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 部或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 Jenscare Scientific Co., Ltd. 寧波健世科技股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：9877） 潘斐先生 董事會會議通告 承董事會命 寧波健世科技股份有限公司 執行董事兼首席執行官 寧波健世科技股份有限公司（「本公司」連同其附屬公司「本集團」）董 事（「董 事」） 會（「董事會」）謹 此 宣 佈，董 事 會 會 議 將 於 二 零 二 五 年 八 月 二 十 七 日（星 期 三）舉 行，藉 以（其 中 包 括）考慮及批准本集團截至二零二五年六月三十日止六個月之 中 期 業 績 及 其 發 佈，並 考 慮 建 議 派 發 中 期 股 息（如 有），及 處 理 任 何 其 他 事 務。 香 港，二 零 二 五 年 八 月 十 五 日 於 本 公 告 日 ...

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: 寧波健世科技股份有限公司 呈交日期: 2025年8月5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) | 09877 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 310,306,209 | RMB | | 1 RMB | | 310,306,209 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 310,306,209 | RMB | | 1 RMB | | 310,306,209 | | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請 ...

Group 1 - CATL's H-shares reached a new high, closing at HKD 418.20 with a 5.87% increase and a market capitalization of HKD 1.91 trillion, following its successful IPO in May 2023, which raised HKD 35.6572 billion, the largest in Hong Kong this year [1] - Sichuan Baili Tianheng Pharmaceutical's prospectus has automatically lapsed due to not being heard within six months, marking the second time the company has submitted its listing application [2] - KEEP expects a significant reduction in losses for the first half of the year, projecting a loss of approximately HKD 36 million, a 78% decrease year-on-year, with adjusted net profit of about HKD 10 million, attributed to improved business structure and efficiency [3] Group 2 - Jianxi Technology-B announced the successful commercial implantation of its core product, the Ken-Valve, in several hospitals across key provinces, marking a significant milestone in its commercialization process [4] - The Hang Seng Index rose by 0.68% to 24,994.14 points, while the Hang Seng Tech Index increased by 0.84% to 5,585.50 points, and the National Enterprises Index gained 0.60% to 9,040.20 points [5]

Core Insights - Ken-Valve, a transcatheter aortic valve replacement (TAVR) product developed by the company, has successfully completed its first commercial implants in key hospitals across China, marking a significant milestone in its commercialization process [1][2] - The product is designed to treat severe aortic regurgitation or combined aortic stenosis, addressing a critical clinical need in the market for TAVR products [1] - The design features of Ken-Valve, including a one-piece clamping positioning key and an active bending delivery system, enhance valve stability and coaxiality during implantation, catering to patients with complex anatomical structures [1] Market Strategy - The successful launch of Ken-Valve signifies the initiation and smooth advancement of its commercial application in China, prompting the company to expand its sales network and pursue global commercialization of its core products, including the Ken-Valve and LuX-Valve series [2] - The company aims to optimize production costs and operational efficiency to achieve its revenue targets as soon as feasible [2]

Core Insights - The TRINITY clinical trial results for LuX-ValvePlus were presented at the 2025 New York Valve Conference, demonstrating its safety and efficacy in patients with severe tricuspid regurgitation and high surgical risk [1][2] Group 1: Clinical Trial Overview - TRINITY is a global, prospective, multi-center, single-arm clinical trial involving 149 patients from 20 centers, primarily located in Europe [1] - The average age of patients was 77.4 years, with a high Tri-Score of 13.6%, indicating significant comorbidities [1] - Over 75% of patients used valve sizes of 55mm, 60mm, 65mm, and 70mm, with a notable percentage showing severe to torrential tricuspid regurgitation [1] Group 2: Efficacy Results - 95.7% of patients showed no moderate or greater regurgitation at 30 days post-procedure, with 95.4% of large annulus patients and 100% of small annulus patients achieving this outcome [3] - 84.1% of patients improved to New York Heart Association functional class I/II, with similar rates for both large and small annulus groups [3] - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 14 points, with large annulus patients showing a 15-point increase [3] Group 3: Safety Results - The overall device success rate was 97% for large annulus patients and approximately 94% for small annulus patients [2] - The 30-day composite event rate was 14.8%, with low rates of cardiovascular mortality (1.3%) and myocardial infarction (0.0%) [2][3] - The study indicated a low incidence of serious adverse events, suggesting a favorable safety profile for LuX-ValvePlus in treating severe tricuspid regurgitation [3]

Core Insights - The article highlights the significant advancements made by the company in the field of cardiovascular intervention, particularly through its products LuX-Valve Plus and JensClip, showcased at the EuroPCR 2025 conference [1][20]. Product Development - LuX-Valve Plus has achieved a 97% success rate in the TRINITY clinical study, which involved high-risk patients with severe tricuspid regurgitation [3][4]. - The device's unique design allows for a wide range of valve sizes (40mm to 70mm), with over 75% of patients using valves ≥55mm, leading to a 95.7% rate of no moderate or severe regurgitation at 30 days post-operation [4][6]. - JensClip has demonstrated a 95% success rate in its one-year follow-up study, with significant improvements in patients' heart function and quality of life [11][13]. Safety and Efficacy - LuX-Valve Plus reported a low 30-day composite event rate of 14.8%, with a cardiovascular mortality rate of just 1.3% [8][9]. - JensClip's one-year all-cause mortality rate was 1.8%, with no incidents of single leaflet grasping or device-related air embolism [14]. Market Positioning - The company is strategically positioned in the global structural heart disease market, which is valued in the hundreds of billions, leveraging its innovative technology and clinical data to build expert consensus [15][20]. - The Chinese medical device industry is experiencing a global expansion, with a reported 5.03% year-on-year increase in medical device exports in Q1 2025 [17]. Global Strategy - The company is executing a multi-regional clinical validation strategy, with ongoing trials in Europe and the U.S., and has established a clinical support network across China and other regions [18][19]. - By cultivating a network of over 90 core operators globally and expanding its presence in approximately 320 key hospitals, the company is enhancing its international medical ecosystem [19]. Financial Performance - The company's stock has surged over 150% year-to-date, indicating market recognition of its differentiated innovative products and strong clinical validation [21].

Core Insights - The recent clinical trial results for LuX-ValvePlus and JensClip were presented at EuroPCR 2025, highlighting their safety and efficacy in treating severe tricuspid and mitral valve regurgitation [1][2] Group 1: LuX-ValvePlus - The TRINITY trial is a global, prospective, multi-center, single-arm clinical study assessing the safety and efficacy of LuX-ValvePlus in high-risk patients with severe tricuspid regurgitation [1] - The study included 161 patients from 20 centers worldwide, primarily from France, Germany, Spain, Denmark, and the UK [1] - The 30-day follow-up results demonstrated good safety and efficacy, with a low incidence of adverse events and improved quality of life for patients [1] - LuX-ValvePlus offers an excellent treatment option for patients with severe tricuspid regurgitation, particularly for those with large annuli, where treatment options are currently limited [1] - Long-term follow-up data and FDA clinical research data for LuX-ValvePlus are still being collected [1] Group 2: JensClip - JensClip is an innovative medical device designed for the treatment of severe mitral valve regurgitation, noted for its ease of use and reliability [2] - The one-year follow-up results showed a low all-cause mortality rate of only 1.8%, with minimal device-related complications [2] - 96.3% of patients exhibited no moderate or severe regurgitation, along with sustained improvements in various clinical metrics such as NYHA functional class, Kansas City Cardiomyopathy Questionnaire scores, and six-minute walk distance [2]

Group 1 - The trend of Chinese medical device companies "going global" is long-term positive, especially in the upstream supply chain which has formed a certain scale [1] - In Q1 2025, China's medical device export trade total is projected to reach 69.26 billion yuan, a year-on-year increase of 5.03%, with high-end medical devices seeing significant growth [1] - The export value of China's medical device industry is expected to reach 48.75 billion USD in 2024, reflecting a year-on-year growth of 7.3% [1] Group 2 - Over 100 listed medical device companies have already initiated "going global" operations in 2024, covering various product areas such as medical consumables and diagnostic equipment [2] - Companies are advised to consider business, supply chain, and localization strategies for global expansion [2][3] - Localized production and supply chain management are essential for adapting to market demands in different regions [3] Group 3 - Companies like Haier Bio emphasize the importance of localizing product design and marketing to enhance user experience in overseas markets [4] - The trend of "going global" is common among mature, growth, and startup medical device companies, focusing on high-value and high-end products [6] - High-value medical devices, such as deep brain stimulators, require careful economic calculations and long-term service planning before entering foreign markets [6] Group 4 - Companies are encouraged to leverage digitalization and smart technologies to enhance their global strategies, as seen with Mindray Medical's remote monitoring capabilities [7] - Brand building is crucial for domestic medical device companies, with strategies including sponsorship of international sports events to enhance global influence [7] - The medical device market in Europe and the US accounts for over 65% of the global market share, making it a primary target for Chinese companies [8] Group 5 - Key conditions for Chinese medical device companies to "go global" include having sufficient capital, production capacity, and independent R&D capabilities [8] - Collaboration with local hospitals and doctors for joint R&D and clinical trials can facilitate product entry into new markets [8]

Financial Performance - The company reported a significant increase in revenue, achieving a total of RMB 500 million for the fiscal year, representing a growth of 25% compared to the previous year[10]. - The company provided a positive outlook for the next fiscal year, projecting a revenue growth of 20% to RMB 600 million[10]. - The company reported a pre-tax loss of RMB 185,829 thousand for the fiscal year ending December 31, 2024, an improvement from a loss of RMB 379,096 thousand in 2023, indicating a reduction of approximately 51% year-over-year[21]. - The company reported a basic and diluted loss per share of RMB 0.43 for the fiscal year 2024, an improvement from RMB 0.89 in 2023[21]. - The company reported a net asset value of RMB 916,953 thousand as of December 31, 2024, down from RMB 1,226,254 thousand in 2023[21]. - The company reported a cash and cash equivalents decrease of 34.7% from RMB 927.8 million in 2023 to RMB 606.0 million in 2024[64]. - The company reported a total of 211 employees, down from 376 employees as of December 31, 2023[75]. Market Expansion and Product Development - User data showed an increase in active users, reaching 1.2 million, which is a 30% increase year-over-year[10]. - New product launches included the LuX Valve Plus, which is expected to contribute an additional RMB 100 million in revenue in the upcoming year[10]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by the end of the next fiscal year[10]. - The company aims to deepen its global strategy and continue providing high-quality treatment solutions for structural heart disease patients[19]. - The company is exploring potential acquisitions to enhance its product portfolio, with a budget of RMB 200 million allocated for this purpose[10]. - The company aims to accelerate the registration process for the LuX-Valve series products in Europe and the US, targeting CE certification and FDA approval as key milestones for international expansion[20]. - The company is actively promoting the commercialization of Ken-Valve, with expectations to achieve commercial implantation in the first half of 2025[29]. Research and Development - Research and development expenses increased by 10%, totaling RMB 50 million, to support innovation and new technology[10]. - R&D expenses decreased from RMB 288.2 million in 2023 to RMB 142.6 million in 2024, primarily due to reductions in share-based compensation, employee costs, and raw material costs[54]. - The company has established a comprehensive commercialization system covering the entire product lifecycle for Ken-Valve, ensuring robust market promotion[15]. - The company has developed proprietary technologies for TAVR, TMVR, and TTVR products, with no guarantee of successful commercialization[44]. Clinical Trials and Regulatory Approvals - LuX-Valve Plus completed a one-year follow-up in clinical trials, showcasing unique advantages for large annulus patients[12]. - Ken-Valve product received market registration certification from the National Medical Products Administration, establishing a solid foundation for rapid market penetration[14]. - JensClip completed all enrollment for confirmatory clinical trials, demonstrating excellent clinical value and potential application prospects[16]. - The company plans to submit registration applications for JensClip to the National Medical Products Administration in 2025, expanding its product pipeline[16]. - The TRAVEL II multi-center clinical trial for LuX-Valve Plus received widespread recognition at major academic conferences in the US and UK[12]. - The company is participating in the FDA's Total Product Life Cycle Advisory Program (TAP) pilot for LuX-Valve Plus, which is expected to enhance clinical development guidance[35]. Corporate Governance and Management - The company has adopted the corporate governance code as per the listing rules, with compliance noted except for the combined roles of chairman and CEO[99]. - The board consists of one executive director, five non-executive directors, and three independent non-executive directors, ensuring strong independence[101]. - The company has implemented a management structure where the executive directors and senior management are responsible for daily operations and strategy execution[104]. - The board is responsible for overseeing major affairs, including policy formulation, overall strategy, and risk management systems[102]. - The company has established a risk management and internal control system, which is reviewed annually and deemed effective and sufficient[135]. Employee Engagement and Development - The company plans to implement a new employee stock ownership plan to enhance employee engagement and retention[10]. - The company emphasizes competitive salaries and benefits to attract and retain employees, along with continuous education and training programs[75]. - The company has a structured performance evaluation system to determine employee compensation, promotions, and career development[75]. - The group has implemented a mentorship program for new employees to help them integrate into the work environment and enhance their business capabilities[188]. - The employee turnover rate for 2024 is 48.2%, with the highest turnover among employees aged 30 and below at 53.9%[184]. Environmental Sustainability - The company is committed to sustainable development by integrating ESG management into its core operations and regularly evaluating the effectiveness of its sustainability strategies[153]. - The total greenhouse gas emissions for 2024 were approximately 841.8 tons of CO2 equivalent, with a density of 3,989.8 kg CO2 equivalent per person, reflecting a 37.5% reduction from 2023[161]. - The company aims to continuously improve energy efficiency and reduce emissions through systematic management and optimization of operational processes[166]. - The company strictly adheres to environmental protection policies and has implemented waste classification and recycling plans to improve resource utilization rates[174]. - The company has set a goal to enhance water usage efficiency by maintaining water equipment and promoting water-saving practices among employees[173]. Shareholder Relations - The company has adopted a shareholder communication policy to enhance dialogue with investors and ensure effective communication regarding business performance and strategies[145]. - Shareholders holding more than 10% of the company's shares can request a special general meeting within 10 days, and those holding over 1% can propose temporary resolutions[142]. - The company encourages shareholders to provide feedback and inquiries, ensuring that the board of directors addresses shareholder concerns during meetings[146].

报名：首届全球眼科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 报名：首届全球骨科大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 心未来 2025年3月24日， 健世科技 发布了2024年度业绩公告。 2024年，公司主营业务尚未产生收入，利润端 亏损 1.8亿元 ，亏损同比收窄 52.2% 。经计算，公司24H2亏损0.75亿元，亏损同比收窄61.6%。 公司经营亮点： 三尖瓣介入置换产品 LuX-Valve Plus 在中国大陆已完成注册临床试验一年期随访，并积极根据国家药监局注册审批要求递交数据； 于欧洲进行以获取CE认证为目标的临床试验完成全部入组；在美国已经进入临床试验阶段，美国本土 临床积极推进中。 # 财报数据 主动脉瓣反流（或兼并狭窄）置换产品 Ken-Valve 已于近期获得国家药监局批准上市注册，预计于2025年上半年实现商业化植入。 二尖瓣反流修复产品 JensClip 完成确证性临床试验全部入组以及一年期随访，临床结果优异，预计在2025年尽快递交国家药监 局注册申请。 # 关于 健世科技 宁波健世科技股份有限公司 （09877.HK，简称" 健世科技 "， ...