FANGDA PARTNERS http://www.fangdalaw.com | E-mail: | email@fangdalaw.com | | --- | --- | | Tel.: Fax: | 86-755-8159-3999 86-755-8159-3900 | | 中国深圳市福田区中心四路1号 嘉里建设广场T1座9楼 邮政编码：518048 | | | 电子邮件 电 话 传 真 | | 9/F, Tower One, Kerry Plaza 1 Zhong Xin Si Road Futian District Shenzhen 518048, China 上海市方达（深圳）律师事务所 关于实际控制人增持 深圳迈瑞生物医疗电子股份有限公司股份的 法律意见书 致：深圳迈瑞生物医疗电子股份有限公司 上海市方达（深圳）律师事务所（以下简称"本所"）是具有中华人民共和 国境内法律执业资格的律师事务所。本所受深圳迈瑞生物医疗电子股份有限公 司（以下简称"迈瑞医疗"或"公司"）的委托，就迈瑞医疗实际控制人李西廷先 生（以下简称"增持人"）自2025年11月27日至2025年12月12日期间内（以下简称" ...

Core Insights - The Chinese medical equipment industry is advancing rapidly during the 14th Five-Year Plan period, integrating cutting-edge technologies like AI and 5G to create an innovative industrial ecosystem, contributing significantly to the "Healthy China" initiative and enhancing global competitiveness in medical equipment manufacturing [1][4]. Group 1: Technological Breakthroughs - Domestic high-end ultrasound systems are achieving unprecedented image resolution, enabling the detection of micro-level structures for more accurate early disease diagnosis [2]. - The introduction of ultra-weak magnetic imaging devices allows for efficient medical examinations without noise or the need for contrast agents, providing patients with comprehensive reports in under three minutes [2]. - Major advancements include ECMO machines, laparoscopic surgical robots, photon counting spectral CT, and high-performance PET/CT systems, showcasing significant technological achievements in the medical equipment sector [2]. Group 2: Innovation and R&D Investment - Companies are transitioning from being "followers" of international technology to "leaders" with independent innovation capabilities, supported by substantial R&D investments, with firms like Mindray allocating approximately 10% of their revenue to R&D annually [3]. - The number of medical equipment enterprises in China reached 33,400 during the 14th Five-Year Plan, with over 4,000 large-scale companies and around 160 listed firms, indicating a robust growth in the sector [3]. Group 3: New Dynamics in Medical Equipment - The integration of AI with medical imaging devices enhances efficiency by automating patient positioning and reducing unnecessary radiation exposure [4]. - The use of 5G technology in surgical robots enables remote surgeries, allowing doctors to collaborate across vast distances, thus improving access to high-quality medical services [4]. - The market size of China's medical equipment industry surpassed 1 trillion yuan during the 14th Five-Year Plan, fostering the development of six national advanced manufacturing industry clusters [4]. Group 4: Ecosystem Development - Innovative models for medical equipment development are emerging, such as Beijing's innovation center for surgical robots and Chongqing's collaborative approach between enterprises and research institutions [5]. - Shenzhen has established a 4 billion yuan fund for high-end medical equipment, facilitating rapid growth and global expansion for domestic companies [5]. - A comprehensive innovation ecosystem is being developed, supported by national and local initiatives, to enhance the medical equipment sector's growth potential [6].

Core Insights - The article highlights the acceleration of business development (BD) activities in the medical device sector from September to November 2025, with a total of 58 transactions identified across various subfields, including cardiovascular, nuclear medicine, and AI-enabled devices [2][3][4]. Group 1: Mergers and Acquisitions - Mergers and acquisitions have become a prominent form of BD, with companies leveraging capital control and product integration for rapid market positioning [7][8]. - Notable acquisitions include HeartLink's $680 million all-stock acquisition of Micro-Invasive Cardiology, enhancing its structural heart disease and rhythm management capabilities [7]. - Hua'an Zhonghui's acquisition of Bangni Medical marks its entry into the absorbable suture market, indicating a shift in surgical instrument competition towards material innovation [7]. Group 2: Strategic Collaborations - Strategic partnerships have been formed during the China International Import Expo, with companies like Shanghai Pharmaceuticals collaborating with international giants such as Boston Scientific and Medtronic to enhance their supply chain and academic promotion systems [7][8]. - The collaboration between GuoYao Medical and BDI Medical aims to deepen market penetration in the biomedicine and medical device sectors, focusing on compliance and distribution channel construction [13]. Group 3: Cross-Border Cooperation - Cross-border transactions have become more active, with foreign companies establishing local R&D and production systems in China, while domestic firms are exporting their solutions globally [9][10]. - The partnership between Trasis SA and Beijing Pait Biotechnology to establish a joint venture reflects a trend towards localized production and phased integration in the Chinese market [12]. Group 4: Ecosystem Building and Channel Expansion - The integration of supply chains and ecosystem building is a key theme, with companies focusing on collaborative agreements to enhance their market presence [11][15]. - The collaboration between Baxter and Neusoft Medical aims to create a comprehensive surgical solution by integrating their respective technologies [12]. Group 5: AI and Smart Healthcare - AI and data-driven approaches are becoming central to BD collaborations, with companies increasingly focusing on smart healthcare solutions [16][17]. - The partnership between Kefu Medical and Tencent Cloud to develop AI-powered hearing aids exemplifies the trend of integrating technology into healthcare products [21]. Group 6: Research and Diagnostic Synergy - The frequency of research-oriented collaborations is rising, indicating a shift from manufacturing-driven to research-driven industry dynamics [18][19]. - The collaboration between BGI and Infinera to enhance clinical applications of sequencing technology highlights the growing importance of research in driving innovation in the medical device sector [21].

Core Insights - The article discusses the ESG-V rating system applied to listed companies in Guangdong, emphasizing its role in assessing the sustainability and investment value of companies in China's economic hubs [1][2][3] Group 1: ESG-V Rating Framework - The ESG-V rating system integrates corporate value into traditional ESG assessments, focusing on objective, industry-specific, and verifiable metrics [1][2] - The evaluation covers four dimensions: Environment (E), Social (S), Governance (G), and Value (V), aiming to provide a comprehensive view of corporate sustainability and investment potential [1][3] Group 2: Environmental (E) Assessment - The environmental evaluation extends beyond pollution control to assess the overall environmental impact across the entire supply chain, including raw material sourcing and product lifecycle [1] - Companies are identified based on their ability to innovate with green technologies and collaborate within the industry to build long-term competitive advantages [1] Group 3: Social (S) Assessment - The social dimension focuses on the legality and authenticity of corporate operations, scrutinizing issues like financial fraud and information disclosure violations [1][2] - It emphasizes the fundamental legal responsibilities and social trust obligations that companies owe to investors, employees, and the public [1] Group 4: Governance (G) Assessment - Governance is defined as "corporate oversight," expanding the evaluation to include relationships with all stakeholders, particularly in tax compliance and debt obligations [2] - The framework incorporates the business environment into governance assessments, highlighting the importance of positive interactions with regulatory bodies [2] Group 5: Value (V) Assessment - The value dimension innovatively integrates corporate value into the ESG framework, utilizing the "Ji'an Pricing" model to assess long-term investment value and valuation rationality [2] - This allows investors to evaluate companies' sustainability capabilities alongside their potential for investment returns within a unified framework [2] Group 6: Guangdong Listed Companies Evaluation - A total of 790 companies were evaluated in Guangdong, with 8 achieving the highest rating of AAA, including notable firms like Haitai Flavor Industry and China Merchants Bank [3][5] - The rating system categorizes companies into ten levels from AAA to D, with 35 companies rated AA and 122 rated A, indicating a solid foundation for sustainable development and value management in Guangdong [3][5]

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, recommending a focus on innovative drugs and sectors with improving performance, such as medical devices and upstream segments [3][4]. Core Insights - The pharmaceutical sector experienced a decline of 1.0% this week, ranking 17th among 31 sub-industries. The overall valuation of the pharmaceutical sector stands at 29.2 times earnings, placing it 10th among the primary industries [2][4][7]. - Key events include Fosun Pharma granting exclusive global rights for its oral GLP-1 drug to Pfizer, with potential total payments reaching $2.085 billion. Additionally, Eli Lilly's GLP-1/GIP/GCGR agonist Retatrutide showed promising Phase III clinical data, achieving a weight loss of 28.7% over 68 weeks [3][14][17]. - The report highlights significant mergers and acquisitions, such as Sobi's acquisition of Arthrosi for $950 million upfront and $550 million in milestone payments, and Zhaoli Pharmaceutical's planned acquisition of a multi-trace element injection asset group for approximately RMB 356 million [3][15][22]. Market Performance - The pharmaceutical index decreased by 1.0% this week, while the Shanghai Composite Index fell by 0.3%. The overall performance of the pharmaceutical sector was ranked 17th among 31 sub-industries [2][4][6]. - The report details the performance of various sub-sectors, with notable declines in medical circulation (-4.2%), offline pharmacies (-4.3%), and blood products (-4.1%), while medical R&D outsourcing saw an increase of 3.7% [7][11]. Recent Key Events - The report discusses recent business developments, including the approval of Shanghai Pharma's new drug, and the change of control at Tailong Pharmaceutical, which will now be under Jiang Pharmaceutical Holdings [20][22]. - It also notes the IPO application of Shiyao Innovation, which was accepted with a market value of RMB 47.9 billion, focusing on health-related sectors and innovative drugs [23]. Company Valuation - The report provides a valuation table for key companies in the pharmaceutical sector, indicating projected earnings per share (EPS) and price-to-earnings (PE) ratios for 2025 to 2027. For instance, Mindray Medical is projected to have a PE of 23 in 2025, while Hengrui Medicine is expected to have a PE of 48 [29].

Investment Rating - The report maintains a rating of "Buy" for the pharmaceutical and biotechnology sector, with a focus on specific companies such as Innovent Biologics, Efang Biologics, and Mindray Medical [4][27]. Core Insights - The report emphasizes the investment opportunities in the "One Old, One Young" sectors, particularly in reproductive assistance, pediatric drugs and vaccines, maternal and infant health monitoring, and aging-related consumer healthcare [2][24]. - It highlights the importance of clinical value in the pharmaceutical sector, suggesting that future investments should focus on innovative drug chains and high-end medical devices [3][25]. - The report notes that the domestic pharmaceutical sector is experiencing a valuation recovery, driven by supportive policies and increasing global competitiveness [26]. Summary by Sections Market Review - The A-share pharmaceutical index fell by 1.04%, underperforming the CSI 300 index by 0.96 percentage points and the ChiNext index by 2.52 percentage points, ranking 17th among 31 sub-industries [1][15]. - The Hong Kong Hang Seng Medical Health Index decreased by 2.26%, lagging behind the Hang Seng Index by 0.97 percentage points [1][15]. R&D Progress - Recent developments include IND applications from Haisimengnuo and clinical trial advancements for various drugs from companies like Hengrui Medicine and Anke Biotechnology [29][30]. Key Companies and Valuation - The report provides a detailed earnings forecast and valuation table for key companies, indicating a positive outlook for companies like WuXi AppTec and Mindray Medical, with projected PE ratios decreasing over the next few years [4][27]. Policy and Industry Resonance - The report discusses the eight key tasks for medical insurance in 2026, focusing on improving coverage for flexible employment and enhancing maternal healthcare services, which are expected to boost the birth rate and the rehabilitation medical device industry [2][20][24]. Investment Strategy - The report suggests a three-stage investment strategy based on clinical value, recommending investments in innovative drugs and high-value medical devices, with a focus on companies that are expanding internationally [3][25][26].

Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]

Core Viewpoint - The continuous share buybacks by the chairman of Mindray Medical reflect confidence in the company's future growth and recovery in performance despite recent challenges [1][2]. Group 1: Share Buyback Activity - On December 9, 2025, the chairman of Mindray Medical, Li Xiting, increased his stake by purchasing 150,600 shares at an average price of 199.12 yuan per share, totaling 29.99 million yuan [1]. - Li Xiting has made four consecutive share purchases since November 27, with cumulative investments exceeding 100 million yuan [1]. - The chairman plans to continue buying shares with a total investment of 200 million yuan over the next six months, without a price range set for the purchases [1]. Group 2: Company Performance and Market Outlook - Despite facing pressure on performance due to high base effects, Mindray Medical reported a year-on-year revenue growth of 1.53% in the third quarter, indicating a potential turning point [1]. - The company anticipates a recovery in domestic business growth next year, with profit growth expected to turn positive by 2026 [1]. - Mindray Medical believes the most challenging period for its domestic business has passed and is focusing on increasing market share, particularly in the IVD sector [2]. Group 3: Strategic Focus and Market Position - The company is leveraging the current market environment to accelerate domestic expansion and enhance industry concentration, with a focus on large-sample clients in the IVD business [2]. - Mindray Medical is investing resources in high-value consumables in minimally invasive surgery, which are expected to grow significantly compared to traditional life support products [2]. - The company aims to rank among the top 20 global medical device manufacturers, maintaining a top-three market share in various product categories such as monitors, anesthesia machines, and ultrasound products [2].

Investment Rating - Industry investment rating is "Outperform" compared to the market, expecting the industry index to perform better than the CSI 300 index by more than 5% in the next six months [22]. Core Insights - The medical device bidding environment remains robust, with a significant trend towards high-end products. Since 2025, the release of equipment update policy dividends has led to sustained market demand growth, keeping bidding activities at a high level. Monthly procurement scales from July to November 2025 were 13.4 billion, 14.6 billion, 16.4 billion, 16.4 billion, and 20.9 billion respectively, with year-on-year growth rates of +24%, +31%, +2%, +14%, and +0% [3][11]. - The bidding environment is benefiting leading companies in the industry, with procurement scales for ultrasound, CT, MRI, DR, DSA, and gastrointestinal endoscopes showing significant year-on-year growth in November 2025 [4][12][14]. - The report emphasizes the importance of high-end and intelligent medical devices, suggesting that leading domestic companies like Mindray, United Imaging, Kaili Medical, and Aohua Endoscopy should be closely monitored for their strategic positioning in the market [5][20]. Summary by Sections Market Trends - The medical device market is experiencing a strong revival, with a notable focus on high-end imaging equipment such as CT, MRI, and ultrasound, which together account for nearly 62% of the total bidding amount [3][11]. - In November 2025, the procurement scale for ultrasound was 2.301 billion (yoy +17%), CT was 2.605 billion (yoy +26%), MRI was 2.394 billion (yoy +6%), DR was 460 million (yoy +50%), and DSA was 1.016 billion (yoy +4%) [12][14]. Company Performance - Domestic companies are aligning with industry trends, with Mindray achieving 1.318 billion (yoy +12%), United Imaging at 1.433 billion (yoy +30%), Kaili Medical at 247 million (yoy +62%), and Aohua at 109 million (yoy +60%) in November 2025 [17]. Investment Recommendations - The report recommends focusing on domestic leading enterprises that are enhancing their high-end and intelligent product offerings, as the bidding environment is expected to remain favorable due to ongoing policy support for equipment updates [5][20].

Group 1 - The core point of the article is the recent large transaction involving Mindray Medical, with a transaction volume of 34,100 shares and a transaction amount of 6.8139 million yuan, executed at a price of 199.82 yuan per share [2] - In the last three months, Mindray Medical has recorded a total of 14 large transactions, amounting to a cumulative transaction value of 195 million yuan [2] - On December 12, the closing price of Mindray Medical was 199.82 yuan, reflecting an increase of 2.07%, with a daily turnover rate of 0.92% and a total transaction amount of 2.223 billion yuan [2] Group 2 - The net inflow of main funds for Mindray Medical on the same day was 124 million yuan, while the stock has seen a cumulative decline of 1.27% over the past five days, with a total net outflow of 26.025 million yuan [2] - The latest margin financing balance for Mindray Medical is 3.893 billion yuan, which has increased by 89.3587 million yuan over the past five days, representing a growth rate of 2.35% [2] - Mindray Medical was established on January 25, 1999, with a registered capital of 12.124 billion yuan [2]