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。 证券代码：300685 证券简称：艾德生物 公告编号：2025-054 厦门艾德生物医药科技股份有限公司 关于回购股份事项前十名股东及前十名无限售条件股东 持股情况的公告 | 序号 | 账户名称 | 持股数量 （股） | 占无限售条件 流通股股本比 | | --- | --- | --- | --- | | | | | 例（%） | | 1 | 前瞻投资（香港）有限公司 | 87,701,616 | 22.51 | | 2 | 香港中央结算有限公司 | 31,394,756 | 8.06 | | 3 | 厦门科英投资合伙企业（有限合伙） | 15,940,946 | 4.09 | | 4 | 宁波屹祥自有资金投资合伙企业（有限合伙） | 8,731,000 | 2.24 | | 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 | 7,964,200 | 2.04 | | 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 ...

Policy Developments - The National Health Commission and five other departments launched a one-year special campaign against illegal ambulances, targeting both registered "ambulance" vehicles and unregistered "black ambulances" [2] - The campaign includes comprehensive inspections, management principles, and encourages social participation in medical transport services [2][3] Drug and Medical Device Approvals - Aied Bio received a medical device registration certificate for its gene mutation detection kit, which is now approved in China, Japan, and Europe, aiding non-small cell lung cancer patients [4] - Hainan Haiyao's subsidiary obtained a drug registration certificate for Fumaric Acid Vonoprazan Tablets, the first P-CAB for reflux esophagitis in China [5] Capital Market Activities - China National Pharmaceutical Modern signed a drug listing license transfer contract for Lactulose Oral Solution, with a total transfer fee of 5.86 million yuan, projected to generate 2.069 billion yuan in sales in 2024 [6] - Jiangsu Hengrui Medicine and Neurocrine Biosciences entered a collaboration for developing NLRP3 inhibitors, with a potential total value of $881.5 million [7][8] Industry Events - The 2025 medical insurance negotiation concluded, with results expected to be announced in early December [9] - The only approved stem cell drug in China, Aimi Maito Sai Injection, is included in the "Beijing Universal Health Insurance" with a maximum reimbursement of 65% [10] Regulatory Issues - The executive director of CSPC Pharmaceutical Group was fined 5 million yuan for insider trading related to a merger announcement [11]

Core Viewpoint - The company, Adebiotech, has recently received a medical device registration certificate from the National Medical Products Administration of China for its EGFR/ALK/ROS1/MET/KRAS gene mutation detection kit, which is significant for non-small cell lung cancer diagnostics [1] Group 1: Product Approval and Features - The product covers 11 essential and extended genes for non-small cell lung cancer, enabling both DNA and RNA testing [1] - The EGFR, ALK, ROS1, MET, and KRAS genes have been approved for companion diagnostics in China, guiding the clinical application of seven targeted therapies [1] Group 2: Market Reach and Impact - The product has been approved for sale in China, Japan, and Europe, with a total of seven genes approved for companion diagnostics [1] - It supports the clinical application of up to 22 targeted therapies, benefiting numerous non-small cell lung cancer patients globally [1]

Core Viewpoint - The company, Adicon Biological, 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] Company Summary - Adicon Biological has been granted a medical device registration certificate, indicating regulatory approval for its gene mutation detection kit [1]

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].