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 ...

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） 截至2024年6月30日止六個月的中期業績公告 上海心瑋醫療科技股份有限公司董事會欣然公佈本集團截至2024年6月30日止 六個月的未經審計簡明綜合中期業績（經審計委員會審閱），連同2023年同期的 比較數字。 | --- | --- | --- | --- | |------------------------|---------|----------|---------------| | | | | | | 收益 | 128,484 | 109,586 | 17.2% | | 毛利 | 82,281 | 79,718 | 3.2% | | 毛利率 | 64.0% ...

ai171280788135_SHMT AR2023 Cover V10 21.5mm_OP.pdf 1 11/4/2024 上午11:58 ...

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 ...

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） | --- | --- | --- | --- | |----------------------|---------------------|---------------------|--------------| | | | | | | | | | | | | 截至 | 截至 | | | | 2023 年 12 月 31 日 | 2022 年 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 | 232,344 | 183,032 | 26.9% | | 毛利 | 163,759 | 124,333 | 31.7% | | 毛利率 | 70.5% | 67.9% | 2.6 個百分點 | | 銷售及分銷及行政開支 | 153,882 | 167,993 | –8.4% | | 研發成本 | ...

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]

8. 股息 於各報告期末，貿易應收款項按發票日期及扣除虧損撥備的賬齡分析如下： 因應VBP政策及DRG/DIP支付方式改革量回升手術量回升及進口替代加速， 我們持續利用高效的銷售渠道提高醫院滲透率及提高醫生對我們產品的 認可度，旨在通過覆蓋香港、澳門及台灣以外的所有省份的廣泛銷售網絡 提高我們於中國神經介入市場的品牌競爭力。同時，當地藥監局批准我們 多款產品註冊後，海外收益有所提振。 我們最終未必能夠就Captor成功開發新的適應症及規格並擴大海外市場。 核心產品 — 左心耳封堵器是永久性植入非瓣膜性房顫(AF)患者左心耳開 口處的腦卒中預防器械，以防止左心耳血栓分離，引起栓塞。左心耳封堵 手術為療效確切的單次手術治療方案，尤其適用於不適合長期口服抗凝 治療且出血性併發症風險較高的患者。我們已取得NMPA批文，並於2022 年下半年開始銷售。 我們矢志成為中國神經介入醫療器械市場的領導者，並成為中國多款創 新醫療器械市場中具競爭力的國產器械公司。 銷售成本 財務成本 外匯風險 董事會不建議派付截至2023年6月30日止六個月的中期股息（截至2022年6月30 日止六個月：無）。 審計委員會與本公司管理層認為截 ...

ANNUAL REPORT 2022 ANNUAL REPORT 2022 年度報告 年度報告 目錄 公司資料 2 財務概要 4 董事長致辭 5 管理層討論及分析 7 董事、監事及高級管理層 18 企業管治報告 26 環境、社會及管治報告 46 董事會報告 73 監事會報告 93 獨立核數師報告 95 綜合損益及其他全面收益表 102 綜合財務狀況表 103 綜合權益變動表 105 綜合現金流量表 106 ...

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） 截至2022年12月31日止年度 全年業績公告 財務概要 截至2022年 截至2021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 183,032 90,089 103.2% 毛利 124,333 54,950 126.3% 毛利率 67.9% 61.0% 6.9個百分點 研發成本 153,693 76,306 101.4% ...

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 d ur LOO D 2 25 D INTERIM REPORT 中期報告 0 L ( ■] □] 0 L C 目錄 | --- | --- | |----------------------------------|-------| | | | | 公司資料 | 2 | | 財務摘要 | 4 | | 管理層討論及分析 | 5 | | 企業管治及其他資料 | 15 | | 獨立審閱報告 | 23 | | 中期簡明綜合損益及其他全面收益表 | 24 | | 中期簡明綜合財務狀況表 | 25 | | 中期簡明綜合權益變動表 | 27 | | 中期簡明綜合現金流量表 | 28 | | 中期簡明綜合財務資 ...