格隆汇9月22日丨三友医疗(688085.SH)公布，公司孵化并投资的联营公司春风化雨（苏州）智能医疗科 技有限公司（以下简称"春风化雨"）脊柱手术机器人及其相关智能化产品于近日通过国家药品监督管理 局医疗器械技术审评中心创新医疗器械特别审查程序，并被命名为脊柱外科手术导航定位系统。 本次春风化雨产品获批进入创新通道，成为三友医疗创新研发体系在2025年的又一重要里程碑。此前， 公司另一控股子公司苏州云合景从新材料科技有限公司开发的"表面多孔聚醚醚酮椎间融合器"已于2025 年4月进入创新通道。该产品进入创新医疗器械特别审查程序，在注册申报时将获得优先办理的权益， 可有效缩短产品注册周期，加快产品的上市速度。该产品如获批上市，将进一步公司相关产品在创新通 道产品下的使用和推广，对公司的业务产生积极影响 该产品融合了先进的多臂人形机器人系统、轻量级医疗级机械结构、电磁导航与光学成像等尖端技术， 实现机器人与手术的卓越融合；围绕模块化平台设计，使医疗专业人员能够根据特定的手术需求定制解 决方案。新一代手术机器人的发展方向在于更加AI智能化和真正能帮助临床医生更精确更安全的完成 手术，并根据标准手术类别，提供专用的 ...

本次春风化雨产品获批进入创新通道，成为三友医疗创新研发体系在2025年的又一重要里程碑。此前， 公司另一控股子公司苏州云合景从新材料科技有限公司开发的"表面多孔聚醚醚酮椎间融合器"已于2025 年4月进入创新通道。该产品进入创新医疗器械特别审查程序，在注册申报时将获得优先办理的权益， 可有效缩短产品注册周期，加快产品的上市速度。该产品如获批上市，将进一步公司相关产品在创新通 道产品下的使用和推广，对公司的业务产生积极影响。 智通财经APP讯，三友医疗(688085.SH)发布公告，公司孵化并投资的联营公司春风化雨(苏州)智能医疗 科技有限公司(简称"春风化雨")脊柱手术机器人及其相关智能化产品于近日通过国家药品监督管理局医 疗器械技术审评中心创新医疗器械特别审查程序，并被命名为脊柱外科手术导航定位系统。 ...

Core Insights - The National Medical Products Administration (NMPA) announced the results of the special review application for innovative medical devices, with 8 products entering the special review process in 2025 [1] - Sanyou Medical's subsidiary, Chunchun Huayu (Suzhou) Intelligent Medical Technology Co., Ltd., successfully had its spinal surgery robot and related intelligent products selected, named the Spinal Surgery Navigation and Positioning System, marking a significant technological breakthrough in the field of intelligent orthopedic surgery [1] - This approval for Chunchun Huayu's product to enter the innovative channel represents another important milestone in Sanyou Medical's innovative R&D system for 2025 [1] - Previously, another subsidiary of the company, Suzhou Yunhejing New Material Technology Co., Ltd., developed a "Surface Porous Polyether Ether Ketone Interbody Fusion Device," which entered the innovative channel in April 2025 [1]

Investment Rating - The report maintains a "Buy" rating for the company [4][8]. Core Insights - The company's main business in the spinal sector has stabilized and is recovering, with rapid growth in international operations [2][3]. - In the first half of 2025, the company achieved revenue of 250 million yuan, a year-on-year increase of 17.77%, and a net profit attributable to shareholders of 37 million yuan, a significant increase of 2083.64% [2]. - The company is transitioning from equipment sales to a sustainable consumables model, driven by high-margin consumables, which has become a core growth engine [3]. Financial Performance - The company expects revenues for 2025-2027 to reach 599 million yuan, 759 million yuan, and 952 million yuan, representing year-on-year growth of 32.0%, 26.8%, and 25.4% respectively [4][10]. - The net profit attributable to shareholders is projected to be 90 million yuan, 154 million yuan, and 238 million yuan for the same period, with growth rates of 684.8%, 71.6%, and 54.0% respectively [4][10]. - The company's gross margin is expected to improve from 71.3% in 2024 to 77.3% by 2027 [10]. Market Expansion - The company has made significant progress in the U.S. market, with a year-on-year growth of 444% in the second quarter of 2025, surpassing the French market for the first time [3]. - The company is developing a product matrix that includes spinal consumables, ultrasonic bone knives, and orthopedic robots, aiming to create a competitive advantage in the North American market [3]. Innovation and Development - The company is actively involved in the development of new medical devices, including a next-generation multi-arm surgical robot and a porous polyether ether ketone interbody fusion device, which is expected to receive approval soon [3]. - The company has a rich pipeline of projects covering advanced fields such as next-generation cervical disc prostheses and minimally invasive fusion systems, ensuring long-term growth [3].

Core Viewpoint - The company is committed to enhancing quality and efficiency while ensuring shareholder returns through a comprehensive action plan for 2025, focusing on core business development, international expansion, and effective governance [2][3]. Group 1: Business Development - The company has deepened its focus on the orthopedic medical device sector, emphasizing original innovation and product development to enhance core competitiveness [2]. - The company achieved a net profit attributable to shareholders of approximately 36.6 million yuan, representing a year-on-year increase of 2,083.64%, and a significant recovery from a previous loss [3]. - The company plans to continue developing innovative therapies and products, leveraging national policies that encourage domestic innovation in medical devices [3]. Group 2: International Expansion - The company has made significant progress in its international business, successfully entering the European and American markets with its Zeus spinal fixation system [4]. - Implanet, a subsidiary, reported revenue of 5.81 million euros in the first half of 2025, a year-on-year increase of 41.1%, with a remarkable 444% growth in the U.S. market in the second quarter [4]. Group 3: Strategic Partnerships and Acquisitions - The company completed the acquisition of the remaining equity in Beijing Waterwood Tianpeng Medical Technology Co., making it a wholly-owned subsidiary, and established a joint venture with a South Korean company to develop innovative biomedical materials [5]. - The introduction of Implanet's JAZZ system into the domestic market enhances the company's product line and competitive advantage in spinal surgery [5]. Group 4: Governance and Shareholder Returns - The company has implemented a stock incentive plan to attract and retain talent, aligning the interests of shareholders and management [7]. - A sustainable dividend strategy has been established, with a cash dividend of 0.042 yuan per share distributed to shareholders [8]. - The company is committed to optimizing its shareholder return mechanism and ensuring a balance between business growth and shareholder returns [9]. Group 5: Investor Relations and Communication - The company has enhanced its investor communication channels, conducting numerous disclosures and hosting events to engage with investors [10]. - Future plans include improving the clarity and transparency of information disclosures to ensure investors are well-informed about the company's operations and strategies [10]. Group 6: Compliance and Risk Management - The company has restructured its governance framework by abolishing the supervisory board and enhancing the roles of various committees to ensure effective oversight and compliance [11]. - Continuous training and communication efforts are in place to strengthen compliance awareness among key personnel [12].

Core Viewpoint - The announcement highlights that the company's subsidiary, Suzhou Yunhejing, has received special review approval from the National Medical Products Administration for its "Surface Porous Polyether Ether Ketone Interbody Fusion Device," which is the only device that meets the criteria of clear imaging, mechanical compatibility, and efficient bone integration. This product is expected to reach a global market size of $3.65 billion by 2032 [1]. Summary by Relevant Categories Product Development - The "Surface Porous Polyether Ether Ketone Interbody Fusion Device" is the only device that simultaneously satisfies clear imaging, mechanical compatibility, and efficient bone integration [1]. - The product's entry into the special review process will shorten the registration cycle and accelerate the time to market [1]. Market Potential - The global market size for this product is projected to reach $3.65 billion by 2032 [1]. - The approval and subsequent market entry are expected to enrich the company's product pipeline and positively impact its business [1].

Core Insights - The National Medical Products Administration has included Suzhou Yunhejing New Material Technology Co., Ltd.'s "Surface Porous Polyether Ether Ketone Interbody Fusion Device" in the special review list for innovative medical devices, marking a significant achievement for the company and the Taicang region [1] - Taicang's medical device industry has shown rapid growth, with nearly 100 production enterprises and a total of around 300 Class II and III medical device registration certificates obtained, along with over 500 Class I medical device filings [2] - The establishment of a global procurement and supply chain center by PerkinElmer in Taicang is expected to inject new momentum into the high-quality development of the local medical device industry [2] Company Developments - Suzhou Yunhejing's interbody fusion device utilizes patented technology to create a PEEK device with a connected porous structure, addressing clinical challenges related to traditional PEEK devices [1] - Zhuoran Medical Technology's biological hernia repair patch has achieved breakthroughs in key technologies, filling several domestic and international technical gaps [1] Industry Support Mechanisms - The introduction of a "special class docking + customized service" mechanism aims to provide tailored support for enterprises, with over 70 services conducted in the biopharmaceutical industry this year [4] - Active collaboration with provincial review and inspection experts has facilitated targeted guidance for enterprises, addressing critical technical issues in the registration process [6] - The Taicang Market Supervision Bureau is committed to enhancing the efficiency of the Jiangsu Provincial Drug Administration's review and inspection work station, promoting the rapid transformation and application of innovative biopharmaceutical achievements [8]

正式报名：首届全球心血管大会 | 重磅亮点 合作伙伴征集：2025全球手术机器人大会 现有取得注册证产品： 取石网篮、肠道支架及输送系统、胆道支架及输送系统、颅内支撑导管等。 2024年临床项目处于快速有序进行中，并以计划启动"下静脉取栓装置用于治疗深静脉血栓形成的安全性和有效性的前瞻性、多中心、随机、开放、平行对 照、非劣效临床试验"。 2025年4月27日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第4号），有9款产品进入创新通道。 1. 产品名称：颅内静脉窦取栓支架 申请人：北京弘海微创科技有限公司 北京弘海微创科技有限公司成立于2017年11月份，是一家以植/介入医疗器械研发、生产、销售于一体的创新型平台公司，聚焦于神经、外周、消化、泌 尿、呼吸等植/介入领域的医疗器械研发，为医患提供完整的治疗方案。公司拥有全球独创的工艺技术，通过自主研发的设备，开发出具有卓越性能的植/介 入医疗器械。 2. 结核分枝杆菌复合群耐药基因突变检测试剂盒（可逆末端终止测序法） 申请人：广州市金圻睿生物科技有限责任公司 广州市金圻睿生物科技有限责任公司（简称"金圻睿"）于2016年成立，聚焦于精准医疗体 ...