Financial Performance - The company reported a revenue of RMB 277.9 million for the fiscal year ending December 31, 2024, representing a year-on-year growth of 19.6%[4] - Gross profit was RMB 181.7 million, with a gross margin of 65.4%, down from 70.5% in the previous year, reflecting a decrease of 5.1 percentage points[3] - The company significantly reduced its pre-tax loss to RMB 12.0 million, an 88.3% improvement compared to a loss of RMB 102.9 million in 2023[4] - The company reported a net loss attributable to equity holders of RMB 13.6 million, significantly reduced from RMB 94.0 million in the previous year, with a basic and diluted loss per share of RMB 0.36 compared to RMB 2.47[6] - Total revenue for 2024 reached RMB 277,899 thousand, an increase of 19.6% compared to RMB 232,344 thousand in 2023[19] - Revenue from medical device sales was RMB 276,931 thousand in 2024, up from RMB 232,344 thousand in 2023, reflecting a growth of 19.2%[19] - Revenue from service provision amounted to RMB 968 thousand in 2024, with no revenue reported in 2023[19] - Revenue from the mainland China market was RMB 269,504 thousand in 2024, compared to RMB 231,273 thousand in 2023, indicating a growth of 16.5%[19] - Other income totaled RMB 17,559 thousand in 2024, down from RMB 22,406 thousand in 2023, representing a decrease of 21.8%[21] - Government subsidies received were RMB 8,793 thousand in 2024, a decrease from RMB 11,211 thousand in 2023, reflecting a decline of 21.5%[21] Cost Management - Research and development costs were RMB 58.9 million, a decrease of 52.4% from RMB 123.8 million in the previous year, indicating effective cost control[3] - Sales and distribution expenses decreased by 10.4% to RMB 137.8 million, contributing to a lower expense ratio of 49.6% compared to 66.2% in 2023[4] - Administrative expenses decreased from RMB 74.6 million for the year ended December 31, 2023, to RMB 58.2 million for the year ending December 31, 2024, primarily due to a reduction in professional service fees[62] - Financial costs decreased from RMB 2.2 million for the year ended December 31, 2023, to RMB 1.7 million for the year ending December 31, 2024[65] Product Development and Market Strategy - The company achieved a 45.5% increase in sales of acute ischemic stroke treatment devices, with hemorrhagic stroke treatment devices and other interventional devices growing by 104.2% and 109.4%, respectively[4] - The company plans to launch at least two major neurointerventional devices in the next 24 months to address the growing demand for stroke treatment in the aging Chinese market[5] - The company has obtained CE or FDA certifications for several products and is currently registering over 40 products in 10 countries, laying the groundwork for long-term overseas sales goals[5] - The company aims to enhance its brand recognition as a comprehensive provider of neurointerventional devices and accelerate the commercialization of its pipeline products[53] - The company is focused on developing innovative medical devices in high-growth potential markets to create a competitive product portfolio beyond its neurointerventional business[53] Financial Stability - Total assets decreased to RMB 1,106.3 million in 2024 from RMB 1,141.5 million in 2023, while total liabilities also decreased, indicating improved financial stability[8] - The total trade receivables increased to RMB 97,381,000 in 2024 from RMB 78,659,000 in 2023, with an expected credit loss of RMB 2,668,000, representing a credit loss rate of 2.74%[28][31] - The company recognized a cumulative tax loss of RMB 686,522,000 as of December 31, 2024, which can be utilized to offset future taxable profits over the next 2 to 10 years[25] - The company has been granted a preferential income tax rate of 15% as a high-tech enterprise, applicable for the years ending December 31, 2023, and December 31, 2024[24] - The company has no supplier financing arrangements, thus recent accounting standard revisions will not impact its financial statements[14] - The company expects no significant impact on its financial performance or position from newly issued accounting standards in the foreseeable future[16] Corporate Governance - The company has adopted the corporate governance code to enhance management standards and protect shareholder interests[84] - The audit committee consists of three members, including two independent non-executive directors, ensuring compliance with listing rules[86] - The company confirms that all directors and supervisors have adhered to the standard code during the reporting period[85] - The company’s consolidated financial statements for the reporting period have been audited and comply with relevant accounting standards[87] - The chairman and CEO roles are held by the same individual, which deviates from the corporate governance code, but the board believes it enhances leadership effectiveness[84] Shareholder Returns - The company did not declare or pay any dividends during the year, consistent with the previous year[26] - The board does not recommend the payment of a final dividend for the reporting period, consistent with the previous year[81] Future Outlook - The company plans to apply for A-share listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board[54] - The company plans to hold its annual general meeting on May 26, 2025[89] - The company’s shares are listed on the Hong Kong Stock Exchange under the stock code 6609[89]

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所產生或 因依賴該等內容而引致的任何損失承擔任何責任。 董事會召開日期 上海心瑋醫療科技股份有限公司（「本公司」）董事（「董事」）會（「董事會」）謹此 宣佈，本公司將於2025年3月27日（星期四）舉行董事會會議，藉以（其中包括） 審議及批准本公司及其附屬公司截至2024年12月31日止年度之全年業績及其發 佈，以及考慮建議派付末期股息（如有）。 承董事會命 上海心瑋醫療科技股份有限公司 Shanghai HeartCare Medical Technology Corporation Limited 上 海 心 瑋 醫 療 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：6609） 董事長 王國輝 上海，2025年3月17日 於本公告日期，執行董事為王國輝先生、張坤女士及韋家威先生；非執行董事為丁魁先生、 陳少雄先生及陳剛先生；及獨立非執行董事為郭少牧先生、馮向前先生及龔平先生 ...

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所產生或 因依賴該等內容而引致的任何損失承擔任何責任。 Shanghai HeartCare Medical Technology Corporation Limited 上 海 心 瑋 醫 療 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：6609） 根據上市規則第13.51B(2)條及第13.51(2)條作出的公告 王國輝 上海，2025年3月6日 於本公告日期，執行董事為王國輝先生、張坤女士及韋家威先生；非執行董事為丁魁先生、 陳少雄先生及陳剛先生；及獨立非執行董事為郭少牧先生、馮向前先生及龔平先生。 茲提述聯交所於2025年3月6日發佈的監管公告（「監管公告」），內容有關針對花 樣年、彩生活服務集團有限公司（聯交所上市公司，股份代號：1778）以及兩間 公司的若干董事或前任董事（包括郭先生）的公開譴責。根據監管公告，聯交所 發現（其中包括），(i)花樣年違反上市規則第十 ...

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所產生或 因依賴該等內容而引致的任何損失承擔任何責任。 Shanghai HeartCare Medical Technology Corporation Limited 臨時股東大會及該等類別股東大會的出席情況 董事會欣然宣佈，本公司於2024年11月7日（星期四）上午十時正假座中國上海 市自由貿易試驗區臨港新片區正博路356號38幢2層心瑋廳先召開臨時股東大會， 並於臨時股東大會結束後隨即召開該等類別股東大會。 臨時股東大會及該等類別股東大會由董事會根據中華人民共和國公司法及組 織章程細則召開，由執行董事兼董事會主席王國輝先生主持。本公司全體董事 王國輝先生、張坤女士、韋家威先生、丁魁先生、陳少雄先生、陳剛先生、郭 少牧先生、馮向前先生及龔平先生均親身或以電子方式出席臨時股東大會及 該等類別股東大會。 上 海 心 瑋 醫 療 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：6 ...

Financial Performance - For the first half of 2024, the company reported revenue of RMB 128.5 million, representing a year-on-year increase of 17.2%[6] - Gross profit was RMB 82.3 million, with a gross margin of 64.0%, down 8.7 percentage points compared to the same period last year[6] - The company narrowed its pre-tax loss to RMB 3.2 million, a 94.1% improvement year-on-year[6] - Revenue increased by 17.2% from RMB 109.6 million for the six months ended June 30, 2023, to RMB 128.5 million for the six months ended June 30, 2024, driven by sales growth in acute ischemic stroke devices and intracranial artery stenosis treatment devices[19] - Gross profit rose from RMB 79.7 million to RMB 82.3 million, but gross margin decreased from 72.7% to 64.0% due to price pressures from volume-based procurement and market competition[21] - The net loss for the six months ended June 30, 2024, was RMB 5,119 thousand, significantly reduced from a net loss of RMB 54,338 thousand in 2023[69] - Basic and diluted loss per share improved to RMB (0.14) from RMB (1.42) year-over-year[69] Research and Development - The company invested RMB 31.8 million in R&D, focusing on diversifying neuro-interventional devices[7] - Research and development costs decreased significantly from RMB 69.9 million to RMB 31.8 million, attributed to reduced raw material costs and a decrease in the number of R&D personnel[23] - The company is focusing on R&D and has incurred RMB 31,752 thousand in R&D expenses for the six months ended June 30, 2024[69] - Research and development expenses increased by 30% to RMB 200 million, focusing on innovative medical technologies[109] Product Development and Market Expansion - Neuro-interventional devices contributed 35.6% of total sales, generating revenue of RMB 45.8 million[7] - The company plans to launch at least five major neuro-interventional devices in the next 18 months, including innovative drug-eluting balloon catheters and self-expanding drug stents[7] - The intracranial drug-eluting balloon catheter is in the NMPA registration phase after completing clinical trials[11] - The company is evaluating opportunities for expanding the Captor product's indications and potential overseas marketing[10] - The company plans to enhance brand awareness as a comprehensive provider of neuro-interventional devices and expand sales of commercialized products[17] - The company aims to develop innovative medical devices in emerging treatment areas to create a competitive product portfolio beyond its neuro-interventional business[17] - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2025[109] - A strategic acquisition of a local competitor is anticipated to enhance the company's product offerings and market reach[109] Regulatory and Compliance - The company has obtained CE or FDA certification for several products and is expanding its registration efforts in over ten other countries[7] - The company has 29 medical device products approved by NMPA, 3 products approved by FDA, and 1 product with CE mark as of the mid-term report date[6] - The company has adopted a code of conduct for trading its securities, confirming compliance by all directors and supervisors during the six months ended June 30, 2024[55] - The company has adhered to the corporate governance code, with all provisions complied with during the six months ended June 30, 2024, except for one[56] - The independent auditor, Ernst & Young, reviewed the group's interim financial data for the same period, ensuring accuracy and compliance[58] Shareholder Information and Incentive Plans - The 2021 H-share incentive plan was adopted on November 1, 2021, and has a validity period of ten years, with approximately 7.5 years remaining[41] - A total of 3,000,000 H-shares are allocated for three-year rewards, with a maximum of 30% vesting in the first year[43] - The plan is designed to align the interests of the leadership with those of shareholders and the overall group[38] - The company continues to implement its 2021 H-share incentive plan to align management interests with shareholder value[62] - The total number of shares available for the 2021 H-share incentive plan is 3,000,000, accounting for approximately 9.5% and 7.7% of the company's total H-share and issued share capital as of the report date[48] Cash Flow and Financial Position - Cash and bank balances as of June 30, 2024, were RMB 613.3 million, a decrease of RMB 8.9 million from RMB 622.2 million as of December 31, 2023[28] - The company reported a net cash flow from operating activities of RMB 8,799 thousand, a significant improvement from a net outflow of RMB 70,167 thousand in the same period of 2023[73] - The company reported an increase in cash and cash equivalents, totaling RMB 613,346 thousand at the end of the period, up from RMB 676,005 thousand in the previous year[74] - The company’s total cash and cash equivalents at the beginning of the period were RMB 605,583 thousand, with a net effect of exchange rate changes of RMB 454 thousand[74] Corporate Governance - The board consists of three non-executive directors, three independent non-executive directors, and three executive directors, ensuring a high level of independence[58] - The company plans to continue reviewing and monitoring its corporate governance standards to maintain high standards[58] - The audit committee, comprising independent non-executive directors, has reviewed the accounting principles and practices adopted by the group[58] - The company emphasizes the importance of internal controls and risk management in its financial reporting processes[58] Market Performance and User Engagement - User data showed an increase in active users by 15%, reaching a total of 3 million active users by June 30, 2024[109] - The company expects revenue growth to continue at a rate of 20% for the second half of 2024, driven by new product launches and market expansion[109] - Gross margin improved to 60%, up from 55% in the previous year, due to cost optimization strategies[109] - The company has launched two new products in Q2 2024, contributing to a 5% increase in overall sales[109]

Financial Performance - The company reported revenue of RMB 128.5 million for the first half of 2024, representing a year-on-year increase of 17.2%[2]. - Gross profit was RMB 82.3 million, with a gross margin of 64.0%, down 8.7 percentage points compared to the same period in 2023[2][3]. - The company narrowed its pre-tax loss to RMB 3.2 million, a decrease of 94.1% year-on-year[2][3]. - Revenue from customer contracts for the six months ended June 30, 2024, was RMB 128,484,000, an increase of 17.2% compared to RMB 109,586,000 for the same period in 2023[15]. - Revenue from medical device sales contributed RMB 128,484,000, with RMB 125,081,000 coming from mainland China, reflecting a growth from RMB 109,269,000 in the previous year[15]. - Other income for the six months ended June 30, 2024, totaled RMB 9,036,000, a decrease from RMB 10,746,000 in the same period of 2023[16]. - Interest income decreased to RMB 4,349,000 from RMB 6,433,000 year-over-year[16]. - Gross profit increased from RMB 79.7 million for the six months ended June 30, 2023, to RMB 82.3 million for the six months ended June 30, 2024, while gross margin decreased from 72.7% to 64.0% due to price impacts from volume-based procurement and market competition[36]. Research and Development - Research and development costs amounted to RMB 31.8 million, significantly reduced by 54.5% compared to the previous year[2][3]. - R&D expenses significantly decreased from RMB 69.9 million to RMB 31.8 million, attributed to reduced raw materials and consumables, a decrease in R&D team size, and lower third-party contracting costs[38]. - The company expects to launch at least five major neuro-interventional devices in the next 18 months, including innovative drug-eluting balloon catheters and self-expanding drug stents[3]. - The intracranial drug-eluting balloon catheter is in the NMPA registration phase after completing clinical trials, aimed at preventing vascular occlusion[27]. Sales and Distribution - Neuro-interventional devices contributed 35.6% of total sales, generating revenue of RMB 45.8 million[3]. - Sales from neurointerventional devices contributed 35.6% of total revenue, amounting to RMB 45.8 million[23]. - The sales of neurointerventional access devices and other products grew by 42.1% year-on-year to RMB 82.7 million[23]. - The company has established a distribution network covering over 2,000 hospitals across all provinces in China, excluding Hong Kong and Macau[30]. Financial Position - Total assets amounted to RMB 1,133.8 million, with net assets of RMB 1,069.98 million[6]. - Inventory increased to RMB 150.5 million, while trade receivables rose to RMB 85.0 million as of June 30, 2024[5]. - Trade receivables as of June 30, 2024, were RMB 85.0 million, compared to RMB 76.9 million as of December 31, 2023[21]. - Trade payables increased to RMB 5.7 million as of June 30, 2024, from RMB 3.7 million as of December 31, 2023[22]. - As of June 30, 2024, the company had no outstanding borrowings, and the debt-to-equity ratio remained stable at 3.4%[43]. - Cash and bank balances as of June 30, 2024, were RMB 613.3 million, a decrease of RMB 8.9 million from RMB 622.2 million as of December 31, 2023[44]. Corporate Governance - The company has adopted the corporate governance code to enhance management standards and protect shareholder interests[55]. - The audit committee consists of three members, including two independent non-executive directors, ensuring compliance with listing rules[56]. - The independent auditor has reviewed the group's interim financial data for the six months ending June 30, 2024[57]. - The board of directors is composed of three non-executive directors, three independent non-executive directors, and three executive directors, ensuring a high level of independence[55]. - The company emphasizes the importance of separating the roles of chairman and CEO, although both roles are currently held by the same individual[55]. - The company is committed to continuously reviewing and monitoring its corporate governance practices[55]. Future Plans - Plans to apply for A-share listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board to support future growth[32]. - The company aims to enhance its brand recognition as a comprehensive provider of neurointerventional devices and expand sales of commercialized products[32]. - The company is evaluating opportunities for overseas marketing of the Captor® device and may apply for registration in the United States[25].

Financial Performance - In 2023, the company achieved revenue of RMB 232.3 million, a 27% increase from RMB 183.0 million in 2022[8]. - The net loss for 2023 was RMB 94.0 million, a 53.1% reduction compared to RMB 200.4 million in 2022[8]. - Revenue increased by 26.9% from RMB 183.0 million in 2022 to RMB 232.3 million in 2023, driven by growth in therapeutic device sales[33]. - In fiscal year 2023, the company's revenue increased to RMB 232.3 million, representing a year-on-year growth of 26.9%, while the pre-tax loss narrowed to RMB 102.9 million, a decrease of 48.9%[13]. - Gross profit rose from RMB 124.3 million in 2022 to RMB 163.8 million in 2023, with gross margin improving from 67.9% to 70.5%[35]. Product Development and Innovation - Revenue from therapeutic devices reached nearly RMB 100 million, growing by 62.9%, with its revenue share increasing from 33.0% in 2022 to 42.3% in 2023[9]. - The company plans to launch at least 5 new therapeutic devices in the next 24 months, including products for aneurysm treatment and intracranial artery stenosis[9]. - The company aims to continue increasing the revenue share of therapeutic neurointerventional devices and optimize its research pipeline[10]. - Research and development costs for 2023 amounted to RMB 123.8 million, aimed at supporting a diverse pipeline of neurointerventional therapeutic devices[14]. - The company anticipates launching at least five major neurointerventional therapeutic devices in the next 24 months, including drug-coated balloons and self-expanding drug stents[14]. Regulatory Approvals and Certifications - The company registered 28 products with NMPA over the past three years, with applications in over 1,500 hospitals in China[8]. - Three products received FDA certification, and the thrombectomy stent obtained CE MDR certification, expanding the company's overseas market presence[9]. - As of the report date, the company has 28 devices approved by NMPA, three devices approved by FDA, and one device with CE mark[15]. - The Captor® thrombectomy device, the first of its kind approved by NMPA, has been upgraded to include various models for different vessel sizes and thrombus dimensions[18]. Operational Efficiency and Cost Control - The gross profit margin for products improved to 70.5%, while the selling and administrative expense ratio decreased to 66.2%, down by 25.6 percentage points year-on-year[9]. - The company is focusing on enhancing operational efficiency and cost control measures to improve profitability[10]. Market Expansion and Sales Strategy - The company is expanding its sales channels in overseas markets, with product registrations ongoing in ten additional countries[14]. - The company aims to become a leader in the Chinese neurointerventional medical device market and plans to enhance brand recognition and expand commercialization of its products[29][31]. Corporate Governance and Management - The company has expanded its board with independent non-executive directors who bring extensive experience in investment banking and financial management[79][80]. - The board's composition reflects a commitment to governance and strategic oversight, leveraging the diverse backgrounds of its members[80][82]. - The company has established policies and practices regarding corporate governance and compliance with legal and regulatory requirements[145]. - The board consists of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring a high level of independence[107]. Environmental Responsibility - The group aims to minimize negative impacts on the environment and strictly adheres to various environmental protection laws and regulations[192]. - The total emissions of waste gas in 2023 were approximately 29.7 kg, with a density of 12.7 kg per RMB 100 million in revenue, a 24.9% decrease compared to 2022[193]. - The company has implemented strict measures to comply with environmental regulations, ensuring that all waste gases are treated effectively before discharge[200]. - Regular monitoring of waste gas emissions is conducted by third-party testing agencies, with no instances of exceeding emission standards reported[200]. Future Outlook and Strategic Goals - The company has set ambitious performance guidance for the upcoming fiscal year, aiming for a revenue growth of over 15%[66]. - The company is exploring potential mergers and acquisitions to strengthen its market position and diversify its product portfolio[68]. - The long-term business model focuses on continuously launching innovative medical devices to redefine care standards and improve patient outcomes[98].

智通财经APP讯，心玮医疗-B(06609)发布截至2023年12月31日止年度业绩，该集团期内取得收益2.32亿元(人民币，下同)，同比增加26.9%;母公司拥有人应占亏损9401.2万元，同比收窄53.08%;每股基本亏损2.47元。 为了适应瞬息万变的市场环境及行业集采的推进，公司不断推动神经介入业务向治疗类器械聚焦的升级。取栓支架及抽吸导管，扩张球囊及栓塞保护系统，以及弹簧圈等神经介入治疗类器械贡献了42.3%的销售收入(2022年：33.0%)，收入金额同比增长62.9%至9820万元;神经介入通路器械及其他产品同比增长9.3%至1.34亿元。 公司研发成本为1.24亿元，用于支持神经介入治疗类器械的多元化在研项目。未来24个月，公司预期将有至少5款重磅神经介入治疗类器械上市，包括用于狭窄治疗的药物球囊(NMPA创新器械资质)、自膨式药物支架以及颈动脉支架，用于出血性卒中治疗的动脉瘤栓塞辅助支架(NMPA创新器械资质)以及血流导向装置。同时，公司针对不同亚型脑梗死的急诊手术需求，提升关键取栓产品(抽吸导管及取栓支架)及一站式医疗器械解决方案的竞争力，以满足老龄化背景下，中国市场日益增长的脑卒中治疗需 ...

Financial Performance - Revenue for the fiscal year 2023 increased to RMB 232.3 million, representing a year-on-year growth of 26.9%[2] - Gross profit rose to RMB 163.8 million, with a gross margin of 70.5%, up 2.6 percentage points from the previous year[2] - Pre-tax loss narrowed to RMB 102.9 million, a decrease of 48.9% compared to the previous year[2] - Basic and diluted loss per share improved to RMB (2.47) from RMB (5.24) year-on-year[3] - Total revenue from medical device sales for 2023 was RMB 232,344,000, an increase of 27% compared to RMB 183,032,000 in 2022[25] - Revenue from the mainland China market was RMB 231,273,000 in 2023, up from RMB 182,909,000 in 2022, reflecting a growth of 26%[50] - The company reported a pre-tax loss of RMB 102,920,000 for 2023, an improvement from a loss of RMB 201,249,000 in 2022, indicating a reduction of about 48.9%[61] - The basic and diluted loss per share for 2023 was RMB 2.47, compared to RMB 5.24 in 2022, reflecting a significant decrease in losses per share[77] Expenses and Cost Management - Sales and distribution expenses decreased by 8.4% to RMB 153.9 million, while R&D costs reduced by 19.4% to RMB 123.8 million[1] - Employee costs amounted to RMB 439 million, representing 35.5% of total costs, compared to RMB 519 million or 33.8% in the previous year[109] - The gross profit margin increased by 2.6 percentage points to 70.5%, with sales and distribution expenses and administrative expenses decreasing to 66.2% of revenue, down from 91.8% in 2022[112] - R&D expenses decreased from RMB 153.7 million for the year ended December 31, 2022, to RMB 123.8 million for the year ended December 31, 2023, primarily due to a reduction in the number of projects and R&D team size[158] Product Development and Innovation - Neurointerventional devices contributed 42.3% of total sales, with revenue from these products growing by 62.9% to RMB 98.2 million[2] - The company plans to launch at least five major neurointerventional devices in the next 24 months, including drug-coated balloons and stents[2] - Research and development costs amounted to RMB 123.8 million, aimed at supporting the diversification of neurointerventional devices, with at least five major products expected to launch in the next 24 months[113] - The core product, Captor® thrombectomy device, was the first in China to receive NMPA approval and has been upgraded to include various models for different vessel diameters and thrombus sizes[93] - The intracranial drug-eluting balloon catheter is in the NMPA registration phase after completing clinical trials, having received green channel approval[96] - The company has a total of 195 registered patents, including 87 invention patents, and 135 pending patent applications, indicating a strong focus on innovation[125] Market Expansion and Sales Channels - The company has obtained CE or FDA certification for several products and is expanding its sales channels in ten other countries[2] - The company has established a distribution network covering over 1,500 hospitals across all provinces in China, excluding Hong Kong, Macau, and Taiwan[101] - The company is evaluating opportunities for overseas marketing of its products, including potential registration applications in the United States[93] Financial Position and Assets - Total current assets decreased to RMB 1,005.4 million from RMB 1,132.0 million in the previous year[5] - The company’s net assets amounted to RMB 1,075.6 million, down from RMB 1,165.5 million in the previous year[5] - Cash and bank balances as of December 31, 2023, were RMB 622.2 million, a decrease of RMB 247.9 million from RMB 870.1 million as of December 31, 2022[139] - The net current assets as of December 31, 2023, were RMB 945.6 million, down from RMB 1,064.5 million as of December 31, 2022[162] Tax and Regulatory Matters - The company has been recognized as a "High-tech Enterprise" since November 2021, allowing it to enjoy a preferential tax rate of 15% for three years starting from 2021[34] - The company has been recognized as a key industry enterprise in the China (Shanghai) Free Trade Zone, benefiting from a preferential income tax rate of 15% for five years starting from 2020[58] - The company has a 200% super deduction rate for eligible R&D expenses for the fiscal year ending December 31, 2023, enhancing its tax efficiency[59] - The company has not been affected by the Pillar Two model rules introduced by the OECD, as it does not fall within the scope of these regulations[22] Corporate Governance and Compliance - The audit committee consists of three members, including two independent non-executive directors, ensuring compliance with the listing rules[200] - The company has confirmed adherence to the standard code of conduct during the reporting period[200] - The company has confirmed no non-compliance issues among senior management during the reporting period[200] - The company is committed to maintaining internal controls and risk management practices as discussed with the audit committee[200] Future Plans and Strategic Focus - The company plans to develop innovative medical devices in high-growth potential markets to establish a competitive product portfolio beyond its neuro-interventional business[152] - The company aims to enhance its manufacturing capabilities to ensure a reliable supply of products[104] - The company plans to enhance its brand recognition as a comprehensive provider of neurointerventional solutions and aims to accelerate the commercialization of its products[129] - The company has set a timeline for the completion of its core product R&D and marketing by December 31, 2025[195]

Financial Performance - Revenue for the six months ended June 30, 2023, increased by 42.9% to RMB 109,586 thousand compared to RMB 76,713 thousand in the same period last year[26] - Gross profit rose by 56.7% to RMB 79,718 thousand, with gross margin improving by 6.4 percentage points to 72.7%[26] - The company's pre-tax loss decreased by 18.4% to RMB (54,636) thousand compared to RMB (66,985) thousand in the same period last year[26] - Revenue for the first half of 2023 reached RMB 109.6 million, a year-on-year increase of 42.9%, driven by strong sales of acute ischemic stroke (AIS) thrombectomy devices, intracranial artery stenosis treatment devices, and innovative access devices[28] - Gross profit increased by RMB 28.9 million, with the gross margin rising to 72.7%, while the sales, distribution, and administrative expense ratio decreased from 96.8% to 65.2%, narrowing the pre-tax loss to RMB 54.6 million[29] - Revenue increased by 42.9% from RMB 76.7 million in the six months ended June 30, 2022, to RMB 109.6 million in the six months ended June 30, 2023, driven by growth in sales of AIS thrombectomy devices, intracranial artery stenosis treatment devices, and innovative access devices[63] - Gross profit rose to RMB 79.7 million in the six months ended June 30, 2023, from RMB 50.9 million in the same period in 2022, with gross margin improving from 66.3% to 72.7% due to increased production and improved manufacturing processes[65] - Net loss narrowed to RMB 54,338 thousand in H1 2023, a 18.7% improvement from RMB 66,815 thousand in H1 2022[185] - Basic and diluted loss per share improved to RMB 1.42 in H1 2023 from RMB 1.75 in H1 2022[185] Product Development and Pipeline - The company's core product, Captor™ thrombectomy device, has been upgraded with nine different models and is being evaluated for new indications and overseas market expansion[13] - The intracranial drug-eluting balloon (DEB) has completed clinical trials and submitted for NMPA registration, with green channel qualification obtained[15] - The company has obtained NMPA approval for its embolic coils, which are used in the treatment of hemorrhagic stroke[16] - The company's spring coil embolization assist stent has completed clinical trials and submitted for NMPA registration, also with green channel qualification[17] - The company's left atrial appendage occluder, a core product for stroke prevention, received NMPA approval and began sales in the second half of 2022[19] - The company has 21 medical devices approved by the NMPA and 2 approved by the FDA, with several advanced pipelines, including drug-eluting balloons and flow diverters, in late-stage development[29][30] - The company’s pipeline includes products for acute ischemic stroke treatment, ischemic stroke prevention, hemorrhagic stroke treatment, and interventional access, with a focus on expanding its product portfolio[31][43] Research and Development - R&D expenses for the reporting period amounted to RMB 69.9 million, focusing on advancing pipelines for stroke and pulmonary embolism treatment[29] - R&D costs increased to RMB 69.9 million in the six months ended June 30, 2023, from RMB 60.9 million in the same period in 2022, primarily due to higher raw material and consumable costs for trial production of pipeline products[67] - R&D expenses increased to RMB 69,850 thousand in H1 2023, up 14.7% from RMB 60,908 thousand in H1 2022[185] Sales and Distribution - The company has a broad sales network covering all provinces in China, excluding Hong Kong, Macau, and Taiwan[22] - The company’s sales network and hospital penetration strategy aim to enhance brand competitiveness in the Chinese neurointerventional market, leveraging the VBP and DRG/DIP payment reforms[28] - Sales and distribution expenses increased to RMB 41.7 million in the six months ended June 30, 2023, from RMB 36.0 million in the same period in 2022, driven by higher market development costs[86] Production and Operations - The company has three production bases in Shanghai and Nanjing, ensuring sufficient product supply[20] - The company’s production process optimization and cost-control measures have improved quality stability and operational efficiency[29] - As of June 30, 2023, the company’s contracted but not yet provided for plant and equipment amounted to RMB 9.11 million, compared to RMB 7.53 million at the end of 2022[40] Financial Position and Capital Expenditures - Cash and bank balances decreased to RMB 694.6 million as of June 30, 2023, from RMB 870.1 million as of December 31, 2022[70] - Capital expenditures totaled approximately RMB 47.2 million in the six months ended June 30, 2023, compared to RMB 23.8 million in the same period in 2022, mainly for the purchase of land use rights[90] - The company's net current assets stood at RMB 978.2 million as of June 30, 2023, down from RMB 1,064.5 million as of December 31, 2022[89] - The company's debt-to-equity ratio decreased to 3.9% as of June 30, 2023, from 4.3% as of December 31, 2022, with no outstanding borrowings as of June 30, 2023[88] Corporate Governance and Shareholder Information - The maximum number of H shares that can be granted under the 2021 H Share Incentive Plan is 3,000,000 H shares, representing approximately 9.5% of the company's H shares and 7.7% of the total issued share capital as of the report date[106] - As of January 1, 2023, and June 30, 2023, the total number of shares available for grant under the 2021 H Share Incentive Plan was 2,717,300 shares and 2,493,840 shares, respectively[106] - The company's global offering in 2021 raised a net amount of approximately HKD 1,014.8 million[109] - The company had 453 full-time employees as of June 30, 2023[116] - The 2021 H Share Incentive Plan allows for two types of awards: (i) three-year awards, which should be granted by December 31, 2024, and vest at the end of the third full fiscal year after grant (for up to 2,700,000 H shares), and (ii) one-year awards, which should vest by June 30 of the year following the grant year (with up to 100,000 H shares in 2022 and up to 300,000 H shares annually thereafter)[121] - The company has no significant contingent liabilities as of June 30, 2023[114] - The company faces foreign exchange risk due to bank cash denominated in USD and HKD, but currently has no foreign exchange hedging policy[115] - The 2021 H Share Incentive Plan is effective for ten years from November 1, 2021, and will remain in effect for any unvested awards granted before its expiration[120] - The company's directors and senior management's compensation policy is determined based on their responsibilities and market conditions, with discretionary and performance bonuses linked to the group's overall performance and individual performance[116] - The company's H shares were first listed on the Main Board of the Hong Kong Stock Exchange on August 20, 2021[109] - The company allocated HKD 459.7 million for the R&D, production, and marketing of its core products, with HKD 223.4 million utilized as of June 30, 2023, leaving a balance of HKD 236.3 million[129] - HKD 404.9 million was planned for the R&D and product registration of other pipeline products, with HKD 185.7 million utilized as of June 30, 2023, and a remaining balance of HKD 219.2 million[129] - HKD 48.7 million was fully utilized for enhancing R&D capabilities and expanding the product portfolio through internal research as of June 30, 2023[129] - HKD 101.5 million was allocated for working capital and general corporate purposes, fully utilized as of June 30, 2023[129] - The total funds raised from the IPO amounted to HKD 1,014.8 million, with HKD 559.3 million utilized as of June 30, 2023, and a remaining balance of HKD 455.5 million[129] - The company granted awards under the 2021 H Share Incentive Plan, with a fair value of approximately RMB 2.96 million, and 100% of the awards will vest by December 31, 2025, subject to performance conditions[150] - The company's independent auditor, Ernst & Young, reviewed the interim financial information for the six months ended June 30, 2023, in accordance with Hong Kong Standard on Review Engagements 2410[135] - The company's directors and senior management held significant equity interests, with Wang Guohui holding 8.21% of non-listed shares and 20.99% of H shares as of June 30, 2023[144] - The company did not purchase, sell, or redeem any of its listed securities during the six months ended June 30, 2023[130] - The company adopted the Standard Code as the code of conduct for directors, supervisors, and senior management regarding the trading of the company's securities[131] - The company does not recommend paying an interim dividend for the six months ended June 30, 2023 (no interim dividend was paid for the six months ended June 30, 2022)[153] - The company's Board of Directors and senior management have complied with the standard code of securities transactions during the six months ended June 30, 2023[154] - Wang Guohui serves as both the Chairman and CEO of the company, deviating from the corporate governance code, but the Board believes this structure enhances leadership and strategic planning efficiency[156] - The Audit Committee and management confirm that the interim financial results for the six months ended June 30, 2023 comply with relevant accounting standards and regulations[157] - Feng Xiangqian was appointed as the Chairman of the Nomination Committee, effective March 20, 2023[159] - Wang Guohui directly holds 1,915,690 non-listed shares and 1,915,690 H shares, with additional interests through related entities[169] - Zhang Yanxia holds 3,188,110 non-listed shares (8.21%) and 8,152,618 H shares (20.99%) through spousal interests[171] - Shanghai Zandaqian Enterprise Management Consulting Center holds 496,183 non-listed shares (1.28%) and 4,777,225 H shares (12.30%) through controlled corporation interests[171] - Ningbo Meishan Bonded Port Area Xinwei Investment Management Partnership holds 776,237 non-listed shares (2.00%) and 1,459,703 H shares (3.76%) as beneficial owner[171] - Ningbo Meishan Bonded Port Area Kaiyuan Investment Management Partnership holds 1,277,192 H shares (3.29%) as beneficial owner[171] - Shanghai Weijun Enterprise Management Consulting Partnership holds 2,800,000 H-shares, representing 7.21% of the total issued shares[174] - Chai Yanpeng holds 1,566,488 non-listed shares, representing 4.03% of the total issued shares[174] - Ningbo Tongchuang Suwei Investment Partnership holds 869,330 non-listed shares, representing 2.24% of the total issued shares[174] - SDIC Chuanghe National Emerging Industry Venture Capital Fund holds 906,220 non-listed shares, representing 2.33% of the total issued shares[174] - Temasek Life Sciences Private Limited holds 1,627,907 H-shares, representing 4.19% of the total issued shares[174] - LYFE Columbia River Limited holds 152,599 non-listed shares, representing 0.39% of the total issued shares[174] - LYFE Ohio River Limited holds 49,147 non-listed shares, representing 0.13% of the total issued shares[174] - Raritan River Limited holds 65,116 non-listed shares, representing 0.17% of the total issued shares[174] - LYFE Capital Fund III (Dragon), L.P. holds 201,746 non-listed shares, representing 0.52% of the total issued shares[174] - LYFE Capital Management Limited holds 13.64% of H-shares and 0.69% of non-listed shares[198] - LYFE Columbia River Limited directly holds 2,899,373 H-shares and 152,599 non-listed shares[199] - LYFE Ohio River Limited directly holds 933,784 H-shares and 49,147 non-listed shares[199] - Raritan River Limited directly holds 1,237,210 H-shares and 65,116 non-listed shares[199] - LYFE Capital Fund III (Dragon), L.P. directly holds 227,300 H-shares[199] Audit and Compliance - The interim financial report for 2023 has been reviewed and no material misstatements were found according to International Accounting Standard 34[183] - The company's independent auditor, Ernst & Young, reviewed the interim financial information for the six months ended June 30, 2023, in accordance with Hong Kong Standard on Review Engagements 2410[135] - The Audit Committee and management confirm that the interim financial results for the six months ended June 30, 2023 comply with relevant accounting standards and regulations[157] Strategic Plans and Market Expansion - The company plans to expand its brand as a comprehensive neurointerventional device provider, improve manufacturing capabilities, and develop innovative medical devices in high-growth potential markets[62] - Overseas revenue increased following the approval of multiple products by local regulatory authorities, supported by a broad sales network covering all provinces in mainland China, excluding Hong Kong, Macau, and Taiwan[28]