Core Points - The stock price of Kaili Medical (300633) closed at 30.31 yuan on April 25, 2025, down by 1.59% with a turnover rate of 0.79% and a trading volume of 34,200 shares, amounting to a transaction value of 104 million yuan [1] Group 1: Trading Information - On April 25, 2025, the capital flow for Kaili Medical showed a net outflow of 6.8552 million yuan from institutional investors and a net outflow of 2.5979 million yuan from speculative investors, while retail investors had a net inflow of 9.453 million yuan [2][8] Group 2: Shareholder Changes - As of March 31, 2025, the number of shareholders for Kaili Medical increased to 14,500, representing a growth of 736 shareholders or 5.34% compared to December 31, 2024. The average number of shares held per shareholder decreased from 31,400 shares to 29,800 shares, with an average market value of 867,600 yuan per shareholder [3][8] Group 3: Performance Disclosure - In the first quarter of 2025, Kaili Medical reported a main revenue of 430 million yuan, a year-on-year decrease of 10.29%. The net profit attributable to shareholders was 8.0746 million yuan, down by 91.94% year-on-year, while the net profit excluding non-recurring items was 5.9981 million yuan, a decline of 93.49% year-on-year. The company's debt ratio stood at 21.81%, with investment income of 979,200 yuan and financial expenses of -17.806 million yuan, resulting in a gross margin of 63.19% [4][8] Group 4: Management Responses - In response to investor inquiries regarding the impact of the US-China tariff conflict on the intravascular ultrasound (IVUS) business, the company noted that some foreign competitors are not affected by tariffs due to their products not originating from the US. The company emphasized its advantages in specialization and experience in ultrasound technology, which positions it well to capture market share in the IVUS segment over the next 3-5 years [5] - Regarding the higher gross margin in the domestic market compared to the international market for 2023-2024, the company attributed this to a higher proportion of high-end product models in its domestic revenue from ultrasound and endoscopy [6]

进入 2025 年，国内医疗设备行业呈现出一幅复杂的图景。 通过持续加码研发、加快高端化布局，开立医疗正在用一场 "新品集中爆发" 的动作，回应行业变革下的拐点挑战。 2025 年一季度，公司在医疗设备招采市场的成交增速远高于整体市场水平，多款重磅新品集中上市，为高端化战略提供了有力支撑。 思宇 MedTech 观察到，开立医疗以 高强度研发投入和多产品线协同布局 为支撑，正在成为国产设备向高端价值链攀升的重要代表，迈向"高端化能力提升"与"系 统化整体解决方案建设"的转型阶段。 本文将结合行业变化与开立医疗的战略实践，探讨国产医疗器械企业在新周期下的成长路径。 一、需求释放但竞争加剧，开立医疗为何坚持高强度研发？ 过去十年，国产医疗设备行业整体经历了一轮高速增长。然而，随着集采政策持续推进，设备价格不断下探，国产与进口品牌在同一张低价牌桌上竞争，小企业被 加速淘汰，大企业也面临利润收缩的考验。 在这样的竞争格局下，单靠规模扩张已难以支撑长期发展。 如何从低价竞争中突围？ 一方面，政策加码下，大规模设备更新提速，市场需求正在修复；另一方面，集采常态化带来的价格压力并未松动，国产与进口品牌在低价竞争中同台竞技， ...

Group 1 - The core concept of the articles revolves around the transformative role of AI in the healthcare industry, particularly in enhancing the capabilities of medical professionals rather than replacing them [1][7] - The "impossible triangle" in healthcare—quality, cost, and efficiency—can be addressed through AI, which empowers primary healthcare institutions to provide expert-level services [1][7] - The company, Kaili Medical, has developed advanced medical technologies over the past decade, including high-end intelligent ultrasound and the iEndo smart endoscope platform, positioning itself as a leader in the domestic medical device sector [1][2] Group 2 - Kaili Medical emphasizes the importance of clinical needs in the development of medical devices, aiming to reduce repetitive tasks for doctors and minimize diagnostic errors through AI technology [2][6] - The company has made significant advancements in ultrasound technology, achieving a 90% diagnostic accuracy rate for liver echinococcosis through its proprietary DCNN model, which integrates over 6,000 patient cases and 9,000 ultrasound images [3][4] - The iEndo platform integrates AI into the endoscopic workflow, enhancing the efficiency and accuracy of gastrointestinal examinations by providing real-time quality control and monitoring capabilities [5][6] Group 3 - The AI applications in healthcare are evolving from isolated solutions to a comprehensive ecosystem that mimics the reasoning and thinking of doctors, facilitating a more integrated approach to patient care [7][8] - The current focus of AI in healthcare is on assisting doctors in basic diagnostic processes, with future developments aimed at enabling AI to identify complex diseases and provide advanced diagnostic capabilities [7][8] - Kaili Medical aims to redefine the boundaries of healthcare by transitioning AI from a supportive tool to a deep diagnostic partner, enhancing the overall quality of medical services [7][8]

Group 1: Company Performance Overview - In 2024, the total procurement amount for medical devices in China significantly decreased due to domestic industry policy factors and the company's strategic investments, leading to a decline in revenue from ultrasound and endoscope businesses [2][3]. - In Q1 2025, the company experienced a noticeable recovery in hospital procurement, with a marked increase in successful bids, although revenue still declined due to a lag between market bids and reported income [2][3]. - The company added over 400 employees in 2024, resulting in increased R&D and sales expenses, which contributed to a significant drop in net profit in Q1 2025 [2][3]. Group 2: Revenue and Product Development Outlook - The company anticipates that the procurement from terminal hospitals in 2025 will exceed that of the previous year, with a return to revenue growth expected [2][3]. - 2025 is projected to be a significant year for new product launches, including the ultrasound 80 platform and HD-580 series endoscopes, which will support stable revenue growth [2][3]. Group 3: Gross Margin Challenges and Strategies - The decline in gross margin is attributed to several factors, including the reclassification of warranty fees to operating costs and a decrease in domestic business revenue proportion [4]. - Increased market competition and concentrated procurement projects have led to a continuous decline in terminal bid prices for ultrasound and endoscope products, impacting overall gross margins [4]. - The company aims to maintain market share while investing heavily in R&D to launch advanced products, which will help sustain higher gross margins [4]. Group 4: Impact of Tariffs and Market Trends - The company’s cost structure shows that raw materials constitute a low percentage, and recent tariff increases are not expected to significantly impact product costs [5]. - The rollout of large-scale procurement plans for medical device updates is anticipated to occur in 2025, potentially increasing market demand [6]. - The concentration of procurement projects may signal a downward trend in overall industry gross margins, prompting the company to adapt its strategy by focusing on high-end products and diversifying its product lines [6]. Group 5: New Product Lines and Growth Potential - The minimally invasive surgery product line achieved a 30% revenue growth in 2024, with expectations for over 100% growth in Q1 2025, indicating a strong upward trend [6][7]. - The cardiovascular intervention product line is still in the strategic investment phase, with plans to introduce a broader product range to improve profitability in the future [7].

Group 1 - The company reported a revenue of 430 million yuan and a net profit of 8.07 million yuan for Q1 2025, with a non-recurring net profit of 5.9981 million yuan [1] - R&D investment for Q1 2025 reached 126 million yuan, representing a year-on-year increase of 23.7% [1] - The company is focusing on integrating medical technology with clinical applications, leveraging "medical devices + AI" to drive smart development [1] Group 2 - The company has launched several key products, including the 4K iEndo smart endoscope platform, which has received NMPA registration and is now in the promotion phase [1] - The iEndo platform features an independent GPU module that enhances image processing and AI computing capabilities, introducing a new super-resolution imaging technology for clearer clinical diagnostics [1] - In the minimally invasive surgery sector, the "Lingzhu" 4K 3D fluorescence imaging platform has been certified, offering a comprehensive solution that combines various imaging technologies [2] Group 3 - The company aims to maintain its competitive edge by continuously innovating and advancing its product lines towards high-end and specialized markets [2] - With the recovery of the domestic medical device market in 2025, the company is increasing its market share in ultrasound and endoscopy, while its strategic layout in minimally invasive surgery and cardiovascular intervention products is maturing [2] - The company is expected to return to a growth trajectory, developing a comprehensive multi-product line strategy that includes "internal medicine + surgery," "diagnosis + treatment," and "equipment + consumables" [2]

Core Insights - The company reported a decline in both revenue and net profit for Q1 2025, with revenue at 430 million yuan and net profit at 8.07 million yuan, indicating a year-on-year decrease [1] - The company is focusing on multi-product line strategies and high-intensity strategic investments, aiming for sustained performance growth in 2025 through high-end and specialized product development [1] - The domestic medical equipment procurement market is expected to grow by over 20% this year, driven by a significant increase in hospital procurement scale and a surge in project approvals [1] Financial Performance - In Q1 2025, the company achieved revenue of 430 million yuan and a net profit of 8.07 million yuan, both showing a certain degree of decline compared to the previous year [1] - The company's R&D investment reached 126 million yuan in Q1, reflecting a year-on-year increase of 23.7% [1] Product Development - The company has launched several key products, including the 4K iEndo smart endoscope platform and the "Lingzhu" 4K 3D fluorescence imaging platform, enhancing its competitive edge in minimally invasive surgery [2] - The integration of AI and medical devices is being emphasized, with the company aiming to create a new engine for intelligent development [1][2] Market Position - The company is witnessing an increase in market share in ultrasound and endoscopy businesses, with a strategic focus on minimally invasive surgery and cardiovascular intervention products [2] - The company aims to establish a comprehensive multi-product line development framework, combining internal and external medicine, diagnosis and treatment, as well as equipment and consumables [2]

Core Viewpoint - Shenzhen Kaili Biomedical Technology Co., Ltd. reported its Q1 2025 performance, showing a focus on multi-product line development and high strategic investment to drive growth in high-end and specialized products [1][2] Financial Performance - The company achieved a revenue of 430 million yuan in Q1 2025, with a net profit attributable to shareholders of 8.07 million yuan and a non-recurring net profit of 5.9981 million yuan [1] Research and Development - R&D investment reached 126 million yuan, reflecting a year-on-year increase of 23.7%, indicating a strong commitment to integrating medical technology with clinical applications [1] Product Innovation - The company launched several new products, including the 4K iEndo smart endoscope platform, which has received NMPA registration and is now in the market promotion phase [1] - The new endoscope features an independent GPU module for enhanced image processing and AI computation, along with a novel ultra-high-resolution imaging technology [1] Market Positioning - The company is focusing on high-end and specialized product development, which is expected to enhance its technological leadership and market share [2] - Future growth is anticipated through a comprehensive multi-product line strategy encompassing "internal medicine + surgery," "diagnosis + treatment," and "equipment + consumables" [2]

Core Viewpoint - The company, Kaili Medical, reported a strong performance in Q1 2025, with a focus on high-end and specialized product development, which is expected to drive continuous revenue growth throughout the year [1][4]. Financial Performance - In Q1 2025, Kaili Medical achieved a revenue of 430 million yuan and a net profit attributable to shareholders of 8.07 million yuan, with a non-recurring net profit of 5.9981 million yuan [1]. - The company’s R&D investment in Q1 2025 was 126 million yuan, reflecting a year-on-year increase of 23.7% [2]. Product Development and Innovation - Kaili Medical launched several high-end products, including the 4K iEndo smart endoscope platform, which has received NMPA registration and is now in the market promotion phase [2]. - The iEndo platform features an independent GPU module that enhances image processing and AI computing capabilities, providing clearer and more precise imaging for clinical diagnosis [2]. - New products in the digestive and respiratory endoscope categories include advanced gastric and intestinal endoscopes, designed with ergonomic improvements to enhance usability and reduce fatigue for physicians [3]. Market Trends and Opportunities - The domestic medical equipment market is expected to grow by over 20% compared to last year, driven by government policies supporting equipment updates and procurement [1]. - The company is positioned to benefit from the increasing market share in ultrasound and endoscopy, alongside the maturation of its minimally invasive surgery and cardiovascular intervention product lines [4]. - Kaili Medical aims to establish a comprehensive multi-product line development strategy, integrating diagnostics and treatment across various specialties [4].

本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 深圳开立生物医疗科技股份有限公司 2025 年一季度报告于 2025 年 4 月 26 日在中国证监会指定的创业板信息披露网站巨潮资讯网（http://www.cninfo.com. cn/）上披露，请投资者注意查阅。 特此公告。 深圳开立生物医疗科技股份有限公司董事会 2025 年 4 月 25 日 证券代码：300633 证券简称：开立医疗 公告编号：2025-023 深圳开立生物医疗科技股份有限公司 2025 年第一季度报告披露提示性公告 ...

第四届监事会第七次会议决议公告 本公司及监事会全体成员保证信息披露内容的真实、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 一、监事会会议召开情况 2025 年 4 月 24 日，深圳开立生物医疗科技股份限公司（以下简称"公司"） 第四届监事会第七次会议在深圳市光明区光电北路 368 号开立医疗大厦一楼会 议室召开。本次会议由监事会主席陈欣主持。应出席监事 3 名，实际出席监事 3 名。符合《公司章程》规定的法定人数，本次监事会会议决议合法有效。 二、监事会会议审议情况 证券代码：300633 证券简称：开立医疗 公告编号：2025-025 深圳开立生物医疗科技股份有限公司 经审核，监事会认为：公司《2025 年一季度报告》的编制和审议程序符合法 律、法规、公司章程和公司内部管理制度的规定，公司《2025 年一季度报告》的 内容和格式符合中国证监会和深圳证券交易所的各项规定，所披露的信息真实、 准确、完整地反映了公司的实际经营情况，不存在虚假记载、误导性陈述或者重 大遗漏。 特此公告。 表决结果：3 票同意，0 票反对，0 票弃权。同意票数占总票数的 100%。 三、备查文件 1、第四届监事会第七次会议 ...