智通财经APP讯，先瑞达医疗-B(06669)发布公告，于2025年7月31日，集团收到中国国家药品监督管理 局对西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna的注册批准。 AcoArt Canna用于血管直径 ≥2.0mm且≤4.0mm的原发冠状动脉分叉病变狭窄的扩张治疗。临床试验结果证明了AcoArt Canna在临床 应用的有效性和安全性：临床试验的主要终点指标为术后9个月时血管造影显示的靶病变分支血管直径 狭窄率 (DS, %)，使用AcoArt Canna的试验组在术后9个月的D.S.为30.52%，使用紫杉醇药物涂层冠脉球 囊扩张导管的对照组在术后9个月的D.S.为33.46%，两组数据无统计学差异;而基于临床安全性数据分 析，试验组相对于对照组也并未呈现出异常风险及事件。公司将适时在中国开展营销活动。 （原标题：先瑞达医疗-B(06669)：西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna®的注册批准获中 国国家药监局批准） ...

先瑞达医疗-B(06669)发布公告，于2025年7月31日，集团收到中国国家药品监督管理局对西罗莫司药物 涂层冠脉球囊扩张导管AcoArt Canna的注册批准。AcoArt Canna用于血管直径≥2.0mm且≤4.0mm的原发 冠状动脉分叉病变狭窄的扩张治疗。临床试验结果证明了AcoArt Canna在临床应用的有效性和安全性： 临床试验的主要终点指标为术后9个月时血管造影显示的靶病变分支血管直径狭窄率(DS,%)，使用 AcoArt Canna的试验组在术后9个月的D.S.为30.52%，使用紫杉醇药物涂层冠脉球囊扩张导管的对照组 在术后9个月的D.S.为33.46%，两组数据无统计学差异;而基于临床安全性数据分析，试验组相对于对照 组也并未呈现出异常风险及事件。公司将适时在中国开展营销活动。 ...

格隆汇8月4日丨先瑞达医疗-B(06669.HK)发布公告，于2025年7月31日，集团收到中国国家药品监督管 理局对西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna®的注册批准。AcoArt Canna®用于血管直径 ≥2.0mm且≤4.0mm的原发冠状动脉分叉病变狭窄的扩张治疗。临床试验结果证明了AcoArt Canna®在临 床应用的有效性和安全性：临床试验的主要终点指标为术后9个月时血管造影显示的靶病变分支血管直 径狭窄率(DS, %)，使用AcoArt Canna®的试验组在术后9个月的D.S.为30.52%，使用紫杉醇药物涂层冠 脉球囊扩张导管的对照组在术后9个月的D.S.为33.46%，两组数据无统计学差异；而基于临床安全性数 据分析，试验组相对于对照组也并未呈现出异常风险及事件。公司将适时在中国开展营销活动。 ...

先瑞達醫療科技控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：6669） 自願性公告 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Acotec Scientific Holdings Limited 西羅莫司藥物塗層冠脈球囊擴張導管ACOART CANNA®的 註冊申請獲中國國家藥品監督管理局批准 本公告由先瑞達醫療科技控股有限公司（「本公司」，連同其附屬公司統稱「本集 團」）自願刊發，以向本公司股東及潛在投資者提供有關本集團最新業務及新產品 開發進展的最新資訊。 本公司董事會（「董事會」）欣然宣佈，於2025年7月31日，本集團收到中國國家藥 品監督管理局對西羅莫司藥物塗層冠脈球囊擴張導管AcoArt Canna®的註冊批准。 AcoArt Canna®用於血管直徑≥2.0mm且≤4.0mm的原發冠狀動脈分叉病變狹窄的擴 張治療。臨床試驗結果證明了AcoArt Canna®在臨床應用的有效性和安全性：臨床 試驗的主要終點指標為術後9 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 先瑞達醫療科技控股有限公司 呈交日期: 2025年8月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06669 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | 10,000,000,000 | | USD | | 0.00001 | USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | | USD | | 0 | | 本月底結存 | | | 10,000,000,000 | USD | | 0.00001 | USD | | 100,000 | 本 ...

Core Viewpoint - Hong Kong's equity financing market achieved the highest new stock financing amount globally in the first half of 2025, driven by improved investor sentiment and a significant influx of quality companies seeking funds [3][4]. Group 1: Market Performance - In the first half of 2025, Hong Kong's new stock financing reached $14.1 billion, a 695% increase compared to the same period in 2024, significantly outpacing the global new stock financing growth of 8% [4]. - The average daily trading volume in Hong Kong increased by 82% year-on-year to HKD 240 billion, with the Hang Seng Index rising over 20% [3]. Group 2: Major Listings - Notable large IPOs included CATL, which raised $5.3 billion, marking the largest IPO globally since 2023. Other significant listings included Heng Rui Pharmaceutical, Hai Tian Flavoring, and Sanhua Intelligent Control, each raising over $1 billion [9]. - Hong Kong secured four positions in the global top ten IPOs for the first half of 2025, with these companies averaging a 14% increase in stock price since their listings [9]. Group 3: A+H Listings and International Companies - Eight A-share companies raised a total of $10.1 billion by listing in Hong Kong, primarily to expand their international presence. The H-shares of these companies generally traded at a smaller discount compared to A-shares, indicating strong international investor demand [11]. - International companies like IFBH and Mi Rui Group successfully listed in Hong Kong, enhancing the city's appeal as an international financing hub [11]. Group 4: Investor Participation - The new stocks issued in the first half of 2025 saw active participation from international institutional investors, including long-term funds, private equity, strategic investors, hedge funds, and sovereign wealth funds from North America, Europe, and the Middle East [13]. - Retail investors also showed strong interest, leading to record-high demand for new stocks, with some experiencing oversubscription [14]. Group 5: Sector Performance - The healthcare sector saw a total equity financing of $5.8 billion, the highest for the first half of the year since 2021. The TMT sector, driven by AI innovations, raised $13.7 billion, while the consumer sector, particularly in new stock listings, saw an average stock price increase of 70% [16]. Group 6: Market Optimization Measures - Regulatory measures, such as the "Tech Company Fast Track" launched in May 2025, have expedited the listing process for tech and biotech companies. The momentum continued into July, with eight companies successfully listing in the first two weeks [20].

Summary of Key Points Core Viewpoint - As of July 14, a total of 138 stocks reached their 52-week highs, indicating a strong performance in the market, with notable leaders including Green Heart Group Holdings, OK Blockchain, and Pearl River Steel Pipe [1]. Group 1: Top Performers - Green Heart Group Holdings (02999) achieved a closing price of 0.013 with a peak of 0.017, marking a 70.00% increase [1]. - OK Blockchain (01499) closed at 0.680, reaching a high of 0.690, reflecting a 48.39% rise [1]. - Pearl River Steel Pipe (01938) had a closing price of 0.335 and a peak of 0.340, resulting in a 33.33% increase [1]. Group 2: Other Notable Stocks - Weishi Jiajie (00856) saw a 32.01% increase, closing at 8.870 with a high of 11.300 [1]. - Cloud Intelligence (09678) reached a high of 520.000, closing at 510.000, which is a 20.99% increase [1]. - China Chengtong Development Group (00217) closed at 0.165 with a peak of 0.166, marking a 14.48% rise [1]. Group 3: Additional Stocks with Significant Increases - Sihuan Pharmaceutical (00460) closed at 1.380, reaching a high of 1.430, which is a 14.40% increase [1]. - Taited Pharmaceutical (03880) had a closing price of 36.950 and a peak of 37.400, reflecting a 13.85% rise [1]. - Beihai Kangcheng-B (01228) closed at 0.850 with a high of 0.960, resulting in a 12.94% increase [1].

Core Viewpoint - The PTCA balloon industry in China is experiencing steady growth due to the increasing prevalence of cardiovascular diseases, the expansion of coronary intervention treatments, and the rise of domestic medical device manufacturers. The market size is projected to grow from 1.059 billion yuan in 2021 to 1.366 billion yuan in 2024, with expectations to exceed 2.274 billion yuan by 2030 [1][11]. Industry Overview - PTCA balloons are medical devices used in cardiovascular interventions to dilate narrowed or blocked coronary arteries, improving blood flow and myocardial supply [1]. - The industry chain consists of upstream raw materials and equipment supply, midstream production, and downstream application in various medical institutions for treating cardiovascular diseases [2]. Industry Environment - The incidence of coronary artery disease (CAD) is rising in China, with the number of patients increasing from 25.272 million in 2020 to 27.953 million in 2024, and projected to exceed 30 million by 2030 [4]. - The mortality rate for CAD has also increased significantly, indicating a growing demand for treatment options [4]. Industry Status - Percutaneous coronary intervention (PCI) is a key treatment method for CAD, with a record of 1.63 million PCI procedures performed in 2023, marking a growth rate of 26.44% [7]. - Despite the increasing number of PCI procedures, the market penetration rate in China remains low at 690.9 procedures per million people, compared to 3022.1 in the U.S., suggesting significant growth potential [9]. Competitive Landscape - The global PTCA balloon market is dominated by international giants like Boston Scientific and Medtronic, which hold over 60% market share, particularly in high-end drug-eluting balloons [13]. - Domestic companies account for 60% of the number of firms but only 40% of the market share, indicating a competitive landscape where local firms are striving to catch up through innovation [13]. Future Trends - The industry is witnessing significant technological innovation and product upgrades, with new polymer materials enhancing balloon performance and the introduction of drug-coated balloons reducing the risk of restenosis [19]. - The trend towards domestic substitution is accelerating, with local companies like MicroPort and Lepu Medical increasing their market share due to improved product quality and performance [20]. - The demand for PTCA balloons is expected to grow as their application expands beyond traditional coronary disease treatment to include peripheral and intracranial vascular diseases [21].

Financial Performance - Total revenue for the year ended December 31, 2024, reached RMB 534.0 million, a year-on-year increase of 12.7% compared to RMB 473.8 million in 2023[8] - Gross profit for the same period was RMB 402.7 million, reflecting a 6.7% increase from RMB 377.4 million in 2023[8] - Pre-tax profit surged to RMB 52.6 million, marking a significant increase of 264.0% from RMB 14.5 million in the previous year[8] - The company's revenue for the reporting period was approximately RMB 534.0 million, representing a year-on-year increase of about 12.7%[17] - Revenue from diversified sources, including peripheral suction systems and radiofrequency ablation systems, contributed approximately RMB 213.7 million, accounting for about 40.0% of total revenue[19] - Revenue from AcoArt Orchid® & Dhalia® sales in China and overseas was approximately RMB 267.0 million, representing a year-over-year decrease of about 2.7%[32] - Revenue from sales of venous intervention, vascular access, and other products was approximately RMB 213.7 million, reflecting an annual increase of about 42.2%[42] - The company achieved revenue of approximately RMB 213.7 million from venous intervention, vascular access, and other products, accounting for about 40.0% of total revenue during the reporting period[108] Product Development and Approvals - The company achieved a record high of 7 new product launches in 2024, including AcoArt Camellia®, RunFlow®, and Peridge®[9] - In 2024, the company received approval for seven products from the National Medical Products Administration, enhancing its product portfolio and market influence[18] - The company has made significant progress in product development, with seven products approved during the reporting period across various medical fields[26] - The product pipeline includes 22 commercialized products and 10 in-development products, categorized under the first, second, and third categories of medical devices[27] - The company has initiated clinical trials for AcoArt Litos® in the US and Europe, marking a significant milestone for market entry[21] - The company has received approvals from the National Medical Products Administration (NMPA) for various products, including those exempt from clinical trials in China[28] - The company plans to commercialize several new products by 2025 and 2026, including a peripheral scoring balloon and a mechanical thrombectomy device[28] - The company expects to obtain regulatory approval for the lower limb rapamycin DCB by 2026, currently undergoing clinical trials[43] Market Expansion and International Business - The company accelerated its international business development, completing preliminary work for market entry in several countries, including Chile, Austria, and the UK[20] - The company has launched AcoArt Orchid® in multiple countries including Germany, Italy, and Switzerland, and is in the process of entering markets such as Chile and Austria[30] - The company plans to continue expanding in both domestic and global markets, focusing on product development through internal growth, mergers, and acquisitions[103] - The company anticipates that its international business will diversify its revenue sources and enhance its flexibility in responding to market changes as it accelerates development in 2024[108] Research and Development - As of December 31, 2024, the total number of employees reached 650, with the R&D team growing to 131 members, enhancing talent reserves[25] - Research and development costs for the year ending December 31, 2024, were approximately RMB 216.8 million, an increase of about 14.0% from RMB 190.1 million for the year ending December 31, 2023[86] - The company has established a strong intellectual property portfolio, holding 57 registered patents and 42 pending patent applications as of December 31, 2024[67][71] - The company has expanded its R&D team to strengthen its capabilities in mechanical design, polymer materials, medicine, pharmacy, and chemistry[67] Corporate Governance and Compliance - The company has adopted a corporate governance code and has complied with all applicable provisions during the reporting period, with some deviations noted[113] - The audit committee has reviewed the audited consolidated financial statements for the year and confirmed they were prepared in accordance with applicable accounting standards[118] - The company has not experienced any significant violations of applicable laws and regulations that would materially impact its business for the year ending December 31, 2024[148] Financial Position and Capital Management - Total assets as of December 31, 2024, amounted to RMB 1,662.6 million, a 3.2% increase from RMB 1,611.1 million in 2023[8] - The net current assets as of December 31, 2024, are approximately RMB 1,075.8 million, a decrease of about 1.7% from RMB 1,094.9 million as of December 31, 2023, primarily due to an increase in trade liabilities[96] - The total capital expenditure during the reporting period is approximately RMB 97.5 million, allocated for the purchase of plants and equipment, capitalized development projects, and intangible assets[99] - The cash and cash equivalents, along with financial assets measured at amortized cost, amount to approximately RMB 864.2 million, a decrease of about 1.7% from RMB 879.2 million as of December 31, 2023, primarily due to increased operating and capital expenditures[94] Risks and Challenges - The company faces significant risks, including the successful commercialization of in-development products and the lengthy, costly nature of clinical product development[145] Shareholder Information - As of December 31, 2024, the company has a total of 313,389,171 issued shares[173] - Boston Scientific Group plc owns 203,702,962 shares, accounting for 65.00% of the company's equity[174] - Ms. Li holds 28,919,456 shares, representing approximately 9.23% of the company's equity[170] - CA Medtech Investment (Cayman) Limited holds 29,965,444 shares, which is about 9.56% of the company's equity[174] - Cosmic Elite Holdings Limited has a stake of 25,599,016 shares, representing 8.17% of the company's equity[174]

Financial Performance - Revenue for the year ended December 31, 2024, was RMB 533.988 million, representing a year-on-year increase of 12.7% compared to RMB 473.848 million in 2023[3]. - Gross profit for the same period was RMB 402.722 million, up 6.7% from RMB 377.415 million in 2023[3]. - Profit before tax surged to RMB 52.601 million, a significant increase of 264.0% from RMB 14.452 million in the previous year[3]. - The net profit for the year was RMB 52,280 thousand, a significant increase from RMB 14,487 thousand in 2023, reflecting a growth of 261.5%[15][17]. - Basic and diluted earnings per share rose to RMB 0.17 from RMB 0.05, marking a 240% increase year-over-year[15]. - The company reported a total comprehensive income of RMB 53,288 thousand for the year, up from RMB 15,179 thousand in 2023[17]. - Revenue from external customers for 2024 reached RMB 533,988,000, an increase of 12.7% from RMB 473,848,000 in 2023[31]. - Revenue from mainland China accounted for RMB 508,787,000, up 11% from RMB 458,226,000 in 2023[31]. - Other income for 2024 was RMB 40,429,000, a rise of 14.4% from RMB 35,397,000 in 2023, driven by increased interest income[33]. - The company reported a revenue of approximately RMB 213.7 million from the sale of venous intervention, vascular access products, and other products, representing an annual increase of about 42.2%[104]. Research and Development - The company registered 11 patents and submitted 16 new patent applications during the reporting period[4]. - Research and development expenses increased to RMB 216,773 thousand from RMB 190,070 thousand, highlighting the company's commitment to innovation[15]. - The company plans to invest in technological innovation to strengthen its R&D capabilities and maintain its leading position in the DCB market[119]. - The company has a robust R&D team and has strengthened its talent pool by adding personnel with expertise in mechanical design, polymer materials, medicine, pharmacy, and chemistry[109]. - The company is investing in R&D for innovative technologies aimed at enhancing product efficacy and expanding market reach[169]. Product Development and Market Expansion - The company has expanded its international business, completing preliminary work for market entry in countries such as Chile, Austria, and the UK[8]. - A distribution agreement with Boston Scientific Group plc was established for the sale of peripheral DCB products in overseas markets[10]. - Seven products received approval from the National Medical Products Administration, enhancing the company's product portfolio and market influence[6]. - The company initiated clinical trials for AcoArt Litos® in the US and Europe, marking a significant milestone for market entry[65]. - The company plans to expand its product offerings across four treatment areas, including vascular surgery, cardiology, nephrology, and neurology, leveraging synergies from its four core technologies[153]. Operational Efficiency and Cost Management - Administrative expenses for the year ending December 31, 2024, were approximately RMB 64.9 million, a decrease of about 22.6% from RMB 83.8 million for the year ending December 31, 2023[135]. - Financing costs increased by approximately 15.5% to RMB 11.5 million for the year ending December 31, 2024, compared to RMB 10.0 million for the year ending December 31, 2023, primarily due to increased interest expenses[136]. - The company reported a decrease in operational costs by D%, which positively impacted overall profitability margins[171]. Future Outlook - The company plans to continue expanding its market presence and investing in new product development to drive future growth[22]. - The company provided an optimistic outlook for the next fiscal year, projecting revenue growth of B% and an expected increase in user engagement metrics[171]. - The company anticipates increased sales from overseas markets as its products and pipeline products gain more marketing approvals outside of China[112]. - Future guidance includes a commitment to maintaining a strong balance sheet while pursuing growth opportunities in emerging markets[171]. Intellectual Property and Regulatory Approvals - The company has a strong intellectual property portfolio, including 57 registered patents and 42 pending patent applications as of December 31, 2024[109]. - The company has received regulatory approval for AcoArt Orchid® & Dhalia® in multiple countries, including Germany, Italy, and Brazil, and is expanding into additional markets such as Chile and Austria[74]. - The coronary microcatheter (Vericor-S2®) received NMPA registration approval on January 20, 2025[76]. Employee and Talent Development - The total number of employees reached 650, with the R&D team growing to 131 members, enhancing the company's talent pool[13]. - The company has improved the design and coating process of its products to enhance treatment efficacy and operational convenience[103].