Core Viewpoint - The company, Aihuilong (688575), has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its iFlash-HBsAg and iFlash-Anti-HBs test kits, enabling entry into the EU market [1] Company Summary - The certified products include the iFlash-HBsAg hepatitis B virus surface antigen test kit and the iFlash-Anti-HBs hepatitis B virus surface antibody test kit, both utilizing chemiluminescence [1] - The certification meets the necessary conditions for the products to enter the EU market, which is expected to positively impact the company's business promotion in the EU and CE-recognized regions [1]

证券代码：688575 证券简称：亚辉龙 公告编号：2025-049 深圳市亚辉龙生物科技股份有限公司 关于自愿披露取得IVDR CE认证的公告 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BSI Group The Netherlands B.V.签发的IVDR CE最高风险等级Class D认证证书， 具体信息如下： 截至目前，公司累计已有 226 个产品获得 IVDR CE 认证。根据欧盟体外诊断医疗 器械法规的规定，本次获得认证的产品已经具备进入欧盟市场的必要条件，对公司在欧 盟地区及认可 CE 认证地区的业务推广将产生积极影响，但产品具体销售情况受到市场 等因素影响，公司尚无法预测上述产品对公司未来业绩的影响，敬请广大投资者理性投 资，注意投资风险。 特此公告。 深圳市亚辉龙生物科技股份有限公司 董事会 2025 年 9 月 6 日 | 序号 | 产品名称 | | 证书编号 | 有效期 | 临床用途 | | --- | --- | ...

Core Viewpoint - The company, 亚辉龙 (688575.SH), has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its products related to hepatitis B virus testing [1] Group 1 - The certified products include the iFlash-HBsAg hepatitis B virus surface antigen detection kit (chemiluminescence method) [1] - The second certified product is the iFlash-Anti-HBs hepatitis B virus surface antibody detection kit (chemiluminescence method) [1]

Core Points - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its products under the IVDR CE marking [1] - A total of 226 products have now obtained IVDR CE certification, allowing them to enter the EU market [1] - The certification will positively impact the company's business promotion in the EU and CE-recognized regions, although the specific sales performance remains uncertain due to market factors [1]

Core Points - Aihua Long (688575.SH) has received the highest risk level Class D certification from BSI Group The Netherlands B.V. under the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746), which replaces the previous directive (IVDD, 98/79/EC) for managing in vitro diagnostic medical devices in the EU market [1] Product Certification Details - Product Name: iFlash-HBsAg Hepatitis B Surface Antigen - Certificate Number: IVDR 781230 - Valid Until: September 1, 2030 - Clinical Use: Quantitative detection of Hepatitis B surface antigen in human serum or plasma, assisting in diagnosis [2] - Product Name: iFlash-Anti-HBs Hepatitis B Surface Antibody - Certificate Number: IVDR 781231 - Valid Until: September 1, 2030 - Clinical Use: Quantitative detection of Hepatitis B surface antibody in human serum or plasma, assisting in monitoring vaccination effects or recovery progress of infected individuals [2]

Core Insights - The company reported a significant decline in revenue and net profit for the first half of 2025, with total revenue of 808 million yuan, down 15.79% year-on-year, and a net profit of 26 million yuan, down 84.82% year-on-year [1] Group 1: Domestic and Overseas Performance - Domestic performance is under pressure due to factors such as medical insurance cost control, price reductions from centralized procurement, and intensified market competition, leading to a total revenue of 671 million yuan from domestic operations, a decrease of 14.98% [2] - Overseas self-operated revenue showed strong growth, reaching 129 million yuan, an increase of 26% [2] - The demand for terminal testing of domestic luminescent reagents is beginning to recover, which, along with continued overseas growth, is expected to drive performance recovery in the second half of the year [2] Group 2: Equipment Installation and Market Expansion - The company accelerated the installation of self-produced luminescent instruments, with 1,090 new installations in the first half of 2025, including 546 in the domestic market and 544 overseas [3] - The company has also installed 57 new production lines, representing a year-on-year growth of 54.05% [3] - The integration of AI technology with the production line is expected to enhance detection efficiency and accuracy, strengthening the company's competitive edge and aiding market expansion, particularly in top-tier hospitals [3] Group 3: Profit Forecast - The company forecasts total revenue for 2025-2027 to be 1.996 billion yuan, 2.290 billion yuan, and 2.632 billion yuan, with year-on-year growth rates of -0.75%, 14.70%, and 14.94% respectively [4] - The projected net profit for the same period is 126 million yuan, 297 million yuan, and 403 million yuan, with year-on-year growth rates of -58.20%, 135.64%, and 35.60% respectively [4]

Group 1 - Dan Yi Investment recently conducted research on two listed companies: YHLO and Sinocare [1] - YHLO has completed the prototype of its second-generation sequencing system, achieving full self-research and production of core reagents, auxiliary reagents, and auxiliary enzyme reagents [1] - YHLO is integrating its product matrix, technology research and development, customer service, and data with AI platforms like DeepSeek, enhancing its laboratory automation solutions [1] - Sinocare's medical AI platform, SinoGPT, has integrated with DeepSeek to scale intelligent services, focusing on diabetes management [1] - Sinocare plans to leverage DeepSeek's reasoning capabilities to develop a specialized model for the diabetes vertical [1] Group 2 - Shanghai Dan Yi Investment Management Partnership is a domestic private investment management institution established in April 2015 with a paid-in capital of 10 million [2] - The core executives of Dan Yi Investment have over ten years of experience in investment research, having worked at prominent institutions like Huabao Xingye Fund and Guotou Ruijin Fund [2] - During their careers, the executives managed funds totaling several billion, ranking among the top in the industry [2]

Group 1: Gao Weida (高伟达) - Gao Weida achieved operating revenue of approximately 520.21 million yuan and a net profit of 13.83 million yuan in the first half of 2025, with a second-quarter net profit of 24.37 million yuan, reflecting a quarter-on-quarter growth of 231.19% [1] - The company is leveraging large model technology to implement multiple AI projects in credit scenarios, enhancing business revenue and exploring new development opportunities [1] - The new business model focuses on providing full lifecycle management for retail credit, rapidly increasing credit scale and managing non-performing assets, shifting from customized development to an operational model with a revenue-sharing approach [1] Group 2: Yahui Long (亚辉龙) - Yahui Long has completed the prototype of its second-generation sequencing project, achieving full self-research and production of core reagents, auxiliary reagents, and auxiliary enzyme reagents [2] - The company is advancing the integration of its product matrix, technology research and development, customer service, and office data with AI platforms like DeepSeek, enhancing laboratory automation [2] Group 3: Haoyang Co., Ltd. (浩洋股份) - Haoyang reported revenue of approximately 522 million yuan in the first half of 2025, a year-on-year decline of 21.99%, and a net profit of 7.8 million yuan, down 61.69% year-on-year [2] - Following the acquisition of Danish SGM company assets, Haoyang has established subsidiaries in Denmark and the United States, with positive market feedback on new product sales [2] - The company anticipates growth in overseas performance activities over the next two years, with expectations for the U.S. market to gradually recover, enhancing its R&D capabilities to improve competitiveness [2] Group 4: Zhonggeng Fund (中庚基金) - Zhonggeng Fund, established in 2015, has an asset management scale of 11.607 billion yuan, ranking 140th out of 210 in total public funds [3] - The fund's best-performing product in the past year is the Zhonggeng Hong Kong Stock Connect Value Fund, with a latest net value of 1.21 and a growth of 58.62% over the past year [3]

Core Viewpoint - The company reported a significant decline in revenue and net profit for the first half of 2025, primarily due to domestic market pressures and increased competition, while overseas business showed growth potential [1][2]. Financial Performance - In H1 2025, the company achieved revenue of 808 million yuan, a year-on-year decrease of 15.79%, and a net profit of 26 million yuan, down 84.82% year-on-year [1]. - In Q2 2025, revenue was 391 million yuan, reflecting a 26.12% year-on-year decline, with net profit at 16 million yuan, down 84.93% year-on-year [1]. - The company's main business revenue was 671 million yuan, a decrease of 14.98% year-on-year, with domestic revenue at 542 million yuan, down 21.08%, while overseas revenue grew by 26.00% to 129 million yuan [2]. Business Segments - The self-produced chemiluminescence business generated 603 million yuan in revenue, down 15.87% year-on-year, with a gross margin of 61.58% [2]. - The company installed 1,090 self-produced chemiluminescence instruments in H1 2025, with 546 units in the domestic market and 544 units overseas [3]. - The pipeline business saw a remarkable growth of 54.05%, with 57 new installations, including 11 new contracts for the self-developed iTLA Max pipeline [3]. Strategic Initiatives - The company is advancing its "AI + IVD" strategy, focusing on product transformation and upgrades based on clinical needs [4]. - In the diabetes sector, the company launched the PIFI digital platform for standardized assessment of pancreatic function, utilizing large-scale clinical data and machine learning [4]. - The company has developed an intelligent interpretation system for autoimmune diseases, achieving a recognition accuracy of 91.3% and deployed it in over 30 top-tier hospitals [4]. Investment Outlook - The company maintains a "buy" rating, with projected revenues of 1.851 billion yuan, 2.167 billion yuan, and 2.542 billion yuan for 2025-2027, reflecting a year-on-year growth of -8.0%, 17.1%, and 17.3% respectively [5]. - Expected net profits for the same period are 114 million yuan, 300 million yuan, and 415 million yuan, with corresponding EPS of 0.20, 0.53, and 0.73 yuan [5].

Investment Rating - The report maintains a "Buy" rating for the company [9] Core Views - The company's revenue for the first half of 2025 was 808 million yuan, a year-on-year decrease of 15.79%, with a net profit attributable to the parent company of 26 million yuan, down 84.82% year-on-year [2] - Domestic business is under short-term pressure due to medical insurance cost control policies, while overseas business continues to grow significantly, with overseas revenue increasing by 26.00% to 129 million yuan [3] - The company's "AI + IVD" strategy is being implemented, enhancing product lines in diabetes and autoimmune disease diagnostics [5] Financial Performance - In the first half of 2025, the company's gross profit margin was 61.58%, with the chemical luminescence reagent business gross margin at 80.15% [3] - The company expects revenues of 1.85 billion yuan in 2025, with a projected net profit of 114 million yuan, reflecting a year-on-year decline of 62.1% [11] - The earnings per share (EPS) is projected to be 0.20 yuan in 2025, with a price-to-earnings (P/E) ratio of 77x [9][11] Business Segments - The company installed 1,090 chemical luminescence instruments in the first half of 2025, with a notable increase in the number of production lines, which grew by 54.05% year-on-year [4] - The company has deepened its customer coverage, with over 6,210 domestic medical institutions, including more than 1,260 top-tier hospitals [4] Strategic Initiatives - The company has launched the PIFI digital platform for diabetes, enhancing clinical diagnosis through machine learning [5] - The development of an intelligent interpretation system for autoimmune diseases has improved accuracy to 91.3% [5] - The integration of AI technology in laboratory automation is being explored to enhance operational efficiency [8]