Core Viewpoint - The company received approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, enhancing its product portfolio in the cardiovascular medical device market [1] Product Approval - The approval is for the "井翼" balloon dilation catheter, which is designed for treating coronary artery stenosis and bypass graft stenosis [1] - The catheter features a diameter range of 2.0-5.0mm, suitable for post-stent dilation [1] Product Features - The "井翼" is a semi-compliant balloon dilation catheter that offers superior passability and pushability due to its smaller head diameter and optimized delivery system [1] - It effectively addresses complex lesions such as chronic total occlusions and severe calcifications, improving procedural efficiency and safety [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]

Core Viewpoint - The company, Xianruida Medical-B (06669), has received registration approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, Jingyi®, which is designed to improve myocardial perfusion in patients with coronary artery stenosis [1] Group 1: Product Details - Jingyi® is suitable for balloon dilation at sites of coronary artery stenosis or bypass graft stenosis, with balloon diameters ranging from 2.0 to 5.0 mm also applicable for post-stent dilation [1] - The product features a semi-compliant balloon dilation catheter with a smaller head diameter and optimized delivery system, enhancing its passability and pushability [1] - Jingyi® effectively addresses complex lesions such as chronic total occlusions and severe calcifications, improving surgical efficiency and safety through its overall exchange design [1] Group 2: Market Strategy - The company plans to conduct marketing activities in China at an appropriate time following the approval [1]

Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, Jingyi®, which is designed to improve myocardial perfusion in patients with coronary artery stenosis [1] Group 1: Product Approval - The approval was granted on November 13, 2025, for the Jingyi® balloon dilation catheter [1] - The product is suitable for balloon dilation at sites of coronary artery stenosis or bypass graft stenosis [1] - The catheter features a diameter range of 2.0-5.0mm, which is also applicable for post-stent dilation [1] Group 2: Product Features - Jingyi® is a semi-compliant balloon dilation catheter that offers superior passability and pushability due to its smaller head diameter and optimized delivery system [1] - The design effectively addresses complex lesions such as chronic total occlusions and severe calcifications [1] - The overall exchange design enhances surgical efficiency and safety [1] Group 3: Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]

本公司董事會（「董事會」）欣然宣佈，於2025年11月13日，本集團收到中國國家 藥品監督管理局對冠脈整體交換型球囊擴張導管井翼®的註冊批准。井翼®適用 於冠狀動脈狹窄部位或冠狀動脈旁路血管狹窄部位進行球囊擴張，以改善心肌灌 注，球囊直徑為2.0-5.0mm的型號還適用於支架遞送後擴張。井翼®是一款半順應 性球囊擴張導管，憑藉其更小的頭端通過外徑和球囊折疊外徑，以及優化的推送 系統，實現了卓越的通過性和推送性，能有效應對慢性完全閉塞及嚴重鈣化等複 雜病變，其整體交換設計也提升了手術效率與安全性。本公司將適時在中國開展 營銷活動。 （於開曼群島註冊成立的有限公司） （股份代號：6669） 自願性公告 冠脈整體交換型球囊擴張導管井翼®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。 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 ...

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10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11月3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 | ...

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 | ...