健世科技(09877) - 2025 - 中期业绩

Financial Summary 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 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] Business Overview 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 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] - 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] Core Product Pipeline Progress 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 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][7][42] - 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][7][8][46][47] - 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][10][50] - The LuX-Valve series products have been implanted in over 800 cases globally, with the longest follow-up record exceeding 6 years[51] Transcatheter Aortic Valve Replacement System (TAVR System) Ken-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][9][10] - 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][53][56] - 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][55] Transcatheter Mitral Valve Repair System (TMVr System) JensClip 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][11][58] - 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][59] - Global expansion is actively underway, with pre-commercial rescue surgeries already performed overseas and preparations for CE registration application in progress[12][60] Other Pipeline Products & Platform Technologies 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] - SimuLock (bionic left atrial appendage occluder system) has completed enrollment for its first confirmatory clinical trial and is currently in registration clinical trials[61] - 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][62] Research and Development & Intellectual Property 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] - 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] - 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] Manufacturing 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] - The company has obtained NMPA manufacturing license certification and ISO13485 certification, strictly adhering to production quality regulations[67][69] - Continuous optimization of process stability, improvement of production capacity and product qualification rates, refined cost control, and enhanced supplier management are ongoing[67] Commercialization Strategy 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][70] - Product awareness and target hospital coverage are rapidly expanding through differentiated product positioning, stable and simple operational performance, and global KOL academic promotion[71] - 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] - 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] - 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][74] Future Development Strategy 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] - 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] - Leveraging global collaboration resources and brand reputation established by LuX-Valve Plus to facilitate overseas business opportunities for the product portfolio[80] - Further expanding and optimizing the product portfolio, improving operational efficiency, accelerating high-growth revenue and profit generation, and achieving sustainable long-term internationalization[80] Financial Statements 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 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] Interim Condensed Consolidated Statement of Financial Position 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] Notes to the Financial Statements 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 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][20] - 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] Basis of Preparation and Accounting Policies 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] - The IAS 21 amendment "Lack of Exchangeability" had no impact on the interim condensed consolidated financial information[23] Operating Segment Information 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] - 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] Revenue 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] Sales Revenue | Indicator | June 30, 2025 (Thousand RMB) | June 30, 2024 (Thousand RMB) | | :--- | :--- | :--- | | Sales Revenue | 13,426 | – | Loss Before Tax 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][26] Income Tax 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][89] - 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][30] Dividends 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][108] Loss Per Share 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] Property, Plant and Equipment 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 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][34] Trade Payables 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] Financial Review 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 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] - 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] Gross Profit and Gross Profit Margin 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 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] Other Income and Gains 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] Research and Development Expenses 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] Administrative Expenses 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] Other Expenses 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] Finance Costs 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] Income Tax Expense No income tax expense was incurred during the reporting period - The Group incurred no income tax expense during the reporting period[89] Loss for the Period and Adjusted Non-IFRS Loss 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][90] Working Capital and Cash Flow 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] - Net current assets decreased from RMB 621.7 million as of December 31, 2024, to RMB 552.2 million during the reporting period[93] Capital Expenditure 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] Key Financial Ratios 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] Liquidity and Financial Resources 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] - Contract liabilities amounted to RMB 13.7 million, reflecting consideration received from customers for goods not yet transferred[96] Pledge of Assets 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] Contingent Liabilities 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] Material Investments, Acquisitions and Disposals 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] Foreign Exchange Risk 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] - 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] Human Resources 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 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] - 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] - The company adopted employee award schemes on October 30, 2020, and April 27, 2021, and an H-share scheme on December 15, 2023[105] Use of Net Proceeds from Global Offering 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 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] - 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] 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 This section covers the Board's recommendation regarding interim dividends and any significant events that occurred after the reporting period Interim Dividends 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] Material Events After the Reporting Period 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] Corporate Governance 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 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] - 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] - 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] - The Board currently comprises one executive director, five non-executive directors, and three independent non-executive directors, demonstrating strong independence in its composition[112] Compliance with the Model Code for Securities Transactions 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] - Following specific inquiries made to all directors and supervisors, each of them confirmed full compliance with the Model Code during the reporting period[113] Purchase, Sale or Redemption of Listed Securities 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] - As of June 30, 2025, the company held no treasury shares[114] Audit Committee Review of Interim Results 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] - 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] - There were no disagreements between the Board and the Audit Committee regarding the accounting treatments adopted by the company[116] Publication of Interim Results and Interim Report 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] - 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] Definitions 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 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][119][120][122]