广州达安基因股份有限公司 证券代码：002030 证券简称：达安基因 公告编号：2025-049 医疗器械名称：人类免疫缺陷病毒 1 型（HIV-1）DNA 检测试剂盒（PCR- 荧光探针法），注册证编号：国械注准 20253401805。有效期自批准之日起至 2030 年 9 月 4 日。预期用途：本产品用于体外定性检测人全血样本中的人类免疫缺陷 病毒 1 型脱氧核糖核酸（HIV-1 DNA）（仅 M 组）。 上述医疗器械注册证的取得丰富了公司的产品组合，拓宽了公司产品的应用 领域。目前，上述产品尚处于市场开发阶段，市场需求存在不确定性，请广大投 资者注意投资风险。 特此公告。 广州达安基因股份有限公司 关于取得一个医疗器械注册证的提示性公告 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。 近日，广州达安基因股份有限公司（以下简称"公司"）取得国家药品监督管 理局颁发的医疗器械注册证一个，具体为： 董 事 会 2025 年 9 月 8 日 ...

（编辑 王雪儿） 证券日报网讯 达安基因9月5日在互动平台回答投资者提问时表示，公司一直重视自身价值提升，但公 司股价受经营情况、宏观环境、行业环境等因素的综合影响，公司将根据市场和经营情况做好市值管理 工作，采取系列减亏增盈的措施，但具体效果还需要市场的验证。公司具体产品和财务情况，请关注公 司定期报告等相关公告。 ...

证券日报网讯达安基因（002030）9月5日在互动平台回答投资者提问时表示，截至2025年8月29日，公 司股东总户数约为14万6千户。 ...

Core Viewpoint - The company emphasizes economic efficiency as its core focus and is committed to optimizing its operational strategies to enhance performance and intrinsic value [2] Group 1: Operational Strategies - The company is continuously optimizing its operational strategies, which include improving the product matrix and optimizing research and development projects [2] - The company is actively working to revitalize production capacity and adjust personnel incentives and sales strategies [2] - The focus remains on core business areas to drive improvements in operational performance [2]

Investment Rating - The report provides a positive outlook on the MASH non-invasive diagnosis technology, suggesting it could accelerate new drug development in the pharmaceutical and biotechnology sector [2]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 0.65% from August 25 to August 29, underperforming compared to the Wind All A index (1.9%) and the CSI 300 index (2.71%). Only the medical research outsourcing (4.9%) and other biological products (0.14%) sectors saw gains, while in vitro diagnostics (-4.12%), raw materials (-3.34%), and vaccines (-0.59%) faced significant declines [2][7]. - The FDA has accepted the proposal for using VCTE-LSM as a reasonable alternative endpoint for clinical trials in adults with MASH and moderate to advanced fibrosis. This non-invasive method is expected to enhance patient compliance and could lead to a surge in drug development in the MASH area within the next two to three years [2][13]. - The report emphasizes the potential for domestic companies in China to leverage their cost advantages and forward-looking strategies in the field of non-invasive companion diagnostics, particularly in the MASH drug development competition [2]. Market Weekly Review - The pharmaceutical and biotechnology sector's performance was notably weaker than the broader market indices, with specific sub-sectors like medical research outsourcing and other biological products showing resilience [7][8]. - Individual stocks such as Tianchen Medical (30.1%), Ailis (25.6%), and Maiwei Biotech-U (22.4%) performed well, while stocks like Lifang Pharmaceutical (-13.9%), Yuekang Pharmaceutical (-11.9%), and Kanghua Biotech (-11.1%) faced significant losses [10][12]. Industry News and Key Company Announcements - On August 28, Kangfang Biotech announced that its drug AK112 received approval for treating advanced non-squamous non-small cell lung cancer, with promising clinical trial results expected to be presented at an international conference [12]. - The report highlights various companies' financial performances, with notable revenue changes and profit margins, indicating a mixed outlook across the sector [16][17].

Core Viewpoint - Da An Gene's financial performance in the 2025 mid-year report shows a significant decline in revenue and a notable increase in net loss, indicating potential challenges in its business model and operational efficiency [1]. Financial Performance Summary - Total revenue for the first half of 2025 was 339 million yuan, a decrease of 15.44% year-on-year [1]. - The net profit attributable to shareholders was -182 million yuan, an increase in loss of 54.37% compared to the previous year [1]. - In Q2 2025, total revenue was 169 million yuan, down 16.15% year-on-year, with a net profit of -235 million yuan, reflecting a drastic decline of 554.32% [1]. - The gross margin was 33.04%, a decrease of 19.84% year-on-year, while the net margin was -56.15%, an improvement of 43.46% year-on-year [1]. - The total of selling, administrative, and financial expenses reached 155 million yuan, accounting for 45.71% of total revenue, an increase of 88.17% year-on-year [1]. - Earnings per share were -0.13 yuan, an increase of 53.57% year-on-year, while operating cash flow per share was -0.01 yuan, a decrease of 153.35% year-on-year [1]. Business Model Insights - The company's performance is primarily driven by research and marketing efforts, necessitating a thorough examination of the underlying factors influencing these drivers [2].

Core Viewpoint - 达安基因 reported a significant decline in revenue and net profit for the first half of 2025, indicating potential challenges in its business operations [1] Financial Performance - The company achieved an operating revenue of 339 million yuan, representing a year-on-year decrease of 15.44% [1] - The net profit attributable to shareholders of the listed company was -182 million yuan [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was -265 million yuan [1] - The basic earnings per share were -0.13 yuan [1]

Core Viewpoint - The company reported a significant decrease in revenue and a net loss for the first half of 2025, attributed to industry competition, policy changes, and adjustments in tax rates, while emphasizing ongoing efforts in operational efficiency and market expansion [6][10][12]. Financial Performance - The company achieved total revenue of CNY 338,574,032.79, a decrease of 15.44% compared to the same period last year [6]. - The total profit amounted to -CNY 219,183,574.64, an increase of 53.95% year-on-year [6]. - The net profit attributable to shareholders was -CNY 182,160,988.30, reflecting a year-on-year increase of 54.37% [6]. Business Strategy and Market Position - The company focused on enhancing its marketing system and expanding into new products and markets, including international markets, with products reaching over 140 countries [6][7]. - The company maintained its leading position in the domestic molecular diagnostics field while diversifying into various sectors such as public health and research [7]. Research and Development - The company invested CNY 131,648,203.29 in R&D, accounting for 38.88% of revenue, despite a year-on-year decrease of 29.66% [9]. - New product approvals included a seasonal flu virus nucleic acid detection kit and a six-pathogen detection kit, enhancing the company's product offerings [9]. Operational Efficiency - The company implemented measures to optimize resource allocation and control costs, resulting in a 1.47% reduction in management expenses compared to the previous year [10]. Corporate Social Responsibility - The company donated CNY 97,000 to support educational initiatives, demonstrating its commitment to social responsibility [11]. Government Support and Recognition - The company received multiple awards and recognitions from government bodies, including being named a "High-tech Enterprise" and receiving various certificates for its contributions to the industry [12].

Group 1 - The company reported total assets of 11,191.56 million yuan and net assets of 2,228.54 million yuan as of June 30, 2025, with an operating income of 0.00 million yuan and a net loss of 45.18 million yuan [2] - The company has a stake of 33.24% in Guangzhou Changtong Medical Technology Co., Ltd., which constitutes an associated relationship [2] - Shanghai Dashan Biotechnology Co., Ltd. is a subsidiary in which the company holds a 21.788% stake, establishing an associated relationship [3] Group 2 - YunKang Health Industry Investment Co., Ltd. is another subsidiary where the company holds a 46.9566% stake, indicating an associated relationship [6] - Guangzhou Sai Jun Biotechnology Co., Ltd. is a joint venture with a 32.63% stake held by the company, also indicating an associated relationship [8] - Guangzhou Financial Holdings Group Co., Ltd. holds a total of 31.63% of the company's shares through its subsidiaries, establishing an associated relationship [10] Group 3 - The company expects to have daily related transactions with Guangzhou Tiancheng Medical Technology Co., Ltd. not exceeding 0.50 million yuan in 2025 [11] - Expected daily related transactions with Guangzhou Changtong Medical Technology Co., Ltd. and its subsidiaries are projected to be no more than 0.01 million yuan [12] - The company anticipates daily related transactions with Shanghai Dashan Biotechnology Co., Ltd. to be up to 5.00 million yuan [13] Group 4 - The company follows a pricing policy based on market fair prices for its related transactions, ensuring transparency and fairness [16] - All related transactions are formalized through written agreements detailing transaction terms, pricing principles, and payment methods [17] - The purpose of these transactions is to support the company's operations and development, leveraging the advantages of associated parties to enhance sales and reduce costs [18] Group 5 - The independent directors of the company have reviewed and approved the related transaction proposals, affirming their alignment with the company's strategic development and benefit to overall efficiency [19] - The board's decision-making process regarding these transactions adhered to legal and regulatory requirements, ensuring no harm to the interests of shareholders [19]

Company Overview - DaAn Gene (SZ 002030) announced its first board meeting of the ninth session held on August 28, 2025, in Guangzhou, discussing the revision and formulation of certain company systems [1] Financial Performance - For the first half of 2025, DaAn Gene's revenue composition was as follows: 95.68% from the bioproducts sector and 4.32% from financial services [1]