支柱产品集采后遗症逐步显现 境外依赖与关联交易风险交织 财务数据显示，天星医疗近年业绩保持增长态势。2022年至2024年，公司收入从1.47亿元增长至3.27亿 元，净利润从4034万元提升至9538万元。2025年前5个月，公司实现收入1.11亿元，净利润3260万元， 同比增长142%。 然而，在这些光鲜的增长数据背后，公司的产品结构隐患日益凸显。天星医疗的收入高度依赖植入物产 品，2022年至2024年，该类产品收入占比分别为79.8%、78.2%和76.4%。尽管比例微降，但依然构成公 司收入的绝对主力。 2023年9月，运动医学类耗材被正式纳入第四批国家高值医用耗材集采目录，并于2024年5月开始执行。 此次集采中选产品平均降价幅度达60%，天星医疗虽有14款产品中标，但也不得不接受大幅降价。 集采政策的直接影响已经体现在公司财务报表中。2024年，公司毛利率为69.6%，较2023年的74.3%下 降4.7个百分点。公司坦言，毛利率下滑主要是植入物产品纳入带量采购计划导致销售价格下调所致。 带量采购政策虽然通过"以价换量"策略在短期内帮助公司维持了收入增长，但长期来看，如果销量增长 无法完全抵消 ...

Core Viewpoint - The National Medical Products Administration (NMPA) is accelerating the establishment of quality management system inspection points for high-end medical products, including surgical robots and recombinant collagen, to support the innovation and development of high-end medical devices [1] Group 1: Regulatory Measures - The NMPA has announced measures to optimize the lifecycle supervision of high-end medical devices, focusing on innovative products [1] - Regulatory discussions will be held for representative innovative medical devices, guiding local supervision in provinces with concentrated innovation [1] - The NMPA aims to analyze innovation points and risk points, and develop targeted regulatory measures [1] Group 2: Quality Management System - The NMPA is expediting the formulation of inspection points for quality management systems for various innovative products, including carbon ion/proton therapy systems and animal-derived artificial heart valves [1] - High-end products such as surgical robots, AI medical devices, and recombinant collagen will also have specific quality management system inspection points established [1] Group 3: Capacity Building - The NMPA plans to strengthen the selection and training of national-level inspectors for high-end medical devices [1] - There will be efforts to validate the quality management systems of provincial inspection agencies and enhance their capabilities [1] - The goal is to improve the quality and efficiency of inspections conducted by provincial agencies [1]