Core Viewpoint - Sanxin Medical (300453) is enhancing its product portfolio around various blood purification treatment models and is focusing on the iterative upgrade of hemodialysis products while expanding into diabetes, early to mid-stage kidney disease, and vascular intervention fields [1] Group 1: Product Development and Innovation - The company is developing innovative medical devices and high-value consumables to replace imports, including artificial blood vessels, anticoagulant-coated catheters, plasma separators, and blood loss monitors [1] - Several projects under research and development have received support from Jiangxi Province's key research and development plan, Ganpo Talent Support Plan, and major provincial and municipal science and technology projects [1] Group 2: Clinical Trials and Progress - The artificial blood vessel project, which is primarily aimed at hemodialysis treatment, is currently in multi-center clinical trials and has achieved significant progress [1]

Core Viewpoint - Company is accelerating its internationalization process and capitalizing on the historical opportunity of "Chinese manufacturing" going global, successfully completing product registrations in countries like Indonesia, Peru, and Mexico, while also advancing certification processes in Turkey, Vietnam, and Brazil [1] Group 1: International Expansion - Company has obtained over a hundred overseas registration certificates for its products, enhancing its global competitiveness and laying a solid foundation for brand globalization [1] - The overseas business achieved revenue of 187 million yuan, representing a year-on-year growth of 67.30% [1] Group 2: Product Performance - Blood purification products accounted for 88% of total export revenue, with sales revenue of 165 million yuan, marking an increase of 83.84% year-on-year [1] - Export sales revenue for blood dialysis equipment grew by approximately 130% year-on-year, while sales revenue for blood dialysis consumables increased by about 70% year-on-year [1] Group 3: Growth Drivers - The stable growth of key product exports has become a significant driver of the company's performance [1]

证券代码：300453 证券简称：三鑫医疗 公告编号：2025-053 江西三鑫医疗科技股份有限公司 关于控股子公司变更医疗器械生产许可证的公告 本公司及董事会全体成员保证公告内容真实、准确和完整，没有虚假记载、 误导性陈述或重大遗漏。 许可证编号：川药监械生产许 20160053 号 统一社会信用代码：91510100794916300L 企业名称：成都威力生生物科技有限公司 法定代表人：陈贵文 企业负责人：陈贵文 住所：成都市高新区科园南路 88 号天府生命科技园 B6 幢 301 生产地址：高新区科园南路 88 号 10 栋 3 楼 303、304 号；高新区科园南路 88 号 10 栋 3 楼 302 号仓库 5、仓库 6、仓库 7；高新区科韵路 368 号 1 栋 1 单元 3 楼 301 号 生产范围：2017 分类目录：II 类：10-03-血液净化及腹膜透析设备 III 类：10-03-血液净化及腹膜透析设备 许可期限：自 2020 年 12 月 10 日至 2025 年 12 月 09 日 江西三鑫医疗科技股份有限公司（以下简称"公司"）控股子公司成都威力生 生物科技有限公司（以下简称"成都 ...

Core Viewpoint - The company announced that its subsidiary, Chengdu Weili Sheng Biological Technology Co., Ltd., has adjusted its production scope in accordance with the changes in the "Medical Device Classification Catalog" and has completed the registration procedures for the change [1] Group 1: Regulatory Changes - Chengdu Weili Sheng has obtained a new "Medical Device Production License" from the Sichuan Provincial Drug Administration, with the license number being Chuan Yao Jian Xie Sheng Chan Xu 20160053 [1] - The production scope now includes Class II and Class III medical devices related to blood purification and peritoneal dialysis equipment [1] - The license is valid from December 10, 2020, to December 9, 2025 [1] Group 2: Impact on Operations - The change in production scope does not affect Chengdu Weili Sheng's production operations and will not have a significant impact on the company [1]

Core Viewpoint - Sanchin Medical is experiencing steady growth in its business for the first half of 2025, with revenue growth accelerating quarter by quarter [1] Revenue Performance - In Q1 2025, the company achieved revenue of 361 million yuan, representing a year-over-year increase of 8.88% - In Q2 2025, revenue reached 400 million yuan, showing a year-over-year growth of 12.65% [1] Regional Analysis - Domestic revenue for the first half of 2025 was 574 million yuan, reflecting a slight year-over-year decline of 0.15% due to price reductions from centralized procurement - The company maintained its market share by exchanging price for volume, and the long-term demand in the domestic blood purification market is expected to be substantial due to the implementation of policies for dialysis centers in county areas [1] International Growth - Overseas revenue amounted to 187 million yuan, marking a significant year-over-year increase of 67.3%, with its revenue contribution rising to 24.6% - The company is accelerating its internationalization process by completing product registrations in countries such as Indonesia, Peru, and Mexico, which is expected to drive future growth [1] Business Outlook - The core business of blood purification continues to grow rapidly, supported by a rich pipeline of products and strong growth momentum [1]

Group 1 - The core viewpoint of the article is that Sanxin Medical announced it will accept an institutional research visit from Yongying Fund and other organizations on August 13, 2025, with company representatives Liu Ming and He Xin participating in the discussions and addressing investor inquiries [2]

Group 1: Company Overview and Financial Performance - The company achieved operating revenue of 760.81 million yuan, a year-on-year increase of 10.83% [2] - Net profit attributable to shareholders reached 115.12 million yuan, up 8.35% from the previous year [2] - The net profit excluding non-recurring gains and losses was 103.23 million yuan, reflecting a growth of 9.26% [2] - Blood purification products generated revenue of 625.59 million yuan, a 19.73% increase, accounting for 82.23% of total revenue [2][3] - Revenue from drug delivery devices decreased by 15.06% to 82.41 million yuan, representing 10.83% of total revenue [3] - Revenue from cardiothoracic products was 34.98 million yuan, a slight increase of 0.74%, making up 4.60% of total revenue [3] Group 2: International Market Expansion - The company has accelerated its internationalization, successfully registering products in countries like Indonesia, Peru, and Mexico [4] - Overseas revenue reached 187.00 million yuan, a significant increase of 67.30% [4] - Blood purification product exports accounted for 88% of total export revenue, with sales increasing by 83.84% [4] - The company focuses on emerging markets along the "Belt and Road" initiative, which have a large and growing population [4] Group 3: Product Innovation and Development - The company is enhancing its product range in blood purification and expanding into diabetes and early-stage kidney disease management [5] - Innovative medical devices and high-value consumables are under development, with several projects receiving provincial support [5][6] - The company has developed a disposable blood dialysis catheter, which has gained market approval and is expected to improve patient safety and experience [8][10] Group 4: Market Challenges and Strategies - The drug delivery device market is facing increased competition and product homogeneity, leading to a 15% decline in revenue [10] - The company plans to innovate and upgrade drug delivery devices to meet rising clinical demands for safety and precision [10] - The blood dialysis product procurement process has expanded nationwide, benefiting domestic manufacturers [11] Group 5: Fundraising and Future Plans - The company plans to issue convertible bonds to raise up to 530 million yuan for expanding production capacity and enhancing financial stability [12][13] - The funds will support projects including the annual production of 10 million blood dialysis membranes and 10 million blood dialysis devices [13]

Core Viewpoint - Sanxin Medical announced the expansion of centralized procurement for blood dialysis products, indicating a significant shift towards nationwide coverage and enhanced market stability for domestic manufacturers [2] Group 1: Centralized Procurement - Since 2019, certain provinces have initiated centralized procurement for blood dialysis products, with the upcoming implementation of centralized procurement in "twenty-three provinces" and the "Beijing-Tianjin-Hebei 3+N" region by 2024 [2] - The centralized procurement scope has nearly achieved nationwide coverage, which is expected to solidify the market position of leading companies [2] Group 2: Impact on Market Dynamics - The procurement documents stipulate that the execution period for centralized procurement is at least one year, with the possibility of extension based on actual procurement and supply conditions, which will help ensure stable sales channels for the company's products [2] - The competitive pricing strategy and supply capabilities of companies are crucial in the context of blood dialysis centralized procurement, particularly for domestic dialysis machines, which have shown a competitive advantage over imported products [2]

Core Insights - Sanxin Medical announced the launch of its self-developed disposable dialysis catheter, which is the first registered certificate for a domestic brand, providing a significant market first-mover advantage and breaking the complete monopoly of imported products in the domestic market [2] Product and Market Position - The product has participated in the "23 provinces" blood dialysis consumables alliance procurement and the "Beijing-Tianjin-Hebei 3+N" blood dialysis consumables alliance procurement, securing the top selection qualification [2] - The pricing of the product is significantly more advantageous compared to similar imported products, which has led to positive market reception and acclaim [2] Clinical Application and Future Plans - The nationwide medical insurance reimbursement policy for the product is still being gradually improved, and factors such as clinical usage habits and medical service price reforms will affect the large-scale clinical application of the product [2] - The company will continue to promote market expansion and clinical application of the product by focusing on continuous research and innovation for iterative upgrades, addressing clinical pain points, and better meeting clinical and patient needs [2] - Additionally, the company aims to optimize processes and reduce costs to actively respond to medical insurance and procurement policies, alleviating the burden on medical insurance and society, thereby promoting wider product usage [2]

Core Viewpoint - Sanxin Medical announced on August 13 that it is expanding its operational scale and increasing its demand for working capital due to the growth in the medical device industry [2] Group 1: Company Overview - Sanxin Medical has a strong foundation in the medical device industry, leading to continuous expansion of its operational scale [2] - The company plans to issue convertible bonds to enhance its financial strength and optimize its asset structure [2] Group 2: Financial Strategy - The company aims to raise no more than 530 million yuan through the issuance of convertible bonds, which will be used for various projects and to supplement working capital [2] - The funds will specifically support the expansion of production lines for blood dialysis membranes and devices, as well as the establishment of a new production line for blood dialysis tubing [2]