致：香港交易及結算所有限公司 公司名稱: 沛嘉醫療有限公司 (「本公司」)（於開曼群島註冊成立的有限公司） 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 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 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09996 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | USD | 0.0001 | USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 1,000,000,000 | USD | 0.0001 | USD | | 100,000 | 本月底法 ...

以下文章来源于RimeData 来觅数据 ，作者来觅研究院 RimeData 来觅数据 . 全面的一级市场数据平台 导读：8月16日消息，唯精医疗资助研发的腹腔镜手术机器人正式量产。据介绍，唯精医疗目前已攻克并掌握腹腔镜手术机器人结构设计、 控制体系、核心算法、智能控制、系统集成等核心技术，目前已经布局了包括三臂、四臂多孔手术机器人以及单孔手术机器人等多产品线 腔镜手术机器人系统。近年来，我国腔镜手术机器人在政策、资本等多重因素的引导下发展迅猛，多家国产企业产品相继获批上市以抢占 长期以来被外资垄断的市场。 01 腔镜手术机器人 腔镜手术机器人是一种用于微创手术的智能医疗设备，它通过机械臂、高清3D视觉系统和计算机辅助控制系统，帮助外科医生在狭小的体腔内完成高精 度、复杂的手术操作。其核心优势在于提高手术精准度、减少首部震颤，并提供放大10-15倍的立体视野，显著降低患者出血量和恢复时间。相比于传统 的腔镜手术，机器人系统具有更高灵活性和更短学习曲线，目前已广泛应用于泌尿、妇科、普外科等领域。 直觉外科通过"设备+耗材+服务"的商业模式建立了深厚的护城河，这种模式通过手术机器人设备以打开市场，随后依靠高毛利的 ...

Core Insights - The Ministry of Industry and Information Technology and the National Medical Products Administration announced the second batch of selected units for the innovative task of biomedical materials, with Suzhou securing 15 positions, representing 17.4% of the national total and 75% of Jiangsu Province's entries, highlighting Suzhou's strong innovation capabilities in the biomedical materials sector [1][2]. Group 1: Innovations in Biomedical Materials - Peijia Medical's micro-nano fiber composite material was selected, showcasing its uniqueness in the valve industry and addressing critical clinical challenges in heart valve applications [1][2]. - Peijia Medical's new polymer valve technology, which uses non-biological, inorganic materials, significantly reduces production costs and is expected to have a longer lifespan than current biological valves, potentially decreasing the need for repeat surgeries [2]. - Haiwang Medical's newly developed block polyether amide resin aims to break the reliance on imported medical polymer materials, targeting a market previously dominated by French companies, with a market size exceeding 10 billion [2]. Group 2: Support for New Material Development - Suzhou has implemented the "Guidance Directory for the First Batch of Key New Material Application Demonstration," providing recognition support and financial incentives to stimulate enterprise investment in key material research [3]. - The new materials industry has emerged as Suzhou's third trillion-level industrial cluster, following electronic information and equipment manufacturing [3].

Investment Rating - The report maintains a "Buy" rating for the company and raises the target price to HKD 9.6, indicating a potential upside of 16% from the current price of HKD 8.31 [2][3]. Core Insights - The company's performance in the first half of 2025 (1H25) is stable, with a revenue of RMB 350 million, representing a 17% year-over-year increase. The gross margin is reported at 70.1%, a decrease of 2.6 percentage points year-over-year. The net loss attributable to shareholders is RMB 69.88 million, narrowing by 2% compared to the same period last year [2][3]. - The heart valve business is evolving from a focus on aortic stenosis (AS) to multiple indications including aortic regurgitation (AR) and transcatheter edge-to-edge repair (TEER). The company has three core valve products nearing commercialization, expected to be approved in 2026, which will contribute to revenue growth starting in 2027 [2][3][12]. - The neurointerventional segment has experienced a slowdown in revenue growth due to the impact of centralized procurement, but is expected to achieve over 20% year-over-year growth as procurement volumes stabilize [2][3]. Financial Performance Summary - For 1H25, the company reported revenues of RMB 350 million, with a gross profit margin of 70.1%. The net loss attributable to shareholders was RMB 69.88 million, showing improvement from the previous year [2][3]. - Revenue projections for the upcoming years are as follows: RMB 748 million in 2025, RMB 939 million in 2026, and RMB 924 million in 2027, with year-over-year growth rates of 21.5%, 25.6%, and -1.6% respectively [3][9]. - The company anticipates a gradual increase in revenue from its core products, with significant contributions expected from new product launches in 2027 [2][3][12]. Product Pipeline Overview - The company has a robust pipeline with several products in various stages of development. Key products include TaurusTrio (AR TAVR), TaurusNXT (third-generation AS TAVR), and GeminiOne (TEER), all expected to receive regulatory approval in 2026 [2][12]. - The company is also preparing for international market entries, with submissions for FDA and CE certifications for its products underway [2][12][13].

Core Viewpoint - CICC maintains the profit forecast for Peijia Medical-B (09996) for 2025/26 and keeps the outperform rating unchanged, raising the target price by 25% to HKD 10, indicating an 18% upside potential from the current price [1] Group 1: TAVR Business Performance - TAVR (Transcatheter Aortic Valve Replacement) revenue for 1H25 reached RMB 162 million, a year-on-year increase of 25%, with terminal implant volume exceeding 2,050 units, up 19.8% [2] - The company achieved its first commercial profitability in the valve segment with RMB 29 million, while the R&D expense ratio decreased by 16.7 percentage points to 33.5% [2] - Three important in-development products, including regurgitant TAVR, long-lasting TAVR, and mitral valve clip, have completed registration clinical follow-ups, with expected approvals between the end of 2025 and mid-2026 [2] Group 2: Neurointervention Business Outlook - Neurointervention revenue for 1H25 was RMB 192 million, a year-on-year increase of 12%, with segment profit reaching RMB 41 million, up 42.4%, and a net profit margin of 21% [3] - The DCwire micro-guidewire has successfully gained traction domestically, with revenue increasing by 140%, and is expected to receive US 510(k) approval by the end of 2025 [3] - The company remains optimistic about the second half of 2025, anticipating a sequential acceleration in growth, with a projected annual revenue growth of 20-30% for the neurointervention segment [3]

Core Viewpoint - 中金 maintains its earnings forecast for Peijia Medical-B (09996) for 2025/26 and keeps its outperform rating unchanged, citing a recovery in the Hong Kong pharmaceutical sector and the expected approval of multiple new products by mid-2026 [1] Group 1: TAVR Business Performance - In 1H25, TAVR (transcatheter aortic valve replacement) revenue reached 162 million HKD, a year-on-year increase of 25%, with over 2,050 units implanted, up 19.8% [2] - The company achieved its first commercial profitability in the valve segment with a profit of 29 million HKD, and the R&D expense ratio decreased by 16.7 percentage points to 33.5% [2] - The company anticipates that three important products, including regurgitant TAVR, long-acting TAVR, and mitral valve clips, will be approved between the end of 2025 and mid-2026, potentially reshaping the competitive landscape in China [2] Group 2: Neurointervention Business Outlook - In 1H25, neurointervention revenue was 192 million HKD, a year-on-year increase of 12%, with segment profit reaching 41 million HKD, up 42.4%, resulting in a net profit margin of 21% [3] - The domestic launch of DCwire micro-guidewires saw a revenue increase of 140%, and the company expects to obtain US 510(k) approval for this product by the end of 2025 [3] - The company remains optimistic about accelerating growth in the neurointervention segment in 2H25, projecting a year-on-year revenue growth of 20-30% for the entire year of 2025 [3]

Summary of Peijia Medical Conference Call Company Overview - **Company**: Peijia Medical - **Date**: August 25, 2025 Key Points Industry and Business Performance - **Valve Business Growth**: Peijia Medical's valve business revenue increased by 24% in the first half of 2025, covering over 700 hospitals with a nearly 20% increase in surgical volume, leading to a continuous market share increase [2][3] - **Neurointervention Business Growth**: The neurointervention segment saw a revenue growth of 12.2%, with effective cost control and a pre-tax profit margin exceeding 20% [2][11] - **Overall Revenue Growth**: The company achieved a 17.3% revenue growth in the first half of 2025, with expectations of maintaining over 20% growth for the full year [3][18] Financial Performance - **Cost Control**: The company effectively reduced its operating expenses, with a significant decrease in sales expense ratio to over 60% [2][4] - **Positive Cash Flow**: Peijia Medical reported positive operating cash flow for the first half of 2025, marking a significant improvement in financial health [8] - **Profitability**: The neurointervention department's pre-tax profit exceeded 40 million yuan, indicating a strong profitability trend [8][23] Product Development and Market Feedback - **Product Pipeline**: Multiple products are receiving positive market feedback, including TORS Max 2.5 and various neurointervention devices. Key products like TORS Trio and Gemini One are progressing as planned for registration [6][19] - **Regulatory Approvals**: The company anticipates approvals for several key products by the end of 2025 or early 2026, which will enhance market competitiveness [5][19] Market Dynamics and Competitive Landscape - **Impact of Medical Insurance Policies**: 24 provinces have implemented varying degrees of medical insurance reimbursement, significantly boosting surgical volumes in regions like Henan and Beijing [13] - **Response to Procurement Policies**: The company is actively adapting to procurement policies, aiming to maintain market share and improve profitability through diversified product lines [37][38] Future Outlook - **Growth Projections**: Peijia Medical expects its valve business market share to reach 25%-30% and neurointervention revenue growth to be between 20%-30% for 2025 [18] - **Long-term Strategy**: The management is focused on innovation and internationalization, with plans to achieve profitability by 2026 while maintaining a commitment to R&D [47] Additional Insights - **Market Potential**: The company sees significant potential in the heart valve market, particularly with the upcoming launch of innovative products that outperform competitors [33] - **International Expansion**: Peijia Medical is exploring partnerships for international market entry, particularly in the U.S., where the regulatory landscape is challenging [26][41] Conclusion Peijia Medical is positioned for robust growth in the medical device industry, particularly in the valve and neurointervention segments, supported by effective cost management, a strong product pipeline, and favorable market dynamics. The company's strategic focus on innovation and international expansion is expected to drive long-term success.

Core Insights - The company reported a total revenue of RMB 353 million for the six months ending June 30, 2025, representing a 17.3% increase compared to the same period in 2024 [1] - The revenue structure remained stable, with TAVR-related products contributing 45.7% and neurointerventional products contributing 54.3% [1] Financial Summary - TAVR-related product sales increased by 24.0% year-on-year to RMB 162 million, driven by market share growth and a shift towards high-end products [2] - Neurointerventional product sales grew by 12.2% year-on-year to RMB 192 million, supported by deeper market penetration of existing products and the successful launch of the YonFlow stent [2] - The company achieved a significant reduction in operating losses, narrowing by 19.4% to RMB 68.32 million, with core business net losses decreasing by 52.4% to RMB 30.72 million [2] Cost Control and Efficiency - The TAVR business segment achieved its first commercial profit of RMB 29.09 million, with sales and distribution expenses decreasing by 8.3% to RMB 100 million [4] - Research and development expenses for the TAVR segment decreased by 17.2% to RMB 54.2 million, primarily due to the completion of major clinical trials [4] - The management expenses for the TAVR segment increased slightly by 2.8% to RMB 50.98 million, mainly due to depreciation costs of a new headquarters [4] Innovation and Product Development - The company successfully completed one-year clinical follow-ups for three in-development products, showcasing excellent safety and efficacy results [5] - The TAVR product line has expanded to cover over 720 medical institutions in China, with total implantations exceeding 2,050 units, reflecting an 18.8% year-on-year growth [3] - The neurointerventional business segment has entered a mature development phase, with strong performance from the DCwire microguidewire and the newly launched YonFlow stent [10] Market Expansion and Competitive Position - The company has prepared for the market launch of new products, particularly the AR valve TaurusTrio, with plans for commercial synergy to enhance its platform advantages [5] - The neurointerventional segment's profit has continued to grow, with a 42.4% increase to RMB 40.9 million, supported by effective cost control and management strategies [12] - The company aims to maintain its market leadership through innovation-driven strategies and operational efficiency improvements [12]

Core Viewpoint - Peijia Medical Limited reported a total revenue of RMB 353 million for the six months ending June 30, 2025, representing a 17.3% increase compared to the same period in 2024, with stable revenue contributions from TAVR and neurointerventional products [1] Financial Summary - The sales revenue from TAVR-related products increased by 24.0% to RMB 162 million, driven by an enhanced market share in China's TAVR market and a shift towards newly launched high-end products [2] - Neurointerventional products saw a 12.2% increase in sales revenue to RMB 192 million, supported by deeper market penetration of existing products and the successful launch of the YonFlow® stent [2] - The overall operating loss narrowed by 19.4% to RMB 68.32 million, with core business net loss significantly reduced by 52.4% to RMB 30.72 million [2] Cost Control and Efficiency - The TAVR business achieved commercial profitability for the first time, generating a profit of RMB 29.09 million, with sales and distribution expenses decreasing by 8.3% to RMB 100 million [4] - R&D expenses for the TAVR division decreased by 17.2% to RMB 54.2 million, primarily due to the completion of major clinical trials [4] - The management expenses slightly increased by 2.8% to RMB 50.98 million, mainly due to depreciation costs of a new headquarters [4] Innovation and Product Development - Three key in-development products are entering the registration application phase, including the TaurusTrio™ TAVR system, TaurusNXT® TAVR system, and GeminiOne® TEER system, with expected approvals between late 2025 and mid-2026 [5] - The DCwire® microguidewire and YonFlow® stent are highlighted as strong performers in the neurointerventional segment, with the former's sales revenue increasing nearly 140% [9] - The company is preparing for the market launch of the TaurusTrio™, which is expected to significantly enhance its competitive position in the AR valve market [5] Operational Efficiency - The neurointerventional division's profit increased by 42.4% to RMB 40.9 million, supported by effective cost control and operational efficiency measures [11] - The company has successfully integrated lean production and supply chain management to mitigate revenue pressures from centralized procurement [11] - The overall strategy emphasizes innovation-driven growth, operational efficiency, and maintaining market leadership in cardiovascular disease treatments [11]

Group 1 - The company reported a revenue of approximately 353 million yuan for the first half of 2025, representing a year-on-year growth of 17.3% [1] - Gross profit reached 248 million yuan, with a year-on-year increase of 13.14% [1] - Research and development expenses were about 116 million yuan, showing a year-on-year growth of 15.1% [1] Group 2 - The sustainable revenue growth is primarily attributed to strong sales growth in transcatheter valve therapy and neurointervention businesses [1] - Sales revenue from TAVR-related products increased by 24.0% to 162 million yuan, driven by market share gains in China's transcatheter aortic valve replacement market and a shift towards newly launched high-end products [1] - The total number of implants exceeded 2,050 units during the reporting period, reflecting a year-on-year growth of approximately 18.8%, surpassing market growth [1] Group 3 - Sales revenue from neurointervention products rose by 12.2% to 192 million yuan, driven by deeper market penetration of existing products and the successful launch of the newly approved YonFlow blood flow-directed mesh stent [1] - The DCwire microcatheter, launched commercially in 2024, significantly expanded market share with a revenue growth of nearly 140% [2] - The YonFlow blood flow-directed mesh stent received regulatory approval in April 2025 and achieved its first commercial implant by June 2025, with procurement completed in over 20 provinces [2]