截至目前，我国上市的创新医疗器械累计 384项 。 # 经导管主动脉 瓣系 统 近日，国家药品监督管理局（NMPA）批准了 沛嘉医疗科技（苏州）有限公司 的 "经导管主动脉瓣系统"（TaurusTrio） （注册证号：国械注准 20253132489） 以及 泰州度博迈医疗器械有限公司 的 一次性使用无菌导尿管 （国械注准 20253142490） 2项创新产品注册申请。 | 383 | 经导管主动脉瓣系统 | 沛嘉医疗科技(苏州) | 2025-12-10 | 江苏 | 国械注准 | | --- | --- | --- | --- | --- | --- | | | | 有限公司 | | | 20253132489 | | 384 | 一次性使用无菌导尿管 | 泰州度博迈医疗器械 | 2025-12-10 | 江苏 | 国械注准 | | | | 有限公司 | | | 20253142490 | 产 品 信 息 ： Ta u r u s Tr i o 的 结 构 设 计 — — 面 向 反 流 难 题 的 专 用 工 程 路 径 主动脉瓣反流（AR）长期被视为 TAVR 领域最具挑战性的适应症之一，核心原因在 ...

人民网北京12月12日电 （记者孙红丽）据国家药监局网站消息，近日，国家药品监督管理局批准 了泰州度博迈医疗器械有限公司"一次性使用无菌导尿管"创新产品注册申请。 药品监督管理部门将加强该产品上市后监管，保护患者用械安全。 该产品分为单腔、双腔和三腔型。导尿管管身外表面含有聚赖氨酸涂层，基于聚赖氨酸与细菌细胞 膜的电荷相互作用机制，以直接接触方式发挥抑菌作用，减少细菌在导尿管表面的定植和生长。 ...

Core Viewpoint - The company, Weili Medical (603309.SH), announced that its products, including disposable sterile catheters and ultrasound-guided nerve block anesthesia puncture needles, have been selected for the second batch of innovative drug and medical device product catalog in Guangzhou, which recognizes the technological advancement and innovation of the company's products [1] Summary by Category - **Product Recognition** - The inclusion of the products in the catalog is a recognition of the technological advancement and innovation of the company's offerings [1] - **Market Impact** - This recognition is expected to enhance the company's brand awareness and market competitiveness, positively influencing the sales of its innovative products [1] - **Short-term Financial Impact** - However, the short-term impact on the company's operating performance is expected to be minimal, and investors are advised to remain cautious regarding investment risks [1]

Investment Rating - The investment rating for the company is not explicitly stated in the provided documents, but the report indicates a positive outlook on the company's performance and growth potential [1][3]. Core Viewpoints - The company has ended inventory destocking with significant localization effects and is experiencing high growth in overseas markets. However, domestic sales are impacted by medical industry regulations, leading to a slowdown in growth [3]. - In 2024, the company achieved a revenue of 1.509 billion yuan, a year-on-year increase of 8.76%, and a net profit of 219 million yuan, up 13.98% year-on-year. The first quarter of 2025 saw a revenue of 348 million yuan, reflecting a year-on-year growth of 12.6% [1][3]. - The company is expanding its market presence in Mexico, Europe, and emerging markets in South America and Southeast Asia, with foreign sales revenue reaching 797 million yuan, a year-on-year increase of 23.74%, accounting for 52.82% of total revenue [3]. - The company has shown strong growth in its anesthesia and urology product lines, with revenues of 477 million yuan and 216 million yuan, respectively, while nursing and catheter products also saw significant growth [3]. Financial Summary - The company’s revenue is projected to grow from 1.753 billion yuan in 2025 to 2.438 billion yuan in 2027, with year-on-year growth rates of 16.1%, 17.6%, and 18.2% respectively [4]. - The net profit attributable to the parent company is expected to increase from 264 million yuan in 2025 to 399 million yuan in 2027, with growth rates of 20.3%, 22.9%, and 23.1% [4]. - The gross margin for 2024 was reported at 44.53%, a decrease of 1.36 percentage points year-on-year, primarily due to the higher proportion of lower-margin overseas sales [3][4]. - The company has effectively controlled expenses, leading to an increase in the net profit margin to 15.14%, up 0.4 percentage points year-on-year [3].

Investment Rating - The investment rating for the company is not explicitly stated in the provided documents, but the report indicates a positive outlook on the company's performance and growth potential [1][3]. Core Viewpoints - The company has ended inventory destocking with significant localization effects and is experiencing high growth in overseas markets. However, domestic sales are impacted by medical industry regulations, leading to a slowdown in growth [3]. - In 2024, the company achieved a revenue of 1.509 billion yuan, a year-on-year increase of 8.76%, and a net profit attributable to the parent company of 219 million yuan, up 13.98% year-on-year [1]. - The company is expanding its production base in Mexico and exploring markets in Europe, South America, and Southeast Asia, resulting in a 23.74% year-on-year increase in foreign sales revenue, which now accounts for 52.82% of total revenue [3]. - The company’s product lines, particularly anesthesia and urology products, are showing stable growth, with revenues of 477 million yuan and 216 million yuan respectively [3]. - The company is focusing on innovation and increasing R&D investment, which is expected to enhance its product line and improve profit margins [3]. Financial Summary - The company’s total revenue for 2024 is projected to be 1.753 billion yuan, with a year-on-year growth rate of 16.1% for 2025, reaching 2.062 billion yuan in 2026 and 2.438 billion yuan in 2027 [4]. - The net profit attributable to the parent company is expected to grow from 264 million yuan in 2025 to 399 million yuan in 2027, reflecting a compound annual growth rate of 20.3% to 23.1% [4]. - The gross margin for 2024 is reported at 44.53%, with a slight decrease attributed to the higher proportion of lower-margin overseas sales [3][4]. - The company’s sales net profit margin improved to 15.14% in 2024, indicating effective cost control measures [3]. Market and Business Outlook - The company is expected to maintain a steady growth trend as domestic demand recovers and overseas markets continue to expand [3]. - The report anticipates that the introduction of new products will not only diversify the product line but also optimize the product structure, potentially enhancing profitability [3].