赛诺医疗科学技术股份有限公司（以下简称"赛诺医疗"或"公司"）于2023年10月向巴基斯坦药品监管局 （Drug Regulatory Authority of Pakistan，以下简称"DRAP"）递交了公司HT Supreme?药物洗脱支架系统 的注册申报资料。公司于近日收到通知，递交的注册申报资料获得DRAP的批准。现将相关情况公告如 下： 一、注册证内容 HT Supreme?药物洗脱支架系统 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 证书编号：ELI-00023 产品名称：HT Supreme?药物洗脱支架系统 本次在巴基斯坦获得注册证的HT Supreme?药物洗脱支架系统是我国支架厂商自主研发的首个在中国、 美国、日本、欧洲同步进行支架上市前临床研究并在前述国家和地区申请产品注册的心脏支架产品，于 2019年12月获得欧盟CE认证，于2020年12月获得中国国家药监局颁发的《医疗器械注册证》，于 2022 年至2025年期间分别获得泰国、乌兹别克斯坦共和国、新加坡、印尼、土耳其、中国台 ...

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]