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。 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） 自願性公告 截至2025年12月31日止年度的未經審核營運數據 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產品開發進 展的最新資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈本集團截至2025年12月31日止年度 （「報告期間」）的若干未經審核營運數據及比較數據載列如下。 1月1日至12月31日期間 | 2025年 | 2024年 | 變動 | | --- | --- | --- | | 人民幣百萬元 | 人民幣百萬元 | % | – 1 – 神經介入所有三大產品線均錄得穩健的收入增長，反映其各自核心產品的強 勁表現。主要驅動因素概述如下： 於報告期間，本 ...

格隆汇2月4日丨三诺生物(300298.SZ)在互动平台表示，公司目前自研的生物传感技术主要应用于糖尿 病及相关慢性疾病的监测及管理，暂未涉及神经介入或脑机接口领域，也未开展专门针对神经生化监测 的临床前研究。 ...

Core Viewpoint - Sanofi Bio (300298.SZ) is currently focused on self-developed biosensing technology primarily for monitoring and managing diabetes and related chronic diseases, with no involvement in neurointervention or brain-computer interface fields, nor has it conducted preclinical research specifically for neurobiochemical monitoring [1] Group 1 - The company is engaged in the development of biosensing technology [1] - The primary application of this technology is in diabetes and related chronic disease management [1] - There is no current involvement in neurointervention or brain-computer interface sectors [1]

Core Viewpoint - The profitability of Xinwei Medical is becoming increasingly clear, with a significant growth forecast for 2025, marking its entry into the profit zone, alongside the acceptance of its innovative self-expanding intracranial drug-eluting stent application by the National Medical Products Administration [1][4]. Financial Performance - Xinwei Medical's 2025 revenue is projected to be between 400 million to 410 million yuan, representing an approximate 44% increase from 278 million yuan in 2024 [6]. - The company expects a pre-tax profit of 80 million yuan, a substantial turnaround from a pre-tax net loss of 12 million yuan in 2024, indicating an increase of nearly 800% [6]. Product Development and Market Position - The growth is primarily driven by the collaborative expansion of the entire product line, particularly in the ischemic stroke sector, where new products and technologies have led to a steady increase in market share [7]. - The sales volume of large-caliber aspiration catheters has seen a 60% year-on-year increase in the first half of 2025, with expectations of over 200% growth for the year [8]. - The "Great Wall" intracranial stent has achieved rapid commercial sales, covering 200 new cooperative hospitals in the first half of the year, significantly boosting the sales of related products [8]. Cost Management and Operational Efficiency - Xinwei Medical's overall gross margin rose to nearly 70% in the first half of 2025, while the sales and management expense ratio decreased by 8 percentage points to 37%, showcasing effective cost control [9]. - The financial characteristics of revenue growth, profit increase, and cost reduction indicate a shift from reliance on financing cash flow to a self-sustaining growth model [9]. Innovation and Long-term Strategy - The acceptance of the self-expanding intracranial drug-eluting stent application highlights the company's leading position in innovation, addressing critical treatment needs in the market [12]. - Xinwei Medical has developed a comprehensive product pipeline for stroke treatment and prevention, including devices for thrombectomy, aneurysm, and stenosis, with several products receiving "priority review" status [12]. - The company is also exploring advanced fields such as the interventional brain-machine interface project, which is expected to begin clinical trials by the end of 2026, potentially expanding its growth horizons [12]. Conclusion - Xinwei Medical's solid profitability, comprehensive product pipeline, leading innovation capabilities, and clear ecological layout constitute its core competitive advantages, gradually gaining market recognition for its investment value [14]. - Short-term growth will be supported by full product line expansion and cost control optimization, while long-term prospects are bolstered by innovative products and strategic positioning in emerging fields [14].

Core Viewpoint - The profitability of Xinwei Medical is becoming increasingly clear, with a significant leap in revenue and profit projected for 2025, marking its entry into the profit zone [1][4]. Financial Performance - Xinwei Medical forecasts a revenue of approximately 400 million to 410 million yuan for 2025, representing a growth of about 44% compared to 278 million yuan in 2024 [6]. - The company expects a pre-tax profit of 80 million yuan, a substantial turnaround from a pre-tax net loss of 12 million yuan in 2024, indicating an increase of nearly 800% [6]. - Adjusted pre-tax profit is projected to reach 77 million yuan, showcasing a clear improvement in profitability quality and capability [6]. Product and Market Development - The growth is primarily driven by the collaborative expansion of the entire product line, particularly in the ischemic stroke sector, where new products and technologies have led to a steady increase in market share [7]. - The sales volume of large-caliber suction catheters has seen a 60% year-on-year increase in the first half of 2025, with an expected annual sales growth of over 200% [7]. - In the hemorrhagic stroke sector, the "Great Wall" intracranial stent has achieved rapid commercial sales, covering 200 new cooperative hospitals in the first half of the year, significantly boosting the sales of spring coil products [8]. Cost Management and Operational Efficiency - Xinwei Medical's overall gross margin has rebounded to nearly 70%, while the sales and management expense ratio has decreased by 8 percentage points to 37%, indicating effective cost control [9]. - The financial characteristics of revenue growth, profit increase, and cost reduction suggest that the company has moved away from a financing-dependent growth model to a self-sustaining cycle of product expansion and profitability [9]. Innovation and Long-term Strategy - The acceptance of the self-expanding intracranial drug-eluting stent application by the National Medical Products Administration represents a significant breakthrough in the company's innovation pipeline [11]. - This product addresses critical treatment needs for intracranial atherosclerotic stenosis and is expected to fill a market gap, enhancing the company's competitive edge in neurointervention [11]. - The company is also advancing its brain-machine interface project, which is expected to begin formal clinical trials by the end of 2026, potentially opening new growth avenues [12]. Conclusion - Xinwei Medical's solid profitability, comprehensive product pipeline, leading innovation capabilities, and clear ecological layout constitute its core competitive advantages, gradually gaining market recognition for its investment value [14]. - Short-term growth will be supported by full product line expansion and cost management optimization, while long-term prospects will be bolstered by innovative products and strategic positioning in emerging fields [14].

Core Viewpoint - Peijia Medical-B (09996) has seen a significant increase in stock price, attributed to the chairman's confidence demonstrated through share buybacks and the recent approval of its TaurusTrio device for market entry [1][2] Group 1: Company Developments - Peijia Medical's stock rose over 6%, with a cumulative increase of over 22% in December [1] - The chairman, Dr. Zhang Yi, plans to invest up to 15 million HKD in purchasing company shares from the open market [1] - The TaurusTrio transcatheter aortic valve system has received approval from the National Medical Products Administration, marking it as the first integrated positioning key transcatheter aortic valve regurgitation intervention device approved in China [1] Group 2: Industry Position - According to CITIC Securities, Peijia Medical holds a leading position in the domestic heart valve intervention market, with positive clinical feedback and increasing market share for its TAVR products since commercialization [2] - The company has a comprehensive product development layout in aortic, mitral, and tricuspid valve treatment areas, which helps solidify its leading position in the heart valve sector [2] - Peijia Medical anticipates the approval and commercialization of three major products by the end of 2025 to 2026, which is expected to drive a rapid recovery in overall performance [2] - The company's neurointerventional business is among the top domestic players, with a promising growth trend expected as the product pipeline continues to expand and commercialization progresses [2]

Core Viewpoint - Peijia Medical (09996) has seen a significant increase in its stock price, rising over 22% in December, with a current price of 6.35 HKD and a trading volume of 10.9 million HKD [1] Group 1: Company Developments - On December 5, Peijia Medical announced that Chairman Dr. Zhang Yi plans to invest up to 15 million HKD to buy back company shares in the open market [1] - On December 11, Peijia Medical received approval from the National Medical Products Administration for its TaurusTrio transcatheter aortic valve system, marking it as the first integrated positioning key transcatheter aortic valve regurgitation (AR) intervention device approved in China [1] Group 2: Market Position and Future Outlook - According to a report from CITIC Securities, Peijia Medical holds a leading position in the domestic heart valve intervention market, with positive clinical feedback and rapid market share growth since the commercialization of its TAVR products [1] - The company has a comprehensive product development pipeline in the aortic, mitral, and tricuspid valve treatment areas, which is expected to strengthen its leading position in the heart valve sector [1] - Peijia Medical anticipates the approval and commercialization of three major products in China by the end of 2025 to 2026, which will support a rapid recovery in overall performance [1] - The company's neurointerventional business is among the top domestic players, and with a continuously enriching product pipeline and ongoing commercialization of certified products, it is expected to maintain a trend of rapid development [1]

投资界12月9日消息，近日，苏州无限医疗科技有限公司（Infinity Neuro）一家专注为神经血管外科提 供创新解决方案的医疗器械公司宣布，已完成数亿元人民币的A轮融资。本轮融资由高特佳领投，国元 股权、金雨茂物等多家机构同步跟投，共同注资，旨在将加速推进公司产品的创新研发和商业化进程， 为神经介入专家提供更优的治疗方式。 无限医疗（Infinity Neuro）主要从事脑血管领域医疗器械的研发、生产和商业化，致力于与神经科医生 深入合作，聚焦神经介入领域未被满足的临床需求，产品覆盖治疗出血性和缺血性卒中的两大核心产品 线。核心团队均来自于跨国医疗器械公司，拥有多次成功创业经历，核心团队深度聚焦神经介入领域出 血性和缺血性卒中市场，具有神经介入医疗器械产品研发、临床、产业化及产品迭代升级的丰富经验。 高特佳投资副总经理王海蛟表示："我们看好神经介入赛道国产替代和国际化的双重机遇，无限医疗作 为国内为数不多具备国际化背景的团队，起步即在全球实现产品上市销售。后续产品管线具备全球创新 的潜力，相信会造福更多患者。" 国元股权投资负责人表示："无限医疗围绕神经介入领域，基于临床痛点研发的组合产品具有很强的创 新 ...

Core Viewpoint - Guichuang Tongqiao (02190) has seen a stock price increase of over 3%, currently trading at 25.52 HKD, following the approval of its intracranial aneurysm embolization assistive stent by the National Medical Products Administration (NMPA) [1] Group 1: Product Approval and Features - The Tongqiao Feilong intracranial aneurysm embolization assistive stent has received NMPA approval for market launch [1] - This stent is designed to be used in conjunction with embolization coils, specifically targeting the treatment of intracranial neurovascular diseases, providing a new and efficient clinical solution [1] - Compared to similar products on the market, the Tongqiao Feilong stent offers better wall adherence and visibility during procedures, enhancing operational safety and visibility [1] Group 2: Market Impact and Company Strategy - CITIC Securities (601066) highlights that the stent utilizes DFT material weaving technology, which allows for clear visibility throughout the procedure, aiding doctors in precise operational control [1] - The approval of the embolization assistive stent is expected to strengthen the company's product pipeline in the neurointerventional field, enhancing its overall solution offerings [1] - This development is anticipated to help the company increase its market share and maintain rapid growth in performance [1]

Core Viewpoint - Guichuang Tongqiao (02190) has seen a stock price increase of over 3%, currently trading at 25.52 HKD, following the approval of its Tongqiao Feilong™ intracranial aneurysm embolization assist stent by the National Medical Products Administration (NMPA) [1] Company Developments - The Tongqiao Feilong™ stent is designed for the treatment of intracranial neurovascular diseases and offers a new efficient solution for clinical diagnosis and treatment [1] - Compared to similar products on the market, the Tongqiao Feilong™ stent provides better wall adherence and visibility during procedures, enhancing operational safety and visibility [1] - The stent's comprehensive range of models meets the treatment needs of various clinical conditions, further strengthening the company's product pipeline in the neurointerventional field [1] Market Implications - CITIC Securities indicates that the approval of the embolization assist stent is expected to enhance the company's overall neurointerventional solutions, contributing to an increase in market share and maintaining rapid growth in performance [1]