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。 ...

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]

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]

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]

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]

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。 ...

Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received approval from the National Medical Products Administration of China for the registration of its drug-coated balloon catheter, AcoArt Canna®, intended for the treatment of coronary artery bifurcation lesions [1] Group 1: Product Approval - AcoArt Canna® is approved for use in patients with a vessel diameter of ≥2.0mm and ≤4.0mm [1] - The approval is significant as it allows the company to market the product in China starting from July 31, 2025 [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna® [1] - The primary endpoint of the trial was the diameter stenosis rate (DS, %) of the target lesion branch at 9 months post-operation, with the trial group showing a DS of 30.52% compared to 33.46% in the control group using paclitaxel-coated balloon catheters [1] - No statistically significant difference was observed between the two groups regarding the DS rates [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 approval [1]

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].