit attributable to shareholders of 302 million yuan and a non-recurring net profit of 287 million yuan [2] - Revenue from the self-owned business segment reached 1.672 billion yuan, marking a year-on-year increase of 26.13% [2] Group 2: R&D and Technological Advancements - The company invested 338 million yuan in R&D for 2024, representing a year-on-year increase of 3.84% and accounting for 16.80% of total revenue [2] - The company has established a humanized antibody technology platform and integrated AI into the development of bioactive raw materials [3] Group 3: Product Development and Market Expansion - The company added 15 new chemical luminescence testing reagent projects, bringing the total to 178 registered projects by the end of the reporting period [3] - In the first quarter of 2025, the company added 6 more projects, increasing the total to 184 [3] - The company achieved a revenue of 250 million yuan from overseas self-owned business, reflecting a year-on-year growth of 64.78% [3] Group 4: Automation and Smart Solutions - The company developed the iTLA Max laboratory automation system, which integrates AI technology and can process up to 1,200 sample tubes per hour [3] - The automation system connects various instruments and utilizes intelligent robots for automatic supply addition [3] Group 5: International Market Performance - In the first quarter of 2025, the company added 283 new installations overseas, representing a year-on-year increase of 92.52% [3] - The overseas market generated a revenue of 52.3813 million yuan from chemical luminescence business, showing a year-on-year growth of 56.31% [3]