Core Viewpoint - The company, Xianruida Medical-B (06669), has received FDA 510(k) market clearance for its intravascular radiofrequency ablation system, which is designed to treat lower limb varicose veins caused by superficial venous reflux [1] Group 1: Product Details - The intravascular radiofrequency ablation system includes the CedarTM intravascular radiofrequency catheter and the intravascular radiofrequency generator, which are used in conjunction for treatment [1] - The system targets lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member of the BSC Group for the sales of this product in the United States [1] - The BSC Group will begin to advance the commercialization of the product in the U.S. at an appropriate time [1]

Core Viewpoint - The company has received FDA 510(k) market clearance for its intravascular radiofrequency ablation system, which is designed to treat lower limb varicose veins caused by superficial venous reflux [1] Group 1: Product Details - The intravascular radiofrequency ablation system includes the CedarTM intravascular radiofrequency catheter and the intravascular radiofrequency generator, which are used in combination for treatment [1] - The system targets lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member company of the BSC Group for the sales of this product in the United States [1] - The BSC Group will initiate the commercialization of the product in the U.S. at an appropriate time [1]

Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received FDA 510(k) market clearance for its intravascular radiofrequency ablation system, which is designed to treat lower limb varicose veins caused by superficial venous reflux [1] Group 1: Product Details - The intravascular radiofrequency ablation system includes the CedarTM intravascular radiofrequency catheter and an intravascular radiofrequency generator, which are used in conjunction for treatment [1] - The system is specifically aimed at addressing lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member of the BSC Group for the sales of this product in the United States [1] - The BSC Group is expected to initiate the commercialization of the product in the U.S. at an appropriate time [1]

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。 本公司董事會（「董事會」）欣然宣佈，於2025年10月7日，本集團的靜脈腔內射頻 消融系統獲得美國食品藥品監督管理局的510(k)市場准入許可。本系統包括靜脈 腔內射頻導管CedarTM及靜脈腔內射頻發生器，兩者配合使用，用於治療因淺靜脈 反流引起的下肢靜脈曲張。本公司已與BSC集團旗下成員公司就本產品在美國的 銷售簽署了分銷協議。未來，BSC集團將適時開始推進本產品在美國的商業化工 作。 本公司最終未必能夠成功營銷靜脈腔內射頻消融系統。本公司股東及潛在投資者 在買賣本公司股份時務請審慎行事。 承董事會命 Acotec Scientific Holdings Limited 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 靜脈腔內射頻消融系統取得美國食品藥品監督管理局510(K)市場准入許可 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 ...

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9月30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10月2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 | ...

Acotec Scientific Holdings Limited 先瑞達醫療科技控股有限公司 (Incorporated in the Cayman Islands with limited liability) （於開曼群島註冊成立的有限公司） (Stock Code 股份代號 : 6669) N O T I F I C AT I O N L E T T E R Dear non-registered shareholder(s), 24 September 2025 Acotec Scientific Holdings Limited (the "Company") – Notice of Publication of 2025 Interim Report (the "Current Corporate Communications") The Current Corporate Communications of the Company have been published in English and Chinese languages and are available on the web ...

Acotec Scientific Holdings Limited 先瑞達醫療科技控股有限公司 (Incorporated in the Cayman Islands with limited liability) （於開曼群島註冊成立的有限公司） (Stock Code 股份代號 : 6669) N O T I F I C AT I O N L E T T E R 24 September 2025 Dear registered shareholders, Acotec Scientific Holdings Limited (the "Company") – Notice of Publication of 2025 Interim Report (the "Current Corporate Communications") The Current Corporate Communications of the Company have been published in English and Chinese languages and are available on the website o ...

Financial Performance - Revenue for the six months ended June 30, 2025, was RMB 351.2 million, representing a year-on-year increase of 20.1% compared to RMB 292.3 million for the same period in 2024[7] - Gross profit for the same period was RMB 260.5 million, up 19.9% from RMB 217.2 million in the previous year[7] - Profit before tax surged to RMB 89.5 million, a significant increase of 124.1% compared to RMB 39.9 million in the prior year[7] - The net profit for the period was RMB 88,577,000, a significant increase of 121.1% compared to RMB 39,957,000 in the prior year[112] - Total comprehensive income for the period was RMB 88,260,000, significantly up from RMB 40,329,000 in the previous year, indicating a year-over-year increase of 118%[114] - Operating profit from core business operations was RMB 95,035,000, up 105.7% from RMB 46,248,000 in the previous year[112] - Revenue from core products AcoArt Orchid® & Dhalia® and AcoArt Tulip® & Litos® generated approximately RMB 175.6 million and RMB 172.9 million, representing year-on-year increases of approximately 0.6% and 46.9% respectively[50] - Other income for the six months ended June 30, 2025, was approximately RMB 27.0 million, a 39.6% increase from RMB 19.3 million in the previous period, mainly due to increased government subsidies[63] Product Development and Innovation - The company has established over 30 product pipelines focused on vascular interventional solutions across four major medical fields[8] - Six products received market approval during the reporting period, enhancing the company's product portfolio and market share[10] - The company registered 2 patents and submitted 4 new patent applications during the reporting period, reflecting ongoing innovation[9] - A strategic partnership with Boston Scientific Group plc was established to enhance product commercialization and development over the next three years[13] - The company is investing in research and development of drug-coated technologies, which are expected to improve treatment outcomes in peripheral artery diseases[21] - The company plans to enhance its product portfolio through strategic acquisitions, targeting complementary technologies to strengthen its competitive edge[21] - The company has a strong R&D team with 66 registered patents and 30 pending patent applications as of June 30, 2025[48] Market Expansion and Strategy - The company has expanded its international presence, with plans to launch ATK DCB and BTK DCB in multiple countries in 2025[13] - Market expansion efforts include entering new regions such as Brazil and Thailand, aiming for a 10% market share in these territories by 2027[21] - The company is focusing on expanding its presence in Europe, with a goal of achieving a 30% increase in sales in that market by 2026[21] - The company plans to continue expanding in both the Chinese and global markets, focusing on product development and utilizing various financing channels to support capital expenditures[83] Regulatory Approvals and Clinical Trials - The AcoArt Verbena® device received approval from the National Medical Products Administration in May 2025, demonstrating a target lesion re-narrowing rate of 13.04% compared to 37.31% in the control group[14] - The company has initiated clinical trial centers in the US and Europe for the AcoArt Litos® product, marking a significant milestone for entry into the US market[15] - Six products received registration approval during the reporting period, including the AcoArt Verbena® and other vascular intervention devices[19] - The company is conducting clinical trials for the lower limb rapamycin DCB, with expected regulatory approval in 2026[36] Financial Position and Resources - The total available financial resources as of June 30, 2025, amounted to approximately RMB 999.7 million, a 15.7% increase from RMB 864.2 million as of December 31, 2024[73] - The total borrowings as of June 30, 2025, were RMB 49.0 million, up from RMB 10.0 million as of December 31, 2024[74] - The capital-to-debt ratio increased from approximately 23.2% as of December 31, 2024, to about 26.6% as of June 30, 2025, primarily due to increased bank loans[74] - The net current assets as of June 30, 2025, were approximately RMB 1,128.0 million, a 4.9% increase from RMB 1,075.8 million as of December 31, 2024[75] Employee and Operational Efficiency - As of June 30, 2025, the total number of employees is 645, with 141 in the R&D team, enhancing talent reserves in various engineering fields[18] - The company aims to reduce production costs by 20% through operational efficiencies and supply chain optimization[21] - Selling and distribution costs for the six months ended June 30, 2025, were approximately RMB 55.8 million, an increase of about 11.6% from RMB 50.0 million in the previous period, mainly due to increased market investments[65] Shareholder Information - As of June 30, 2025, the total number of issued shares of the company is 313,389,171[1] - Boston Scientific Group plc owns 203,702,962 shares, accounting for 65% of the company's equity[1] - The company issued 2,410,000 restricted shares on June 19, 2025, under the restricted share unit plan[1] - The board does not recommend the distribution of an interim dividend for the six months ended June 30, 2025, consistent with the previous year[169]

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8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9月3日 I. 法定/註冊股本變動 第 1 頁 共 10 頁 v 1.1.1 FF301 | 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 | | 10 ...

Summary of Xianruida Medical Conference Call Company Overview - **Company**: Xianruida Medical - **Industry**: Medical Devices, specifically focusing on drug-coated balloons (DCB) and related products Key Financial Performance - **Revenue**: Achieved 351 million yuan in H1 2025, a year-on-year increase of 20.1% [3] - **Net Profit**: Increased by 121% to 88.58 million yuan, with a net profit margin of 25% [2][3] - **Gross Margin**: Maintained at a high level of 74.2% [2][3][25] Product Development and Market Expansion - **Product Approvals**: Over 9 new products approved in 2025, including the first vertebral artery drug balloon [18][27] - **Clinical Trials**: The first Xisha drug balloon is undergoing IDE clinical trials in the US [2][4] - **International Expansion**: Registered in over 20 countries and initiated 41 new country registration projects [2][4][5] - **Partnerships**: Collaboration with Boston Scientific (波科) for distribution agreements in Europe and joint product development [2][7] Cost Control and Operational Efficiency - **Cost Management**: Reduced R&D expense ratio from 34% to 29% and sales expense ratio from 16% to 11% [2][6] - **Production Optimization**: Implemented measures such as using self-produced raw materials to replace external sourcing, enhancing operational efficiency [6][23] Market Trends and Product Performance - **Peripheral DCB Products**: Contributed 176 million yuan in revenue, indicating rapid growth [3] - **Domestic Market Share**: Achieved a 30% market share in lower limb drug balloon products, with increasing usage in hospitals [2][10] - **Clinical Data**: Vertebral artery drug balloon showed a 12-month target lesion revascularization rate of only 13.04%, significantly lower than the control group [4][15] Future Outlook and Strategic Focus - **Revenue Guidance**: Full-year revenue guidance adjusted to a growth of 20%-25%, with net profit target raised to 120 million yuan [4][24] - **Product Pipeline**: Focus on expanding product lines, enhancing innovation speed, and deepening international partnerships [8][9] - **R&D Investment**: Continued emphasis on R&D to maintain industry leadership and explore new treatment areas [29][30] Regulatory and Market Challenges - **Collective Procurement Impact**: Current gross margin is expected to remain stable despite potential impacts from collective procurement policies [25][26] - **Market Competition**: Despite the emergence of over 20 competitors, the company maintains a leading position in the market [13] Conclusion - **Competitive Advantage**: Xianruida Medical's focus on innovation, market expansion, and operational efficiency positions it well for future growth despite a complex market environment [39][40]