Core Viewpoint - The company, Sainuo Medical Technology Co., Ltd., has received approval from the Drug Regulatory Authority of Pakistan (DRAP) for its HT Supreme™ drug-eluting stent system, marking a significant step in its overseas business expansion [1][3]. Group 1: Product Registration Details - The HT Supreme™ drug-eluting stent system is a combination product consisting of a cobalt-chromium alloy stent and a balloon delivery system, featuring a non-corrosive polymer layer and a biodegradable polymer layer for drug release [1][2]. - The product is designed for patients with symptomatic coronary artery disease due to primary coronary artery lesions (length ≤ 40 mm) and is applicable for reference vessel diameters ranging from 2.25 mm to 5.00 mm [2]. Group 2: Historical Context and Certifications - The HT Supreme™ stent is the first heart stent product developed by a Chinese manufacturer to undergo pre-market clinical studies simultaneously in China, the USA, Japan, and Europe, receiving CE certification in December 2019 and registration from the National Medical Products Administration of China in December 2020 [2]. - The product has also obtained medical device registration certificates in multiple countries, including Thailand, Uzbekistan, Singapore, and others, from 2022 to 2025 [2]. Group 3: Impact on Company Operations - The approval of the product in Pakistan is expected to enhance the company's sales in international markets, contributing positively to its overseas business development [3]. - The company acknowledges that international market sales may be influenced by regulatory policies, market environment changes, and exchange rate fluctuations, which could impact future performance [3].

Core Points - The company has received approval from ANVISA for its SC HONKYTONKTM coronary balloon dilation catheter, marking a significant milestone in its overseas business expansion [1][2]. Group 1: Product Registration Details - The SC HONKYTONKTM coronary balloon dilation catheter is designed for the dilation of narrowed segments of coronary arteries and can be used for pre-dilation before PCI stent implantation [2]. - The product has a rapid exchange design and is composed of multiple components, including a tip, balloon protective sheath, and a platinum-iridium alloy radiopaque ring [2]. - The product has previously received various international certifications, including from the National Medical Products Administration of China and the FDA in the United States, among others [2]. Group 2: Impact on the Company - The approval of the product in Brazil is expected to enhance the company's sales in international markets, contributing positively to its overseas business growth [3]. - The company acknowledges that international market sales may be influenced by regulatory policies, market environment changes, and exchange rate fluctuations, which could impact future performance [3].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The report highlights that the company is making steady progress in the European market and is experiencing continuous breakthroughs in Continuous Glucose Monitoring (CGM) [8] - The company's revenue for the first half of 2025 reached 2.264 billion yuan, reflecting a year-on-year increase of 6.12%, while the net profit attributable to the parent company was 181 million yuan, down 8.52% year-on-year [8] - The report anticipates that the company's net profit attributable to the parent company will be 4.27 billion yuan, 5.32 billion yuan, and 6.61 billion yuan for 2025, 2026, and 2027 respectively, with corresponding P/E ratios of 28, 22, and 18 times [8] Financial Performance Summary - For 2025, the company is projected to achieve total revenue of 5.035 billion yuan, representing a year-on-year growth of 13.31% [1] - The net profit attributable to the parent company is expected to reach 427.04 million yuan in 2025, reflecting a growth of 30.88% compared to 2024 [1] - The earnings per share (EPS) is forecasted to be 0.76 yuan in 2025, with a P/E ratio of 27.50 times based on the latest diluted EPS [1] Market Performance Summary - The company's domestic revenue for the first half of 2025 was 1.266 billion yuan, up 5.40% year-on-year, while overseas revenue was 744 million yuan, up 7.06% year-on-year [8] - The report notes that the company has expanded its CGM product registration to several countries, including Brazil, Iran, and Vietnam, enhancing its competitiveness in overseas markets [8]

Investment Rating - The report suggests a positive outlook for the medical device industry, indicating that the adjustment period is nearing its end and a recovery is expected in the second half of 2025 [2][4]. Core Insights - The medical device sector is experiencing a recovery trend, with domestic bidding demand showing signs of restoration in the second half of 2025 after a significant decline due to policy delays [2]. - The medical consumables segment is steadily growing, with a slight increase in gross margin, indicating resilience in demand related to patient treatment needs [2]. - The in-vitro diagnostics sector is under pressure, but there is potential for increased domestic market share for local manufacturers in the long term [2]. - Leading medical device companies are accelerating their overseas market expansion, with many reporting higher growth rates in international markets compared to domestic ones [2]. Summary by Sections Medical Equipment - Revenue for Q2 2025 showed a year-on-year decline of 5.26%, with net profit down 27.93% and gross margin decreasing from 53.07% in Q2 2024 to 49.00% in Q2 2025 [16]. - The industry is expected to reach a turning point as domestic bidding demand recovers [2][18]. Medical Consumables - Q2 2025 revenue increased by 1.33% year-on-year, with net profit down 6.28% and a slight improvement in gross margin from 42.13% to 42.24% [23]. - The segment is characterized by stable growth, with companies focusing more on R&D and innovative products [2]. In-Vitro Diagnostics - Revenue for Q2 2025 decreased by 16.53% year-on-year, with net profit down 37.58% and gross margin declining from 62.43% to 59.66% [29]. - The sector faces short-term demand pressure but may benefit from increased domestic production rates in the long run [2]. Investment Recommendations - The report recommends focusing on three key areas: companies leading in international market product and channel expansion, domestic medical device industry leaders, and high-value consumables firms with strong innovation capabilities [34]. - Specific companies to watch include Nanwei Medical, Mindray Medical, Sanofi, and Xinjiang Technology [34].

Core Points - Company announced that five products have received EU CE certification, including a film dyeing integrated machine, an automatic slide maker, and three consumable products [1] - The certification allows these products to be sold in the EU and European Economic Area (EEA) markets, facilitating entry into other international markets that recognize or reference EU standards [1] - The certificates for the certified products are valid from July 2025 and are long-term [1] Market Expansion - The actual sales performance of the certified products will depend on market promotion effectiveness, brand influence, and actual market demand, indicating significant uncertainty [1] - The company stated that obtaining the EU In Vitro Diagnostic Medical Device Regulation (IVDR) certification will aid in entering other international markets that recognize EU standards, further broadening the overseas application scenarios for these products [1] - The company has already obtained market access qualifications in multiple countries and regions, including Japan, the EU, Ukraine, Ecuador, and Vietnam, and plans to accelerate the expansion of its overseas access footprint [1]

Core Points - Vili Medical's stock closed at 12.28 yuan on May 23, 2025, with a 0.82% increase and a trading volume of 41,500 shares, amounting to a turnover of 51.31 million yuan [1] Group 1: Financial Information - The company announced a cash dividend of 0.5 yuan per share for the 2024 annual equity distribution, with the record date set for May 28, 2025, and the payment date on May 29, 2025 [1][3] - The total cash dividend distribution amounts to 146.43 million yuan based on the total share capital of 292,868,018 shares [1] Group 2: Market Activity - On May 23, 2025, the net outflow of funds from major investors was 3.44 million yuan, while retail investors saw a net inflow of 7.75 million yuan [1][3] Group 3: Regulatory News - Vili Medical's product, the Extraction Bag, received a Class II medical device registration certificate from Health Canada, allowing for legal sales in the Canadian market [2][3] - The certification was issued on May 20, 2025, and is expected to positively impact overseas market promotion and sales [2]