Core Insights - The completion of the TARGET confirmatory clinical study with 150 patients marks a significant milestone for Cardiovalve in the treatment of tricuspid regurgitation, advancing its path towards CE MDR approval [1][2] - Cardiovalve is a self-developed transcatheter replacement product that can treat both mitral and tricuspid regurgitation, offering enhanced safety and applicability for approximately 95% of patients [1] Group 1 - The TARGET confirmatory clinical study is a prospective, multi-center, single-arm study conducted across over 30 cardiovascular centers in Europe (mainly Germany, Italy, Spain), the UK, and Canada [1] - Cardiovalve features a unique design with a maximum 55mm valve ring and a short valve frame that effectively reduces the risk of left ventricular outflow tract obstruction [1] Group 2 - The board believes that the completion of the clinical trial is a major milestone for the product's market entry and represents significant progress in innovative therapies for tricuspid regurgitation globally [2] - The company aims to leverage its established advantages in research, production, and commercialization in the global structural heart disease field to expedite the clinical registration and approval of innovative products like Cardiovalve [2]

Core Insights - The completion of the TARGET confirmatory clinical study with 150 patients marks a significant milestone for Cardiovalve in the treatment of tricuspid regurgitation, advancing its path towards CE MDR approval [1][2] - Cardiovalve is a self-developed transcatheter replacement product that can treat both mitral and tricuspid regurgitation, offering enhanced safety and suitability for approximately 95% of patients [1] - The company aims to leverage its established advantages in research, production, and commercialization in the global structural heart disease field to expedite the global clinical registration and approval of innovative products like Cardiovalve [2] Summary by Sections Clinical Study - The TARGET confirmatory clinical study is a prospective, multi-center, single-arm study conducted across over 30 cardiovascular centers in Europe (mainly Germany, Italy, Spain), the UK, and Canada, successfully enrolling 150 patients [1] - The study's completion is viewed as a major advancement in innovative therapies for tricuspid regurgitation on a global scale [2] Product Features - Cardiovalve features a unique design with a maximum 55mm valve ring, significantly improving treatment safety and reducing the risk of left ventricular outflow tract obstruction [1] - The product's operation is straightforward, requiring only three steps: positioning, anchoring, and releasing [1] Strategic Goals - The company is committed to advancing the global clinical registration development process for innovative products, including Cardiovalve, to benefit more patients and achieve its internationalization strategy [2]

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之內容概不負責， 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之任何損失承擔任何責任。 杭州啓明醫療器械股份有限公司 TARGET確證性臨床研究是針對三尖瓣反流的患者的一項前瞻性、多中心、單臂研 究，該 研 究 在 歐 洲（主 要 於 德 國、義 大 利、西 班 牙）、英 國 及 加 拿 大30餘家心血管中 心進行，共計招募150名患者。 Cardiovalve是一款自主研發、同時可用於治療二尖瓣反流和三尖瓣反流的經導管介 入置換產品。與同類產品相比，Cardiovalve經股靜脈的入路方式顯著提升了治療安 全 性，產 品 最 大55mm的大瓣環設計適用約95%的 患 者 群 體，同 時，其 獨 特 的 短 瓣 架設計可有效降低心室流出道梗阻風險。Cardiovalve操作簡單、安全、可複製性強， 只需定位、錨定、釋放三個步驟完成。 – 1 – 董 事 會 深 信，Cardiovalve完 成 歐 洲 確 證 性 臨 床 試 驗 ...

Core Insights - Southbound funds reduced their holdings in Qiming Medical-B (02500.HK) by 121,500 shares on October 15, 2025, marking a decrease of 0.22% [1] - Over the past five trading days, there has been a cumulative net reduction of 437,000 shares, while in the last twenty trading days, the total net reduction reached 1,048,000 shares [1] - As of now, southbound funds hold 53,968,600 shares of Qiming Medical-B, which accounts for 12.23% of the company's total issued ordinary shares [1] Company Overview - Qiming Medical is primarily engaged in the research, development, production, and sales of biological heart valves, focusing on minimally invasive medical devices for treating heart valve diseases [2] - The company's product line includes devices for aortic, pulmonary, mitral, and tricuspid valve interventions, as well as systems for treating hypertrophic cardiomyopathy and renal artery denervation [2] - Key products include the VenusA-Valve system, VenusA-Plus system, VenusA-Pilot system, VenusP-Valve system, TMVR valve, TTVR valve, balloon for valve repair V8/TAV8, and TriGUARD3 cerebral embolic protection device [2]

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 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02500 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 441,010,235 | RMB | | 1 RMB | | 441,010,235 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 441,010,235 | RMB | | 1 RMB | | 441,010,235 | | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- ...

2025 中期報告 目錄 | 2 | 公司資料 | | --- | --- | | 4 | 財務摘要 | | 5 | 管理層討論與分析 | | 29 | 企業管治及其他資料 | | 50 | 簡明綜合財務報表審閱報告 | | 52 | 簡 明綜合損益及其他全面收益表 | | 54 | 簡 明綜合財務狀況表 | | 56 | 簡 明綜合權益變動表 | | 58 | 簡 明綜合現金流量表 | | 61 | 簡 明綜合財務 報 表 附 註 | | 89 | 釋 義 | | 公司資料 | | --- | （截至二零二五年六月三十日） | 中文名稱： | 杭州啓明醫療器械股份有限公司 | | --- | --- | | 英文名稱： | Venus Medtech (Hangzhou) Inc. | | 法定代表： | 林浩昇先生 | | 董事長： | 胡定旭先生 | | 註冊資本： | 人民幣441,011,443元 | | 中國總部： | | | 註冊及辦事處地址： | 中國杭州濱江區江陵路88號2幢3樓311室 | | 公司網址： | http://www.venusmedtech.com/ | | 電郵： | i ...

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: 杭州啓明醫療器械股份有限公司 (「本公司」) 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02500 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 441,010,235 | RMB | | 1 RMB | | 441,010,235 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 441,010,235 | RMB | | 1 RMB | | 441,010,235 | | 2. 股份分類 | 普通股 | 股份類別 ...

Core Viewpoint - The company reported a significant decline in revenue for the first half of 2025, primarily due to a decrease in product pricing driven by market competition and a shift in sales strategy [1] Revenue Performance - The company's revenue for the six months ending June 30, 2025, was RMB 187.1 million, representing an 18.9% year-on-year decrease [1] - The decline in revenue is attributed to two main factors: intense market competition leading to a strategic pricing adjustment, and a transition from a direct sales model to a platform sales model [1] Profitability - The loss attributable to equity holders of the parent company was RMB 135 million, compared to a loss of RMB 206 million in the same period last year [1]

Group 1 - The core viewpoint of the article is that Qiming Medical-B (02500) reported a decline in revenue and a reduction in shareholder losses for the six months ending June 30, 2025 [1] Group 2 - The company's revenue for the period was RMB 187 million, representing a year-on-year decrease of 18.9% [1] - The loss attributable to shareholders was RMB 135 million, which is a year-on-year narrowing of 34.7% [1] - The loss per share was RMB 0.31 [1]

Core Viewpoint - The company reported a decline in revenue and a reduced loss for the first half of the fiscal year ending June 30, 2025, indicating ongoing challenges but some improvement in financial performance [1] Financial Performance - The company's revenue for the six months was RMB 187 million, representing a year-on-year decrease of 18.9% [1] - The loss attributable to shareholders was RMB 135 million, which is a year-on-year reduction of 34.7% [1] - The loss per share was RMB 0.31 [1]