深圳普门科技股份有限公司 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。 深圳普门科技股份有限公司（以下简称"公司"）于近期收到了1个广东省 药品监督管理局颁发的《中华人民共和国医疗器械注册证（体外诊断试剂）》， 具体情况如下： 证券代码：688389 证券简称：普门科技 公告编号：2025-063 上述注册证的取得仅代表公司相关产品获得国内市场准入资格，产品上市后 的实际销售情况取决于未来市场的推广效果，目前尚无法预测上述产品对公司未 1 / 2 来业绩的具体影响。 敬请投资者理性投资，注意投资风险。 特此公告。 深圳普门科技股份有限公司董事会 一、医疗器械注册证的具体情况 | 产品名称 | 注册 | 注册证 | 注册证 | | 预期用途 | | --- | --- | --- | --- | --- | --- | | | 分类 | 编号 | 有效期至 | | | | β-人绒毛膜促性腺激素 （β-HCG | | 粤械注准 | | 年 | 用于体外定量测定人血清或血 浆中β-人绒毛 ...

Policy Developments - The National Health Commission and five other departments released measures to enhance the experience of family doctor contract services, focusing on improving service quality and health management for residents [2] Drug and Device Approvals - Novo Nordisk's Wegovy (semaglutide 2.4mg) received FDA approval for treating metabolic-associated fatty liver disease (MASH) with moderate to severe liver fibrosis, which is expected to boost sales [3] - Yiling Pharmaceutical's new traditional Chinese medicine, "Children's Lianhua Qinggan Granules," has received acceptance for its new drug registration application [4] - Pumen Technology obtained a medical device registration certificate for its high-sensitivity cardiac troponin I testing kit, which aids in diagnosing myocardial infarction [5] Financial Reports - Ping An Good Doctor reported a 19.5% increase in revenue to approximately 2.502 billion yuan and a net profit increase of 136.8% to 134 million yuan for the first half of the year [6] - Weier Pharmaceutical's revenue decreased by 2.1% to 674 million yuan, with a net profit decline of 7.77% to 72.77 million yuan in the same period [7] Capital Market Activities - Jianzhijia plans to sell its Qinhuangdao logistics center assets for approximately 24 million yuan, which does not constitute a related party transaction [8] - Gilead Sciences announced a placement of 52.4 million shares at a discount of about 9.9%, with expected net proceeds of approximately 467.69 million HKD, primarily for clinical trials related to obesity [9] Industry News - The National Disease Control Bureau reported a decline in new cases of Chikungunya fever in Foshan, with daily cases dropping from over 600 to below 100, indicating effective control measures [10] - A breakthrough study from Harvard University demonstrated the ability to induce human pluripotent stem cells to initiate meiosis, offering new hope for addressing infertility [11] Public Sentiment Alerts - Baiotai announced that Xinyu Qiheng reduced its stake by 0.78%, selling 3.2169 million shares and raising approximately 105 million yuan [12]

风险提示：本文所提及个股仅作客观陈述，不构成投资建议。市场有风险，投资需谨慎。 8月19日公司公告称，获得广东省药监局颁发的《医疗器械注册证》，产品为高敏心肌肌钙蛋白I测定试 剂盒。该试剂采用电化学发光法，用于检测心肌损伤标志物，当心肌受损时能快速检测外周血中cTnI浓 度变化。 资金流向方面，当日主力资金净流出1352.27万元，近五日累计净流出2395.26万元。 普门科技8月19日报收14.49元，较前一交易日下跌0.11元，跌幅0.75%。当日成交量为60910手，成交金 额达0.89亿元，总市值62.09亿元。 该公司主营业务为医疗器械制造，产品涵盖体外诊断、治疗与康复等领域。2024年财报显示，医疗器械 业务占营收比重达98.56%。2025年一季度实现营业收入2.15亿元，净利润5368万元。 ...

Core Viewpoint - Pumen Technology has received a medical device registration certificate for its high-sensitivity cardiac troponin I (hs-cTnISTAT) assay kit from the Guangdong Provincial Drug Administration [1] Company Summary - The product is classified as an in vitro diagnostic reagent and utilizes electrochemical luminescence technology [1]

Group 1 - Pumen Technology (SH 688389, closing price: 14.49 yuan) announced on August 19 that it has received a Medical Device Registration Certificate from the Guangdong Provincial Drug Administration for its product "High-Sensitivity Cardiac Troponin I Test Kit" [2] - For the year 2024, Pumen Technology's revenue composition is as follows: 98.56% from medical devices and 1.44% from other businesses [2]

证券代码：688389 证券简称：普门科技 公告编号：2025-062 深圳普门科技股份有限公司 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。 深圳普门科技股份有限公司（以下简称"公司"）于近期收到了1个广东省 药品监督管理局颁发的《中华人民共和国医疗器械注册证（体外诊断试剂）》， 具体情况如下： 一、医疗器械注册证的具体情况 | 产品名称 | | | | | 注册 | 注册证 | 注册证 | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | 分类 | 编号 | 有效期至 | | | | 高 敏 心 肌 （hs-cTnI STAT）测定试 | 肌 | 钙 | 蛋 | 白 I | 类 II | 粤械注准 | 2030 | 年 | 用于体外定量测定人血清或血 浆中肌钙蛋白 （I cTnI）的含量。 | | | | | | | | 20252401126 | 月 日 8 | ...

格隆汇8月19日丨普门科技(688389.SH)公布，近期收到了1个广东省药品监督管理局颁发的《中华人民 共和国医疗器械注册证（体外诊断试剂）》，产品名称：高敏心肌肌钙蛋白I（hs-cTnISTAT）测定试剂 盒（电化学发光法）。心肌肌钙蛋白I（cTnI）是临床诊断中高度敏感的心肌损伤标志物。当心肌发生 损伤后，细胞中多种形式的心肌肌钙蛋白（包括I-C复合物、I-T-C三聚体以及游离肌钙蛋白I、游离肌钙 蛋白T）释放到血液中，导致外周血中cTnI浓度迅速上升。大量临床研究表明，在急性心肌梗死发病后 4-10小时，心肌肌钙蛋白会出现在血清中，其浓度在12-48小时达到峰值，并在随后4-10天内维持升高状 态。心肌肌钙蛋白水平的动态变化，是鉴别急性和慢性心肌损伤的关键，同时可以辅助诊断心肌梗死。 ...

Company Overview - Pumen Technology specializes in the research, manufacturing, global sales, and services of in vitro diagnostics, clinical medicine, skin aesthetics, and consumer health products [2] - The main products include medical products, home products, testing equipment, and testing reagents [2] Recent Achievements - In January 2024, Pumen Technology was awarded the "Smart Health and Elderly Care Application Pilot Demonstration - Demonstration Enterprise" by three ministries [2] - The project "Micro-tube Inner Surface Wear-resistant Superhydrophobic Coating and Its Application in Medical Devices" won the "2023 China Corrosion and Protection Society Science and Technology Award" first prize [2] - The subsidiary Guangdong Pumen Biomedical Technology Co., Ltd. was recognized as a "Specialized, Refined, Characteristic, and Innovative Small and Medium-sized Enterprise" by the Guangdong Provincial Department of Industry and Information Technology [2] - A collaborative project with Chongqing University on "Key Technology Development and Industrialization of Fully Automatic Specific Protein Analyzer" received the "2023 China Industry-University-Research Cooperation Innovation Achievement Award" second prize [2] Financial Performance - In Q1 2025, the company reported revenue of 215 million yuan, a year-on-year decrease of 29.69% [2] - Net profit for the same period was 53.68 million yuan, down 49.93% year-on-year [2] - The sales gross margin stood at 64.97% [2] Market Position - As of August 15, Pumen Technology's stock closed at 14.68 yuan, with a PE ratio of 21.55, marking a new low in 92 days [1] - The company's total market capitalization is 6.29 billion yuan [1] - In comparison to the medical device industry, which has an average PE ratio of 56.58 and a median of 39.97, Pumen Technology ranks 45th [1][3] Shareholder Information - As of March 31, 2025, Pumen Technology had 13,289 shareholders, an increase of 3,464 from the previous count [1] - The average market value of shares held by each shareholder is 352,800 yuan, with an average holding of 27,600 shares [1]

Group 1 - The core viewpoint of the news highlights the financial performance and market position of Pumen Technology, indicating a decline in revenue and profit for the first quarter of 2025, alongside a relatively low PE ratio compared to the industry average [1][2][3] Group 2 - Pumen Technology's main business includes research, manufacturing, global sales, and services of in vitro diagnostics, clinical medicine, skin aesthetics, and consumer health products [2] - The company achieved a revenue of 215 million yuan in Q1 2025, representing a year-on-year decrease of 29.69%, and a net profit of 53.68 million yuan, down 49.93% year-on-year, with a gross margin of 64.97% [2] - As of March 31, 2025, the number of shareholders increased to 13,289, with an average holding value of 352,800 yuan and an average holding quantity of 27,600 shares [1] - Pumen Technology's current PE ratio is 20.98, while the industry average is 55.76, and the industry median is 39.14, placing the company at the 45th position in the industry ranking [1][3] - The company received several awards, including the "Smart Health Elderly Care Application Pilot Demonstration - Demonstration Enterprise" and the "2023 China Corrosion and Protection Society Science and Technology Award" [2]

Core Insights - The article highlights the development and implementation of a digital health management platform by Guangfa Bank in collaboration with Shenzhen Elderly Care Home, showcasing the bank's commitment to "elderly finance" and its technological and comprehensive financial advantages [1][7]. Group 1: Elderly Finance Development - Guangfa Bank is accelerating the construction of its elderly finance service system, aiming to become a leading account manager in this sector, with a focus on digital transformation and a five-in-one development matrix [2][3]. - The bank has developed over 220 personal pension products to meet diverse customer needs and has established a unique elderly finance service system that addresses the financial service challenges faced by the elderly [3]. Group 2: Digital Health Management Platform - The digital health management platform allows for information sharing among institutions, caregivers, elderly individuals, and their families, enhancing care quality and management efficiency [8]. - The platform integrates various smart devices to monitor health and provides tailored care plans based on health assessments, significantly improving the quality of life for the elderly [8]. Group 3: Collaboration with Healthcare Enterprises - Guangfa Bank focuses on providing financial support to quality projects in the health and elderly care sectors, exemplified by its partnership with Pumen Technology, which has received comprehensive financial solutions to support its growth [4][5]. - The bank has facilitated a collaboration between Pumen Technology and China Life Property Insurance, exploring investment and elderly finance cooperation opportunities [6].