北京市中伦（深圳）律师事务所 关于深圳开立生物医疗科技股份有限公司 2025年第一次临时股东大会的 法律意见书 二〇二五年九月 北京市中伦（深圳）律师事务所 关于深圳开立生物医疗科技股份有限公司 2025 年第一次临时股东大会的 法律意见书 致：深圳开立生物医疗科技股份有限公司 上述公告载明了召开本次股东大会的时间、地点、议案、会议召开方式、会 议出席对象、会议登记事项等。公司已按照有关规定对议案内容进行了披露。 根据《中华人民共和国公司法》（以下简称"《公司法》"）、《上市公司股东 会规则》（以下简称"《股东会规则》"）和《深圳开立生物医疗科技股份有限公 司章程》（以下简称"《公司章程》"）的规定，北京市中伦（深圳）律师事务所 （以下简称"本所"）接受深圳开立生物医疗科技股份有限公司（以下简称"公司"） 的委托，指派律师出席公司 2025 年第一次临时股东大会（以下简称"本次股东大 会"），并就本次股东大会的召集和召开程序、出席和列席会议人员资格、表决程 序及表决结果等事宜发表法律意见。 本所律师根据《股东会规则》的要求，按照律师行业公认的业务标准、道德 规范和勤勉尽责的精神，参加了本次股东大会现场会议，并 ...

Core Viewpoint - The report from Zhongyou Securities indicates that Kaili Medical's net profit attributable to the parent company for H1 2025 is 47 million yuan, a year-on-year decrease of 72.43% [1] - The net profit attributable to the parent company after deducting non-recurring gains and losses is 40 million yuan, a year-on-year decrease of 74.26% [1] - Despite the decline in profits, the domestic medical device industry is showing signs of recovery, with significant growth in the bidding success of ultrasound and endoscope products [1] Industry Summary - The domestic medical device industry is experiencing a revival in terminal bidding, which is expected to positively impact company performance as market demand continues to improve [1] - The past two years of industry restructuring have created a lag between market bidding and revenue growth reported by companies [1] Company Summary - Kaili Medical is actively building its marketing network both domestically and internationally, with a focus on local construction, product innovation, and channel network integration [1] - The company currently has a presence in nearly 170 countries and regions globally [1] - Domestically, the company maintains a clinical value-oriented approach, enhancing regional service capabilities, channel network advantages, and clinical collaborative innovation to support sustained business growth [1] - The company has been given an "Accumulate" rating based on its potential for recovery and growth [1]

Core Viewpoint - The company reported a decline in revenue and net profit for the first half of 2025, but there are signs of recovery in overseas markets and product innovation [1][2][3] Financial Performance - In the first half of 2025, the company achieved revenue of 964 million yuan, a year-on-year decrease of 4.78%, and a net profit attributable to shareholders of 47 million yuan, down 72.43% [1] - The second quarter revenue was 534 million yuan, showing a slight year-on-year increase of 0.17%, while net profit decreased by 44.65% to 39 million yuan [1] - The overall gross margin decreased by 5.34 percentage points to 62.08%, with net profit margin dropping by 11.97 percentage points to 4.88% [2] Product Performance - The ultrasound segment generated revenue of 550 million yuan, down 9.87% year-on-year, while the endoscope segment saw a slight increase in revenue to 388 million yuan, up 0.08% [1] - The company launched the new iEndo series 4K smart endoscope platform, enhancing its competitive position in the domestic market [1] Market Dynamics - Domestic business revenue was 495 million yuan, down 9.17%, while overseas revenue was 469 million yuan, up 0.33% [2] - The domestic medical device industry is beginning to recover, with significant growth in the bidding success of ultrasound and endoscope products [2] Future Outlook - The company has adjusted its revenue forecasts for 2025-2027 to 2.253 billion, 2.614 billion, and 3.030 billion yuan, with expected growth rates of 12%, 16%, and 16% respectively [3] - Net profit forecasts for the same period are 299 million, 384 million, and 503 million yuan, reflecting growth rates of 110%, 28%, and 31% [3]

Group 1: Pharmaceutical and Medical Device Sector - The pharmaceutical and medical device sector experienced an overall decline of 2.07% from September 15 to September 19, 2025, ranking 23rd among 31 industries, underperforming the CSI 300 index by 1.63 percentage points. Year-to-date, the sector has risen by 24.17%, ranking 10th among 31 industries and outperforming the CSI 300 index by 9.76 percentage points. The current PE valuation for the sector is 31.18 times, at the historical median level, with a 136% premium over the CSI 300 valuation [5][6][7]. - The National Medical Insurance Administration has completed the review of the 2025 National Basic Medical Insurance Directory and the commercial insurance innovative drug directory, moving into the core negotiation and price consultation phase. The 11th batch of national procurement has officially included 55 major varieties, with optimizations in application requirements, volume, and rules, indicating a potential turning point for the industry [6][7]. - The Shanghai government has issued a comprehensive action plan to promote the high-end medical device industry, focusing on innovation, clinical empowerment, regulatory approval, market application, enterprise cultivation, and international development, with 20 key tasks outlined to support industry growth [6][7]. Group 2: Non-Bank Financial Sector - The non-bank financial index fell by 3.7% last week, underperforming the CSI 300 index by 3.3 percentage points, with both brokerage and insurance indices showing synchronized declines of -3.5% and -4.8%, respectively. The average daily trading volume for stock funds was 29,885 billion yuan, an 8% increase from the previous week [9][10]. - Market enthusiasm and activity remain high, with a focus on the performance catalysts from the upcoming third-quarter reports. The average daily trading volume for stock funds has increased by 108% year-on-year as of September 19, 2025, positively impacting brokerage, credit, and proprietary trading sectors [10][12]. - The establishment of a health management company by PICC and the continued increase of holdings in China Pacific Insurance by Ping An Life indicate a trend towards integrating health management with health insurance, enhancing operational efficiency and profitability [11][12]. Group 3: Economic and Market Overview - The LPR for both the 5-year and 1-year terms remained unchanged at 3.5% and 3%, respectively, as of September 2025, indicating stable lending rates [14]. - The steel industry has set a target for an average annual growth of 4% over the next two years, with a strict prohibition on new capacity additions, reflecting a focus on structural adjustment and high-quality development [16]. - The A-share market showed mixed performance, with the Shanghai Composite Index closing at 3,828 points, up 0.22%, while the Shenzhen Component and ChiNext indices also saw gains, indicating a cautious recovery amid ongoing market volatility [17][18].

Investment Rating - The report maintains a "Strong Buy" rating for the company [3]. Core Views - The company is experiencing short-term pressure on performance, but there are expectations for recovery driven by new product launches [7][8]. - The financial performance shows a decline in revenue and net profit for the first half of 2025, with a revenue of 964 million yuan, down 4.78% year-on-year, and a net profit of 47 million yuan, down 72.43% year-on-year [2][7]. - The company is focusing on enhancing its product matrix, particularly in ultrasound and endoscopy, with new product launches expected to strengthen its market position [7]. Financial Data and Valuation - The projected total revenue for 2025 is 2.253 billion yuan, with a year-on-year growth of 12% [2][10]. - The projected net profit for 2025 is 299 million yuan, with a significant expected growth of 110% in 2026 [2][10]. - The company's PE ratio is projected to decrease from 47.3 in 2025 to 28.2 in 2027, indicating potential valuation improvement [2][10]. Product Performance - The ultrasound segment generated 550 million yuan in revenue, a decline of 9.87% year-on-year, while the endoscopy segment saw a slight increase in revenue to 388 million yuan [7]. - The company is set to launch the new iEndo series 4K smart endoscope platform, which is expected to enhance its competitive edge in the domestic market [7]. Market Dynamics - Domestic revenue is under pressure, with a reported decline of 9.17%, while overseas revenue showed a slight increase of 0.33% [7]. - The report anticipates a gradual recovery in performance as the domestic medical equipment industry begins to rebound from recent challenges [7].

Investment Rating - The report assigns an "Accumulate" rating for the company, marking its first coverage [2]. Core Views - The company's performance is under short-term pressure, but there are expectations for new product launches to drive growth in the second half of the year [5]. - The domestic medical equipment industry is showing signs of recovery, with significant growth in the company's ultrasound and endoscope products [6]. - The company has launched several new products across its business lines, including advanced endoscope platforms and bronchoscopes, which are expected to enhance its market position [6]. - The company is expanding its domestic and international marketing networks, which is anticipated to support ongoing business growth [7]. - Revenue forecasts for 2025-2027 are projected at 2.22 billion, 2.68 billion, and 3.18 billion yuan, with corresponding net profits expected to be 188 million, 391 million, and 503 million yuan [8]. Company Overview - The latest closing price of the company's stock is 34.45 yuan, with a total market capitalization of 14.9 billion yuan [4]. - The company reported a revenue of 964 million yuan in H1 2025, a year-on-year decrease of 4.78%, and a net profit of 47 million yuan, down 72.43% year-on-year [5]. - The company has a debt-to-asset ratio of 27.9% and a price-to-earnings ratio of 104.39 [4].

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Core Points - The 8th Hainan International Health Industry Expo (Health Expo) will be held from December 19 to 22 in Sanya, focusing on global health resources and promoting the health industry development [1][2] - The event aims to leverage Hainan's free trade port policies to create investment platforms for international medical institutions and high-end health enterprises [2] - The expo will feature six major highlights, including stimulating innovation in smart healthcare, facilitating high-level industry exchanges, enhancing health consumption, and supporting talent cultivation in the health industry [2][3] Event Details - The Health Expo will last for four days, covering an exhibition area of 20,000 square meters and an interactive experience area of 10,000 square meters [3] - It will include six core exhibition areas: smart healthcare, innovative pharmaceuticals and medical devices, high-end health maintenance, traditional Chinese medicine, tourism and health services, and health and beauty [3] - The event has attracted participation from renowned healthcare companies such as Takeda Pharmaceutical, AstraZeneca, and GSK, as well as key domestic parks and provinces [3][4] Forums and Activities - Over 10 parallel forums will be held during the expo, focusing on topics like marine biomedicine, smart disease control, and AI in medicine [3][4] - The event aims to gather over 4,000 representatives from healthcare departments, research institutions, and industry associations, along with at least 20,000 general attendees [4] - A comprehensive media promotion strategy will be implemented, utilizing various platforms to enhance the expo's visibility and impact [4]

Group 1 - The core viewpoint of the news is that Kaili Medical (SZ 300633) is actively engaging with investors and has announced a scheduled investor meeting from September 8 to 19, 2025, where the company’s board secretary will participate [1] - As of the latest report, Kaili Medical's market capitalization stands at 14.9 billion yuan [3] - For the year 2024, Kaili Medical's revenue composition is entirely from the medical device industry, accounting for 100% [2]

Group 1: Company Performance and Market Outlook - The company anticipates a positive trend in performance following the recovery from the industry's low point since the 2023 medical sector restructuring, with a notable improvement in quarterly results [2] - The company has established a diversified product portfolio across four lines: ultrasound, endoscopy, surgery, and cardiovascular intervention, enhancing its competitive edge [2] - International business accounts for 50% of total revenue, indicating a strong global market presence and improved risk resilience [2] Group 2: Product Sales and Market Acceptance - The HD-650 endoscope has shown promising sales performance, with expectations for increased volume throughout the year, reflecting high clinical acceptance and competitive advantages [3] - The proportion of multi-scope configurations in orders from top-tier hospitals has increased, demonstrating the product's growing recognition in the market [3] Group 3: AI Integration in Medical Devices - The company employs over 30 dedicated R&D personnel in AI, focusing on enhancing ultrasound and endoscopy products with advanced functionalities [4] - AI applications in endoscopy include independent software for polyp detection and quality control, which significantly reduces the workload for frontline doctors [4] - In ultrasound, AI solutions have been developed for obstetrics and gynecology, improving diagnostic capabilities and clinical value [4] Group 4: Competitive Landscape and R&D Investment - The company views the influx of startups in the endoscopy sector as a challenge, citing high technical barriers and the lengthy process required for new products to gain clinical acceptance [5] - Continuous high-level investment in R&D allows the company to maintain its leading position in the endoscopy market and effectively compete against emerging players [5]