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先瑞达医疗-B(06669.HK):微导丝的注册申请获北京市药品监督管理局批准
Ge Long Hui· 2025-08-18 09:09
Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received registration approval from the Beijing Drug Administration for its micro-guide wire, which is designed for routine peripheral vascular use to guide and place diagnostic or therapeutic devices [1] Product Details - The micro-guide wire is available in two outer diameter specifications: 0.014 inches and 0.018 inches [1] - The product features a 10 cm soft segment at the tip with a tapered core wire design and a laser-etched wave tube, ensuring excellent delivery and torque control performance [1] - This design aims to assist physicians in addressing complex vascular challenges [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]
先瑞达医疗-B(06669):微导丝的注册申请获北京市药品监督管理局批准
智通财经网· 2025-08-18 08:57
Core Viewpoint - The company received registration approval for its micro-guide wire from the Beijing Drug Administration, which is designed for routine peripheral vascular use, aiding in the guidance and placement of diagnostic or therapeutic devices [1] Group 1: Product Details - The micro-guide wire is available in two outer diameter specifications: 0.014" and 0.018" [1] - The product features a soft segment at the tip measuring 10 centimeters, designed with a tapered core wire structure [1] - The outer sheath is made of laser-engraved wave tube, ensuring excellent delivery and torque control performance [1] Group 2: Market Strategy - The company plans to conduct marketing activities in China at an appropriate time following the approval [1]
先瑞达医疗-B:微导丝的注册申请获北京市药品监督管理局批准
Zhi Tong Cai Jing· 2025-08-18 08:55
Core Viewpoint - The company, Xianruida Medical-B (06669), has received registration approval from the Beijing Drug Administration for its micro-guide wire, which is designed for routine peripheral vascular use to guide and place diagnostic or therapeutic devices [1] Product Details - The micro-guide wire is available in two outer diameter specifications: 0.014 inches and 0.018 inches [1] - The product features a 10 cm soft segment at the tip with a tapered core wire design and a laser-etched wave tube, ensuring excellent delivery and torque control performance [1] Market Strategy - The company plans to conduct marketing activities in China at an appropriate time following the approval [1]
先瑞达医疗(06669) - 自愿性公告微导丝的註册申请获北京市药品监督管理局批准
2025-08-18 08:45
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 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 微導絲的註冊申請獲北京市藥品監督管理局批准 李靜 香港,2025年8月18日 於本公告日期,執行董事為李靜女士,非執行董事為Silvio Rudolf SCHAFFNER 先生、Arthur Crosswell BUTCHER先生及June CHANG女士,以及獨立非執行董 事為王玉琦醫師、倪虹女士及潘建而女士。 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8月13日,本集團收到北京市藥品 監督管理局對微導絲的註冊批准。微導絲適用於常規外周血管內使用,用於引導 和放置 ...
先瑞达医疗-B(06669.HK)拟8月26日举行董事会会议批准中期业绩
Ge Long Hui· 2025-08-14 08:56
格隆汇8月14日丨先瑞达医疗-B(06669.HK)宣布,本公司将于2025年8月26日(星期二)举行董事会会 议,藉以(其中包括)考虑及批准本公司及其附属公司截至2025年6月30日止六个月的未经审核的中期 业绩及其发布,以及考虑派付中期股息(如有)。 ...
先瑞达医疗(06669) - 董事会会议通告
2025-08-14 08:37
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,概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Acotec Scientific Holdings Limited (於開曼群島註冊成立的有限公司) (股份代號:6669) 董事會會議通告 先瑞達醫療科技控股有限公司(「本公司」)董事會(「董事會」)謹此宣佈,本公司 將於2025年8月26日(星期二)舉行董事會會議,藉以(其中包括)考慮及批准本公 司及其附屬公司截至2025年6月30日止六個月的未經審核之中期業績及其發佈, 以及考慮派付中期股息(如有)。 承董事會命 先瑞達醫療科技控股有限公司 執行董事、董事會主席及首席執行官 李靜 香港,2025年8月14日 先瑞達醫療科技控股有限公司 於本公告日期,執行董事為李靜女士,非執行董事為Silvio Rudolf SCHAFFNER 先生、Arthur Crosswell BUTCHER先生及June CHANG女士,以及獨立非執行董 事為王玉琦醫師、倪虹女士及潘建而女士。 ...
港股异动 | 先瑞达医疗-B(06669)涨超4% 近日西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna®注册获批
智通财经网· 2025-08-12 07:03
Core Viewpoint - The approval of AcoArt Canna by the National Medical Products Administration of China is a significant milestone for the company, potentially enhancing its market position in the cardiovascular medical device sector [1] Company Summary - The stock of Xianruida Medical-B (06669) increased by over 4%, specifically by 4.63%, reaching HKD 11.97 with a trading volume of HKD 6.2497 million [1] - The company has received registration approval for its sirolimus drug-coated balloon catheter, AcoArt Canna, which is intended for the treatment of primary coronary bifurcation lesions with a vessel diameter between 2.0mm and 4.0mm [1] Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna, with the primary endpoint being the diameter stenosis rate (DS, %) of the target lesion branch at 9 months post-operation [1] - The trial group using AcoArt Canna showed a DS of 30.52% at 9 months, compared to 33.46% in the control group using paclitaxel drug-coated balloon catheters, with no statistically significant difference between the two groups [1] - Safety data analysis indicated that the trial group did not present abnormal risks or events compared to the control group [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]
先瑞达医疗-B涨超4% 近日西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna 注册获批
Zhi Tong Cai Jing· 2025-08-12 07:01
Group 1 - The core viewpoint of the article is that AcoArt Canna, a drug-coated balloon catheter developed by the company, has received registration approval from the National Medical Products Administration of China, which is expected to enhance the company's market position [1] - The stock price of the company increased by 4.63%, reaching HKD 11.97, with a trading volume of HKD 6.25 million [1] - AcoArt Canna is indicated for the treatment of primary coronary artery bifurcation lesions with a vessel diameter between 2.0mm and 4.0mm [1] Group 2 - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna, with a target lesion branch vessel diameter stenosis rate (DS%) of 30.52% at 9 months post-operation, compared to 33.46% for the control group using a paclitaxel-coated balloon, showing no statistical difference [1] - Safety data analysis indicated that the trial group did not present abnormal risks or events compared to the control group [1] - The company plans to initiate marketing activities in China at an appropriate time [1]
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
智通财经网· 2025-08-04 10:32
Core Viewpoint - The company received approval from the National Medical Products Administration of China for the AcoArt Canna® drug-coated balloon catheter, indicating a significant advancement in its product offerings for treating coronary artery bifurcation lesions [1] Group 1: Product Approval - The AcoArt Canna® is approved for the treatment of primary coronary artery bifurcation lesions with vessel diameters between 2.0mm and 4.0mm [1] - The approval is set to take effect on July 31, 2025, allowing the company to initiate marketing activities in China [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna®: the primary endpoint showed a target lesion branch vessel diameter stenosis (DS) rate of 30.52% at 9 months post-operation for the trial group [1] - The control group, which used a paclitaxel drug-coated balloon catheter, had a DS rate of 33.46% at the same time point, with no statistically significant difference between the two groups [1] - Safety data analysis indicated that the trial group did not present any abnormal risks or events compared to the control group [1]
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
Zhi Tong Cai Jing· 2025-08-04 10:28
Core Viewpoint - The approval of AcoArt Canna, a sirolimus drug-coated balloon catheter, by the National Medical Products Administration of China marks a significant milestone for the company in expanding its product offerings in the cardiovascular market [1] Group 1: Product Approval - The company received registration approval for AcoArt Canna on July 31, 2025, from the National Medical Products Administration of China [1] - AcoArt Canna is designed for the treatment of primary coronary bifurcation lesions with vessel diameters ranging from 2.0mm to 4.0mm [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the efficacy and safety of AcoArt Canna, with the primary endpoint being the diameter stenosis (DS, %) of the target lesion branch at 9 months post-operation [1] - The trial group using AcoArt Canna showed a DS of 30.52% at 9 months, compared to 33.46% in the control group using a paclitaxel drug-coated balloon, with no statistically significant difference between the two groups [1] - Safety data analysis indicated that the trial group did not present abnormal risks or events compared to the control group [1] Group 3: Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the product approval [1]