Core Viewpoint - The company is a leading player in the structural heart and peripheral intervention high-value consumables sector, with a diversified business model and strategic partnerships aimed at expanding its product offerings and market reach [1][2]. Group 1: Business Overview - The company operates under a "3+N" business layout, which includes three main product lines: structural heart disease, peripheral vascular intervention, and electrophysiology, along with multiple strategic cooperation projects [1]. - For the fiscal year 2024, the company reported a revenue of 1.304 billion yuan, reflecting a year-on-year growth of 2.88%, positioning it among the few high-value consumables firms in China with revenues exceeding 1 billion yuan [1]. - As of December 31, 2024, the company has established a robust patent portfolio with 2,426 patents and has received NMPA approval for 15 products under the "Special Review Procedure for Innovative Medical Devices" [1]. Group 2: Market Dynamics - In 2024, the National Healthcare Security Administration mandated 12 domestic and foreign companies, including the company, to revise the pricing of thoracic aortic stent products to enhance price transparency and reduce excessive markups [2]. - The price adjustments resulting from centralized procurement have led to a decline in the ex-factory prices of the company's related products, impacting revenue and profit in the second half of 2024 [2]. - The company is expected to see a recovery from these pricing challenges by the second half of 2025, as the market stabilizes [2]. Group 3: International Expansion and Product Development - The company has adopted a dual strategy of "innovation" and "internationalization," maintaining a leading market share in its primary products domestically [2]. - By the end of 2024, the company had established seven overseas subsidiaries and obtained 1,059 overseas registrations, with a sales network covering 117 countries and regions [2]. - The company anticipates that several second-generation aortic stent products will receive overseas registration approvals between 2025 and 2026, contributing to international revenue growth [2][3]. Group 4: Product Innovation - The company is pioneering iron-based absorbable stent technology, which addresses significant clinical challenges associated with existing biodegradable stents [3]. - The IBS Angle stent has received regulatory approvals in Malaysia and the EU, while the IBS Titan has been granted compassionate use approval in the U.S. [3]. - The company is progressing with its IBS drug-eluting coronary stent system, with clinical trials completed and applications submitted for NMPA and CE registration, expected to be approved by 2025-2026 [3]. Group 5: Financial Projections - Revenue projections for the company from 2025 to 2027 are estimated at 1.403 billion, 1.528 billion, and 1.736 billion yuan, representing year-on-year growth rates of 8%, 9%, and 14% respectively [3]. - The net profit attributable to the parent company is projected to reach 316 million, 388 million, and 526 million yuan for the same period, with growth rates of 42%, 23%, and 35% respectively [3].

AI基金平安医疗健康混合A（003032）披露2025年二季报，第二季度基金利润2.1亿元，加权平均基金份额本期利润0.5108元。报告期内，基金净值增长率为 21.53%，截至二季度末，基金规模为9.66亿元。 该基金属于偏股混合型基金，长期投资于医药医疗股票。截至7月17日，单位净值为2.876元。基金经理是周思聪，目前管理4只基金。其中，截至7月17日， 平安医药精选股票A近一年复权单位净值增长率最高，达103.36%；平安医疗健康混合A最低，为84.73%。 基金管理人在二季报中表示，本报告期内，以子行业的景气度为投资的重要策略，在商业模式、竞争力和业绩的多维度比较中寻找具有估值性价比的优秀公 司，重点布局了创新药方向。未来仍然看好以创新药、创新医疗器械为代表的成长型的医药子行业。 截至7月17日，平安医疗健康混合A近三个月复权单位净值增长率为43.84%，位于同类可比基金9/138；近半年复权单位净值增长率为85.59%，位于同类可比 基金7/138；近一年复权单位净值增长率为84.73%，位于同类可比基金5/133；近三年复权单位净值增长率为48.57%，位于同类可比基金12/106。 截至7月1 ...

Core Viewpoint - The Hong Kong innovative medical device sector has seen significant growth this year, with the Hang Seng Healthcare Index rising over 50% year-to-date, driven by profit recovery and valuation adjustments [1][3]. Group 1: Market Dynamics - The National Medical Products Administration (NMPA) has announced ten measures to support the innovation and development of high-end medical devices, further enhancing long-term investment expectations for innovative medical device companies [1][3]. - The current investment environment is warming, leading to increased focus on the validation of innovative technologies and their commercial potential [3][9]. Group 2: Company Performance - Peijia Medical (09996) has experienced a stock price increase of over 95% year-to-date, significantly outperforming the index and bringing its market capitalization to around HKD 5 billion [1][3]. - The company has established itself as a leading brand in the Chinese transcatheter aortic valve replacement (TAVR) market, with a market share increase from 5% in 2021 to over 25% currently [4][10]. Group 3: Product Development and Innovation - Peijia Medical is advancing its product pipeline, with its second-generation TAVI product nearing market approval and its third-generation product expected to enter the market in the first half of next year [4][10]. - The company has a robust pipeline that includes innovative technologies such as non-glutaraldehyde cross-linked valves and shockwave calcification reconstruction technology, positioning it well against competitors [10][12]. Group 4: Market Potential - The TAVR market in China is projected to grow significantly, with an expected compound annual growth rate (CAGR) of 36.6% from 2021 to 2030, reaching approximately 109.5 billion yuan by 2030 [9][11]. - The current TAVR penetration rate in China is only 5.7% of the global total, indicating substantial growth potential for the market [11]. Group 5: Future Outlook - Peijia Medical aims to solidify its position as the leading TAVR brand in China by expanding its product offerings and increasing market share to 25-30% by 2025 [4][12]. - The company is also pursuing international expansion, with plans to apply for CE certification for its products and engage in global clinical studies [12][13].

Group 1 - The core objective of the delegation visit from various countries is to deepen international medical cooperation and explore development opportunities in cross-border medical services and innovative medical devices [1][2] - There is a growing demand for high-quality traditional Chinese medicine (TCM) services in Russia and surrounding countries, with proposals for business medical tours and international medical tourism [1][2] - Shanghai Pudong Hospital aims to become a significant engine for cross-border medical services and a model project for internationalization and marketization in the context of consumption upgrade trends [2] Group 2 - The Pudong Hospital is the largest medical education and research center in the southern part of the Pudong New Area, with plans to integrate resources from Fudan University and leverage the advantages of the Lingang New Area [2] - The Lingang New Area Medical Device Innovation Center is looking to establish comprehensive cooperation with Shanghai Pudong Hospital in areas such as medical device testing and TCM diagnosis [2] - The recent signing ceremony for cross-border medical cooperation projects marks a significant step in building a network for cross-border medical services, education, and insurance [1]

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 | 首届全球医美科技大会 即将召开： 2025年7月17日，第二届全球医疗科技大会 2025年9月3-5日，第三届全球手术机器人大会 公司介绍 中欧智薇（上海）机器人有限公司是华科润旗下子公司， 专注于数字化骨科产品和微型手术机器人技术。 2021年底，华科润与欧洲创新手术机器人公司 Interventional Systems（简称 INS）在上海合作成立中欧智薇（上海）机器人有限公司，向市场推出 具有显著差异 化及创新性的新一代微型骨科手术机器人 。 ▲图片源 自公司官方公众号 2025年6月27日，国家药品监督管理局批准了 中欧智薇（上海）机器人有限公司 的 "脊柱外科手术导航定位设备" （国械注准20253011259）， 深圳迈微医疗 科技有限公司 的" 心脏脉冲电场消融设备 "（国械注准20253011258）和 德国新特利斯股份公司 的" 生物可吸收镁合金加压螺钉 "（国械注进20253130280） 三个创新产品注册申请 。 截至目前，我国上市的创新医疗器械累计 360 项。 | 358 | 脊柱外科手术导航定 ...

据国家药品监督管理局官网消息，6月20日，国家药监局党组书记、局长李利主持召开会议，研究部署支持高 端医疗器械创新发展举措，审议通过《关于优化全生命周期监管支持高端医疗器械创新发展的举措》（以下简 称《举措》）。《举措》的出台对支持高端医疗器械重大创新，促进更多新技术、新材料、新工艺和新方法应 用于医疗健康领域。 从此前发布的征求意见稿来看，研究机构认为，国家药监局将创新医疗器械定位为医疗器械新质生产力的关键 领域，意见稿从审评、注册、上市后监管以及出海等多方面提出相关支持举措，创新医疗器械有良好的产业发 展前景。未来行业有望依托企业技术平台化、AI诊疗拓展、消费医疗延伸突破等实现多维发展，行业将从规 模扩张转向更高层次的发展阶段，看好行业高质量发展及长期投资机遇。 重磅来了！ 6月20日，国家药监局党组书记、局长李利主持召开会议，研究部署支持高端医疗器械创新发展举措，审议通 过《关于优化全生命周期监管支持高端医疗器械创新发展的举措》。 会议指出，党中央、国务院高度重视高端医疗器械创新发展，党的二十届三中全会明确提出要健全支持创新医 疗器械发展机制，2024年，国务院办公厅印发《关于全面深化药品医疗器械监管改 ...

近日， 苏州美创医疗科技有限公司 （以下简称"美创医疗"）宣布完成新一轮亿元级股权融资，投资方包括 苏创投、天堂硅谷、光华梧桐和Medpark ， 凯乘资本 连续担任独家财务顾问。 此次融资距2025年1月红杉中国、倚锋资本等参与的上一轮融资不足半年，累计融资金额 超2亿元 。资金将主要用于加速核心产品的临床转化、注册 申报及商业化布局。 # 关于 美创医疗 思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 即将召开： 2025年7月17日，第二届全球医疗科技大会 2025年9月4-5日，第三届全球手术机器人大会 2025年9月4-5日，第三届全球手术机器人大会 美创医疗成立于2021年，总部位于苏州高新区，由拥有30余年外周血管和肿瘤介入行业经验的刘文菁创立。公司专注于外周血管和肿瘤介入领域，致 力于开发适合中国患者的创新医疗器械。其核心团队具备丰富的行业经验，技术积累深厚，已成为国内该领域的重要参与者。 产品与技术介绍 美创医疗的核心技术为 医用植入级ePTFE（膨体聚四氟乙烯）材料 ，已实现量产，成为国内首家攻克该"卡脖子"技术的企业。公司已完成ePTFE管材 和膜材的 ...

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 即将召开： 2025年6月12日，首届全球医美科技大会 2025年7月17日，第二届全球医疗科技大会 2025年9月4-5日，第三届全球手术机器人大会 2025年5月27日，国家药品监督管理局批准了 科凯（南通）生命科学有限公司 的 " 经导管二尖瓣修复系统 "（国械注准20253130967 ）创新产品注册申请。 截至目前，我国上市的创新医疗器械累计 353 项。 # 产品介绍 该产品由 夹合器及输送系统、导管鞘组件 组成。夹合器及输送系统由夹合器、植入导管和可操控套管组成。导管鞘组件由导管鞘和扩张器组成，导管鞘包括可调 弯鞘和手柄。 该产品采用经皮方式， 适用于经心脏团队评估后认为存在外科手术高风险，且二尖瓣瓣膜解剖结构适合的退行性二尖瓣反流（MR≥3+）患者 。 # 市场概况 全球二尖瓣反流市场规模 2017年全球中度到重度二尖瓣反流的患病率为 1.25%，2021年时患病率达1.28%，预计到2027年时， 全球中度到重度二尖瓣反流的患病率将进一步增加到 1.37%。全球中度到重度二尖瓣反流的患病人数从2017年的 9 ...

Group 1 - The pilot program aims to promote the full-chain innovation development of medical devices, including R&D design, clinical evaluation, pilot application, iterative upgrades, and radiation promotion [1] - The first batch of innovative medical device integration application pilot list in Sichuan Province includes 40 innovative medical device products, such as cardiac pulse field ablation instruments and SPECT/CT systems [1] - The pilot program will provide support for the construction of provincial medical enterprise joint laboratories and training bases, as well as recommend high-end medical equipment promotion projects [1] Group 2 - The Sichuan Provincial Implementation Plan for Promoting Innovative Medical Device Integration Application specifies that the pilot will be led by one local medical institution and one provincial medical device manufacturer [1] - Chengdu Yongxin Medical Equipment Co., Ltd. has developed a SPECT/CT system that fills a domestic gap and meets international advanced standards, but faces challenges in gaining user trust due to reliance on imported high-end medical equipment [1] - Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd. is leading a pilot for the application of domestic pulse ablation catheters for early atrial fibrillation combined with diastolic heart failure, aiming to establish clinical usage and operational processes [2]

报名：首届 全球医美科技大会 | 奖项评选 报名： 第二届全球医疗科技大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 2025年5月15日，国家药品监督管理局批准了 先健科技（深圳）有限公司 （简称"先健科技"）的 " 主动脉弓支架系统 "（国械注准20253130950 ）创新产品注 册申请。 该产品包括主动脉弓主体支架系统和主动脉弓分支支架系统，与同公司主动脉覆膜支架破膜系统配合使用，适用于治疗需要 重建左锁骨下动脉血运的Stanford B型 夹层患者 。 截至目前，我国上市的创新医疗器械累计 352 项。 | 索引号 | XZXK-2025-211 | 主题分类 | | --- | --- | --- | | 标题 | 主动脉弓支架系统获批上市 | | | 发布日期 | 2025-05-15 | | # 产品研发背景 主动脉腔内介入治疗 近年来受到临床医生的高度认可，已进入高速发展时期。累及升主动脉及主动脉弓部的病变占全部主动脉夹层病变的 70% 左右，但由于人体 主动脉弓部血管解剖形态复杂并负责颅内供血，一直以来是主动脉疾病腔内治疗的难点，尤其是 弓上3个分支动脉的重建 ，通常面临较大 ...