Group 1 - The core point of the article highlights that southbound funds have reduced their holdings in Qiming Medical-B (02500.HK) by 2,500 shares on November 21, 2025, marking a continuous trend of reduction over the past trading days [1] - Over the last 5 trading days, southbound funds have cumulatively reduced their holdings by 47,500 shares, while in the last 20 trading days, the total reduction amounts to 666,000 shares [1] - As of now, southbound funds hold 53,424,100 shares of Qiming Medical-B, which represents 12.11% of the company's total issued ordinary shares [1] Group 2 - Qiming Medical is primarily engaged in the research, production, and sales of biological heart valves, focusing on minimally invasive medical devices and auxiliary instruments for treating heart valve diseases [2] - The company's product line includes devices for treating various heart valve diseases, such as aortic valve, pulmonary valve, mitral valve, and tricuspid valve interventions, as well as systems for radiofrequency ablation and renal artery ultrasound ablation [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 embolic protection device [2]

Core Insights - The company, Qiming Medical, is facing severe cash flow challenges, highlighted by its recent decision to sell a health industry park in Hangzhou at a 12% discount, primarily to repay bank debts [1][2] - The aggressive expansion strategy has led to a significant disconnect between investment and actual revenue, with annual revenues stagnating between 400 million to 500 million yuan from 2021 to 2024, while the health park project has become a financial burden [1][2] - The core business is experiencing stagnation, compounded by intensified competition in the heart valve market, with a reported 18.9% year-on-year revenue decline in the first half of 2025 [1][2] Financial Challenges - The company invested 310 million yuan in the health park project by the end of 2024, with an additional 700 million yuan needed, while cash reserves have dwindled to 298 million yuan [1] - As of June 2025, cash and equivalents are only 279 million yuan against borrowings of 419 million yuan, indicating a precarious debt repayment capacity [1] Market Dynamics - The heart valve market is becoming increasingly competitive, with 11 products approved domestically, leading to aggressive price competition [1][2] - The inclusion of heart valves in inter-provincial alliance procurement could further compress profit margins, raising uncertainty about the company's ability to offset potential price reductions with increased volume [2] Governance and Trust Issues - Internal governance issues have led to a trust crisis, exemplified by a 475-day suspension due to executive embezzlement, resulting in a significant market value loss upon resumption of trading [2] - The recent asset sale, while addressing immediate financial needs, underscores the company's lack of sustainable financing capabilities and strategic direction [2] Conclusion - The asset sale is a temporary measure in the face of mounting pressures from procurement policies, competitive market conditions, and tight cash flow [3] - The company must urgently redefine its business focus, control costs, and seek new growth avenues to avoid being eliminated from the market [3]

Core Viewpoint - Qiming Medical-B (02500.HK) has seen a significant increase in its stock price, rising over 7% to reach 2.44 HKD with a trading volume of 4.5441 million HKD [1] Group 1 - The stock price of Qiming Medical-B increased by 7.02% [1] - The current trading price is 2.44 HKD [1] - The total trading volume reached 454.41 million HKD [1]

Core Insights - The stock of Qiming Medical-B (02500) rose over 7%, reaching HKD 2.44 with a trading volume of HKD 4.5441 million, following the announcement of positive mid-term clinical results for the Cardiovalve transcatheter tricuspid valve replacement system [1] Group 1: Clinical Trial Results - The TARGET study is a prospective, multi-center, single-arm clinical trial conducted across 25 centers in Germany, Spain, Italy, Canada, and the UK, involving 125 patients with an average age of 77 [1] - The average procedure time was reported at 58±29 minutes, with an intraoperative success rate of 88% and an implantation success rate of 95% [1] - At the 6-month follow-up, 100% of patients showed no moderate or severe regurgitation, with 88% improving to New York Heart Association (NYHA) functional class I/II, increasing to 90% at 12 months, and an average quality of life score improvement of 20 points [1] Group 2: Safety and Efficacy - The overall mortality rate was 6.4% (8 out of 125), with a heart failure readmission rate of 1.6%, and low incidence rates for pericardial effusion, disabling stroke, and acute kidney injury requiring renal replacement therapy [2] - The mid-term clinical data for the Cardiovalve system received high recognition from international clinical experts at the PCR London Valves 2025 conference, showcasing its excellent clinical efficacy in treating severe tricuspid regurgitation [2] - The company plans to continue advancing the global clinical registration and development process for innovative products, including the Cardiovalve system [2]

Core Insights - The stock of Qiming Medical (02500) rose over 7%, reaching HKD 2.44 with a trading volume of HKD 4.5441 million following the announcement of mid-term clinical results for the Cardiovalve transcatheter tricuspid valve replacement system in the TARGET study [1] Group 1: Clinical Study Results - The TARGET study is a prospective, multi-center, single-arm clinical trial conducted across 25 centers in Germany, Spain, Italy, Canada, and the UK, involving 125 patients with an average age of 77 [1] - The average procedure time for the device was 58±29 minutes, with an intraoperative success rate of 88% and an implant success rate of 95% [1] - At the 6-month follow-up, 100% of patients had no moderate or severe regurgitation, with 88% showing improvement in heart function to NYHA class I/II, increasing to 90% at 12 months; quality of life scores improved by an average of 20 points, and 6-minute walking distances increased by 44 meters and 32 meters respectively [1] Group 2: Safety and Expert Recognition - The overall mortality rate was 6.4% (8 out of 125), with a heart failure readmission rate of 1.6%; the incidence of pericardial effusion, disabling stroke, and acute kidney injury requiring renal replacement therapy was low [2] - Qiming Medical highlighted that the mid-term clinical data for the Cardiovalve system, presented at the PCR London Valves 2025 conference, demonstrated the product's excellent clinical efficacy in treating severe tricuspid regurgitation, receiving high recognition from international clinical experts [2] - The company will continue to actively advance the global clinical registration and development process for innovative products, including the Cardiovalve system [2]

Core Viewpoint - The mid-term clinical results of the Cardiovalve transcatheter valve replacement system from the TARGET study demonstrate its safety and clinical performance in treating severe tricuspid regurgitation, with positive feedback from international clinical experts at the PCRL London Valves 2025 conference [1][5]. Clinical Results - The TARGET study is a prospective, single-arm, multi-center clinical trial involving 125 patients across 25 centers in Germany, Spain, Italy, Canada, and the UK, with an average patient age of 77 years [1]. - The average procedure time for the device was 58±29 minutes, with the shortest recorded time being 16 minutes, and the overall procedural success rate was 88%, with a success rate of 95% in the device implantation group [1]. Efficacy Results - At the 6-month follow-up, 100% of patients showed no moderate or severe tricuspid regurgitation, with this efficacy maintained at the 12-month follow-up [2]. - According to the New York Heart Association (NYHA) classification, 88% of patients improved to NYHA class I/II at 6 months, increasing to 90% at 12 months, with no patients classified as NYHA class IV during the 6-month follow-up [2]. - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 20 points at 6 months, with sustained efficacy at the 12-month follow-up, and the 6-minute walk distance increased by an average of 44 meters and 32 meters at 6 and 12 months, respectively [2]. Safety Results - The 30-day major adverse event (MAE) rates included an all-cause mortality rate of 6.4%, heart failure readmission rate of 1.6%, and a rate of 3.2% for re-intervention due to progression of tricuspid regurgitation or device-related complications [3]. - The study reported a 12.8% incidence of BARC type IIIb-V bleeding, with 5.6% experiencing major vascular injury at the puncture site [3]. - Among the 125 patients, 20.8% experienced MAEs within 30 days, with a total of 41 events reported [4]. Long-term Follow-up - The TARGET study's 12-month follow-up data indicate that Cardiovalve shows good safety and clinical performance, with sustained improvement in patients' quality of life and a stable low incidence of safety events compared to the 30-day follow-up [4]. - 65.8% of enrolled patients received a large-sized (55mm) prosthetic valve, and long-term follow-up data and global clinical evidence for Cardiovalve are still being collected [4]. Future Development - The company is committed to advancing the global clinical registration and development process for innovative products, including the Cardiovalve system, aiming for timely market approval to benefit more patients and achieve its international strategy [5].

Core Insights - The TARGET study demonstrates the safety and clinical performance of the Cardiovalve transcatheter valve replacement system, with positive mid-term clinical results [1][5] Efficacy Results - 100% of patients showed no moderate or severe tricuspid regurgitation at 6 months, with sustained efficacy at 12 months [2] - 88% of patients improved to NYHA functional class I/II at 6 months, increasing to 90% at 12 months, with no NYHA class IV patients observed during the 6-month follow-up [2] - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 20 points at 6 months, maintained at 12 months; 6-minute walk distance increased by an average of 44 meters at 6 months and 32 meters at 12 months [2] Safety Results - The overall major adverse event (MAE) rate within 30 days post-surgery was 20.8%, with 41 total events reported among 26 patients [3][4] - The all-cause mortality rate was 6.4%, with heart failure readmission at 1.6% and re-intervention due to tricuspid regurgitation progression at 3.2% [3] - The study reported a 12.8% incidence of BARC IIIb-V bleeding events, with 5.6% vascular injury at the puncture site [3] Long-term Follow-up - The TARGET study indicates that Cardiovalve shows good safety and clinical performance over 12 months, with a stable low incidence of safety events compared to the 30-day follow-up [4] - 65.8% of enrolled patients received a large-sized (55mm) prosthetic valve, with ongoing accumulation of long-term follow-up data and global clinical evidence [4] Industry Recognition - The mid-term clinical data presented at the PCR London Valves 2025 conference highlighted the Cardiovalve system's exceptional clinical efficacy in treating severe tricuspid regurgitation, receiving high recognition from international clinical experts [5] - The company aims to advance the global clinical registration and development process for innovative products, including the Cardiovalve system, to benefit more patients and achieve its international strategy [5]

Core Viewpoint - The mid-term clinical results of the Cardiovalve transcatheter valve replacement system from the TARGET study demonstrate its safety and clinical performance, highlighting its effectiveness in treating severe tricuspid regurgitation [1] Group 1: Clinical Study Overview - The TARGET study is a prospective, single-arm, multi-center clinical trial conducted across 25 clinical centers in Germany, Spain, Italy, Canada, and the UK, involving 125 patients with an average age of 77 years [1] - The average procedure time for the device was 58±29 minutes, with the shortest recorded procedure time being 16 minutes [1] - The overall intraoperative success rate was reported at 88% according to the TVARC standard, with a success rate of 95% for the device implantation group [1] Group 2: Product Recognition and Future Plans - The mid-term clinical data for the Cardiovalve tricuspid valve replacement system was presented at the PCR London Valves 2025 conference, receiving high recognition from international clinical experts [1] - The company aims to actively advance the global clinical registration and development process for innovative products, including the Cardiovalve system, to expedite market approval and benefit more patients while pursuing its internationalization strategy [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 Venus Medtech (Hangzhou) Inc. （股份代號：2500） （於中華人民共和國註冊成立的股份有限公司） 自願性公告 業務最新情況 本公告由杭州啓明醫療器械股份有限公司（「本公司」，連同其附屬公司統稱「本集團」） 自 願 刊 發，以 告 知 股 東 及 潛 在 投 資 者 有 關 本 集 團 最 新 業 務 發 展 及 新 產 品 研 發 進 度 的最新資訊。 本 公 司 董 事 會（「董事會」）欣 然 宣 佈 本 公 司 的 創 新 經 導 管 瓣 膜 置 換 系 統Cardiovalve的 TARGET研 究（「TARGET研 究」）中 期 臨 床 結 果。TARGET研究為一項前瞻性、單組、 多中心臨床研究，旨在評估Cardiovalve經導管瓣膜置換系統的安全性及臨床表現。 TARGE ...

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。 本公告僅供參考之用，並不構成邀請或招攬收購、購買或認購證券之要約，亦非邀 請 訂 立 協 議 進 行 上 述 任 何 事 宜，且 不 旨 在 邀 請 任 何 收 購、購 買 或 認 購 任 何 證 券 之 要約。 杭州啓明醫療器械股份有限公司 Venus Medtech (Hangzhou) Inc. （股份代號：2500） （於中華人民共和國註冊成立的股份有限公司） 補充公告 建議根據一般授權發行可轉換債券及訂立補充協議 誠 如 該 公 告 所 披 露，認 購 人 與 本 公 司 訂 立 一 份 框 架 協 議，約 定（其 中 包 括），在 認 購 人 完 成 境 外 投 資 備 案 手 續 之 前，認 購 人 應 分 兩 期 提 供 不 超 過 債 券 全 部 本 金 的 過 渡 性貸款。 董事會謹此就過渡性貸款的其他關鍵條款及本公司自框架 ...