深圳先进院研究成果填补行业空白 “含镁可降解高分子骨修复材料”获国家药监局批准上市

Core Viewpoint - The "magnesium-containing biodegradable polymer bone repair material" developed by the Shenzhen Advanced Institute of Technology has received approval from the National Medical Products Administration, marking a significant advancement in bone defect repair technology and filling a gap in the industry [1][2]. Group 1: Product Development - The product was developed over 15 years by a team led by Qin Ling and Lai Yuxiao at the Translational Medicine Research and Development Center [1]. - The material utilizes a low-temperature 3D printing method, overcoming multiple technical challenges in orthopedic device manufacturing [1]. - The inclusion of magnesium allows the material to achieve mechanical strength comparable to human cancellous bone, providing stable mechanical support during surgical procedures [1]. Group 2: Clinical Trials - A multicenter clinical trial involving 176 patients with bone defects was conducted across eight major research hospitals in China, including Beijing Jishuitan Hospital and Shanghai Sixth People's Hospital [2]. - The results indicated a bone fusion rate exceeding 98% at 24 weeks, with no reported adverse reactions, demonstrating excellent biocompatibility of the material [2]. - Currently, there are no magnesium-related bone repair materials approved for clinical use as medical devices according to public data from the National Medical Products Administration and the U.S. Food and Drug Administration [2].