机构：华创证券 事项： 公司发布25 年中报，25H1 实现营业收入4.82 亿元（+31.7%）；净利润1.21 亿元（+76.0%）。 评论： 业绩持续高增长。2025H1，公司实现营业收入4.82 亿元（+31.7%）；净利润大幅增长至1.21 亿元 （+76.0%），毛利率在集采扩围下稳定在71.2%（-0.1pct），研发、销售和管理费率较同期整体下降7 个百分点，实现净利率25.1%。 神经介入：25H1 公司神经介入收入3.04 亿元（+25.0%），保持快速增长。其中颅内中间导管、弹簧圈 及神经血管导丝等主要成熟产品收入大幅增长，密网支架等较新产品在进入集采后快速入院，公司持续 致力于提高产品在各级医院的渗透率。 外周介入：25H1 外周血管介入业务实现收入约1.76 亿元（+46.2%），持续高速增长。其中成熟产品 DCB、腔静脉滤器、腔静脉滤器抓捕器及静脉腔内射频闭合导管的销售收入保持快速增长，外周可解 脱带纤维毛弹簧圈、髂静脉支架、血管缝合器等较新的产品组合在全国范围内商业化上市，贡献收入增 量。 研究员：郑辰/李婵娟 风险提示：1）集采降价幅度超预期；2）神经/外周介入行业渗透率、国产 ...

Core Viewpoint - The article discusses the recent developments in the medical device industry, particularly focusing on the centralized procurement of medical consumables such as inferior vena cava filters and ablation electrodes, highlighting the implications for market dynamics and investment opportunities [2][9][15]. Group 1: Centralized Procurement Initiatives - The Heilongjiang Provincial Medical Security Bureau has initiated information maintenance for inferior vena cava filters and ablation electrodes, affecting over 20 provinces, which aims to enhance the accuracy and transparency of the procurement process [2][5]. - This information maintenance is crucial for medical device companies to ensure their products can enter the centralized procurement system and receive insurance payments, impacting market access and future pricing strategies [2][6]. - The expansion of centralized procurement is expected to lead to price reductions and increased competition in the high-value consumables sector, particularly for inferior vena cava filters and ablation electrodes [2][9]. Group 2: Market Trends and Price Dynamics - The price of inferior vena cava filters has significantly decreased, with a reported drop of 58% from 23,000 yuan to 9,000 yuan during the 2022 procurement in the Lupu Jiyu Alliance [10]. - The average annual implantation of inferior vena cava filters in China is around 60,000, with a competitive landscape featuring both domestic and international manufacturers [11][12]. - The ablation electrodes market has also seen substantial price reductions, with an average decrease of 53.86% reported in 2023, and specific products experiencing price drops of up to 78.63% [15][16]. Group 3: Competitive Landscape and Innovation - The domestic market for inferior vena cava filters is rapidly developing, with 17 approved domestic products and 8 imported products, indicating a competitive environment [11][14]. - Despite the advantages of domestic products, there is a notable gap in performance compared to international counterparts, particularly in terms of retrieval success rates and longevity of use [14]. - The centralized procurement model is reshaping the competitive landscape, favoring companies that can innovate and optimize costs, thus driving the need for technological advancements and efficient production processes [19][18].

证券研究报告 前沿高值耗材研究系列（五） 外周介入行业全景图：国产企业厚积待发， 替代进口有望加速 生物医药行业 强于大市（维持） 证券分析师 叶 寅 投资咨询资格编号：S1060514100001 倪亦道 投资咨询资格编号：S1060518070001 裴晓鹏 投资咨询资格编号：S1060523090002 2025年8月1日 请务必阅读正文后免责条款 投资要点 投资建议：关注产品布局完善的国产领军企业 2 *资料来源： 弗若斯特沙利文、阿里健康等《2021静脉曲张互联网健康洞察报告》，平安证券研究所 1 外周介入行业快速发展叠加国产替代，双重机遇并存。外周血管疾病患者基数庞大，2021年国内外周动脉疾病患者超过5100万人，2021年静脉曲张患者人数达1.2 亿，治疗需求旺盛*。目前国内外周介入治疗渗透率较低，比如根据动脉网2019年外周动脉疾病手术渗透率仅为0.2%，远低于美国的5.4%。随着患者治疗意愿提升、 医院治疗能力增强、术式下沉至基层医院、国家政策支持、以及介入器械持续迭代升级、指南完善等，外周介入治疗渗透率有望快速提升。根据弗若斯特沙利文预 测，2021年至2030年外周动脉介入手术量CAG ...

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].

正式报名：首届全球心血管大会 | 赠送纸质白皮书 合作伙伴征集：2025全球手术机器人大会 近日， 科塞尔医疗科技（苏州）有限公司 宣布完成近亿元 B+轮融资，此轮融资由铁投巨石领投，苏高新金 控持续追加投资，园雍投资跟投，所筹资金主要用于核心产品研发、全球市场推广及产能扩建。 历次融资情况 技术平台与专利 ： 科塞尔医疗累计研发投入超 3 亿元， 构建了丰富技术平台，拥有近百人研发、工艺和 注册团队，取得国内外发明专利数百项，包括 PCT 专利近百项。 核心产品与应用领域 ： 其外周领域的创新产品腔 静脉滤器 成功注册并顺利商业化，是国内首个获准注册 的伞形长效滤器。 冠脉领域的球囊类产品获得中国 NMPA、美国 FDA、欧盟 CE、日本 PMDA、韩国 KFDA 等多国注册证书并进入国际主流市场。目前已有两个创新产品成功商业化。 市场表现 ：公司产品已在国内 2000 家医院使用，在海外 20 余个国家完成产品注册。 2017 年初 ：完成由达晨财智中国风险投资基金领投的数千万元 Pre - A 轮融资。 2018 年中 ：获得博远资本领投，达晨财智跟投的数千万元 A 轮融资。 2020 年底 ：完成由渶 ...

Core Viewpoint - The company, Xianjian Technology, reported a slight increase in revenue for 2024, but a significant decline in operating profit and net profit attributable to shareholders, indicating challenges in maintaining profitability despite revenue growth [2][3]. Financial Performance - Revenue for 2024 reached approximately RMB 1.304 billion, reflecting a year-on-year growth of about 2.9% [2][3]. - Gross profit was approximately RMB 981.4 million, showing a decrease of 1.4% compared to the previous year [2]. - Operating profit fell sharply by 51.4% to RMB 186.3 million [2]. - Profit before tax increased by 13.3% to RMB 199.0 million [2]. - Net profit attributable to shareholders was approximately RMB 222.4 million, down 15.5% from the previous year [2]. - Basic earnings per share decreased by 15.0% to RMB 0.051 [2]. Business Drivers - Xianjian Technology, established in 1999 and listed in 2011, focuses on the R&D, production, and sales of cardiovascular and peripheral vascular interventional medical devices [4]. - The company has a strong patent portfolio with 2,198 patents and 15 products approved for the "Special Review Procedure for Innovative Medical Devices" by the National Medical Products Administration (NMPA) [4]. Innovation and Market Expansion - R&D investment for 2024 was approximately RMB 303 million, aimed at driving technological innovation and product upgrades [5]. - Overseas sales reached approximately RMB 347 million, marking a year-on-year growth of 26.0%, with significant growth in Asia (excluding mainland China) and Europe [5]. - Domestic sales amounted to approximately RMB 957 million, accounting for 73.4% of total revenue, maintaining a leading market share [5]. Product Segmentation - Structural heart disease business generated sales of approximately RMB 528 million, up 6.4% year-on-year [8]. - Peripheral vascular business contributed approximately RMB 751 million in revenue, an increase of 6.2% [8]. - Cardiac pacing and electrophysiology business achieved sales of approximately RMB 25 million [8].

Core Insights - Koser Medical Technology (Suzhou) Co., Ltd. has completed nearly 100 million yuan in B+ round financing, led by Tietou Jushi, with funds allocated for core product development, global market promotion, and capacity expansion [1] Company Overview - Koser Medical was established in November 2013 and is a platform company with comprehensive production and R&D capabilities in vascular interventional devices, aiming to provide systematic solutions for clinical applications [1] - The company has successfully commercialized its innovative product, the inferior vena cava filter, which is the first umbrella-shaped long-term filter approved for registration in China, with several other innovative products set to enter clinical trials [1] - Koser Medical's balloon products in the coronary field have received registration certificates from multiple countries, including China (NMPA), the USA (FDA), the EU (CE), Japan (PMDA), and South Korea (KFDA), and have entered mainstream international markets [1] Leadership - The Chairman, General Manager, and CEO, Hu Qing, is a member of the second Life Science Instrument Professional Committee of the Chinese Society of Biomedical Engineering and has received multiple honors. He has extensive experience in management roles at Fortune 500 companies and has been in the medical device industry since 2002 [1] Financing History - The company has completed four rounds of financing prior to the recent B+ round, with investors including Dacheng Caizhi and Jushi Chuangtou [2] Business Structure - Koser Medical has formed a "one core, three wings" business layout, with the parent company focusing on a one-stop treatment system for peripheral intervention, while subsidiaries specialize in cardiac electrophysiology, coronary intervention product development, and breakthrough core medical materials technology [3] Global Strategy - The company actively practices a "Local Base, Global Reach" strategy, having acquired Ireland's Micell in 2021 to gain access to extensive clinical data and special coating technology, marking a significant step towards globalization [3] - Koser Medical has completed product registrations in over 20 countries and plans to establish more overseas subsidiaries and offices, with global sales set to officially launch in 2024 and aims for large-scale international expansion by 2026 [3]

Core Viewpoint - The company faces pressure on its 2024 annual performance due to price adjustments in aortic stents, but its competitiveness in the aortic field remains strong, and its layout in peripheral and tumor intervention areas continues to improve, maintaining a buy rating [1] Group 1: Financial Performance - The company maintains a buy rating and forecasts EPS of 4.95/6.19 yuan for 2025-2026, with a new EPS forecast of 7.30 yuan for 2027, adjusting the target price to 123.75 yuan from 133.65 yuan, based on a target PE of 25X for 2025 [2] - In 2024, the company expects revenue of 1.206 billion yuan (up 1.6% year-on-year) and a net profit attributable to shareholders of 502 million yuan (up 2.0%), with a non-recurring net profit of 396 million yuan (down 14.4%) [2] - The first half of 2024 saw high growth with revenue and net profit increasing by 27% and 44% year-on-year, respectively, but the second half is expected to decline by 26% and 54% due to the impact of aortic stent price adjustments [2] Group 2: International Expansion - The company is increasing its efforts in overseas market promotion, achieving market access and promotion for aortic and peripheral products in Europe, Latin America, and Asia-Pacific, with overseas sales revenue exceeding 160 million yuan in 2024, nearly doubling year-on-year [3] - The full acquisition of the UK joint venture Lombard in mid-2024 is expected to enhance cooperation and leverage its professional sales team and established distributor network in Europe, supporting the company's international strategy [3] Group 3: Product Development - The company continues to upgrade its aortic product line, with the new generation Cratos branched thoracic stent approved in March 2025, and ongoing clinical trials for Aegis II abdominal stent and Hector multi-branch thoracic stent, which are expected to maintain strong competitiveness in the aortic field [3] - The company is actively expanding into the peripheral and tumor intervention markets, with a complete product line including venous stents and filters, and ongoing clinical and registration work for new products [4] - In the fifth batch of national procurement in December 2024, the company’s self-developed peripheral venous stents and 3D peripheral arterial stents won bids, indicating potential for rapid market entry and volume growth [4]