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 茲提述杭州啓明醫療器械股份有限公司（「本公司」）日期為2025年11月12日的通函（「通 函」）。除 文 義 另 有 所 指 外，本 公 告 所 用 詞 彙 與 通 函 所 界 定 者 具 有 相 同 涵 義。 董 事 會 謹 此 宣 佈，於 臨 時 股 東 會（「臨時股東會」）提 呈 之 決 議 案 已 獲 正 式 通 過。 臨時股東會於2025年11月28日（星 期 五）假 座 中 國 杭 州 濱 江 區 江 陵 路88號2幢3樓311 室舉行。 臨時股東會之表決結果 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） 臨時股東會之表決結果 於 臨 時 股 東 會 日 期，(i)已發行股份總數為441,011,443股 股 份，包 括4 ...

Group 1 - The core point of the article highlights that southbound funds have reduced their holdings in Qiming Medical-B (02500.HK) by 12,500 shares on November 26, 2025, marking a total net reduction of 383,500 shares over the past five trading days and 735,500 shares over the past twenty trading days [1][2] - As of now, southbound funds hold 53,061,100 shares of Qiming Medical-B, which accounts for 12.02% of the company's total issued ordinary shares [1][2] Group 2 - Qiming Medical Co., Ltd. specializes in the research, development, 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 interventional treatment of various heart valve diseases, such as aortic valve, pulmonary valve, mitral valve, and tricuspid valve, as well as systems for radiofrequency ablation and ultrasound ablation for hypertension treatment [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 embolism protection device, with operations in both domestic and overseas markets [2]

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]

每经AI快讯，启明医疗-B(02500.HK)涨超7%，截至发稿，涨7.02%，报2.44港元，成交额454.41万港 元。 ...

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]

启明医疗-B(02500)发布公告，本公司的创新经导管瓣膜置换系统Cardiovalve的TARGET研究(TARGET研究)中期 临床结果。TARGET研究为一项前瞻性、单组、多中心临床研究，旨在评估Cardiovalve经导管瓣膜置换系统的安 全性及临床表现。TARGET研究的中期临床试验数据包括在德国、西班牙、意大利、加拿大和英国的25个临床中 心的125例患者，患者平均年龄为77岁。 TARGET研究临床结果显示：(1)器械平均手术时间为58±29分钟，最短器械手术时间仅为16分钟;及(2)依据三尖 瓣学术联盟(TVARC)标准，总体术中成功率为88%。器械植入组成功率高达95%。 有效性结果显示： (1)对于三尖瓣反流程度的改善情况，术后6个月随访显示，100%患者未出现中度以上反流，且该疗效在12个月随 访期间保持稳定; 本公司将持续积极推进包括Cardiovalve系统在内的创新产品的全球临床注册开发进程。启明医疗致力将有商业竞 争力的产品早日获批上市，使得更多患者获益及实现本公司的国际化战略。 经临床事件委员会(CEC)裁定，术后30天内主要不良事件(MAE)发生率如下： | | | 意向治療 ...

安全性结果显示： 经临床事件委员会(CEC)裁定，术后30天内主要不良事件(MAE)发生率如下： 智通财经APP讯，启明医疗-B(02500)发布公告，本公司的创新经导管瓣膜置换系统Cardiovalve的TARGET研究 (TARGET研究)中期临床结果。TARGET研究为一项前瞻性、单组、多中心临床研究，旨在评估Cardiovalve经导 管瓣膜置换系统的安全性及临床表现。TARGET研究的中期临床试验数据包括在德国、西班牙、意大利、加拿大 和英国的25个临床中心的125例患者，患者平均年龄为77岁。 TARGET研究临床结果显示：(1)器械平均手术时间为58±29分钟，最短器械手术时间仅为16分钟;及(2)依据三尖 瓣学术联盟(TVARC)标准，总体术中成功率为88%。器械植入组成功率高达95%。 有效性结果显示： (1)对于三尖瓣反流程度的改善情况，术后6个月随访显示，100%患者未出现中度以上反流，且该疗效在12个月随 访期间保持稳定; (2)根据纽约心脏协会标准，在心功能改善情况方面，术后6个月时88%患者心功能恢复至I/II级，12个月时该比例 提升至90%。6个月随访期间未观察到纽约心脏协会I ...

本次在PCR London Valves 2025年大会上发布的Cardiovalve三尖瓣置换系统中期临床数据，充分展现了 该产品在治疗严重三尖瓣反流方面的卓越临床效果，获得与会国际临床专家的高度认可。公司将持续积 极推进包括Cardiovalve系统在内的创新产品的全球临床注册开发进程。启明医疗致力将有商业竞争力的 产品早日获批上市，使得更多患者获益及实现公司的国际化战略。 格隆汇11月19日丨启明医疗-B(02500.HK)宣布公司的创新经导管瓣膜置换系统Cardiovalve的TARGET研 究("TARGET研究")中期临床结果。TARGET研究为一项前瞻性、单组、多中心临床研究，旨在评估 Cardiovalve经导管瓣膜置换系统的安全性及临床表现。TARGET研究的中期临床试验数据包括在德国、 西班牙、意大利、加拿大和英国的25个临床中心的125例患者，患者平均年龄为77岁。 TARGET研究临床结果显示：(1)器械平均手术时间为58±29分钟，最短器械手术时间仅为16分钟；及(2) 依据三尖瓣学术联盟(TVARC)标准，总体术中成功率为88%。器械植入组成功率高达95%。 ...