中期報告 INTERIM REPORT 2025 INTERI M REPO R T 2025 中期報告 目錄 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 | 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 | 23 | | 獨立審閱報告 | 32 | | 中期簡明綜合損益及其他全面收益表 | 33 | | 中期簡明綜合財務狀況表 | 34 | | 中期簡明綜合權益變動表 | 36 | | 中期簡明綜合現金流量表 | 37 | | 中期簡明綜合財務資料附註 | 39 | | 釋義 | 50 | 2 上海心瑋醫療科技股份有限公司 公司資料 董事會 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 馮向前先生 （主席） 郭少牧先生 張坤女士 （於2025年3月27日任職） 王國輝先生 （於2025年3月27日不再為成員） 戰略委 ...

Key Points Summary Market Performance - The Hang Seng Index closed at 26,544, down 1.35% for the day but up 32.33% year-to-date [1] - The Hang Seng Tech Index closed at 6,271, down 0.99% for the day and up 40.36% year-to-date [1] - The CSI 300 Index closed at 4,498, down 1.16% for the day and up 14.31% year-to-date [1] - The Dow Jones Index closed at 46,142, up 0.27% for the day and up 8.46% year-to-date [1] Currency and Commodity Trends - The Renminbi Index is at 96.600, up 0.58% over the last month but down 2.47% over the last six months [2] - Brent crude oil is priced at $67.76 per barrel, up 2.85% over the last month but down 0.51% over the last six months [2] - Gold is priced at $3,668.34 per ounce, up 10.05% over the last month and up 20.86% over the last six months [2] Company News - Alibaba's AliExpress has received conditional approval to form a joint venture with South Korea's Shinsegae [5][14] - Huawei plans to launch its self-developed Ascend 950PR chip in the first quarter of next year [5][16] - The China Securities Regulatory Commission reported that the shareholding of Shankai Holdings is highly concentrated, with 24% held by 20 shareholders [5][17][18] Economic Indicators - Initial jobless claims in the U.S. fell to 231,000, below expectations, indicating a strengthening labor market [5][11] - The Bank of England's interest rate remains at 4.00%, unchanged from the previous period [5][12][13] - Reports indicate that China has terminated its antitrust investigation into Android ahead of U.S.-China talks [5][15] Stock Market Movements - The Hong Kong stock market experienced significant volatility, with the Hang Seng Index reaching a four-year high before closing lower [5][6] - Semiconductor-related stocks saw gains, with Hua Hong Semiconductor rising nearly 9% [5][6] - The A-share market showed weakness, with major indices closing down over 1% [6] Upcoming Economic Data - Key economic data releases include the Eurozone consumer confidence index and U.S. manufacturing PMI [5][29]

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） 有關董事於禁售期進行證券交易的公告 本公告由上海心瑋醫療科技股份有限公司（「本公司」）根據香港聯合交易所有 限公司證券上市規則（「上市規則」）附錄C3第D.15段刊發。 本公司董事（「董事」）會（「董事會」）已獲執行董事張坤女士（「張女士」）告知， 寧波同創速維投資合夥企業（有限合夥）（「同創速維」，由柴燕鵬先生（張女士 的配偶）作為普通合夥人控制的有限合夥企業，且張女士被視為於同創速維擁 有權益的相同數量股份中擁有權益）於2025年7月30日至2025年8月22日期間進 行場內交易，出售本公司合共99,650股H股（「H股」），代價為每股H股52.0港元至 65.2港元（「該轉讓」），惟於該轉讓前並無根據上市規則附錄C3第B.8段的規定事 先告知本公司。由於該轉讓，張女士被視為擁有的持股權益由約4.42%減少至 於2025年8月22 ...

Core Viewpoint - The company reported significant growth in its mid-year performance, with a notable increase in revenue and a return to profitability, driven by product launches and an integrated operational model [1] Financial Performance - The company's revenue for the first half reached 186 million yuan, representing a year-on-year growth of 44.4% [1] - Shareholder net profit was 50.9 million yuan, marking a turnaround from previous losses and successfully crossing the breakeven point [1] Product Development and Market Strategy - The company has launched hemorrhagic products that are contributing quantitatively, while continuously iterating its ischemic product matrix [1] - An integrated operational model has been established, enhancing the company's ability to transition from structural groundwork to commercial realization [1] - Currently, the company has 32 medical device products approved by NMPA, three products approved by FDA, and one product with CE marking, covering a wide range of treatments for acute ischemic stroke, neurovascular stenosis, and hemorrhagic stroke [1]

Core Viewpoint - Heartway Medical-B (06609) has shown significant growth in its mid-year performance, with a notable increase in revenue and a return to profitability, indicating a strong operational turnaround [1] Financial Performance - The company reported a revenue of 186 million yuan for the first half of the year, representing a year-on-year growth of 44.4% [1] - Shareholder net profit reached 50.9 million yuan, marking a successful turnaround from previous losses and crossing the breakeven point [1] Product Development and Market Strategy - Heartway Medical has enhanced its integrated research, production, and sales model, which is crucial for transitioning from structural groundwork to commercial realization [1] - The company has received NMPA approval for 32 medical device products, with three products approved by the FDA and one product obtaining CE marking, showcasing a broad product pipeline [1] - The product line includes treatments for acute ischemic stroke, neurovascular stenosis, prevention of ischemic stroke, treatment of hemorrhagic stroke, and interventional pathways, indicating a comprehensive approach to addressing various medical needs [1] Market Reaction - Following the announcement of its mid-year results, Heartway Medical's stock price increased by nearly 7%, reflecting positive investor sentiment and confidence in the company's growth trajectory [1]

Core Viewpoint - The domestic medical device industry has experienced a bifurcated landscape in the first half of the year, with overall revenue declining while innovative companies like Xinwei Medical have shown significant growth and profitability improvements [1][14]. Group 1: Industry Overview - The medical device sector's overall revenue in Q2 2025 declined by 4.77% year-on-year, with net profit dropping by 23.71% [1]. - Despite the industry's challenges, the medical device sector has seen a market increase of over 20% year-to-date, indicating investor confidence in innovative medical devices [1]. Group 2: Company Performance - Xinwei Medical reported a revenue of 186 million yuan in the first half of 2025, marking a 44.4% year-on-year increase, and achieved a net profit of 50.9 million yuan, successfully turning a profit [4][14]. - The company has demonstrated strong internal growth capabilities, with a 60% increase in the overall implantation volume of its ischemic products and a 563% increase in revenue from hemorrhagic products [5][6]. Group 3: Product Development and Innovation - Xinwei Medical has launched several key products, including the "Great Wall" stent for aneurysm embolization, which has rapidly expanded its market presence [6]. - The company has a robust pipeline with 32 products approved by NMPA and several others in various stages of clinical trials and registration [9][11]. Group 4: Operational Efficiency - Xinwei Medical has improved its operational efficiency, reducing sales and management expenses as a percentage of total revenue from 44.8% to 37.0% [8]. - The company achieved a significant increase in operating cash flow, reaching 5.4 million yuan, a year-on-year growth of over 80% [7]. Group 5: Market Expansion - Xinwei Medical has established a wide distribution network covering over 2,500 hospitals across China and is actively pursuing international market opportunities [12][13]. - The global peripheral intervention market is estimated at $10 billion, with the Chinese market accounting for approximately 12%-15% of this total [12].

Core Viewpoint - The domestic medical device industry is experiencing a bifurcated landscape, with revenue and profit declines in the sector due to factors like volume-based procurement and DRG cost control, while innovative companies like Xinwei Medical are showing strong growth and profitability, indicating market confidence in long-term value [1][14]. Industry Overview - The medical device sector saw a 4.77% year-on-year decline in overall revenue and a 23.71% drop in net profit attributable to shareholders in Q2 2025 [1]. - Despite the challenges, the medical device sector has shown a more than 20% increase in the secondary market, reflecting optimism for innovative medical devices [1]. Company Performance - Xinwei Medical reported a 44.4% year-on-year increase in revenue for the first half of 2025, reaching 186 million yuan, and achieved a net profit of 50.9 million yuan, marking a turnaround from losses [4][13]. - The company’s strong performance is attributed to its innovative product offerings and effective operational strategies, which have led to a significant improvement in its financial health [4][7]. Product Development - Xinwei Medical has successfully launched several key products, including the Captor® thrombectomy stent and a comprehensive treatment solution for intracranial aneurysms, contributing to a 563% increase in revenue from hemorrhagic products [5][6]. - The company has a robust pipeline with 32 products approved by NMPA and several others in various stages of clinical trials and registration [9][11]. Operational Efficiency - Xinwei Medical has improved its operational efficiency, with a significant reduction in sales and management expenses from 44.8% to 37.0% of total revenue, and a 35.1% decrease in R&D spending [8]. - The company achieved a gross profit of 127 million yuan, a 53.9% increase year-on-year, with a gross margin of 68.2% [8]. Market Expansion - Xinwei Medical is expanding its market presence, with over 1,400 hospitals actively implanting its ischemic products, a 24% increase year-on-year [12]. - The company is also pursuing international markets, with products registered in 15 countries and ongoing registration efforts in 21 additional regions [13]. Strategic Outlook - The company is positioned for growth through a combination of innovative R&D, integrated operations, and international expansion, aiming to become a leading player in the global medical device market [14].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 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有限責任公司) 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06609 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 31,565,804 | RMB | | 1 RMB | | 31,565,804 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 31,565,804 | RMB | | 1 RMB | | 31,565,804 | | 2. 股份分類 ...

Core Viewpoint - The company has successfully transitioned to a profitable phase in 2024, showcasing strong commercialization capabilities and resilience in profitability through differentiated product layout, efficient cost control, and a global strategic vision [1][2]. Financial Performance - In the first half of the year, the company achieved revenue of 186 million RMB, a year-on-year increase of 44.4%, driven by the collaborative performance of three major business lines [3]. - The net profit reached 50.94 million RMB, reversing the loss from the same period last year, with operating cash flow rising to 53.6 million RMB, indicating a sustainable self-sustaining development phase [4]. - The gross margin improved by 4 percentage points to 68.2%, reflecting enhanced production process maturity and cost optimization from scale effects [4]. - The sales and management expense ratio decreased from 44.8% to 37%, marking a transition from high investment in market expansion to a new phase of efficiency improvement [4]. Research and Development - The company focused R&D resources on core pipelines, resulting in a 35.1% decrease in R&D expenses to 20.62 million RMB, while accelerating the approval and market entry of key products [5][10]. - The complete commercialization of core product matrices, including devices for hemorrhagic stroke treatment, has established a competitive barrier against imported brands [11]. Global Expansion - The company has accelerated its internationalization process, obtaining CE or FDA certifications for several products and registering approximately 100 products in 21 countries [16]. - The global strategy aligns with the industry's growth window, as the demand for medical infrastructure in emerging markets and the cost-performance advantage of Chinese devices create a favorable environment for expansion [18]. Market Dynamics - The continuous improvement in the company's fundamentals resonates with positive signals from the capital market, reflecting a reconstruction opportunity in the innovative medical device industry [20]. - The recent recovery in the Hong Kong pharmaceutical sector, with the Hang Seng Healthcare Index rising over 100% this year, indicates a consensus on the industry's turning point [20][23]. - The combination of accelerated approvals and optimized payment policies is expected to benefit companies like the company that possess both innovative strength and profitability resilience [23]. Valuation Potential - Despite a stock price increase of over 300% in the past year, the company's valuation remains at historical low levels, suggesting that its growth potential is not fully reflected in the current stock price [24]. - The company is entering a critical phase of value reassessment, supported by comprehensive financial improvements, a dense pipeline of innovations, and steady progress in global expansion [24].

Core Viewpoint - Company achieved profitability in the first half of the year with a net profit of 50.94 million yuan, entering a phase of scaled profitability [2] - The company plans to initiate clinical trials for its intravascular brain-machine interface by the end of next year and will conduct a share buyback of 80 million HKD to demonstrate confidence in future prospects [2] Financial Performance - The company reported sales revenue of nearly 200 million yuan, with a growth rate exceeding 40%, and an overall gross margin returning to nearly 70% [2] - Sales and management expense ratio decreased by 8 percentage points to 37% [2] - The company forecasts a profit level of approximately 70 to 80 million yuan for the full year of 2025, aiming for a compound annual growth rate of 35% in revenue and over 50% in profit growth in the coming years [2] Product Development and Market Expansion - The company has three main product lines: ischemic stroke, hemorrhagic stroke, and access devices, all showing strong performance this year [2] - In the hemorrhagic stroke sector, the company has rapidly expanded hospital partnerships, with nearly 200 new collaborations, aiming for over 400 to 500 hospital approvals by year-end [2] - The launch of the first domestic coated flow-directed stent positions the company as the only entity with a complete aneurysm treatment solution in China [2] Ischemic Stroke Sector - The company is focusing on promoting aspiration catheter products and related technologies, with a significant increase in active implanting hospitals and a 60% year-on-year growth in implant volume [3] - The projected market size for product terminal implantation is expected to approach 700 million yuan, with a conservative market share estimate of 10% to 12% [3] - New products, including carotid stents and intracranial drug-eluting stents, are in the registration process, with significant market potential anticipated [3] Interventional Access Products - Sales in this segment grew by 28% in the first half of 2025, with a market share exceeding 20% in the vascular closure field [3] - The company completed its first business development project in collaboration with Matrix to launch a new generation of occluders, which will further expand market share [3] International Expansion - The company's overseas business has reached over 30 countries and regions, with plans to expand to more than 50 by 2026 [3] - Expected overseas sales for this year are around 2 million USD, with growth rates projected between 50% and 100% in the coming years [3] Policy Environment - The company expressed optimism regarding healthcare policies, believing that innovative devices will benefit from diverse payment methods and that their products will be supported by commercial insurance [5] - The company anticipates that its innovative products, such as intracranial drug-eluting stents and brain-machine interfaces, will gain from favorable policy changes [5] Brain-Machine Interface Development - The company is set to begin formal clinical trials for its interventional brain-machine interface by the end of next year, utilizing a minimally invasive approach [6] - The brain-machine interface product, which uses stent electrodes, has shown high signal stability and clarity, with advantages over traditional methods [6] - The project has been in collaboration with Nankai University since 2021, with multiple animal experiments completed and theoretical validation concluded [6]