Core Viewpoint - Sutra Medical, Inc. has successfully completed the first human implantation of its Sutra Hemi-valve transcatheter mitral valve repair system, indicating a significant advancement in treating severe functional mitral regurgitation in high-risk patients [1] Company Summary - Sutra Medical, Inc. is a company in which the group holds a strategic investment, focusing on innovative medical solutions [1] - The first implantation was performed on an 83-year-old high-risk patient with severe functional mitral regurgitation at Waikato Hospital in New Zealand [1] - The patient had a successful recovery and was discharged three days post-operation, showcasing the potential effectiveness of the Sutra Hemi-valve system [1]

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。 本公司董事（「董事」）會（「董事會」）欣然公佈，最近，Sutra Medical, Inc.（「Sutra」） （本集團持有戰略投資的公司）成功完成其Sutra Hemi-valve經導管二尖瓣修復系 統第一次應用於人體（「FIM」）的臨床試驗首例植入。該手術於新西蘭懷卡托醫 院對一名患有嚴重功能性二尖瓣反流（「二尖瓣反流」）的83歲高風險患者進行， 傳統治療方案不適用於該情況。患者恢復良好，於第三天出院。 Peijia Medical Limited 沛嘉醫療有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股 份 代 號：9996） 自願公告 Sutra Hemi-valve經導管二尖瓣修復系統 第一次應用於人體的臨床試驗首例植入 本公告由沛嘉醫療有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願 刊發，以向本公司股東及潛在投資者提供有關本集團最新業務及新產品開發 進 ...

近日，工业和信息化部、国家药品监督管理局联合发布《生物医用材料创新任务揭榜挂帅（第二批）入围揭榜单位公示》通知，沛嘉医疗作为牵头申报 单位，凭借微纳米纤维复合材料项目成功入围。 | 女子、T.U.OMO/VO 、40 X 三月 、 图 +**** T . T /~ T | | 请输入关键字 | | | | | | --- | --- | --- | --- | --- | --- | --- | | 网 中华人民共和国工业和信息化部 Ministry of Industry and Information Technology of the People's Republic of China 10 组织机构 | 首页 | 互动交流 | 新闻发布 | 政务公开 | 政务服务 | ■ 阳光小信 无障碍 手机端 邮箱 RSS订阅 | | 攻关材料名称 | 揭榜团队牵头单位名称 | 推荐省(区、市) | 备注 | | --- | --- | --- | --- | | 一、高分子材料方向 | | | | | 北京 汇福康科技有限公司 | | 北京市 | | | 微纳米纤维复合材料 沛嘉医疗科技(苏州)有限公司 | ...

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 ...

Core Viewpoint - The laparoscopic surgical robot developed by Weijing Medical has officially entered mass production, marking a significant advancement in China's medical robotics industry, which has been rapidly evolving due to supportive policies and capital investments [3][8]. Group 1: Laparoscopic Surgical Robots - Laparoscopic surgical robots are intelligent medical devices designed for minimally invasive surgeries, enhancing precision, reducing tremors, and providing a 10-15 times magnified 3D view, which significantly lowers patient blood loss and recovery time [4][5]. - The core advantages of laparoscopic surgical robots include superior precision control, immersive surgical visualization, and ergonomic operation, which collectively redefine surgical standards [4][5]. - Compared to traditional open and laparoscopic surgeries, robotic systems offer higher precision, greater flexibility, improved visualization, and reduced operator fatigue, leading to better clinical outcomes for patients [7]. Group 2: Commercialization Progress - The global laparoscopic surgical robot market has been historically dominated by Intuitive Surgical's da Vinci system, which has undergone several upgrades since its FDA approval in 2000, with the latest version (dV5) showing significant technological advancements [9][10]. - The da Vinci system's business model, which combines equipment sales with high-margin consumables and services, has created a strong competitive moat, ensuring long-term revenue stability [10]. - In China, the market for laparoscopic surgical robots is experiencing rapid growth, with domestic companies successfully launching products and capturing market share previously held by foreign brands [11][12]. Group 3: Capital Dynamics - The investment landscape for laparoscopic surgical robots in China is shifting from an early-stage boom to a more rational phase, with capital increasingly favoring companies that have demonstrated successful product approvals and clinical usage [14]. - Recent financing activities indicate a slowdown in investment heat, with a focus on companies that have proven their commercialization potential and have established hospital installations [14][16].

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.