Core Viewpoint - The company, Aide Biology (300685.SZ), has recently received a medical device registration certificate from the National Medical Products Administration for its product, the human EGFR/ALK/ROS1/MET/KRAS gene mutation detection kit (multiplex fluorescent PCR method) [1] Group 1 - The product is designed for detecting multiple gene mutations, which is significant for personalized medicine and targeted therapies [1] - The approval from the regulatory authority indicates the product meets necessary safety and efficacy standards, potentially enhancing the company's market position [1] - This development may open new revenue streams for the company, as gene mutation testing is increasingly important in oncology [1]

Group 1 - The company,艾德生物, has recently received a medical device registration certificate from the National Medical Products Administration of China for its product named "Human EGFR/ALK/ROS1/MET/KRAS Gene Mutation Detection Kit" [1]

证券代码：300685 证券简称：艾德生物 公告编号：2025-053 厦门艾德生物医药科技股份有限公司 关于公司获得医疗器械注册证的公告 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。 该产品共覆盖11个非小细胞肺癌的必检基因和扩展基因，实现DNA与RNA 共检，其中EGFR、ALK、ROS1、MET、KRAS基因已在中国获批伴随诊断用 途，指导7种靶向药在国内的临床应用。目前，该产品已实现中日欧三地的获批 上市，累计已有七个基因获批伴随诊断，用于指导多达22种靶向药物的临床应 用，惠及全球众多非小细胞肺癌患者。 该伴随诊断产品医疗器械注册证的取得，进一步丰富了公司肿瘤伴随诊断 产品线，有利于增强公司综合竞争力，提高公司市场拓展能力，对公司未来的 发展将产生积极影响。 三、风险提示 上述产品实际销售情况取决于未来市场的推广效果，目前尚无法预测其对 公司未来业绩的影响，敬请广大投资者谨慎决策，注意防范投资风险。 四、备查文件 医疗器械注册证。 厦门艾德生物医药科技股份有限公司（以下简称"公司"）于近日获得由 国家药品监督管理局颁发的《中华人民共和国医疗器械注册 ...

Core Viewpoint - The stock of Aide Biological has shown a modest increase, with a current price of 23.30 CNY per share and a market capitalization of 9.123 billion CNY, reflecting a stable performance in the medical diagnostics sector [1]. Financial Performance - For the period from January to September 2025, Aide Biological reported a revenue of 866 million CNY, representing a year-on-year growth of 2.08%, while the net profit attributable to shareholders was 263 million CNY, marking a 15.50% increase compared to the previous year [2]. - The company has distributed a total of 421 million CNY in dividends since its A-share listing, with 232 million CNY distributed over the last three years [3]. Shareholder Information - As of September 30, 2025, the number of shareholders for Aide Biological increased to 26,600, up by 5.23%, while the average number of circulating shares per person decreased by 4.97% to 14,628 shares [2]. - The second-largest circulating shareholder is Hong Kong Central Clearing Limited, holding 35.3892 million shares, an increase of 3.7186 million shares from the previous period [3]. Stock Performance - Aide Biological's stock has increased by 3.56% year-to-date, with a 1.48% rise over the last five trading days and a 3.74% increase over the last 20 days, although it has seen a decline of 1.81% over the past 60 days [1]. Business Overview - Aide Biological, established on February 21, 2008, and listed on August 2, 2017, specializes in the research, production, and sales of molecular diagnostic products for precision oncology, with a revenue composition of 83.43% from testing reagents, 9.84% from clinical research services, and 5.61% from testing services [1]. - The company operates within the pharmaceutical and biotechnology sector, specifically in medical devices and in vitro diagnostics, and is associated with concepts such as gene sequencing and precision medicine [1].

Investment Rating - The report maintains a "Buy" rating for the company, indicating expected returns exceeding the market benchmark by more than 15% over the next 6-12 months [4][6]. Core Insights - The company reported a revenue of 866 million yuan for the first three quarters of 2025, a year-on-year increase of 2.08%. However, Q3 revenue declined by 6.12% to 286 million yuan, with a net profit of 73 million yuan, down 11.92% year-on-year [1][2]. - The decline in revenue is attributed to the impact of VAT rate adjustments on domestic sales and a decrease in project milestones for drug clinical research services [2]. - R&D expenses decreased by 28.03% year-on-year to 41.85 million yuan, accounting for 14.62% of revenue. The company is actively involved in multiple product registrations, including gene detection kits [3]. - The Southeast Asian market shows good growth, with strategic expansions in countries like Singapore, Vietnam, Malaysia, and Indonesia [3]. Summary by Sections Financial Performance - For Q3 2025, the company achieved a revenue of 286 million yuan, a decrease of 6.12% year-on-year. The net profit for the same period was 73 million yuan, down 11.92% year-on-year. The first three quarters of 2025 saw a total revenue of 866 million yuan, with a net profit of 263 million yuan, reflecting a 15.50% increase year-on-year [1][2]. R&D and Product Development - R&D expenses for Q3 2025 were 41.85 million yuan, a decline of 28.03% year-on-year. The company is involved in a Phase II clinical trial and has several products in the registration phase, including gene mutation detection kits [3]. Market Expansion - The company has established a strategic presence in the Southeast Asian market, which is experiencing good growth. Key markets include Singapore, Vietnam, Malaysia, and Indonesia, with a focus on building channels through partnerships with distributors and major pharmaceutical companies [3]. Profit Forecast and Valuation - The company is projected to maintain rapid growth, with net profit estimates of 342 million yuan, 379 million yuan, and 425 million yuan for 2025, 2026, and 2027, respectively. The current price corresponds to a PE ratio of 26 for 2025, 24 for 2026, and 21 for 2027 [4][5].

Investment Rating - The report maintains a "Buy" rating for the company [4][6]. Core Insights - The company reported a revenue of 866 million yuan for the first three quarters of 2025, a year-on-year increase of 2.08%, while the net profit attributable to shareholders was 263 million yuan, up 15.50% year-on-year [1][4]. - In Q3 2025, the company experienced a revenue decline of 6.12% year-on-year, primarily due to the impact of VAT rate adjustments and a decrease in project milestones for clinical research services [2][4]. - The company's R&D expenses decreased by 28.03% year-on-year in Q3 2025, accounting for 14.62% of revenue, with several products currently in the registration phase [3][4]. Summary by Sections Financial Performance - For Q3 2025, the company achieved a revenue of 286 million yuan, a decline of 6.12% year-on-year, and a net profit of 73 million yuan, down 11.92% year-on-year [1][2]. - The company’s sales expense ratio was 33.66%, an increase of 3.61 percentage points year-on-year, while the management expense ratio was 4.79%, up 0.12 percentage points year-on-year [2]. R&D and Product Development - The company’s R&D expenses in Q3 2025 were 41.85 million yuan, down 28.03% year-on-year, with several products in the registration phase, including gene detection kits [3][4]. - The company is actively expanding its international business, particularly in Southeast Asia, with a focus on markets like Singapore, Vietnam, Malaysia, and Indonesia [3]. Profit Forecast and Valuation - The company is projected to maintain rapid growth, with net profit forecasts for 2025, 2026, and 2027 at 342 million, 379 million, and 425 million yuan, respectively [4][5]. - The current price corresponds to a PE ratio of 26 for 2025, 24 for 2026, and 21 for 2027 [4][5].

Core Insights - The stock price of Aide Biological increased by 2.00% on October 31, reaching 22.95 CNY per share, with a market capitalization of 8.986 billion CNY [1] - The company reported a revenue of 866 million CNY for the first nine months of 2025, reflecting a year-on-year growth of 2.08%, and a net profit of 263 million CNY, up 15.50% year-on-year [2] - Aide Biological's main business includes the development, production, and sales of molecular diagnostic products for precision oncology, with testing reagents accounting for 83.43% of revenue [1] Financial Performance - As of September 30, 2025, Aide Biological had 26,600 shareholders, an increase of 5.23% from the previous period, with an average of 14,628 circulating shares per shareholder, down 4.97% [2] - Cumulative cash dividends since the company's A-share listing amount to 421 million CNY, with 232 million CNY distributed over the last three years [3] Shareholding Structure - As of September 30, 2025, Hong Kong Central Clearing Limited is the second-largest circulating shareholder, holding 35.3892 million shares, an increase of 3.7186 million shares from the previous period [3] - The fifth-largest circulating shareholder, Huabao CSI Medical ETF, holds 7.7022 million shares, a decrease of 1.3344 million shares from the previous period [3] - The tenth-largest circulating shareholder, Southern CSI 1000 ETF, holds 2.5088 million shares, marking a new entry [3]

艾德生物成立于2008年2月21日，于2017年8月2日在深圳证券交易所上市，注册及办公地址均为福建省厦 门市。它是国内肿瘤精准医疗分子诊断领域的领先企业，拥有全流程技术平台和丰富的产品管线。 艾德生物主营业务为肿瘤精准医疗分子诊断产品的研发、生产及销售，并提供相关的检测服务，所属申万 行业为医药生物 - 医疗器械 - 体外诊断，涉及基因测序、体外诊断、精准医疗等概念板块。 经营业绩：营收行业第12，净利润行业第5 2025年三季度，艾德生物实现营业收入8.66亿元，在行业39家公司中排名第12。行业第一名新产业营收 34.28亿元，第二名安图生物营收31.27亿元，行业平均数为7.08亿元，中位数为3.3亿元。主营业务构成 中，检测试剂4.83亿元占比83.43%，药物临床研究服务5698.83万元占比9.84%，检测服务3250.49万元占比 5.61%，其他（补充）651.67万元占比1.12%。当期净利润为2.63亿元，行业排名第5，行业第一名九安医疗 净利润15.88亿元，第二名新产业净利润12.05亿元，行业平均数为1.1亿元，中位数为2618.92万元。 资产负债率低于同业平均，毛利率高于同业平 ...

证券代码：300685 证券简称：艾德生物 公告编号：2025-052 | 序号 | 账户名称 | 持股数量 | 占公司总股本 | | --- | --- | --- | --- | | | | （股） | 比例（%） | | 1 | 前瞻投资（香港）有限公司 | 87,701,616 | 22.40 | | 2 | 香港中央结算有限公司 | 31,069,942 | 7.94 | | 3 | 厦门科英投资合伙企业（有限合伙） | 15,940,946 | 4.07 | | 4 | 宁波屹祥自有资金投资合伙企业（有限合伙） | 8,731,000 | 2.23 | | 5 | 中国银行股份有限公司－华宝中证医疗交易型开放式 指数证券投资基金 | 8,062,000 | 2.06 | | 6 | 厦门市海沧区润鼎盛投资合伙企业（普通合伙） | 4,098,726 | 1.05 | | 7 | 宋宁 | 3,440,000 | 0.88 | | 8 | 林作华 | 3,393,263 | 0.87 | | 9 | 全国社保基金四一三组合 | 3,111,820 | 0.79 | | 10 | 基本养老保险基金一二 ...

Financial Performance - In the first three quarters of 2025, the company achieved revenue of 866 million RMB, a year-on-year increase of 2.08% [2] - Net profit attributable to shareholders reached 263 million RMB, up 15.50% year-on-year, with a non-recurring net profit growth of 18.05% [2] - The net profit for 2025 has already surpassed the total for the entire year of 2024, indicating a robust growth trend [2] Sales Structure Adjustments - The domestic sales structure was adjusted in Q4 2024, leading to improved growth in 2025, with a reduction in related expense ratios [2] - International sales structure adjustments were made in the first half of 2025, focusing on key markets and optimizing the distributor system [3] Quarterly Performance Insights - In Q3 2025, net profit decreased by 11.92% due to a provision for bad debts amounting to 18.18 million RMB related to a long-term receivable from a technology transfer [4] - Revenue in Q3 declined by 6.12%, primarily due to changes in VAT rates and a decrease in income from clinical research services [4] Expense Management - Sales expenses increased in Q3 due to higher marketing and personnel costs, but the overall trend shows a decrease in sales expense ratio over recent years [6] - R&D expenses fluctuated between 15% and 18%, while management expenses remained stable at around 7% to 8% [6] Market Expansion - The company has strategically entered Southeast Asian markets, focusing on countries like Singapore, Vietnam, Malaysia, and Indonesia, which are expected to drive future growth [9] - The Southeast Asian market is seen as a significant growth point for international business, despite its current smaller revenue base [9] Product Development and Collaborations - New products in the registration process include HRD products and PCR tests, with data to be disclosed at the upcoming ESMO-Asia conference [10] - Collaboration with Sailu Medical aims to enhance the company's competitive edge in the NGS market by integrating core technologies [11] Regulatory and Market Access - Currently, the company's products are not included in national health insurance, but tumor gene testing has been incorporated into local insurance schemes, enhancing market penetration [12] - The company is preparing for potential participation in the upcoming round of centralized procurement in Jiangsu Province [12] Share Buyback Plan - The board plans to use 100 to 200 million RMB for share repurchase, pending shareholder approval [5]