[Financial Summary](index=1&type=section&id=I.%20%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) This section provides an overview of the company's financial performance, highlighting key figures such as revenue, loss for the period, and adjusted non-IFRS loss [Overview of Financial Performance](index=1&type=section&id=1.1%20%E8%B2%A1%E5%8B%99%E8%A1%A8%E7%8F%BE%E6%A6%82%E8%A7%88) During the reporting period, the company recorded its first revenue of **RMB 13.4 million**, with a loss for the period expanding to **RMB 170.3 million**, but adjusted non-IFRS loss slightly narrowed year-on-year due to revenue growth and improved operational efficiency Financial Performance Overview | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | Year-on-Year Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 13,426 | – | – | | Other Income and Gains | 12,144 | 16,950 | (28.35%) | | Loss for the Period | (170,289) | (105,765) | 61.01% | | Adjusted Non-IFRS Loss for the Period | (91,756) | (94,159) | (2.55%) | - Adjusted non-IFRS loss for the period decreased by **RMB 2.4 million** year-on-year, primarily due to revenue growth and continuous improvements in management operational efficiency and cost control[4](index=4&type=chunk) [Business Overview](index=2&type=section&id=II.%20%E6%A5%AD%E5%8B%99%E6%A6%82%E8%A7%88) This section details the company's overall business progress, core product pipeline developments, R&D and intellectual property, manufacturing capabilities, commercialization strategy, and future development plans [Overall Business Progress](index=2&type=section&id=2.1%20%E6%95%B4%E4%BD%93%E4%B8%9A%E5%8B%A7%E8%BF%9B) In the first half of 2025, the company made significant progress in interventional structural heart disease treatment, diversifying its product portfolio with great potential and actively expanding into international markets to lay a foundation for future high growth - The product pipeline achieved significant progress in transcatheter tricuspid, aortic, and mitral valve disease interventions, forming a diversified, high-potential product portfolio[5](index=5&type=chunk) - The company continues to expand its international business presence, enhancing product influence and clinical application scale, solidifying the foundation for long-term high growth[5](index=5&type=chunk) [Core Product Pipeline Progress](index=2&type=section&id=2.2%20%E6%A0%B8%E5%BF%83%E4%BA%A7%E5%93%81%E7%BA%BF%E8%BF%9B%E5%B1%95) The company's core products, LuX-Valve Plus, Ken-Valve, and JensClip, achieved significant milestones in global clinical trials and registration, with Ken-Valve commercialized in China and JensClip submitted for NMPA registration, establishing a multi-product pipeline [Transcatheter Tricuspid Valve Replacement System (TTVR System) LuX-Valve Plus](index=2&type=section&id=2.2.1%20%E7%BB%8F%E5%AF%BC%E7%AE%A1%E4%B8%89%E5%B0%96%E7%93%A3%E5%8F%8D%E6%B5%81%E4%BB%8B%E5%85%A5%E7%BD%AE%E6%8D%A2%E7%B3%BB%E7%BB%9F%20(TTVR%20System)%20LuX-Valve%20Plus) LuX-Valve Plus achieved significant clinical and regulatory progress in China, Europe, and the US, with China's RCT trial completing enrollment and submitting NMPA registration, excellent 30-day follow-up results from Europe's TRINITY study, and US EFS study completing enrollment with FDA IDE approval and CMS reimbursement - China's NMPA registration clinical trial is in the long-term follow-up phase, with all RCT subjects enrolled, and the NMPA registration review application submitted and accepted[6](index=6&type=chunk)[7](index=7&type=chunk)[42](index=42&type=chunk) - The European TRINITY study completed **6-month** follow-up and entered the registration review phase, with **30-day** follow-up results presented at EuroPCR 2025, showing good safety and efficacy, especially for patients with large annuli[6](index=6&type=chunk)[7](index=7&type=chunk)[8](index=8&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk) - The US FDA IDE early feasibility clinical study completed enrollment of all subjects and received CMS medical insurance reimbursement, actively advancing critical clinical study approval[6](index=6&type=chunk)[10](index=10&type=chunk)[50](index=50&type=chunk) - The LuX-Valve series products have been implanted in over **800 cases** globally, with the longest follow-up record exceeding **6 years**[51](index=51&type=chunk) [Transcatheter Aortic Valve Replacement System (TAVR System) Ken-Valve](index=3&type=section&id=2.2.2%20%E7%BB%8F%E5%AF%BC%E7%AE%A1%E4%B8%BB%E5%8A%A8%E8%84%89%E7%93%A3%E5%8F%8D%E6%B5%81%E4%BB%8B%E5%85%A5%E7%BD%AE%E6%8D%A2%E7%B3%BB%E7%BB%9F%20(TAVR%20System)%20Ken-Valve) Ken-Valve received NMPA registration and is rapidly commercializing in China, gaining widespread market recognition for its unique design and excellent clinical efficacy, particularly for patients with large annuli and complex anatomies - Ken-Valve rapidly initiated domestic commercialization after obtaining NMPA registration approval, continuously increasing hospital coverage and implantation volumes[6](index=6&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) - The product features a unique design suitable for severe aortic regurgitation (or combined with stenosis), performing excellently in patients with large annuli and complex anatomies, with an average device operation time of less than **10 minutes**[10](index=10&type=chunk)[53](index=53&type=chunk)[56](index=56&type=chunk) - One-year clinical follow-up results show a device success rate of **97.18%**, with **100%** of patients' aortic regurgitation reduced to mild or less from implantation to **1 year** post-surgery, improving cardiac function and quality of life[12](index=12&type=chunk)[55](index=55&type=chunk) [Transcatheter Mitral Valve Repair System (TMVr System) JensClip](index=4&type=section&id=2.2.3%20%E4%BA%8C%E5%B0%96%E7%93%A3%E5%8F%8D%E6%B5%81%E4%BB%8B%E5%85%A5%E4%BF%AE%E5%A4%8D%E7%B3%BB%E7%BB%9F%20(TMVr%20System)%20JensClip) JensClip's NMPA registration application in China is complete, with excellent one-year clinical follow-up results presented at EuroPCR 2025, demonstrating strong safety and efficacy, while global expansion is actively underway with pre-commercial rescue surgeries performed overseas - JensClip has completed its NMPA registration application submission and entered the registration phase[6](index=6&type=chunk)[11](index=11&type=chunk)[58](index=58&type=chunk) - One-year clinical follow-up results presented at EuroPCR 2025 showed an all-cause mortality rate of only **1.8%**, with **96.3%** of patients free from moderate or greater regurgitation, and sustained improvements in cardiac function and quality of life[12](index=12&type=chunk)[59](index=59&type=chunk) - Global expansion is actively underway, with pre-commercial rescue surgeries already performed overseas and preparations for CE registration application in progress[12](index=12&type=chunk)[60](index=60&type=chunk) [Other Pipeline Products & Platform Technologies](index=4&type=section&id=2.2.4%20%E5%85%B6%E4%BB%96%E5%9C%A8%E7%A0%94%E4%BA%A7%E5%93%81%E5%8F%8A%E5%B9%B3%E5%8F%B0%E6%8A%80%E6%9C%AF%20(Other%20Pipeline%20Products%20%26%20Platform%20Technologies)) The company also has JensRelive (transcatheter mitral valve replacement system) in preclinical research, SimuLock (bionic left atrial appendage occluder system) in registration clinical trials, and platform technologies like catheter sheath products, JeniGal anti-calcification technology, and dry valve and polymer leaflet technologies, continuously enriching its product pipeline - JensRelive (transcatheter mitral valve replacement system) is in the preclinical research stage, featuring a unique anchoring design and steerable function[60](index=60&type=chunk) - SimuLock (bionic left atrial appendage occluder system) has completed enrollment for its first confirmatory clinical trial and is currently in registration clinical trials[61](index=61&type=chunk) - Platform technologies include NMPA-registered catheter sheath products, JeniGal anti-calcification technology applicable to all commercialized and pipeline products, and dry valve and polymer leaflet technologies[37](index=37&type=chunk)[62](index=62&type=chunk) [Research and Development & Intellectual Property](index=5&type=section&id=2.3%20%E7%A0%94%E5%8F%91%E4%B8%8E%E7%9F%A5%E8%AF%86%E4%BA%A7%E6%9D%83) Innovative R&D is a core strategic pillar, driving technological iteration through strengthened R&D systems, deepened collaborations, and alignment with clinical needs, supported by **418 patent applications**, **237 granted patents**, **75 trademark applications**, and **52 registered trademarks**, forming a multi-layered IP protection system - Innovative R&D is a core strategic pillar, guided by clinical pain points, continuously deepening the R&D layout in the field of interventional structural heart disease treatment[63](index=63&type=chunk) - The company holds **418 patent applications** and **237 granted patents** in over **20 countries or regions**, along with **75 trademark registration applications** and **52 registered trademarks**[68](index=68&type=chunk) - A patent matrix covering core technologies and peripheral applications has been established, with patent grants obtained in major markets including the US, Europe, Australia, South America, and Japan[66](index=66&type=chunk) [Manufacturing](index=5&type=section&id=2.4%20%E7%94%9F%E4%BA%A7%E5%88%B6%E9%80%A0) The company operates a **7,000 square meter** GMP-compliant manufacturing facility in Ningbo with full-scale production capabilities, holding NMPA manufacturing licenses and ISO13485 certification, ensuring strict cost and quality control for commercialization and clinical supply - Manufacturing facilities are located in Ningbo, Zhejiang, China, covering approximately **7,000 square meters**, meeting GMP requirements, and possessing comprehensive large-scale production capabilities[67](index=67&type=chunk) - The company has obtained NMPA manufacturing license certification and ISO13485 certification, strictly adhering to production quality regulations[67](index=67&type=chunk)[69](index=69&type=chunk) - Continuous optimization of process stability, improvement of production capacity and product qualification rates, refined cost control, and enhanced supplier management are ongoing[67](index=67&type=chunk) [Commercialization Strategy](index=5&type=section&id=2.5%20%E5%95%86%E4%B8%9A%E5%8C%96%E6%88%98%E7%95%A5) The company has officially entered the commercialization phase, with a product portfolio covering tricuspid, mitral, and aortic valve diseases, rapidly expanding market awareness through differentiated product positioning and KOL academic promotion; Ken-Valve has established a regional distribution network in China, covering **24 provinces** and over **90 cities**, with ongoing overseas commercialization preparations - The company has officially entered the commercialization phase, with a product portfolio comprehensively covering structural heart diseases such as tricuspid, mitral, and aortic valves[13](index=13&type=chunk)[70](index=70&type=chunk) - Product awareness and target hospital coverage are rapidly expanding through differentiated product positioning, stable and simple operational performance, and global KOL academic promotion[71](index=71&type=chunk) - Ken-Valve has established a comprehensive regional distributor network in China, covering **24 provinces** and over **90 cities**, with flexible pricing and sales strategies in place[72](index=72&type=chunk) - Overseas commercialization preparation activities, primarily for the LuX-Valve series products, are continuously underway, exploring global business development collaborations with overseas medical device manufacturers and enterprises[72](index=72&type=chunk) - A professional and efficient commercialization team and a comprehensive internal and external training system have been established, actively participating in domestic and international industry academic conferences to enhance product market visibility[73](index=73&type=chunk)[74](index=74&type=chunk) [Future Development Strategy](index=25&type=section&id=2.6%20%E6%9C%AA%E6%9D%A5%E5%8F%91%E5%B1%95%E6%88%98%E7%95%A5) The company's vision is to become a global leader in innovative structural heart disease products, planning to accelerate the global business expansion of the LuX-Valve series, broaden its product portfolio to meet clinical needs, and enhance operational efficiency to achieve high-growth revenue and profit, ultimately realizing sustainable long-term internationalization - The vision is to become a high-potential medical device enterprise with a global perspective and business layout, offering comprehensive innovative products[75](index=75&type=chunk) - The strategy includes accelerating the global business expansion of the LuX-Valve series products, aiming to become a benchmark in the field of transcatheter tricuspid valve replacement procedures[75](index=75&type=chunk) - Leveraging global collaboration resources and brand reputation established by LuX-Valve Plus to facilitate overseas business opportunities for the product portfolio[80](index=80&type=chunk) - Further expanding and optimizing the product portfolio, improving operational efficiency, accelerating high-growth revenue and profit generation, and achieving sustainable long-term internationalization[80](index=80&type=chunk) [Financial Statements](index=6&type=section&id=III.%20%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8) This section presents the interim condensed consolidated statement of profit or loss and other comprehensive income, and the interim condensed consolidated statement of financial position [Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=6&type=section&id=3.1%20%E4%B8%AD%E6%9C%9F%E7%AE%80%E6%98%8E%E7%BB%BC%E5%90%88%E6%8D%9F%E7%9B%8A%E5%8F%8A%E5%85%B6%E4%BB%96%E5%85%A8%E9%9D%A2%E6%94%B6%E7%9B%8A%E8%A1%A8) For the six months ended June 30, 2025, the company recorded its first revenue of **RMB 13.4 million** and a gross profit of **RMB 11.8 million**; however, due to significant increases in R&D, administrative, and other expenses, the loss for the period expanded from **RMB 105.8 million** in the prior year to **RMB 170.3 million** Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Revenue | 13,426 | – | | Cost of Sales | (1,599) | – | | Gross Profit | 11,827 | – | | Other Income and Gains | 12,144 | 16,950 | | Research and Development Expenses | (88,885) | (82,233) | | Administrative Expenses | (57,433) | (35,291) | | Selling and Distribution Expenses | (3,844) | – | | Other Expenses | (43,960) | (5,050) | | Finance Costs | (138) | (141) | | Loss Before Tax | (170,289) | (105,765) | | Income Tax Expense | – | – | | Loss for the Period | (170,289) | (105,765) | - Loss attributable to owners of the parent company was **RMB 169.6 million**, and loss attributable to non-controlling interests was **RMB 0.7 million**[15](index=15&type=chunk) [Interim Condensed Consolidated Statement of Financial Position](index=8&type=section&id=3.2%20%E4%B8%AD%E6%9C%9F%E7%AE%80%E6%98%8E%E7%BB%BC%E5%90%88%E8%B2%A1%E5%8B%99%E7%8A%B6%E5%86%B5%E8%A1%A8) As of June 30, 2025, the company's total assets less current liabilities decreased to **RMB 872.1 million** from **RMB 963.4 million** at the end of 2024; net current assets decreased to **RMB 552.2 million**, and cash and cash equivalents decreased by **RMB 110.6 million** to **RMB 495.4 million** Interim Condensed Consolidated Statement of Financial Position | Indicator | June 30, 2025 (Thousand RMB) | December 31, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Total Non-Current Assets | 319,867 | 341,710 | | Total Current Assets | 647,899 | 685,855 | | Total Current Liabilities | 95,663 | 64,201 | | Net Current Assets | 552,236 | 621,654 | | Net Assets | 855,104 | 916,953 | | Cash and Cash Equivalents | 495,412 | 605,991 | | Trade Receivables | 6,259 | – | | Contract Liabilities | 13,742 | – | - Equity attributable to owners of the parent company was **RMB 870.6 million**, and non-controlling interests were **RMB (15.5) million**[18](index=18&type=chunk) [Notes to the Financial Statements](index=10&type=section&id=IV.%20%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8%E9%99%84%E6%B3%A8) This section provides detailed notes on the company's and group's information, basis of preparation, accounting policies, operating segment data, revenue recognition, loss before tax, income tax, dividends, loss per share, property, plant and equipment, trade receivables, and trade payables [Company and Group Information](index=10&type=section&id=4.1%20%E5%85%AC%E5%8F%B8%E5%8F%8A%E9%9B%86%E5%9B%A2%E8%B3%87%E6%96%99) Ningbo Jenscare Biotechnology Co., Ltd. was incorporated in China in **2011** and listed on the Main Board of the Hong Kong Stock Exchange in October **2022**, primarily engaged in the R&D, manufacturing, and sales of interventional products for structural heart disease and related medical products - The company was incorporated in China on November 8, **2011**, and listed on the Main Board of the Hong Kong Stock Exchange on October 10, **2022**[19](index=19&type=chunk)[20](index=20&type=chunk) - The Group is primarily engaged in the research, development, manufacturing, and sale of interventional products for the treatment of structural heart diseases and other related medical products[20](index=20&type=chunk) [Basis of Preparation and Accounting Policies](index=10&type=section&id=4.2%20%E7%BC%96%E5%88%B6%E5%9F%BA%E5%87%86%E4%B8%8E%E4%BC%9A%E8%AE%A1%E6%94%BF%E7%AD%96) The interim condensed consolidated financial information is prepared in accordance with IAS 34 and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2024; the first-time adoption of IAS 21 amendment 'Lack of Exchangeability' had no impact on the financial information - The interim condensed consolidated financial information is prepared in accordance with International Accounting Standard **34** and presented in RMB[21](index=21&type=chunk) - The IAS **21** amendment "Lack of Exchangeability" had no impact on the interim condensed consolidated financial information[23](index=23&type=chunk) [Operating Segment Information](index=11&type=section&id=4.3%20%E7%BB%8F%E8%90%A5%E5%88%86%E9%83%A8%E8%B3%87%E6%96%99) The Group has only one reportable operating segment, with management monitoring overall operating results; no further geographical information is presented as the vast majority of non-current assets are located in China - The Group does not classify business units by product and has only one reportable operating segment[24](index=24&type=chunk) - As the vast majority of the Group's non-current assets were located in China during the reporting period, no further geographical information is presented[25](index=25&type=chunk) [Revenue](index=11&type=section&id=4.4%20%E6%94%B6%E5%85%A5) Revenue from the sale of interventional products is recognized when control of the product is transferred, meaning goods are delivered to the specified location and accepted by the customer, or objective evidence of meeting acceptance criteria is obtained, with sales revenue of **RMB 13.4 million** for the reporting period - Revenue from the sale of interventional products is recognized when control of the product is transferred[26](index=26&type=chunk) Sales Revenue | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Sales Revenue | 13,426 | – | [Loss Before Tax](index=11&type=section&id=4.5%20%E9%99%A4%E7%A8%85%E5%89%8D%E4%BA%8F%E6%8D%9F) Loss before tax for the reporting period was **RMB 170.3 million**, primarily impacted by increased R&D, administrative, and other expenses (such as contract termination fees and foreign exchange losses), while government grants and bank interest income provided some contribution Components of Loss Before Tax | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Depreciation of Property, Plant and Equipment | 3,705 | 4,572 | | Research and Development Expenses | 88,885 | 82,233 | | Other Receivables (Reversal of Impairment)/Impairment | (321) | 876 | | Inventory Write-down | 669 | 2,311 | | Government Grants | (3,022) | (1,119) | | Bank Interest Income | (7,197) | (7,674) | | Net Exchange Differences | 6,782 | (2,666) | - Loss before tax was **RMB 170.3 million**, an increase from **RMB 105.8 million** in the prior year[14](index=14&type=chunk)[26](index=26&type=chunk) [Income Tax](index=12&type=section&id=4.6%20%E6%89%80%E5%BE%97%E7%A8%85) No income tax expense was incurred during the reporting period, as entities in China, Hong Kong, the Netherlands, and the US had no estimated taxable profits, and no deferred tax assets were recognized - The Group incurred no income tax expense during the reporting period[27](index=27&type=chunk)[89](index=89&type=chunk) - The Group's entities in China, Hong Kong, the Netherlands, and the US had no estimated taxable profits during the period, thus no provision for income tax was made, and no deferred tax assets were recognized[27](index=27&type=chunk)[30](index=30&type=chunk) [Dividends](index=12&type=section&id=4.7%20%E8%82%A1%E6%81%AF) For the six months ended June 30, 2025, the company neither paid nor declared any dividends - The company neither paid nor declared any dividends for the six months ended June 30, 2025[28](index=28&type=chunk)[108](index=108&type=chunk) [Loss Per Share](index=12&type=section&id=4.8%20%E6%AF%8F%E8%82%A1%E4%BA%8F%E6%8D%9F) Basic and diluted loss per share was **RMB (0.41)**, calculated based on the loss for the period attributable to ordinary equity holders of the parent company and the weighted average number of shares; due to negative financial performance, shares held under the share award scheme had an anti-dilutive effect on loss per share, thus diluted loss per share equaled basic loss per share Loss Per Share | Indicator | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Basic and Diluted Loss Per Share | RMB (0.41) | RMB (0.25) | | Weighted Average Number of Ordinary Shares Issued | 408,934,000 shares | 413,015,000 shares | - Due to the Group's negative financial performance during the period, shares held under the share award scheme had an anti-dilutive effect on the Group's loss per share; therefore, diluted loss per share was equal to basic loss per share[29](index=29&type=chunk) [Property, Plant and Equipment](index=13&type=section&id=4.9%20%E7%89%A9%E4%B8%9A%E3%80%81%E5%8E%82%E6%88%BF%E5%8F%8A%E8%AE%BE%E5%A4%87) For the six months ended June 30, 2025, the Group's cost of acquiring assets was **RMB 6.7 million**, a significant decrease from **RMB 20.0 million** in the prior year Acquisition Cost of Assets | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Cost of Acquiring Assets | 6,719 | 20,033 | [Trade Receivables](index=13&type=section&id=4.10%20%E8%B2%BF%E6%98%93%E5%BA%94%E6%94%B6%E6%AC%BE%E9%A0%85) As of June 30, 2025, trade receivables amounted to **RMB 6.3 million**, all due within one year, an increase from zero at the end of 2024, reflecting sales growth from commercialization activities Trade Receivables by Ageing | Ageing | June 30, 2025 (Thousand RMB) | December 31, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Within 1 year | 6,259 | – | - Trade receivables increased to **RMB 6.3 million**, with no provision for doubtful debts made[32](index=32&type=chunk)[34](index=34&type=chunk) [Trade Payables](index=14&type=section&id=4.11%20%E8%B2%BF%E6%98%93%E5%BA%94%E4%BB%98%E6%AC%BE%E9%A0%85) As of June 30, 2025, total trade payables were **RMB 15.6 million**, with **RMB 13.0 million** due within one year and **RMB 2.6 million** over one year; amounts due to related parties were **RMB 1.3 million** Trade Payables by Ageing | Ageing | June 30, 2025 (Thousand RMB) | December 31, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Within 1 year | 12,959 | 9,821 | | Over 1 year | 2,649 | 2,276 | | **Total** | **15,608** | **12,097** | - Trade payables include **RMB 1.3 million** due to related parties, repayable within **1 year**[35](index=35&type=chunk) [Financial Review](index=26&type=section&id=V.%20%E8%B2%A1%E5%8B%99%E5%9B%9E%E9%A1%A7) This section provides a detailed review of the company's financial performance, including revenue, cost of sales, gross profit, operating expenses, finance costs, loss for the period, cash flow, capital expenditure, key financial ratios, liquidity, asset pledges, contingent liabilities, material investments, and foreign exchange risk [Revenue and Cost of Sales](index=26&type=section&id=5.1%20%E6%94%B6%E5%85%A5%E4%B8%8E%E9%94%80%E5%94%AE%E6%88%90%E6%9C%AC) During the reporting period, the company recorded its first revenue of **RMB 13.4 million**, primarily from increased sales of interventional structural heart disease products, with cost of sales at **RMB 1.6 million**, rising with sales volume - Revenue for the reporting period was **RMB 13.4 million** (June 30, 2024: nil), primarily due to the continuous commercialization of interventional products for structural heart disease, leading to increased sales volume[76](index=76&type=chunk) - Cost of sales was **RMB 1.6 million** (June 30, 2024: nil), mainly due to increased raw material costs, labor costs, and manufacturing expenses resulting from higher sales volume[77](index=77&type=chunk) [Gross Profit and Gross Profit Margin](index=26&type=section&id=5.2%20%E6%AF%9B%E5%88%A9%E5%8F%8A%E6%AF%9B%E5%88%A9%E7%8E%87) Gross profit for the reporting period was **RMB 11.8 million**, with a gross profit margin of **88.1%**, consistent with revenue growth Gross Profit and Gross Profit Margin | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Gross Profit | 11,827 | – | | Gross Profit Margin | 88.1% | – | [Selling and Distribution Expenses](index=26&type=section&id=5.3%20%E9%94%80%E5%94%AE%E5%8F%8A%E5%88%86%E9%94%80%E5%BC%80%E6%94%AF) Selling and distribution expenses for the reporting period were **RMB 3.8 million**, primarily due to increased frequency and scale of marketing campaigns and expanded regional coverage Selling and Distribution Expenses | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Selling and Distribution Expenses | 3,844 | – | - Selling and distribution expenses increased, primarily attributable to the continuous increase in the frequency and scale of market promotion and expanded regional coverage[79](index=79&type=chunk) [Other Income and Gains](index=27&type=section&id=5.4%20%E5%85%B6%E4%BB%96%E6%94%B6%E5%85%A5%E5%8F%8A%E6%94%B6%E7%9B%8A) Other income and gains decreased from **RMB 17.0 million** in the prior year to **RMB 12.1 million**, primarily due to reduced gains from financial assets at fair value through profit or loss and foreign exchange gains Other Income and Gains | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Other Income and Gains | 12,144 | 16,950 | - The decrease was primarily attributable to reduced gains from financial assets at fair value through profit or loss and foreign exchange gains[81](index=81&type=chunk) [Research and Development Expenses](index=27&type=section&id=5.5%20%E7%A0%94%E5%8F%91%E5%BC%80%E6%94%AF) R&D expenses increased from **RMB 82.2 million** in the prior year to **RMB 88.9 million**, primarily due to a significant **RMB 24.5 million** increase in share-based payment expenses, partially offset by lower staff costs, raw materials, and consumables Research and Development Expenses Breakdown | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Share-based Payment Expenses | 36,238 | 11,716 | | Staff Costs | 15,622 | 25,160 | | Raw Materials and Consumables Costs | 6,755 | 11,857 | | Third-Party Contract Costs | 18,877 | 17,135 | | Depreciation and Amortization | 2,761 | 4,386 | | Others | 8,632 | 11,979 | | **Total** | **88,885** | **82,233** | - The increase in R&D expenses was primarily attributable to share-based payment expenses increasing by **RMB 24.5 million** from **RMB 11.7 million** to **RMB 36.2 million**[83](index=83&type=chunk) [Administrative Expenses](index=28&type=section&id=5.6%20%E8%A1%8C%E6%94%BF%E5%BC%80%E6%94%AF) Administrative expenses increased from **RMB 35.3 million** in the prior year to **RMB 57.4 million**, primarily due to a significant **RMB 32.9 million** increase in share-based payment expenses, partially offset by lower staff costs and professional service fees Administrative Expenses Breakdown | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Share-based Payment Expenses | 35,448 | 2,556 | | Staff Costs | 9,855 | 17,667 | | Professional Service Fees | 3,668 | 5,795 | | Depreciation and Amortization | 2,076 | 2,185 | | Travel and Transportation Expenses | 1,433 | 1,739 | | Utilities and Office Expenses | 935 | 498 | | Others | 4,018 | 4,851 | | **Total** | **57,433** | **35,291** | - The increase in administrative expenses was primarily attributable to share-based payment expenses increasing by **RMB 32.9 million** from **RMB 2.6 million** to **RMB 35.4 million**[85](index=85&type=chunk) [Other Expenses](index=28&type=section&id=5.7%20%E5%85%B6%E4%BB%96%E5%BC%80%E6%94%AF) Other expenses significantly increased from **RMB 5.1 million** in the prior year to **RMB 44.0 million**, primarily attributable to increased contract termination fees, foreign exchange losses, and external donations Other Expenses | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Other Expenses | 43,960 | 5,050 | - The increase in other expenses was primarily attributable to increased contract termination fees, foreign exchange losses, and external donations[87](index=87&type=chunk) [Finance Costs](index=29&type=section&id=5.8%20%E8%9E%8D%E8%B3%87%E6%88%90%E6%9C%AC) Finance costs decreased from **RMB 141 thousand** in the prior year to **RMB 138 thousand**, primarily due to reduced interest expenses on lease liabilities Finance Costs | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Finance Costs | 138 | 141 | - The decrease in finance costs was primarily attributable to reduced interest expenses on lease liabilities[88](index=88&type=chunk) [Income Tax Expense](index=29&type=section&id=5.9%20%E6%89%80%E5%BE%97%E7%A8%85%E5%BC%80%E6%94%AF) No income tax expense was incurred during the reporting period - The Group incurred no income tax expense during the reporting period[89](index=89&type=chunk) [Loss for the Period and Adjusted Non-IFRS Loss](index=29&type=section&id=5.10%20%E6%9C%9F%E5%85%A7%E4%BA%8F%E6%8D%9F%E5%8F%8A%E7%BB%8F%E8%B0%83%E6%95%B4%E9%9D%9EIFRS%E4%BA%8F%E6%8D%9F) Loss for the period expanded to **RMB 170.3 million**, while adjusted non-IFRS loss was **RMB 91.8 million**, narrowing from **RMB 94.2 million** in the prior year, primarily due to revenue growth and improved operational efficiency Reconciliation of Loss for the Period to Adjusted Non-IFRS Loss | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Loss for the Period | (170,289) | (105,765) | | Add: Share-based Payment Expenses | 71,751 | 14,272 | | Add: Net Exchange Differences | 6,782 | (2,666) | | **Adjusted Non-IFRS Loss for the Period** | **(91,756)** | **(94,159)** | - Adjusted non-IFRS loss for the period was **RMB 91.8 million**, a decrease of **RMB 2.4 million** from **RMB 94.2 million** in the prior year, primarily due to revenue growth and continuous improvements in management operational efficiency and cost control[4](index=4&type=chunk)[90](index=90&type=chunk) [Working Capital and Cash Flow](index=30&type=section&id=5.11%20%E8%90%A5%E8%BF%90%E8%B3%87%E9%87%91%E4%B8%8E%E7%8E%B0%E9%87%91%E6%B5%81) During the reporting period, net cash outflow from operating activities was **RMB 92.7 million**, from investing activities **RMB 10.0 million**, and from financing activities **RMB 8.2 million**; cash and cash equivalents decreased by **RMB 110.6 million** to **RMB 495.4 million**, and net current assets decreased to **RMB 552.2 million** Cash Flow Summary | Cash Flow Type | June 30, 2025 (Thousand RMB) | | :--- | :--- | | Net Cash Outflow from Operating Activities | (92,700) | | Net Cash Outflow from Investing Activities | (10,000) | | Net Cash Outflow from Financing Activities | (8,200) | - As of June 30, 2025, cash and cash equivalents amounted to **RMB 495.4 million**, a decrease of **RMB 110.6 million** from December 31, 2024[93](index=93&type=chunk) - Net current assets decreased from **RMB 621.7 million** as of December 31, 2024, to **RMB 552.2 million** during the reporting period[93](index=93&type=chunk) [Capital Expenditure](index=30&type=section&id=5.12%20%E8%B3%87%E6%9C%AC%E5%BC%80%E6%94%AF) Capital expenditure decreased from **RMB 21.5 million** in the prior year to **RMB 6.0 million**, primarily due to reduced spending on property, plant, and equipment acquisitions Capital Expenditure | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Capital Expenditure | 6,000 | 21,500 | - The decrease in capital expenditure was primarily attributable to reduced spending on property, plant, and equipment acquisition projects[94](index=94&type=chunk) [Key Financial Ratios](index=31&type=section&id=5.13%20%E4%B8%BB%E8%A6%81%E8%B2%A1%E5%8B%99%E6%AF%94%E7%8E%87) As of June 30, 2025, the current ratio was **6.77**, quick ratio **6.39**, and debt-to-asset ratio **11.6%**; compared to the end of 2024, current and quick ratios significantly decreased, while the debt-to-asset ratio increased Key Financial Ratios | Indicator | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Ratio | 6.77 | 17.1 | | Quick Ratio | 6.39 | 16.6 | | Debt-to-Asset Ratio | 11.6% | 9.0% | - Current and quick ratios significantly decreased, while the debt-to-asset ratio increased, reflecting a tightening of liquidity[95](index=95&type=chunk) [Liquidity and Financial Resources](index=31&type=section&id=5.14%20%E6%B5%81%E5%8B%95%E8%B3%87%E9%87%91%E5%8F%8A%E8%B2%A1%E5%8B%99%E8%B3%87%E6%BA%90) As of June 30, 2025, total cash and cash equivalents and time deposits were approximately **RMB 567.3 million**, a decrease of **RMB 140.2 million** from the end of 2024; the company maintains a sound financial position, confident in meeting daily operational needs, and expects to generate more cash flow through continuous product sales Cash and Deposits | Indicator | June 30, 2025 (Thousand RMB) | December 31, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Total Cash and Cash Equivalents, Time Deposits | 567,300 | 707,500 | - The company relies on equity contributions and funds generated from commercialized product sales as its primary sources of liquidity, expecting to generate more cash flow through continuous product sales[98](index=98&type=chunk) - Contract liabilities amounted to **RMB 13.7 million**, reflecting consideration received from customers for goods not yet transferred[96](index=96&type=chunk) [Pledge of Assets](index=32&type=section&id=5.15%20%E8%B3%87%E4%BA%A7%E6%8A%B5%E6%8A%BC) As of June 30, 2025, certain leasehold land with a carrying value of **RMB 24.1 million** was pledged as collateral for bank borrowings of **RMB 15.8 million** - As of June 30, 2025, certain leasehold land with a carrying value of **RMB 24.1 million** was pledged as collateral for bank borrowings of **RMB 15.8 million**[99](index=99&type=chunk) [Contingent Liabilities](index=32&type=section&id=5.16%20%E6%88%96%E7%84%B6%E8%B2%A0%E5%80%BA) As of June 30, 2025, the Group had no significant contingent liabilities - As of June 30, 2025, the Group had no significant contingent liabilities[100](index=100&type=chunk) [Material Investments, Acquisitions and Disposals](index=32&type=section&id=5.17%20%E9%87%8D%E5%A4%A7%E6%8A%95%E8%B3%87%E3%80%81%E6%94%B6%E8%B3%BC%E5%8F%8A%E5%87%BA%E5%94%AE) During the reporting period, the Group held no material investments and undertook no material acquisitions or disposals of subsidiaries, associates, or joint ventures - During the reporting period, the Group held no material investments and undertook no material acquisitions or disposals of subsidiaries, associates, or joint ventures[101](index=101&type=chunk) [Foreign Exchange Risk](index=32&type=section&id=5.18%20%E5%A4%96%E6%B1%87%E9%A3%8E%E9%99%A9) The company primarily operates in mainland China, with most transactions settled in RMB, facing foreign currency risk mainly from USD to RMB exchange rate fluctuations; currently, there is no foreign currency hedging policy, but management monitors and will consider appropriate hedging measures in the future - The company faces foreign currency risk primarily arising from fluctuations in the USD to RMB exchange rate[102](index=102&type=chunk) - The company currently has no foreign currency hedging policy; management monitors foreign exchange risk and will consider appropriate hedging measures if needed in the future[102](index=102&type=chunk) [Human Resources](index=32&type=section&id=VI.%20%E4%BA%BA%E5%8A%9B%E8%B3%87%E6%BA%90) This section outlines the company's employee situation and benefits, including the total number of employees, compensation, incentive plans, and training programs [Employee Information and Benefits](index=32&type=section&id=6.1%20%E9%9B%87%E5%91%98%E6%83%85%E5%86%B5%E4%B8%8E%E7%A6%8F%E5%88%A9) As of June 30, 2025, the Group had **174 employees**, offering competitive salaries, incentive programs, and benefits, along with continuous education and training to enhance skills and knowledge, complemented by employee award schemes and an H-share scheme - As of June 30, 2025, the Group had a total of **174 employees**[103](index=103&type=chunk) - The company provides employees with competitive salaries, opportunities to participate in various incentive programs, and other benefits, along with continuous education and training programs to enhance their skills and knowledge[104](index=104&type=chunk) - The company adopted employee award schemes on October 30, 2020, and April 27, 2021, and an H-share scheme on December 15, 2023[105](index=105&type=chunk) [Use of Net Proceeds from Global Offering](index=33&type=section&id=VII.%20%E5%85%A8%E7%90%83%E5%8F%91%E5%94%AE%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%8D%E5%87%80%E9%A1%8D%E7%94%A8%E9%80%94) This section details the net proceeds received from the global offering, the subsequent changes in their allocation, and the actual utilization of these funds [Changes in Use of Proceeds and Actual Utilization](index=33&type=section&id=7.1%20%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%8D%E7%94%A8%E9%80%94%E5%8F%98%E6%9B%B4%E5%8F%8A%E5%AE%9E%E9%99%85%E4%BD%BF%E7%94%A8%E6%83%85%E5%86%B5) The company listed in October **2022**, with net proceeds from the global offering of **HKD 206.4 million**; on May 22, 2025, shareholders approved changes to the use of net proceeds, primarily adjusting allocations for R&D, manufacturing, and commercialization of the LuX-Valve series and Ken-Valve, as well as R&D, clinical trials, and product registration for other pipeline products including KenFlex and JensClip - The net proceeds received by the company from the global offering (after deducting underwriting fees and related expenses) amounted to **HKD 206.4 million**[106](index=106&type=chunk) - On May 22, 2025, shareholders approved changes to the use of net proceeds from the global offering at the company's annual general meeting[106](index=106&type=chunk) Use of Net Proceeds from Global Offering | Business Objective as per Prospectus | Initial Allocation (Million HKD) | Revised Allocation (Million HKD) | Utilized as of June 30, 2025 (Million HKD) | Unutilized as of June 30, 2025 (Million HKD) | Expected Timeline for Utilizing Unutilized Net Proceeds | | :--- | :--- | :--- | :--- | :--- | :--- | | Funding R&D, Manufacturing, and Commercialization of LuX-Valve and Ken-Valve | 134.1 | 129.5 | 5.4 | 124.1 | Before June 30, 2028 | | Funding R&D, Clinical Trials, and Product Registration for Other Pipeline Products (including KenFlex and JensClip) | 51.6 | 15.5 | 1.6 | 13.9 | Before June 30, 2028 | | Working Capital and General Corporate Purposes | 20.7 | 9.9 | 0.1 | 9.8 | Before December 31, 2027 | | **Total** | **206.4** | **154.9** | **7.1** | **147.8** | | [Dividends and Subsequent Events](index=34&type=section&id=VIII.%20%E8%82%A1%E6%81%AF%E5%8F%8A%E6%9C%9F%E5%90%8E%E4%BA%8B%E9%A0%85) This section covers the Board's recommendation regarding interim dividends and any significant events that occurred after the reporting period [Interim Dividends](index=34&type=section&id=8.1%20%E4%B8%AD%E6%9C%9F%E8%82%A1%E6%81%AF) The Board does not recommend the payment of an interim dividend for the reporting period - The Board does not recommend the payment of an interim dividend for the reporting period (six months ended June 30, 2024: nil)[108](index=108&type=chunk) [Material Events After the Reporting Period](index=34&type=section&id=8.2%20%E6%8A%A5%E5%91%8A%E6%9C%9F%E9%97%B4%E5%90%8E%E7%9A%84%E9%87%8D%E5%A4%A7%E4%BA%8B%E9%A0%85) Subsequent to the reporting period and up to the date of this announcement, neither the Company nor the Group undertook any material post-reporting period events - Subsequent to the reporting period and up to the date of this announcement, neither the company nor the Group undertook any material post-reporting period events[109](index=109&type=chunk) [Corporate Governance](index=35&type=section&id=IX.%20%E4%BC%81%E4%B8%9A%E7%AE%A1%E6%B2%BB) This section outlines the company's corporate governance measures, compliance with securities trading standards, policies on purchasing, selling, or redeeming listed securities, the Audit Committee's review of interim results, and the publication of interim results and reports [Corporate Governance Measures](index=35&type=section&id=9.1%20%E4%BC%81%E4%B8%9A%E7%AE%A1%E6%B2%BB%E6%8E%AA%E6%96%BD) The company has adopted and is committed to maintaining high standards of corporate governance, fully complying with all applicable code provisions during the reporting period, except for the dual role of Chairman and CEO held by Mr. Lu, which was resolved upon Mr. Pan Fei's appointment as CEO on January 15, 2025 - The company has adopted the Corporate Governance Code set out in Appendix C1 of the Listing Rules as its own corporate governance code[110](index=110&type=chunk) - During the reporting period and until January 15, 2025, the roles of Chairman and Chief Executive Officer were combined and held by Mr. Lu, representing a deviation from Code Provision C.2.1 of the Corporate Governance Code[111](index=111&type=chunk) - Following Mr. Lu's resignation as the company's Chief Executive Officer and Mr. Pan Fei's appointment as Chief Executive Officer on January 15, 2025, the company has fully complied with all code provisions set out in the Corporate Governance Code[111](index=111&type=chunk) - The Board currently comprises one executive director, five non-executive directors, and three independent non-executive directors, demonstrating strong independence in its composition[112](index=112&type=chunk) [Compliance with the Model Code for Securities Transactions](index=35&type=section&id=9.2%20%E9%81%B5%E5%AE%88%E8%BF%9B%E8%A1%8C%E8%AF%81%E5%88%B8%E4%BA%A4%E6%98%93%E7%9A%84%E6%A0%87%E5%87%86%E5%AE%88%E5%88%99) The company adopted the Model Code in Appendix C3 of the Listing Rules as its code of conduct for securities transactions by directors and supervisors, requiring compliance from relevant senior officers and employees; all directors and supervisors confirmed full compliance with the Model Code during the reporting period - The company has adopted the Model Code set out in Appendix C3 of the Listing Rules as its own code of conduct for securities transactions by directors and supervisors[113](index=113&type=chunk) - Following specific inquiries made to all directors and supervisors, each of them confirmed full compliance with the Model Code during the reporting period[113](index=113&type=chunk) [Purchase, Sale or Redemption of Listed Securities](index=36&type=section&id=9.3%20%E8%B4%AD%E4%B9%B0%E3%80%81%E5%87%BA%E5%94%AE%E6%88%96%E8%B5%8E%E5%9B%9E%E4%B8%8A%E5%B8%82%E8%AF%81%E5%88%B8) During the reporting period, neither the company nor its subsidiaries purchased, sold, or redeemed any of the company's listed securities; as of June 30, 2025, the company held no treasury shares - During the reporting period, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities[114](index=114&type=chunk) - As of June 30, 2025, the company held no treasury shares[114](index=114&type=chunk) [Audit Committee Review of Interim Results](index=36&type=section&id=9.4%20%E5%AE%A1%E6%A0%B8%E5%A7%94%E5%91%98%E4%BC%9A%E5%AE%A1%E9%98%85%E4%B8%AD%E6%9C%9F%E4%B8%9A%E7%BB%A9) The Audit Committee, comprising three independent non-executive directors, reviewed the Group's interim results and adopted accounting principles and policies for the reporting period, concluding that the interim results were prepared in accordance with applicable accounting standards, rules, and regulations, with proper disclosures - The Audit Committee comprises three independent non-executive directors, with Ms. Du Jiliu serving as the Audit Committee Chairman[115](index=115&type=chunk) - The Audit Committee has reviewed and considered the Group's interim results for the reporting period and the accounting principles and policies adopted by the company, concluding that the Group's interim results were prepared in accordance with applicable accounting standards, rules, and regulations, and proper disclosures were made[116](index=116&type=chunk) - There were no disagreements between the Board and the Audit Committee regarding the accounting treatments adopted by the company[116](index=116&type=chunk) [Publication of Interim Results and Interim Report](index=36&type=section&id=9.5%20%E5%88%8A%E5%8F%91%E4%B8%AD%E6%9C%9F%E4%B8%9A%E7%BB%A9%E5%8F%8A%E4%B8%AD%E6%9C%9F%E6%8A%A5%E5%91%8A) This interim results announcement has been published on the HKEX and company websites; the 2025 interim report will be dispatched to shareholders requesting printed copies and posted on the HKEX and company websites by the end of September - This interim results announcement has been published on the HKEX website and the company's website, respectively[117](index=117&type=chunk) - The company's 2025 interim report will be dispatched to shareholders requesting printed copies and posted on the HKEX and company websites by the end of September[117](index=117&type=chunk) [Definitions](index=37&type=section&id=X.%20%E9%87%8B%E7%BE%A9) This section provides definitions for key terms and abbreviations used in the report, including company entities, regulatory bodies, product names, financial terminology, and listing-related concepts, to ensure clear understanding of the report content [Definitions of Terms](index=37&type=section&id=10.1%20%E6%9C%AF%E8%AF%AD%E5%AE%9A%E4%B9%89) This section provides definitions for key terms and abbreviations used in the report, including company entities, regulatory bodies, product names, financial terminology, and listing-related concepts, to ensure clear understanding of the report content - This section provides definitions for key terms and abbreviations used in the report, such as "Audit Committee", "Board", "CE Mark", "China", "Company", "Controlling Shareholder", "Core Products", "Directors", "Domestic Shares", "Global Offering", "Group", "H Shares", "Hong Kong", "HKD", "Listing Rules", "Model Code", "Mr. Lu", "NMPA", "Prospectus", "R&D", "Reporting Period", "RMB", "Shares", "Shareholders", "Stock Exchange", "Supervisors", "Treasury Shares", "US", "Unlisted Foreign Shares", "Unlisted Shares", and "%"[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk)

Core Viewpoint - The company, 健世科技-B (09877.HK), has announced a board meeting scheduled for August 27, 2025, to consider and approve its interim results for the six months ending June 30, 2025, and to discuss the potential declaration of an interim dividend, among other matters [1] Group 1 - The board meeting will focus on the approval of the group's interim performance for the first half of 2025 [1] - The meeting will also consider the recommendation for an interim dividend, if applicable [1] - Additional business matters will be addressed during the board meeting [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 ...

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **domestic medical device industry**, highlighting advancements in various companies and their innovative products. Key Companies and Their Innovations 1. **Peijia Medical** - The shockwave balloon technology shows a **30%-50% efficacy** in early clinical trials for treating aortic valve calcification [1] - The transcatheter aortic valve replacement product **Mona Q** has enrolled **9 patients** in the global Fame clinical trial, with no deaths or strokes reported during long-term follow-up. It has received **IDE clinical approval** in the U.S. and is expected to advance to U.S. clinical trials within the year [2][4] 2. **Jianxi Technology** - The tricuspid valve replacement product has completed clinical registration trials in Europe with a **97% success rate** and is expected to receive CE certification by **2025** [1][3] 3. **Xenon Medical** - The self-expanding intracranial drug-eluting stent has a **restenosis rate of only 1.7%-1.87%** and a **100% surgical success rate**. Approval is anticipated this year, with a market exclusivity period of **1.5 to 2 years** [1][6][7] 4. **HeartTech Medical** - Leading market share in domestic occluder products with a series of **four generations of biodegradable occluders**. The aortic valve product has been approved for commercialization since Q1 [1][8] 5. **Qiming Medical** - Four TAVI products have been approved and marketed in over **ten countries**. New TAVI products are under development, with expectations for a tricuspid valve replacement product to be approved in Europe by **2027** [1][9] Market Trends and Future Outlook - The medical device sector is expected to see a **catalyst for growth** in the second half of the year due to potential equipment upgrades, particularly in **3.0T MRI and 64-slice CT** products [2][17] - Companies like **Huitai Medical** are projected to have strong performance due to new product launches and market expansion [11][23] Competitive Strategies - Domestic medical device companies are enhancing their international competitiveness through: - **Patent breakthroughs** and early clinical trials [4] - Focusing on less crowded market segments for differentiation [4] - Collaborations with international firms to leverage global networks for faster commercialization [5] Financial Performance Expectations - Companies such as **Huitai Medical** and **Mingrui Medical** are expected to show strong growth in the second half of the year, despite some companies facing short-term pressures due to high bases from previous years [10][11][15] - The **IVD sector** is experiencing pressure from policy changes, but improvements are anticipated in the latter half of the year as companies adjust pricing strategies [28] Regulatory and Policy Impact - The medical industry is facing challenges from **DRG cost control policies** and increased compliance requirements, impacting overall performance and cash flow [33] Conclusion - The domestic medical device industry is poised for growth with innovative products and strategic collaborations, despite facing regulatory challenges and market competition. Companies are actively seeking to enhance their international presence and capitalize on emerging market opportunities.

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].

Financial Performance - The company reported a pre-tax loss of RMB 185,829,000 for the year ending December 31, 2024, a 51.0% improvement compared to RMB 379,096,000 in 2023[3]. - The net loss attributable to the parent company was RMB 177,510,000, representing a 52.2% decrease from RMB 371,736,000 in the previous year[3]. - Total revenue for the year ended December 31, 2024, was RMB 41,559,000, a decrease from RMB 43,828,000 in 2023[12]. - The company reported a pre-tax loss of RMB 185,829,000 for 2024, an improvement from a loss of RMB 379,096,000 in 2023[12]. - The net loss for the year was RMB 185,829,000, compared to RMB 379,096,000 in the previous year, reflecting a significant reduction in losses[14]. - The group incurred a pre-tax loss of RMB 70,318 thousand in 2024, significantly reduced from RMB 238,906 thousand in 2023, indicating an improvement of about 70.7%[25]. - The company did not declare or pay any dividends during the year, consistent with the previous year[26]. - The company reported total other income of RMB 41,559 thousand for the year 2024, a decrease from RMB 43,828 thousand in 2023, representing a decline of approximately 5.2%[24]. Research and Development - Research and development expenses for 2024 were RMB 142,637,000, down from RMB 288,151,000 in 2023, indicating a reduction of approximately 50.5%[12]. - The company aims to enhance R&D efficiency through process reengineering and internal collaboration, optimizing the R&D cost structure[57]. - The company focuses on developing innovative products to address core clinical pain points in structural heart disease, ensuring a sustainable leading position in the market[58]. - The company is committed to deepening collaboration between industry, academia, and healthcare to provide more effective treatment strategies for structural heart disease patients[58]. - The company emphasizes continuous improvement in R&D capabilities and product technology innovation to maintain its competitive edge in the global market[55]. Product Development and Commercialization - The company has received regulatory approval for its Ken-Valve product, which is expected to enhance its market presence in treating aortic regurgitation[4]. - The LuX-Valve Plus clinical trial results demonstrated a low incidence of safety events and improved patient outcomes, with significant attention from global professionals[5]. - The company is actively preparing for the commercialization of Ken-Valve, expanding its sales and marketing teams to cover more hospitals[8]. - JensClip registration is being expedited to enhance the company's product pipeline and commercialization efforts[9]. - The company is focused on the global promotion of the LuX-Valve series and the commercialization of the Ken-Valve product, with expectations to achieve commercialization by the first half of 2025[35]. - The company has multiple products in various stages of commercialization and development, including TTVR, TAVR, and TMVR systems[34]. - The company aims to establish international strategic partnerships to enhance the global technical advantage of its product series[35]. - The company has initiated the commercialization process for Ken-Valve® and is actively promoting its products in hospitals across several provinces and municipalities[35]. Financial Position and Assets - Non-current assets increased to RMB 341,710,000 in 2024 from RMB 172,179,000 in 2023, indicating a growth of approximately 98.7%[16]. - Current assets decreased to RMB 685,855,000 in 2024 from RMB 1,154,913,000 in 2023, a decline of about 40.6%[16]. - Cash and cash equivalents decreased by 34.7% from RMB 927.8 million as of December 31, 2023, to RMB 606.0 million as of December 31, 2024[78]. - Current assets net value decreased from RMB 1,096.2 million to RMB 621.7 million, attributed to bank deposits, R&D expenses, and administrative costs incurred during the reporting period[79]. - Total bank and other borrowings increased from RMB 40.7 million in 2023 to RMB 60.3 million in 2024, with approximately RMB 44.3 million due after one year[85]. Governance and Compliance - The company has adopted the corporate governance code as per the listing rules, ensuring compliance with all applicable rules except for a specific deviation regarding the roles of the Chairman and CEO[102]. - The board consists of one executive director, five non-executive directors, and three independent non-executive directors, ensuring strong independence and diverse skills[104]. - The audit committee, composed of three independent non-executive directors, has reviewed the annual performance and internal controls, confirming compliance with applicable accounting standards[110]. - The company is committed to compliance with international financial reporting standards as set by the International Accounting Standards Board[116]. Market Presence and Partnerships - The company is exploring partnerships with overseas collaborators to accelerate global commercialization of its products[11]. - The company improved its global intellectual property layout, enhancing protection of its intellectual property rights[11]. - The company has participated in various high-quality academic conferences to enhance market awareness of its products and share clinical results[64]. - The company is exploring global business development partnerships with overseas medical device manufacturers to accelerate product commercialization[65]. Employee and Operational Changes - As of December 31, 2024, the company had 211 employees, a decrease from 376 employees as of December 31, 2023[91]. - Administrative expenses decreased from RMB 150.3 million in 2023 to RMB 68.2 million in 2024, primarily due to reductions in share-based compensation and professional service fees[69]. - Share-based compensation expenses dropped significantly from RMB 80.3 million in 2023 to RMB 1.3 million in 2024[71].

Financial Performance - The company reported a revenue of RMB 500 million for the first half of 2024, representing a 20% increase compared to the same period last year[13]. - The company reported a pre-tax loss of RMB 105,765,000 for the first half of 2024, a 40.64% improvement compared to a loss of RMB 178,161,000 in the same period of 2023[19]. - The total comprehensive loss for the period was RMB (107,867,000), a decrease of 35.8% from RMB (167,966,000) in the same period last year[80]. - Basic and diluted loss per share for the period was RMB (0.25), compared to RMB (0.42) in the previous year[80]. - The company reported a loss attributable to equity holders of the parent of RMB 102,261,000 for the six months ended June 30, 2024, compared to a loss of RMB 175,754,000 for the same period in 2023, representing a 41.7% improvement in losses year-over-year[96]. Revenue and Growth Expectations - The company expects revenue growth to continue at a rate of 25% for the second half of 2024, driven by new product launches and market expansion[18]. - User data showed a growth in active users by 15%, reaching a total of 1.2 million users by June 30, 2024[14]. - Other income and gains decreased from RMB 341 million to RMB 170 million, primarily due to reduced government subsidies and foreign exchange gains[39]. Research and Development - Research and development expenses increased by 30% to RMB 50 million, focusing on the development of the new LuX-Valve Plus product line[14]. - Research and development expenses for the period were RMB (82,233,000), down 40.3% from RMB (137,603,000) in the previous year[80]. - The company aims to optimize its product pipeline by focusing resources on core products and accelerating global commercialization to achieve breakeven and high growth profitability[27]. Product Development and Clinical Trials - The LuX-Valve Plus device achieved a clinical success rate of approximately 97% in the TRAVEL II study, with an average procedure time of 35.56 minutes and 91.86% of patients improving their NYHA heart function classification[20]. - The LuX-Valve Plus device has completed a one-year clinical follow-up and is expected to submit a registration application to the National Medical Products Administration soon[20]. - The Ken-Valve is currently in the registration application review stage and has entered the priority review process by the National Medical Products Administration, making it the first valve product in this program[21]. - The LuX-Valve Plus clinical trial has received positive feedback from multiple clinical centers across seven countries, with a six-month follow-up result presented at major conferences in July 2024[29]. Market Expansion and Strategic Initiatives - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2025[13]. - A strategic acquisition of a local competitor is anticipated to be completed by Q4 2024, expected to enhance the company's product offerings and market reach[18]. - The company is exploring global partnerships with overseas medical device manufacturers to accelerate the application of its products worldwide[22]. Financial Position and Cash Flow - Cash and cash equivalents increased by 1.9% to RMB 714.3 million as of June 30, 2024, from RMB 701.1 million as of June 30, 2023[48]. - The company reported a net cash outflow from investing activities of RMB 58,383,000, compared to a cash inflow of RMB 12,410,000 in the prior year[85]. - The company incurred a loss of RMB 1,463,000 due to impairment of property, plant, and equipment, which was not recorded in the previous year[91]. Shareholder Actions and Corporate Governance - The board has approved a share buyback program of up to RMB 100 million to enhance shareholder value[17]. - The company does not recommend the payment of an interim dividend for the reporting period ending June 30, 2023[59]. - The board has adopted corporate governance measures to enhance accountability and protect shareholder interests, complying with applicable governance codes[60]. Management and Key Personnel - Total remuneration paid to key management personnel was a loss of RMB 9,732,000 for the six months ended June 30, 2024, compared to RMB 68,019,000 for the same period in 2023, indicating a significant reduction in management costs[107]. - The company has trained over 50 independent doctors in mainland China and nearly 30 independent doctors in regions outside of China, covering North America, Europe, Asia-Pacific, and Latin America[23].

Financial Performance - The company reported a net loss of RMB 105,765,000 for the six months ending June 30, 2024, compared to a net loss of RMB 178,161,000 for the same period in 2023, representing a 40.64% improvement [2]. - The loss attributable to equity holders of the parent company was RMB 102,261,000, down from RMB 175,754,000 in the previous year, marking a 41.82% reduction [2]. - The basic and diluted loss per share was RMB 0.25, a decrease of 40.48% from RMB 0.42 in the prior year [2]. - The group reported a pre-tax loss of RMB 102,261,000 for the six months ended June 30, 2024, compared to a loss of RMB 175,754,000 for the same period in 2023, indicating a reduction in losses [20]. - The net loss for the six months ending June 30, 2023, was RMB 1,782 million, compared to RMB 1,058 million for the reporting period [48]. - The company reported other income and gains of RMB 16,950,000 for the six months ended June 30, 2024, down from RMB 34,050,000 in the same period of 2023 [6]. - Research and development expenses decreased to RMB 82,233,000 in the first half of 2024 from RMB 137,603,000 in the same period of 2023 [6]. - The company incurred a pre-tax loss of RMB 105,765,000 for the six months ended June 30, 2024, compared to a loss of RMB 178,161,000 in the same period of 2023 [6]. - The group did not declare any dividends for the six months ended June 30, 2024, consistent with the previous year [19]. Clinical Trials and Product Development - The clinical trial results for LuX-Valve Plus showed a device success rate of approximately 97% and an average procedure time of 35.56 minutes [3]. - 97.62% of patients in the TRAVEL II study experienced improvement in tricuspid regurgitation severity, with 91.86% of patients improving from NYHA class III/IV to I/II [3]. - The company plans to submit a registration application for LuX-Valve Plus to the National Medical Products Administration following the completion of a one-year clinical follow-up [3]. - LuX-Valve Plus achieved a 100% success rate in a clinical study in Hong Kong, with no adverse events reported [4]. - Ken-Valve is currently under review for market registration and has entered the priority review process by the National Medical Products Administration [3]. - The company is focused on developing interventional products for treating structural heart diseases, having established operations in China since November 2011 [25]. - The company has six products in different stages of development, focusing on optimizing its product pipeline and accelerating global commercialization efforts [26]. - The LuX-Valve Plus, a second-generation transcatheter tricuspid valve replacement system, is designed for patients with severe tricuspid regurgitation and high surgical risk, with CE certification trials ongoing [29]. - The company expects to submit registration approval for LuX-Valve Plus to the National Medical Products Administration (NMPA) in the first half of 2025, with commercialization anticipated in the second half of 2025 [27]. - The FDA has approved the Investigational Device Exemption (IDE) for the Early Feasibility Study (EFS) of LuX-Valve Plus, with enrollment expected to be completed by Q4 2024 [30]. - The company has completed nearly 600 global implantations of the LuX-Valve series, with the longest follow-up record exceeding five years [31]. - The Ken-Valve transcatheter aortic valve replacement system is expected to receive NMPA approval in Q4 2024 [27]. - The JensClip transcatheter mitral valve repair system is set to submit for NMPA approval in the first half of 2025, with commercialization expected in the first half of 2026 [27]. - JensClip, a transcatheter mitral valve repair system, completed its feasibility clinical trial in December 2022 and is set to finish all patient enrollment and one-month follow-up by March 2024 [33]. - JensRelive, a transcatheter mitral valve replacement system, is currently undergoing animal trials [33]. - SimuLock, a left atrial appendage occluder system, initiated its feasibility clinical trial in Q3 2023 and completed the first confirmed clinical trial and patient enrollment in November 2023 [34]. Market Expansion and Commercialization - The company is exploring global partnerships with overseas medical device manufacturers to accelerate product application worldwide [4]. - The company aims to enhance its global academic position and influence through continued product application in various regions [4]. - The company has established a professional commercialization team responsible for the preliminary market introduction and education of core products, enhancing its commercialization capabilities [5]. - Over 50 independent doctors and trainers have been trained for the LuX-Valve series products in mainland China [5]. - The company has expanded its LuX-Valve series products to over 220 influential hospitals across more than 30 provinces, municipalities, and autonomous regions in mainland China [5]. - The company plans to accelerate the global application of core products to meet the urgent treatment needs for structural heart disease [40]. - The company aims to expand its product coverage to become an industry leader in innovative products for structural heart disease [40]. - The company has a strong commitment to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value [58]. Financial Position and Cash Flow - Total non-current assets increased to RMB 293,412,000 as of June 30, 2024, from RMB 172,179,000 as of December 31, 2023 [9]. - Current assets decreased to RMB 883,100,000 as of June 30, 2024, from RMB 1,154,913,000 as of December 31, 2023 [9]. - The company's net assets decreased to RMB 1,070,477,000 as of June 30, 2024, from RMB 1,226,254,000 as of December 31, 2023 [10]. - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 107.4 million, primarily due to R&D and administrative expenses [49]. - Cash and cash equivalents as of June 30, 2024, amounted to RMB 714.3 million, an increase of 1.9% from RMB 701.1 million as of June 30, 2023 [49]. - Capital expenditures decreased from RMB 43.6 million for the six months ended June 30, 2023, to RMB 21.5 million during the reporting period, mainly due to reduced spending on properties, plants, and equipment [50]. - The current ratio improved to 17.1 from 15.2, and the quick ratio increased to 16.6 from 14.9, indicating better liquidity [51]. - Total bank and other borrowings amounted to RMB 51.2 million as of June 30, 2024, with RMB 15.8 million secured by collateral [52]. - The company has no significant contingent liabilities as of June 30, 2024, and did not engage in any major investments or acquisitions during the reporting period [54]. Corporate Governance - The company has adopted the corporate governance code as per Appendix C1 of the listing rules, ensuring compliance with all applicable provisions except for the separation of the roles of Chairman and CEO [58]. - The board consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence in its composition [58]. - The audit committee, chaired by an independent non-executive director, oversees the financial reporting process and internal controls, ensuring compliance with applicable accounting standards [61]. - The company has confirmed adherence to the standard code for securities trading by all directors and supervisors during the reporting period [59]. - The audit committee and management have reviewed the mid-term performance and confirmed that it is prepared in accordance with applicable accounting principles and regulations [61]. - The board will continue to review the effectiveness of the corporate governance structure to assess the necessity of separating the roles of Chairman and CEO [58]. Future Outlook - The company provided a positive outlook for the next quarter, projecting a revenue growth of 20% to RMB 1.8 billion [66]. - New product launches are expected to contribute an additional RMB 300 million in revenue over the next six months [66]. - The company is investing heavily in R&D, with an allocation of RMB 200 million for new technology development [66]. - Market expansion plans include entering two new international markets by the end of the fiscal year [66]. - The company is considering strategic acquisitions to enhance its market position, with a budget of up to RMB 500 million for potential targets [66]. - The board emphasized the importance of maintaining operational efficiency, aiming for a 10% reduction in costs over the next year [66]. - Customer satisfaction ratings improved to 90%, reflecting the effectiveness of recent service enhancements [66]. - The company plans to implement a new marketing strategy that is expected to increase brand awareness by 30% in the upcoming quarter [66].

Financial Performance - The company reported a revenue of RMB 1.2 billion for the fiscal year 2023, representing a year-on-year growth of 15%[1]. - The company reported a net loss attributable to equity holders of the parent of RMB 371,736 thousand for the year 2023, compared to RMB 439,311 thousand in 2022, indicating a decrease in losses by approximately 15.4%[16]. - The company reported a net asset value of RMB 1,226,254 thousand in 2023, a decrease from RMB 1,373,027 thousand in 2022, reflecting a decline of approximately 10.7%[17]. - The net loss for the year was RMB 379.1 million in 2023 compared to RMB 440.9 million in 2022[52]. - Other income and gains decreased from RMB 54.4 million in 2022 to RMB 43.8 million in 2023, primarily due to a reduction in foreign exchange gains[45]. - Cash and cash equivalents increased by 27.6% from RMB 727.4 million at the end of 2022 to RMB 927.8 million at the end of 2023[54]. - Current assets increased to RMB 1,154,913 thousand in 2023 from RMB 855,359 thousand in 2022, representing a growth of approximately 35.1%[17]. - The company has no distributable reserves as of December 31, 2023[200]. Product Development and Innovation - New product launches included the LuX-Valve and Ken-Valve, which are expected to contribute an additional RMB 300 million in revenue[1]. - The core product, LuX-Valve, is designed for patients with severe tricuspid regurgitation and high surgical risk, and it has been included in the green channel for expedited review by the National Medical Products Administration (NMPA) since January 2019[33]. - The company has seven products in various stages of development, focusing on optimizing its product pipeline and accelerating global commercialization to achieve breakeven and high growth profitability[30]. - The company aims to enhance its market penetration in hospitals, although actual market size may be smaller than anticipated, impacting profitability[187]. - The company’s innovative products are designed to adapt to various degrees of tricuspid annulus dilation, improving surgical safety and outcomes[180]. - The company has successfully launched the LuX-Valve Plus transcatheter tricuspid valve replacement product, addressing severe tricuspid regurgitation, with significant clinical improvements reported[179]. - The LuX-Valve Plus product has been applied in multiple hospitals across the Asia-Pacific region, demonstrating high reliability and ease of operation[179]. Market Expansion and Strategy - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by 2025[1]. - The company plans to invest RMB 200 million in marketing efforts to boost brand awareness in new markets[1]. - The company is exploring global partnerships with overseas medical device manufacturers to enhance its commercial influence[12]. - The company is actively exploring partnerships with overseas medical device manufacturers to accelerate global commercialization of its products[24]. - The company aims to achieve a stable return for shareholders through long-term sustainable development by concentrating resources on core products[30]. - The company aims to expand its product coverage to become an industry leader in structural heart disease[44]. Research and Development - Research and development expenses increased by 30% to RMB 150 million, focusing on innovative medical technologies[1]. - The company has a strong focus on research and development, with key personnel having experience in significant national R&D programs[72]. - The company has established a reward system for intellectual property to encourage employee innovation and enhance overall R&D capabilities[175]. Environmental, Social, and Governance (ESG) - Environmental, social, and governance (ESG) initiatives are being prioritized, with a commitment to reduce carbon emissions by 25% by 2025[1]. - The company integrates ESG management into various aspects of operations, focusing on product quality, employee growth, community development, and compliance[122]. - The company has established a governance structure for ESG, with the board of directors responsible for setting ESG strategies and goals[122]. - The company emphasizes communication with stakeholders, including government, investors, customers, and employees, to align sustainable development strategies[124]. Corporate Governance - The company has adopted a corporate governance code, ensuring compliance with applicable governance provisions, although the roles of Chairman and CEO are held by the same individual, Mr. Lü Shiweng[78]. - The board consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence in its composition[78]. - The company has implemented a diversity policy for the board, currently comprising 7 male and 2 female members, with a focus on increasing female representation[85][87]. - The company has established various committees, including the Audit Committee, Remuneration and Assessment Committee, Nomination Committee, and Strategic Committee[96]. Employee Management and Development - The group has not experienced any work-related fatalities from 2021 to 2023, emphasizing a strong commitment to employee health and safety[157]. - The group provides annual health check-ups and maintains health records for employees, particularly for those in high-risk positions[157]. - A multi-level performance management system has been established, including monthly, quarterly, semi-annual, and annual assessments to recognize and reward employee performance[148]. - The overall employee turnover rate for the reporting period is 17.2%, with male turnover at 15.4% and female turnover at 18.4%[155]. Financial Risks and Challenges - The company faces ongoing operational losses and anticipates continued cash outflows, necessitating additional financing for operations[186]. - Future growth is heavily reliant on the successful development and commercialization of in-progress products, with potential risks in clinical trials and regulatory approvals[187]. - The company is exposed to risks associated with potential product liability claims, which may not be fully covered by insurance[189]. - The company faced strict regulatory scrutiny in the research, development, and commercialization of its products, which could adversely affect its business due to any changes in regulations[188]. Community Engagement - The company actively engages in community investment, focusing on health and medical fields, and aims to provide safer and more effective treatment solutions for global patients[178].