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].

智通财经APP获悉，健世科技-B(09877)最高涨超23%，截至发稿，涨18.01%，报4.26港元，成交额 4448.86万港元。 消息面上，健世科技2023年归母净亏损收窄至3.72亿元；截至2023年12月31日，公司账面货币资金为 9.28亿元，同比增长27.6%，主要因为对成本开支的严格把控，以及出售前期财务投资股权所得回款， 公司货币资金充裕，确保长期可持续经营与发展。 此外，2023年度，公司持续推进核心产品LuX-Valve系列产品于全球范围内的临床与商业化，以及推进 其他在研产品管线的研发临床工作，丰富产品种类，并计划于2024年全面推进产品获批后商业化工作。 中泰证券此前指出，LuX-Valve 预计为国内首发、全球第二款三尖瓣置换产品，具有较强产品力。 ...

智通财经APP获悉，健世科技-B(09877)最高涨超22%，截至发稿，涨19.05%，报4港元，成交额2596.36 万港元。 消息面上，健世科技2023年财报显示，公司去年归母净亏损收窄至3.72亿元；截至2023年12月31日，公 司账面货币资金为9.28亿元，同比增长27.6%，主要因为对成本开支的严格把控，以及出售前期财务投 资股权所得回款，公司货币资金充裕，确保长期可持续经营与发展。 2023年度，公司持续推进核心产品LuX-Valve系列产品于全球范围内的临床与商业化，以及推进其他在 研产品管线的研发临床工作，丰富产品种类，并计划于2024年全面推进产品获批后商业化工作。此外， 今年2月，LuX-Valve Plus在巴西完成拉丁美洲的首例临床植入手术，进一步扩大产品推广范围。 ...

Financial Performance - The company reported a net loss of RMB 379,096, a decrease of 14.0% compared to the previous year's loss of RMB 440,914[2] - The loss attributable to equity holders of the parent company was RMB 371,736, down 15.4% from RMB 439,311 in the previous year[2] - The basic and diluted loss per share was RMB 0.89, a decrease of 25.8% from RMB 1.20 in the previous year[2] - Total revenue for the year ended December 31, 2023, was RMB 43,828,000, a decrease of 19.5% compared to RMB 54,424,000 in 2022[8] - Research and development expenses for 2023 were RMB 288,151,000, slightly down from RMB 291,580,000 in 2022[8] - The company reported a loss before tax of RMB 379,096,000 for 2023, an improvement from a loss of RMB 440,914,000 in 2022, indicating a reduction of approximately 13.9%[8] - Basic and diluted loss per share for the year was RMB 0.89, compared to RMB 1.20 in the previous year, reflecting a 25.8% improvement[10] - The company’s net asset value decreased to RMB 1,226,254,000 in 2023 from RMB 1,373,027,000 in 2022, a decline of about 10.7%[11] - The company’s other income and gains decreased from RMB 544 million in 2022 to RMB 438 million in 2023, primarily due to a reduction in foreign exchange gains[45] - The company has not declared or paid any dividends during the year[24] Product Development and Clinical Trials - The company announced the completion of confirmatory clinical trials for LuX-Valve Plus, with plans to submit for registration approval to the National Medical Products Administration soon[3] - LuX-Valve's registration application has been formally accepted by the National Medical Products Administration, entering the priority review process[3] - LuX-Valve Plus has received positive feedback from clinical centers in Europe, with ongoing clinical trials aimed at obtaining CE certification[3] - The company plans to conduct commercialization activities globally to meet the urgent treatment needs of patients with tricuspid regurgitation[4] - The company has established a professional commercialization team to enhance market expansion and marketing capabilities for its core products[4] - The company has been developing a series of interventional products for treating structural heart diseases since its establishment in November 2011[29] - The core product, LuX-Valve, is designed for patients with severe tricuspid regurgitation and high surgical risk, with 16 related patents and 20 patent applications filed[32] - LuX-Valve has entered the registration review stage, but the company may not obtain registration approval on schedule due to the need for additional clinical evidence[32] - LuX-Valve Plus, the second-generation product, is expected to simplify the procedure and reduce surgical time, with clinical trials ongoing in multiple European countries[33] - The company anticipates that LuX-Valve Plus will complete patient enrollment for CE certification clinical trials in Europe by the end of 2023[33] - The company is actively working on the commercialization foundation for its product series through various means, including clinical trials and approvals[30] - The company has received positive feedback from clinical centers participating in the LuX-Valve Plus trials, indicating strong support for the product[33] - LuX-Valve Plus has received formal acceptance for EFS pre-submission by the FDA and is expected to complete EFS clinical research by Q4 2024[34] - The company has completed several clinical implants of LuX-Valve Plus in North America and is advancing commercialization efforts in the region[34] - Ken-Valve has received acceptance from the National Medical Products Administration (NMPA) in October 2023, with commercialization expected in H2 2024[35] - JensClip has completed feasibility clinical trials in December 2022, with all subjects enrolled and one-month follow-up completed as of the announcement date[36] - MicroFlux is currently undergoing confirmatory clinical trials in China, aimed at treating heart failure with preserved ejection fraction[37] - SimuLock initiated feasibility clinical trials in Q3 2023, with the first confirmatory clinical trial and subject enrollment completed in November 2023[37] Market Expansion and Commercialization - The company has trained over 50 independent doctors and instructors for the LuX-Valve series products domestically, and 24 independent doctors abroad[5] - The company has expanded its coverage to over 220 influential hospitals in China for the LuX-Valve series products, covering more than 30 provinces and municipalities[6] - The company aims to establish strategic collaborations and expand regional business development for the LuX-Valve product line[30] - The company is collaborating with Xianjian Technology in the Asia-Pacific region for pre-commercialization activities[34] - The company has established a commercialization team of over 60 members, focusing on market introduction and education for core products, and has expanded its reach to over 220 influential hospitals across more than 30 provinces and municipalities in China[42] - The company plans to accelerate the commercialization of its core products in the rapidly growing transcatheter valve replacement market[44] Financial Position and Assets - Total assets as of December 31, 2023, amounted to RMB 1,445,092,000, a decrease from RMB 1,431,339,000 in 2022[11] - Current assets increased to RMB 1,154,913,000 in 2023 from RMB 855,359,000 in 2022, representing a growth of approximately 35.1%[11] - The company’s non-current assets totaled RMB 172,179,000 in 2023, significantly down from RMB 575,970,000 in 2022, a decrease of approximately 70.1%[11] - Cash and cash equivalents increased by 27.6% from RMB 727.4 million as of December 31, 2022, to RMB 927.8 million as of December 31, 2023[54] - Capital expenditures rose from RMB 49.6 million in 2022 to RMB 78.6 million in 2023, attributed mainly to the purchase of properties, plants, and equipment[55] - The company's current ratio improved to 19.7 in 2023 from 15.1 in 2022, indicating better short-term financial health[56] - Total bank borrowings amounted to RMB 40.7 million as of December 31, 2023, with RMB 15.8 million secured by collateral[57] - The company generated net cash from investing activities of RMB 358.1 million, primarily from the sale of equity in a joint venture[53] Governance and Compliance - The board of directors consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence[69] - The audit committee, composed of three independent non-executive directors, oversees financial reporting and internal controls[72] - The company has adopted the corporate governance code as per the listing rules and has complied with all applicable provisions during the reporting period, except for a deviation regarding the roles of the chairman and CEO[69] - The company has confirmed that all directors and supervisors adhered to the standards for securities trading during the reporting period[70] - The company has no significant litigation or arbitration pending as of December 31, 2023[61] - The board of directors does not recommend a final dividend for the year ended December 31, 2023[66] - The company emphasizes adherence to International Financial Reporting Standards, ensuring transparency and compliance in financial reporting[77] Employee and Operational Metrics - The company has a total of 376 employees as of December 31, 2023, an increase from 292 employees as of December 31, 2022[62] - The company has expanded its annual production capacity from 3,500 units to approximately 4,000 to 5,000 units, with a target to reach about 10,000 units by the end of 2024[41] - The company’s manufacturing facility in Ningbo, Zhejiang, spans approximately 7,000 square meters and is designed to meet GMP requirements for large-scale production[41] Future Plans and Strategic Initiatives - The company plans to hold a special general meeting on December 15, 2023, to approve the H-share incentive and trust plan[76] - The expected timeline for utilizing the net proceeds includes completion by December 31, 2026, for core product development and by December 31, 2024, for working capital[65] - The company is focused on expanding its market presence, particularly in the Hong Kong region, to enhance shareholder value[76] - The company is actively engaging with stakeholders to align its strategic objectives with market expectations and regulatory requirements[76]

Financial Performance - The company reported a revenue of RMB 150 million for the first half of 2023, representing a 25% increase compared to the same period last year[12]. - The company has provided a revenue guidance of RMB 320 million for the full year 2023, which reflects an expected growth of 20% year-over-year[12]. - For the six months ended June 30, 2023, the company reported a loss of RMB 178,161,000, compared to a loss of RMB 73,529,000 in the same period of 2022, representing a 142.30% increase in losses[13]. - The net loss for the six months ended June 30, 2023, was RMB 178.2 million, compared to a net loss of RMB 73.5 million for the same period in 2022[44]. - The company reported a total loss of RMB 178,161 thousand, compared to a loss of RMB 73,529 thousand in the same period of 2022, representing an increase of 142.5% in losses[83]. - The basic and diluted loss per share for the first half of 2023 was RMB 0.20, compared to RMB 0.42 in the same period of 2022, indicating an improvement in loss per share[83]. User Growth and Market Expansion - User data indicates a growth in active users by 30%, reaching a total of 1.2 million users as of June 30, 2023[12]. - Market expansion efforts are underway in Southeast Asia, with plans to enter three new countries by the end of 2023[12]. - The company has expanded its coverage to over 200 influential hospitals across more than 30 provinces and municipalities in China, with plans to train over 50 independent operators and 15 teaching experts within 2023[17]. Product Development and R&D - New product launches include the LuX-Valve and Ken-Valve, which are expected to contribute significantly to future revenue streams[12]. - The company is investing RMB 20 million in R&D for new technologies aimed at enhancing product efficiency and safety standards[12]. - The company has 12 products in various stages of development, with several expected to enter the market between 2024 and 2026[24]. - The company holds 13 patents and 20 patent applications related to LuX-Valve, indicating a strong intellectual property position in the market[25]. - The company has received breakthrough medical device designation from the FDA for LuX-Valve, enhancing its regulatory pathway in the U.S.[25]. Clinical Trials and Approvals - The LuX-Valve is expected to receive approval from the National Medical Products Administration (NMPA) in Q4 2023, following the submission of registration materials[15]. - The LuX-Valve Plus has completed confirmatory clinical trials and is expected to submit for NMPA registration approval in September 2023[15]. - The company has initiated clinical applications in Europe aiming for CE certification, with successful clinical implants in major countries such as France, Germany, and Italy[15]. - The Ken-Valve is anticipated to submit for NMPA registration approval in Q3 2023, following the completion of confirmatory clinical trials[21]. - JensClip, a transcatheter mitral valve repair system, has completed subject enrollment for its feasibility clinical trial in China, with confirmatory trials ongoing and expected to complete enrollment by Q4 2023[28]. Financial Position and Cash Flow - Cash and cash equivalents increased by 77.2% to RMB 701.1 million as of June 30, 2023, compared to RMB 395.7 million as of June 30, 2022[46]. - The company reported a foreign exchange reserve of RMB 10,195 thousand for the first half of 2023, which was not present in the previous year[86]. - The company’s total assets as of June 30, 2023, were RMB 1,365,689 thousand, down from RMB 1,374,593 thousand at the end of 2022, reflecting a decrease of 0.6%[85]. - The company’s total liabilities as of June 30, 2023, were RMB 1,354,133 thousand, compared to RMB 1,373,027 thousand at the end of 2022, reflecting a decrease of 1.4%[85]. - The company experienced a net cash outflow of RMB 45,186,000 in cash and cash equivalents for the period, a significant decrease from RMB 430,455,000 in the same period last year[88]. Administrative and R&D Expenses - R&D expenses increased from RMB 84.5 million to RMB 137.6 million, driven by higher share-based compensation, employee costs, and third-party contract costs[37]. - Administrative expenses increased from RMB 40.5 million for the six months ended June 30, 2022, to RMB 82.1 million for the six months ended June 30, 2023, primarily due to increased share-based compensation and employee costs[39]. - The company incurred research and development expenses of RMB 1,286,000 for the six months ended June 30, 2023, a significant decrease from RMB 84,541,000 in the same period of 2022[97]. Shareholder Structure and Governance - The board consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence[58]. - The company has a significant concentration of ownership, with several shareholders holding over 2% of the total shares[71]. - The total number of issued shares as of June 30, 2023, is 417,167,290[72]. - The company is primarily focused on maintaining its current shareholder structure without significant changes in the near term[77]. Other Financial Metrics - Other income decreased from RMB 38.3 million to RMB 34.1 million due to reduced foreign exchange gains[36]. - The company reported a net sale of RMB 97,746,000 from financial assets at fair value through profit or loss for the six months ended June 30, 2023, compared to a loss of RMB 2,509,000 in the same period of 2022[112]. - The company recognized government grants of RMB 600,000 during the reporting period, a significant improvement from a loss of RMB 8,848,000 in the previous year[97].

Financial Performance - The company reported a net loss of RMB 178,161,000 for the six months ended June 30, 2023, compared to a loss of RMB 73,529,000 in the same period of 2022, representing an increase of 142.30%[2]. - Basic and diluted loss per share for the period was RMB 0.42, compared to RMB 0.20 in the previous year, reflecting an increase of 110.00%[2]. - The total comprehensive loss for the period was RMB 167,966,000, compared to RMB 73,529,000 in the same period last year[7]. - Other income and gains for the period were RMB 34,050,000, down from RMB 38,346,000 in the previous year[6]. - The group reported a pre-tax loss of RMB 137,603 thousand for the six months ended June 30, 2023, compared to a loss of RMB 84,541 thousand in the previous year[16]. - Total expenses for the six months ended June 30, 2023, amounted to RMB 82,137,000, a significant increase from RMB 40,534,000 for the same period in 2022[44]. - The company's other income decreased from RMB 38.3 million to RMB 34.1 million, primarily due to reduced foreign exchange gains[40]. - Cash used in operating activities for the six months ended June 30, 2023, was RMB 90.9 million, primarily due to R&D and administrative expenses[48]. - Cash and cash equivalents increased by 77.2% to RMB 701.1 million as of June 30, 2023, compared to RMB 395.7 million as of June 30, 2022[49]. Research and Development - Research and development expenses increased to RMB 137,603,000 from RMB 84,541,000 year-on-year, indicating a significant investment in product development[6]. - Research and development expenses for the period reached RMB 137,603 thousand, highlighting the company's commitment to innovation[16]. - R&D expenses increased from RMB 84.5 million to RMB 137.6 million, primarily due to increased share-based compensation and employee costs[41]. Product Development and Commercialization - The company has established a commercialization team of over 60 members to enhance market entry and education efforts for core products[4]. - The company has 12 products in various stages of development, including several that are in clinical trials[24]. - LuX-Valve has entered the registration review stage, with approval expected from the National Medical Products Administration in Q4 2023[3]. - The company has completed several clinical implants in North America, continuing the commercialization process for LuX-Valve Plus[3]. - The LuX-Valve product is expected to receive regulatory approval in Q4 2023, with commercialization anticipated in the same quarter[25]. - The Ken-Valve product is set to submit for regulatory approval in Q3 2023, with expected commercialization in H2 2024[25]. - The MicroFlux system is preparing to initiate confirmatory clinical trials in Q4 2023, with commercialization expected in H1 2025[25]. - The SimuLock product is expected to start feasibility clinical trials in Q3 2023, with commercialization anticipated in H2 2025[26]. - The company has not reported any significant changes in its core product pipeline, maintaining focus on structural heart disease interventions[23]. Financial Position - As of June 30, 2023, total non-current assets amounted to RMB 625,424 thousand, an increase from RMB 575,970 thousand as of December 31, 2022, representing an increase of approximately 8.6%[9]. - Current assets totaled RMB 792,234 thousand, up from RMB 727,364 thousand as of December 31, 2022, indicating an increase of about 8.9%[9]. - The net current asset value decreased to RMB 740,265 thousand from RMB 798,623 thousand, reflecting a decline of approximately 7.3%[9]. - The total assets less current liabilities stood at RMB 1,365,689 thousand, slightly down from RMB 1,374,593 thousand, a decrease of about 0.6%[9]. - The total equity attributable to the owners of the parent company was RMB 1,354,133 thousand, a slight decrease from RMB 1,373,027 thousand as of December 31, 2022[9]. Corporate Governance - The board consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring a strong level of independence[64]. - The company has adopted a standard code for securities trading, confirming compliance by all directors and supervisors during the reporting period[65]. - The company established an audit committee consisting of three independent non-executive directors to oversee financial reporting and risk management[67]. - The independent auditor, Ernst & Young, reviewed the interim financial information for the six months ending June 30, 2023, in accordance with the relevant auditing standards[67]. - The audit committee has reviewed the group's interim performance and internal controls, confirming compliance with applicable accounting standards and regulations[67]. - The company emphasizes the importance of internal controls and risk management systems in its financial reporting[67]. Market Expansion and Strategy - The company aims to train over 50 independent operators and more than 15 teaching experts within 2023[5]. - The company plans to expand its annual production capacity from approximately 4,000 to 5,000 units by the end of 2024, aiming to reach about 10,000 units[36]. - The company intends to expand its international presence to become an industry leader[39]. - The marketing team has expanded to over 200 influential hospitals across more than 30 provinces, municipalities, and autonomous regions in China[38]. Legal and Compliance - There were no significant legal proceedings or arbitration involving the company during the reporting period[58]. - The company has not engaged in any major post-reporting period events up to the announcement date[63]. - The interim report for 2023 will be published on the Hong Kong Stock Exchange and the company's website, containing all required information as per listing rules[68]. - The company will distribute the interim report to shareholders in a timely manner[68].

Company Overview - The company was listed on October 10, 2022, with H shares available for trading on the Hong Kong Stock Exchange[4]. - The core products include LuX-Valve and Ken-Valve, which are defined under the listing rules[4]. - The company has successfully listed on the Hong Kong Stock Exchange, providing a solid foundation for ongoing product innovation and international strategy[11]. Financial Performance - The company reported a loss before tax of RMB 440.914 million for the fiscal year ending December 31, 2022, compared to a loss of RMB 500.673 million in 2021[18]. - Other income and gains increased from RMB 8.9 million in 2021 to RMB 54.4 million in 2022, primarily due to currency exchange gains and additional government subsidies[48]. - R&D expenses rose from RMB 265.3 million in 2021 to RMB 291.6 million in 2022, driven by increased employee costs and third-party contract costs[49]. - Administrative expenses decreased from RMB 238.5 million in 2021 to RMB 219.7 million in 2022, mainly due to a reduction in share-based compensation expenses[51]. - The company reported a net loss of RMB 500.7 million in 2021 and RMB 440.9 million in 2022, with no income tax provision due to lack of taxable profit[56]. - Cash and cash equivalents decreased by 9.1% from RMB 800.6 million at the end of 2021 to RMB 727.4 million at the end of 2022[56]. - The company’s net cash used in investing activities was RMB 146.6 million in 2022, primarily for property and equipment purchases[56]. - Capital expenditures increased from RMB 15.4 million in 2021 to RMB 49.6 million in 2022, primarily due to the purchase of machinery, office equipment, and leasehold improvements[57]. Market Strategy and Growth - The company aims to expand its market presence in Southeast Asia, targeting a 30% increase in market share by 2025[6]. - A strategic acquisition is planned to enhance technological capabilities, with an estimated investment of $50 million[6]. - The company expects revenue growth of 20% for the next fiscal year, driven by new product launches and market expansion[6]. - The company aims to accelerate the commercialization of its core products in the growing transcatheter tricuspid valve replacement market[47]. - The company plans to expand its international presence to become an industry leader in structural heart disease treatment[47]. Research and Development - Research and development efforts are focused on enhancing product features and expanding the product line, with a budget allocation of 15% of total revenue for R&D[6]. - The company has 12 products in various stages of development, including 4 core products in the transcatheter heart valve category[29]. - The company expects to launch 1-2 significant products annually starting in 2023, ensuring continuous innovation and commercialization[15]. - LuX-Valve received registration submission to the National Medical Products Administration (NMPA) in December 2022, with commercialization expected in Q3 2023[32]. - The company has initiated early feasibility clinical trials for the LuX-Valve Plus product in France, Germany, Spain, and Switzerland, and has also started trials in the US and Canada[11]. - The company is advancing its confirmatory clinical trial for the mitral valve repair device JensClip, with completion expected by the end of 2023[12]. - Ken-Valve, a first-generation transcatheter aortic valve replacement system, completed its confirmatory clinical trial in March 2023, with commercialization approval anticipated in H1 2024[34]. Corporate Governance - The company has adopted the corporate governance code as per the listing rules, with a commitment to reviewing its governance structure regularly[92]. - The board consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring a strong level of independence[92]. - The company emphasizes the importance of separating the roles of Chairman and CEO, although currently, Mr. Lu holds both positions, which the board believes benefits management[92]. - The company has a diverse board with members holding advanced degrees in finance, economics, and engineering from prestigious institutions[78]. - The board is responsible for overseeing major company affairs, including policy formulation, overall strategy, and risk management systems[94]. Environmental, Social, and Governance (ESG) Initiatives - The company has implemented measures to reduce carbon emissions and enhance energy management as part of its ESG strategy[151]. - The company’s environmental performance report adheres to the guidelines set by the Hong Kong Stock Exchange, ensuring transparency and accuracy in its disclosures[148]. - The company aims to achieve a 10% reduction in electricity consumption, a 5% reduction in water usage, and a 10% reduction in oil consumption in 2023[174]. - The company has established a waste management system to ensure compliance with environmental regulations and to minimize waste generation[169]. - The company’s mission includes providing safe and effective treatment solutions, reflecting its commitment to corporate social responsibility[150]. Employee Management and Development - The company has established a performance management system that includes monthly, quarterly, semi-annual, and annual assessments[179]. - The employee demographic shows that 60.3% are female, and 52.7% hold a university degree or higher[182]. - The company provides competitive compensation packages, including basic salary, stock options, and various allowances[180]. - The company has established a comprehensive employee health and safety management system, achieving ISO14001 and ISO45001 certifications[189]. - The company conducts regular safety training to enhance employee awareness of production risks[190].

Financial Performance - For the year ended December 31, 2022, the company reported a loss before tax of RMB 440,914,000, a decrease of 11.9% compared to RMB 500,673,000 in the previous year[2]. - The net loss for the year was RMB 440,914,000, reflecting a reduction of 11.9% from RMB 500,673,000 in 2021[2]. - The loss attributable to equity holders of the parent company was RMB 439,311,000, down 12.2% from RMB 500,517,000 in the prior year[2]. - Basic and diluted loss per share for the year was RMB 1.20, a decrease of 18.9% compared to RMB 1.48 in 2021[2]. - The total comprehensive loss for the year was RMB 432,629,000, compared to RMB 500,673,000 in the previous year[6]. - The net loss for the years 2021 and 2022 was RMB 500.7 million and RMB 440.9 million, respectively[48]. - The net cash used in operating activities for 2022 was RMB 158.5 million, primarily due to significant R&D and administrative expenses[49]. - Cash and cash equivalents as of December 31, 2022, were RMB 727.4 million, a decrease of 9.2% from RMB 800.6 million as of December 31, 2021[49]. - The company has no declared dividends for the year ending December 31, 2022, consistent with the previous year[21]. - The board of directors does not recommend the payment of a final dividend for the year ended December 31, 2022[61]. Research and Development - The company focuses on the research and development of interventional products for treating structural heart diseases, indicating a strategic emphasis on medical innovation[10]. - Research and development expenses increased to RMB 291,580,000 from RMB 265,336,000 in the previous year[5]. - The company has a total of 12 products in various stages of development, focusing on interventional products for structural heart disease[27]. - The company aims to enhance its product development capabilities and seek strategic partnerships to expand its product portfolio[39]. - The company is committed to research and development (R&D) initiatives[71]. Clinical Trials and Product Development - The company completed the feasibility clinical trial for LuX-Valve Plus and is expected to submit registration to the National Medical Products Administration in Q3 2023[3]. - The company has initiated early feasibility clinical trials for LuX-Valve in Europe and is also starting trials in the US and Canada[3]. - The company completed the confirmatory clinical trial for Ken-Valve and is analyzing data, with plans to submit for registration in Q2 2023[4]. - LuX-Valve received approval from the National Medical Products Administration (NMPA) and is expected to achieve commercialization approval in Q3 2023[29]. - LuX-Valve Plus is currently undergoing confirmatory clinical trials, with enrollment expected to be completed in Q2 2023 and registration submission to NMPA anticipated in Q3 2023[30]. - Ken-Valve has completed confirmatory clinical trials and submitted for NMPA approval, with commercialization expected in H1 2024[29]. - JensClip is in confirmatory clinical trials, with enrollment completion expected in Q4 2023 and commercialization projected for H2 2025[29]. - MicroFlux is in feasibility clinical trials, with confirmatory trials expected to start in H2 2023 and commercialization anticipated in H2 2025[29]. - SimuLock is preparing for feasibility clinical trials, expected to start in H1 2023, with commercialization projected for H2 2025[29]. - JensFlag and JensRelive are in early feasibility clinical trials, with expected commercialization in H1 2026 and H2 2026 respectively[29]. - KenFlex, a next-generation transcatheter aortic valve replacement system, is currently preparing for feasibility clinical trials, aiming to enhance accuracy and stability during valve placement[31]. - JensClip, a transcatheter mitral valve repair system, completed feasibility clinical trials in December 2022, with confirmatory trials ongoing and patient enrollment expected to finish in Q4 2023[32]. - MicroFlux, a first-generation transcatheter device for treating heart failure with preserved ejection fraction (HFpEF), is currently in feasibility clinical trials in China[34]. - AlginSys, a biocompatible injectable polymer product for preventing late-stage heart failure, is undergoing animal testing as of the announcement date[34]. - SimuLock, a left atrial appendage occluder system, is expected to initiate feasibility clinical trials in H1 2023 after obtaining ethical approval[35]. - OmniSeal, a biodegradable patent foramen ovale (PFO) occluder system, is currently in animal testing[35]. Financial Position and Assets - Total non-current assets increased to RMB 575,970 thousand in 2022 from RMB 512,554 thousand in 2021, representing a growth of 12.35%[8]. - Current assets rose to RMB 855,359 thousand in 2022, up from RMB 828,805 thousand in 2021, reflecting a 3.14% increase[8]. - Total liabilities increased to RMB 56,736 thousand in 2022, compared to RMB 49,700 thousand in 2021, marking a rise of 14.09%[8]. - Net assets reached RMB 1,373,027 thousand in 2022, up from RMB 1,290,591 thousand in 2021, indicating a growth of 6.38%[8]. - The current ratio as of December 31, 2022, was 15.1, down from 16.7 in 2021, while the debt-to-asset ratio increased to 4.1% from 3.8%[52]. - The company has no outstanding borrowings or unused bank financing as of December 31, 2022[53]. - The net cash from financing activities for 2022 was RMB 188.9 million, primarily from global sales proceeds[49]. - The company has not engaged in any significant investments or acquisitions as of December 31, 2022[55]. Corporate Governance and Compliance - The company has adopted new and revised International Financial Reporting Standards, ensuring compliance with updated accounting practices[12]. - The company has adopted the corporate governance code as its own governance guidelines and has complied with all applicable provisions during the period from listing to December 31, 2022, with some deviations noted[63]. - The audit committee, consisting of three independent non-executive directors, has reviewed the annual performance and financial reporting procedures, ensuring compliance with applicable accounting standards[66]. - The preliminary announcement of the consolidated financial statements for the year ended December 31, 2022, has been confirmed by the auditors, ensuring consistency with the draft financial statements[67]. - The company is recognized for compliance with health, safety, and environmental standards in the European Economic Area[69]. - The National Medical Products Administration oversees the company's regulatory compliance in China[71]. Market Presence and Strategic Initiatives - The company was listed on the Hong Kong Stock Exchange on October 10, 2022, enhancing its market presence[10]. - The company aims to expand its market presence by developing solutions for various types of structural heart diseases, including tricuspid valve disease and heart failure[26]. - The company entered into a strategic cooperation agreement with Xianjian Technology on February 6, 2023, focusing on potential collaboration in business development, project investment, and financing in both mainland China and overseas[60]. - The company successfully completed its initial public offering on the Hong Kong Stock Exchange, issuing 8,076,400 shares at a price of HKD 27.80 per share[25]. - The company aims to accelerate the commercialization of its core products to capture opportunities in the growing market for transcatheter trileaflet valve replacements[39].