全球神经介入领域的聚光灯终于投向中国舞台。 近期，东方脑血管病会议（OCIN 2025）与世界神经介入大会（WLNC）首次联合办会，搭建起东西方医学交融的顶级平台。 会议上，心玮医疗携国产首款颅内动脉瘤栓塞辅助支架"长城"、首款涂层密网支架"如意"及革命性取栓技术"CATCH级联"重磅亮相，以"中国智造"硬实力赢 得海内外同行的高度肯定。 从学术研讨到手术直播，从产品发布到跨国对话，心玮医疗以创新技术诠释了"中国方案"的临床价值与国际竞争力。 多个"国产首款"夯实领军地位，硬核创新构建技术护城河 不难看出，在实现进口替代向国际竞标进阶的过程中，心玮医疗通过底层技术突破、材料工艺革新与临床术式升级的三维创新路径，形成了具有战略纵深的 技术壁垒。 首先，长城支架作为国产首款颅内动脉瘤栓塞辅助支架，上市不仅填补了国内技术空白，更以突破性创新实现了国产神经介入器械的跨越式发展。 从临床应用角度来看，长城支架30/40双系列分别覆盖1.5-3.0mm和2.5-5.0mm血管范围，同时新增60mm长度规格有效应对长段夹层病变，构建出完整的解决 方案矩阵。目前，其通过小口径导管实现精准释放的技术指标已达到国际领先水平。 而 ...

中证智能财讯 心玮医疗-B（06609）4月23日披露2024年度报告。报告期内，公司实现营业总收入3.01亿元，同比增长16.46%；归母净利润亏损1362.2万元， 上年同期亏损9401.2万元；经营活动产生的现金流量净额为-323.4万元，上年同期为-8840.6万元；据报告显示，心玮医疗-B基本每股收益为-0.36元，加权平 均净资产收益率为-1.26%。 以4月23日收盘价计算，心玮医疗-B目前市净率（TTM）约0.95倍，市销率（TTM）约3.62倍。 公司是从事创新型神经介入医疗器械研发的中国公司。该公司产品组合包括神经介入及心脏医疗器械，其主要产品为Captor取栓器械(Captor)及左心耳封堵 器。该公司产品组合从治疗及预防缺血性脑卒中(包括急性缺血性脑卒中及颅内动脉狭窄)到出血性脑卒中的治疗。该公司其他产品包括封堵球囊导管、 ExtraFlexTM远端通路导管及SupSelekTM微导管。该公司主要在国内市场开展业务。 市净率(LF)历史分位(%) 001 190 80 75.93 70 68:17 64.23 63 33 60 50 50×51 40 3486 30 31661 20 ...

年度報告 Annual Report 2024 2 上海心瑋醫療科技股份有限公司 公司資料 董事會 ANNUAL REPO R T 2024 年度報告 目錄 | 2 | 公司資料 | | --- | --- | | 4 | 財務概要 | | 5 | 董事長致辭 | | 7 | 管理層討論及分析 | | 17 | 董事、監事及高級管理層 | | 27 | 企業管治報告 | | 45 | 環境、社會及管治報告 | | 87 | 董事會報告 | | 106 | 監事會報告 | | 109 | 獨立核數師報告 | | 115 | 綜合損益及其他全面收益表 | | 116 | 綜合財務狀況表 | | 118 | 綜合權益變動表 | | 119 | 綜合現金流量表 | | 121 | 財務報表附註 | | 188 | 釋義 | 執行董事 王國輝先生 （董事長、首席執行官） 張坤女士 韋家威先生 （副總經理） 非執行董事 丁魁先生 陳少雄先生 陳剛先生 獨立非執行董事 郭少牧先生 馮向前先生 龔平先生 審計委員會 龔平先生 （主席） 馮向前先生 丁魁先生 薪酬委員會 郭少牧先生 （主席） 龔平先生 王國輝先生 提名委員會 ...

智通财经APP讯，心玮医疗-B(06609)发布截至2024年12月31日止年度业绩，该集团取得收益人民币2.78 亿元(单位下同)，同比增加19.6%;研发成本5894万元，同比减少52.4%;母公司拥有人应占亏损1362.2万 元，同比减少85.51%;每股亏损0.36元。 于2024财政年度，本公司取得收入2.78亿元，同比增长19.6%。尽管受批量采购价格影响及市场竞争导 致毛利率下降，本公司税前亏损大幅收窄至1200万元，同比减少88.3%。随着业务规模扩张及成本控制 与增效措施成效显现，销售及分销开支与行政开支的费用率降至49.6%(2023年： 66.2%)。 年内，为适应快速变化的市场环境，本公司持续推动神经介入业务升级，聚焦差异化治疗器械。急性缺 血性脑卒中治疗器械(如颅内取栓支架、远端通路导管、颅内血栓抽吸导管及支撑导管等)销量增长 45.5%。出血性脑卒中治疗器械及其他介入通路器械收入分别增长104.2%及109.4%。 2024年，本公司研发成本为5890万元，以支持多元化神经介入治疗器械在研产品。截至本公告日期，用 于治疗出血性脑卒中的颅内动脉瘤栓塞辅助支架(NMPA创新器械资质)及 ...

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，概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 Shanghai HeartCare Medical Technology 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） 截至2024年12月31日止年度 全年業績公告 | 財務概要 | | | | | --- | --- | --- | --- | | | 截至 | 截至 | | | | 2024年 | 2023年 | | | | 12月31日 | 12月31日 | | | | 止年度 | 止年度 | 同比變動 | | | 人民幣千元 | 人民幣千元 | | | 收益 | 277,899 | 232,344 | 19.6% | | 毛利 | 181,716 | 163,759 | 11.0% | | 毛利率 | 65.4% | 70.5% | –5.1個百分點 | | 銷售及分銷及行政 ...

上海心瑋醫療科技股份有限公司 Shanghai HeartCare Medical Technology Corporation Limited (A joint stock company incorporated in the People's Republic of China with limited liability) (於中華人民共和國註冊成立的股份有限公司) Stock Code 股份代號：6609 2024 INTERIM REPORT 中 期 報 告 0 目錄 | --- | --- | --- | |----------------------------------|-------|-------| | | | | | 公司資料 | 2 | | | 財務摘要 | 4 | | | 管理層討論與分析 | 5 | | | 企業管治及其他資料 | 19 | | | 獨立審閱報告 | 27 | | | 中期簡明綜合損益及其他全面收益表 | 28 | | | 中期簡明綜合財務狀況表 | 29 | | | 中期簡明綜合權益變動表 | 31 | | | 中期簡明綜合現金流量表 | 32 | | | 中 ...

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]