长城证券股份有限公司 关于深圳开立生物医疗科技股份有限公司 2024 年度持续督导跟踪报告 | 项 目 | 工作内容 | | --- | --- | | 1．公司信息披露审阅情况 | | | （1）是否及时审阅公司信息披露文件 | 是 | | （2）未及时审阅公司信息披露文件的次数 | 0 次 | | 2．督导公司建立健全并有效执行规章制度的情况 | | | （1）是否督导公司建立健全规章制度（包括但不限 | | | 于防止关联方占用公司资源的制度、募集资金管理 | 是 | | 制度、内控制度、内部审计制度、关联交易制度） | | | （2）公司是否有效执行相关规章制度 | 是 | | 3．募集资金监督情况 | | | （1）查询公司募集资金专户次数 | 每月 次 1 | | （2）公司募集资金项目进展是否与信息披露文件 | 是 | | 一致 | | | 4．公司治理督导情况 | | | （1）列席公司股东大会次数 | 次 0 | | （2）列席公司董事会次数 | 次 0 | | （3）列席公司监事会次数 | 0 次 | | 项 目 | 工作内容 | | --- | --- | | 5．现场检查情况 | | ...

长城证券股份有限公司 关于深圳开立生物医疗科技股份有限公司 向特定对象发行股票之保荐工作总结报告书 经中国证券监督管理委员会（以下简称"中国证监会"）出具的《关于同意 深圳开立生物医疗科技股份有限公司向特定对象发行股票注册的批复》（证监许 可[2021]668 号）核准，深圳开立生物医疗科技股份有限公司（以下简称"开立 医疗"、"上市公司"、"发行人"或"公司"）向特定对象发行人民币普通股 （A 股）27,851,745 股，发行价格为 27.79 元/股，募集资金总额为人民币 773,999,993.55 元，扣除发行费用（不含税）合计人民币 4,944,026.20 元后，募 集资金净额为人民币 769,055,967.35 元。天健会计师事务所（特殊普通合伙）对 以上募集资金到账情况出具了《深圳开立生物医疗科技股份有限公司验资报告》 （天健验[2021]3-78 号）。 长城证券股份有限公司（以下简称"保荐机构"或"长城证券"）作为开立 医疗本次向特定对象发行股票的保荐机构，自公司向特定对象发行股票发行完成 之日至 2024 年 12 月 31 日（以下简称"本持续督导期间"）履行持续督导责任。 目前， ...

长城证券股份有限公司关于 深圳开立生物医疗科技股份有限公司 2024 年度持续督导现场检查报告 | 保荐人名称：长城证券股份有限公司 被保荐公司简称：开立医疗 | | --- | | 保荐代表人姓名：郭小元 联系电话：010-88366060 | | 保荐代表人姓名：杨虎 联系电话：0755-83516072 | | 现场检查人员姓名：杨虎 | | 年度 现场检查对应期间：2024 | | 现场检查时间：2025 年 月 日-2025 年 月 日 4 17 4 18 | | 一、现场检查事项 现场检查意见 | | （一）公司治理 是 否 不适用 | | 现场检查手段：1.查阅公司章程和公司治理相关制度；2.查阅公司三会文件及相关信息披 | | 露文件，核查其执行情况；3.核查董监高人员变动及相关决策文件、公告文件；4.核查控 | | 股股东、实际控制人是否发生变动情况及其对外投资情况 | | 1.公司章程和公司治理制度是否完备、合规 √ | | 2.公司章程和三会规则是否得到有效执行 √ | | 3.三会会议记录是否完整，时间、地点、出席人员及会议内 √ | | 容等要件是否齐备，会议资料是否保存完整 | | ...

长城证券股份有限公司关于 深圳开立生物医疗科技股份有限公司持续督导期 2024 年度培训情况的报告 深圳证券交易所： 长城证券股份有限公司（以下简称"长城证券"、"保荐机构"）作为深圳开 立生物医疗科技股份有限公司（以下简称"开立医疗"、"公司"） 2020 年度向特 定对象发行 A 股股票（以下简称"本次发行"）的保荐机构，根据《深圳证券交 易所创业板股票上市规则（2024 年修订）》《深圳证券交易所上市公司自律监管 指引第 13 号——保荐业务》和《深圳证券交易所上市公司自律监管指引第 2 号 ——创业板上市公司规范运作》等相关法律法规和规范性文件的要求，结合开立 医疗的实际情况，认真履行保荐机构应尽的职责，对开立医疗实际控制人、董事、 监事、高级管理人员等相关人员进行了持续督导培训，培训内容严格按照中国证 券监督管理委员会及深圳证券交易所创业板有关持续督导的最新要求进行。现将 相关情况报告如下： 一、培训时间 2025 年 4 月 17 日 二、培训地点 四、培训对象 开立医疗控股股东及实际控制人、董事、监事、高级管理人员等相关人员。 五、培训内容 本次培训内容包括：2024 年度创业板上市公司处罚案例 ...

Core Insights - The article focuses on the endoscope industry, highlighting its evolution, market dynamics, and investment opportunities, particularly in the medical sector [1] Group 1: Endoscope Overview - An endoscope is a medical device that integrates optics, ergonomics, precision mechanics, modern electronics, and image processing software to provide internal anatomical images of the human body [3] - Endoscopes can be classified into rigid and flexible types, with each having distinct characteristics and applications [4][6][7] Group 2: Market Dynamics - The Chinese flexible endoscope market was valued at 5.34 billion yuan in 2019, with a compound annual growth rate (CAGR) of 16.79% from 2015 to 2019, significantly outpacing global growth [17] - The market is expected to reach 8.12 billion yuan by 2025, driven by the increasing prevalence of gastrointestinal cancers and the need for early screening [17] - The incidence of colorectal cancer in urban China has been rising, with a nearly 2% annual increase in cases among individuals under 45 [16] Group 3: Industry Characteristics - The flexible endoscope market is characterized by a high degree of integration and significant barriers to entry, particularly in midstream manufacturing [12][14] - Domestic brands like Kaili and Aohua have increased their market share from 5% in 2018 to 15% in 2022, reflecting a trend towards domestic substitution [24][27] Group 4: Key Players - Olympus holds a nearly 50% market share in China, leveraging its training programs and proprietary technologies to maintain a competitive edge [30][31] - Kaili Medical and Aohua Endoscopy are notable domestic players, with Kaili's revenue from endoscopes growing from 3.1 billion yuan in 2020 to 8.0 billion yuan in 2024, representing a CAGR of 21% [34] Group 5: Emerging Trends - The disposable endoscope market is rapidly growing, with a global market size of approximately $1.1 billion in 2022, expected to reach $2 billion by 2024, reflecting a CAGR of 26% [39] - In China, the disposable endoscope market saw a remarkable growth rate of 158% in 2022, driven by the need to prevent cross-infection [41] Group 6: Future Considerations - The article raises questions about the future of disposable endoscopes in China, particularly regarding market acceptance and integration into healthcare reimbursement systems [55]

产品的演进，从来不是一蹴而就。 在技术高度密集的医疗产业中，设备设计的成熟通常历经三个阶段：首先是"能用"——满足基本诊疗需求； 接着是"适用"——操作顺手，提升效率与精度；最后，是"好用"——贴合使用者的身体与感知，减轻操作负 担。 能用，是技术门槛；适用，是设计水平；而"好用"，才是判断产品真正成熟的标志。 这正是"人因工程"发挥作用的时刻。 Mayo Clinic 的研究进一步发现 [2] 84.4% 的内镜医师报告存在活动性疼痛，其中超过一半集中于手、腕 或手指；手痛者操作结肠镜时，插入时间增加，年均操作量下降超三成。 这些伤痛与内镜医师高频、重复的手部操作密切相关。 人因工程 （ Human Factors Engineering ） 通过系统纳入使用者的生理、心理与行为特征，提升产品的安 全性、舒适性和效率。对医疗设备而言，它不仅关乎医生的身体健康，也影响诊疗质量与流程稳定性。 在调研人因工程在医疗器械领 域的落地案例时，一家本土企业—— 开立医疗 ，引起了关注。他们在开发新一 代内镜操作部时，做了一件特别的事： 研究医生的手——如何握、怎么转、何时开始疲劳…… 开立团队深入一线医院，花大量时间观 ...

Core Viewpoint - The evolution of medical devices is a gradual process that requires a focus on user experience, particularly through Human Factors Engineering, to enhance safety, comfort, and efficiency in medical equipment design [1][3][18]. Group 1: Importance of Human Factors Engineering - Human Factors Engineering integrates the physiological, psychological, and behavioral characteristics of users to improve product safety and efficiency [3][18]. - A local company, Kaili Medical, has made significant strides in applying Human Factors Engineering by studying doctors' hand movements and fatigue during procedures [3][4]. Group 2: Impact of Ergonomic Design on Medical Professionals - Studies indicate a high prevalence of musculoskeletal pain among endoscopists, with 95.08% reporting pain, and 19.7% specifically in the hands [4][5]. - The design of medical devices often overlooks the user experience, prioritizing technical specifications over comfort, which can lead to long-term health issues for medical professionals [5][6]. Group 3: Innovations by Kaili Medical - Kaili Medical's new endoscope operation unit focuses on reducing the physical strain on doctors by implementing ergonomic design changes [7][9]. - Key innovations include a 20% reduction in handle weight and a 15% decrease in thickness, which help alleviate muscle fatigue during prolonged use [9]. - The design also features a 30% reduction in handwheel resistance, making it easier for users, especially those with smaller hands, to operate the device [11]. Group 4: Design Features Enhancing User Experience - The button layout is designed to mimic natural finger movements, allowing for seamless operation without changing grip, thus enhancing workflow continuity [13][14]. - An ergonomic grip design aligns with the natural contours of the hand, improving comfort during extended use [16][17]. - The overall design improvements reflect a deep understanding of user experience, emphasizing the importance of considering the user's physical and cognitive demands [17][18]. Group 5: Broader Implications for the Industry - The evolution of medical devices should not only focus on performance but also on the well-being of the users, addressing the diverse needs of medical professionals [18][19]. - Companies are encouraged to adopt a user-centered design approach, which can lead to improved service quality and greater satisfaction among healthcare providers and patients alike [18][19].

R&D Investment and Strategy - The company maintains a high level of R&D investment, with R&D expenses accounting for approximately 20% of revenue each year [4] - As of the end of 2024, the R&D team consists of 841 members, with over 50% holding master's degrees or higher [4] - Future R&D efforts will focus on expanding product lines in ultrasound diagnostic equipment, endoscopy, minimally invasive surgery, and cardiovascular intervention products [2][3] Financial Performance and Shareholder Returns - In 2024, the company achieved revenue of 2.014 billion yuan, a decrease of 5.02% year-on-year, and a net profit of 142 million yuan, down 68.67% from the previous year [6] - The company distributed cash dividends amounting to 138 million yuan, representing 30% of the net profit for 2023 [3] - The average cash dividend payout ratio over recent years has been maintained at over 20% [3] Market Trends and Business Outlook - The current procurement ratio between county and urban hospitals is approximately 30:70, with expectations for an increase in county-level procurement in the next 2-3 years [5] - The company anticipates continued growth in high-end endoscopy products, supported by a long-term strategy focused on high-end, specialized, and diversified product lines [5][7] - The overseas market revenue for 2024 is projected at 970 million yuan, reflecting a year-on-year growth of 3.27% [11] Industry Challenges and Competitive Position - The medical device industry has faced significant pressure due to domestic policy changes, leading to a reduction in hospital procurement [8] - Despite these challenges, the company has shown resilience through ongoing R&D and market investments, positioning itself for better growth relative to the industry [8] - The overall market demand for medical devices is expected to remain stable, driven by an aging population and increasing healthcare needs [9] Social Responsibility Initiatives - The company has engaged in various social responsibility activities, including partnerships with hospitals to provide medical services for diseases like echinococcosis [12] - In 2024, the company donated advanced medical equipment to hospitals in remote areas, enhancing local healthcare capabilities [13][14] - The company actively participates in international medical cooperation initiatives to improve global healthcare standards [12][13]

4月22日，开立医疗今日收盘32.21元，上涨3.27%，滚动市盈率PE（当前股价与前四季度每股收益总和 的比值）达到97.88倍，创83天以来新低，总市值139.38亿元。 最新一期业绩显示，2024年年报，公司实现营业收入20.14亿元，同比-5.02%；净利润1.42亿元，同 比-68.67%，销售毛利率63.78%。 序号股票简称PE(TTM)PE(静)市净率总市值(元)108开立医疗97.8897.884.48139.38亿行业平均 48.0850.954.83103.18亿行业中值30.2131.172.3544.33亿1天益医疗-2739.91-2739.911.7220.38亿2硕世生 物-1894.86-1894.861.1737.93亿3诺唯赞-517.67-517.672.3793.67亿4澳华内镜-515.47258.534.1354.32亿5博 晖创新-353.40-217.583.8954.24亿6康泰医学-265.4831.152.7151.63亿7华大基因-197.23215.742.04200.43亿 8奥精医疗-123.37-123.371.5722.35亿9热景生物-72 ...

Investment Rating - The investment rating for the company is "Outperform the Market" [6][4][25] Core Views - The company is experiencing short-term pressure on performance due to a slight decline in revenue and significant profit impact from increased expenses. Revenue for 2024 is projected at 2.014 billion yuan, down 5.02%, with a net profit of 142 million yuan, down 68.67% [1][9] - Despite the current challenges, the company is making strategic investments in talent and product innovation, which are expected to yield positive results in the future as the industry environment improves [4][3][21] Financial Performance Summary - Revenue for 2024 is expected to be 2.014 billion yuan, a decrease of 5.02% from the previous year. The net profit is projected at 142 million yuan, reflecting a significant decline of 68.67% [1][5] - The gross margin for 2024 is forecasted at 63.78%, showing a decline of 5.63 percentage points, influenced by a higher proportion of lower-margin overseas business and price pressures from county-level medical equipment procurement [2][18] - The company has increased its workforce by 16% year-on-year, reaching a total of 3,122 employees, indicating a strong commitment to enhancing its research and sales capabilities [3][21] Future Projections - Revenue projections for 2025, 2026, and 2027 are 2.334 billion yuan, 2.694 billion yuan, and 3.089 billion yuan, respectively, with expected growth rates of 16%, 15%, and 15% [4][25] - The net profit forecasts for the same years are 310 million yuan, 400 million yuan, and 480 million yuan, with growth rates of 120%, 27%, and 22% respectively [4][25] Market Position and Strategy - The company is focusing on high-end product launches in various fields, including ultrasound and endoscopy, to strengthen its market position. Notable products include the high-end S80 and P80 ultrasound machines and the HD650 smart endoscope platform [3][21] - The company is maintaining a high level of investment in research and development, which is expected to enhance its competitive edge in the market [2][4][21]