Financial Performance - Total operating revenue for 2025 reached CNY 164,009.37 million, an increase of 9.31% compared to the previous year[4] - Net profit attributable to shareholders was CNY 26,248.93 million, reflecting a growth of 15.43% year-on-year[4] - Net profit attributable to shareholders after deducting non-recurring gains and losses was CNY 23,926.34 million, up 14.01% from the previous year[4] - Basic earnings per share increased to CNY 0.5076, a rise of 14.95% compared to the same period last year[4] Assets and Equity - Total assets at the end of the reporting period were CNY 242,703.91 million, a 9.19% increase from the beginning of the period[5] - Shareholders' equity attributable to the company reached CNY 145,584.51 million, growing by 9.95% from the start of the period[5] - Net asset value per share increased to CNY 2.79, reflecting a growth of 10.28% compared to the beginning of the period[5] Strategic Focus - The company focused on strategic development goals, product innovation, and international market expansion to enhance competitiveness and profitability[5] Financial Condition - The financial condition of the company is stable, with significant growth in asset scale and shareholder equity[5] - The financial data presented is preliminary and subject to audit, with final figures to be disclosed in the 2025 annual report[7]

Core Viewpoint - Sanxin Medical has recently obtained EU MDR certification for its product, which may enhance its market access in Europe and positively impact future international business, although actual sales are subject to regulatory and market environment constraints [2] Recent Events - The EU MDR certification was granted on January 29, 2026, for the "single-use sterile dialysis care package," which is expected to improve the company's entry conditions in the EU market [2] Fund Movements - On January 30, 2026, Sanxin Medical's stock price increased by 2.39%, but there was a net outflow of main funds amounting to 1.1131 million yuan, with a cumulative decline of 1.87% over the past five days. This indicates a divergence in short-term market sentiment [3] - On January 8, 2026, main funds saw a net inflow of 12.2415 million yuan, with a cumulative inflow of 19.8708 million yuan over the past five days, driven by the enthusiasm in the medical device sector, but frequent fund inflow and outflow reflect cautious sentiment in the short term [3] Industry Policy and Environment - The medical device sector benefits from demographic aging, upgraded medical demand, and expectations of industrial internet policies. Sanxin Medical's valuation is at a medium level within the industry, with a TTM price-to-earnings ratio of approximately 19.37 times. The company's Q3 2025 report shows revenue and net profit growth, but attention is needed on industry competition, procurement policy changes, and performance realization pace [4] Shareholder Situation - As of September 30, 2025, the number of shareholders increased to 23,100, a rise of 26.57% compared to the previous period. Institutional investors, such as Dacheng Fund, have entered the top ten circulating shareholders. The increase in shareholder numbers may lead to greater dispersion of shares, potentially affecting stock price stability [5]

（编辑 任世碧） 证券日报网讯 2月5日，三鑫医疗发布公告称，公司控股子公司成都威力生生物科技有限公司（简称"成 都威力生"）因生产经营需要，对《医疗器械生产许可证》的生产地址进行变更并完成了变更登记手 续，于近日取得了四川省药品监督管理局换发的《医疗器械生产许可证》。 ...

Core Viewpoint - Sanxin Medical (300453.SZ) announced that its subsidiary Chengdu Weili Biological Technology Co., Ltd. has changed the production address for its Medical Device Production License, which has been officially registered and approved by the Sichuan Provincial Drug Administration. This change is necessary for operational needs and does not involve substantial changes to the production operations, thus will not significantly impact the company's overall business operations [1]. Group 1 - The subsidiary Chengdu Weili has completed the registration procedures for the change of the production address of its Medical Device Production License [1]. - The change in production address is aligned with the actual operational needs of Chengdu Weili [1]. - The modification does not entail any significant changes to the production operations of Chengdu Weili [1].

证券代码：300453 证券简称：三鑫医疗 公告编号：2026-007 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：眉山经济开发区新区眉州大道西六段 2 号 3#楼 1F101；眉山经济开 发区新区眉州大道西六段 2 号 2#楼 3FA 区；高新区科园南路 88 号 10 栋 3 楼 303、 304 号（仓库 1、仓库 2、仓库 3 除外） 生产范围：（2017 年分类目录）II 类：10-03-血液净化及腹膜透析设备 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。 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"成都威力生"）因生产经营需要，对《医疗器械生 产许可证》的生产地址进行变更并完成了变更登记手续，于近日取得了四川省 ...

证券代码：300453 证券简称：三鑫医疗 公告编号：2026-006 江西三鑫医疗科技股份有限公司 关于全资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。 江西三鑫医疗科技股份有限公司（以下简称"公司"）全资子公司云南三鑫医 疗科技有限公司（以下简称"云南三鑫"）因办理了医用外科口罩、医用防护口罩、 一次性使用医用口罩三项医疗器械注册证的注销手续，相应对《医疗器械生产许可 证》的生产范围进行变更并完成了变更登记手续，于近日取得了云南省药品监督管 理局换发的《医疗器械生产许可证》，现将具体内容公告如下： | 变更事项 | 变更前内容 | 变更后内容 | | --- | --- | --- | | 生产范围 | 2002 分类目录 II 类：6815-注射穿刺器 | | | | 械 III 类：6815-注射穿刺器械，6845-7 | 2002 分类目录 II 类：6815-注射穿刺器 | | | 透析粉、透析液，6866-1 输液、输血器 | 械，III 类：6815-注射穿刺器械，6845-7 | | | 具及管路 | 透析粉、 ...

Core Viewpoint - Sanxin Medical (300453.SZ) is a national high-tech enterprise focused on the research, development, manufacturing, sales, and service of medical devices for the global market, with current products covering three main areas: blood purification, drug delivery devices, and cardiothoracic surgery, while also expanding into vascular intervention and diabetes fields [1] Group 1 - The company is positioned as a high-tech enterprise in the medical device sector [1] - Current product offerings include blood purification, drug delivery devices, and cardiothoracic surgery [1] - The company is exploring expansion into vascular intervention and diabetes [1] Group 2 - There is currently no involvement in brain-machine interface (human brain engineering) fields [1]

Core Viewpoint - Sanxin Medical has received EU MDR certification for several medical products, indicating compliance with EU regulations and enhancing market access in EU countries and other regions recognizing this certification [1] Group 1: Certification Details - The products certified include single-use blood dialysis tubing, single-use blood collection devices, single-use sterile injection needles, single-use retractable self-destructing sterile syringes with needles, single-use precision filter infusion sets, single-use infusion sets, and single-use sterile dialysis care packages [1] - The certification type is EU Certificate, issued by TÜV Rheinland LGA Products GmbH, a German certification body [1] - The approval date for the certification is January 20, 2026, covering Class Ib, Class IIa, and Class Is products [1] Group 2: Market Implications - The certification signifies that the company has established a quality management system that meets EU MDR regulatory requirements [1] - This approval is expected to positively impact the promotion and sales of the company's products in EU countries and other nations that recognize EU MDR certification [1]

证券代码：300453 证券简称：三鑫医疗 公告编号：2026-005 江西三鑫医疗科技股份有限公司 关于公司产品获得欧盟MDR认证的公告 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。 公司四项产品一次性使用无菌注射针（Sterile Hypodermic Needles）、一 次性使用回缩自毁式无菌注射器 带针（Sterile Retractable Safety Syringes for Single Use）、一次性使用精密过滤输液器（Precise Filter Infusion Sets for Single Use）、一次性使用输液器（Sterile Infusion Sets for Single Use） 已于 2025 年 8 月获得 MDR 认证，具体内容详见公司在中国证监会指定的创业板 信息披露网站刊登的《关于公司产品获得欧盟 MDR 认证的公告》（公告编号： 2025-055）。 二、MDR 认证证书的主要内容 证书名称：EU Certificate 制造商：江西三鑫医疗科技股份有限公司 地址：江西省南昌县小蓝经济开发区富山大道 999 号 ...

Core Viewpoint - Sanxin Medical announced the completion of a business change for its wholly-owned subsidiary, Jiangxi Xinweikang Trading Co., Ltd., which enhances its supply chain and comprehensive service capabilities, supporting the integrated layout of medical devices and health products [2]. Group 1 - The business change was officially completed on January 19, 2026, with the issuance of a new business license by the Nanchang Market Supervision Administration [2]. - This change is expected to strengthen the company's operational capabilities in the medical device and health product sectors [2].