麦得发生物：拿下医用级生物基PHA微球备案，领跑生物医用材料创新赛道！

Core Viewpoint - The successful registration of medical-grade PHA microsphere materials by Zhuhai Maide Biological Technology Co., Ltd. marks a significant advancement in the standardization and regulation of domestic biomedical materials, providing new momentum for the development and industrialization of downstream medical device products [1][5]. Group 1: Main Document Registration - The main document registration system aims to streamline the registration process for medical devices by standardizing the quality data management of key raw materials [2]. - The registration of Maide Biological's medical-grade PHA microspheres will serve as a standardized raw material for Class III absorbable medical devices and drug delivery applications [2]. - Key benefits of the registration include lowering registration barriers, shortening review cycles, and ensuring controllable quality through comprehensive data on the physicochemical properties and biocompatibility of PHA microspheres [2]. Group 2: PHA as a Future Star in Biomedical Materials - Polyhydroxyalkanoates (PHA) are natural polymers synthesized by microorganisms, known for their biodegradability, biocompatibility, and customizable mechanical properties [3]. - PHA degrades into carbon dioxide and water in the body, promoting ATP production and aiding tissue repair, making it an ideal choice for implantable medical devices [3]. - Maide Biological has established a comprehensive technological barrier covering the purification, large-scale production, and end-use applications of medical-grade PHA [3]. Group 3: Core Patent and Production Capacity - The company has developed proprietary purification processes for medical-grade PHA, addressing batch stability issues and has applied for over 50 domestic and international patents [4]. - The production capacity has been upgraded with a thousand-ton production line in Zhanjiang, ensuring a stable supply of industrial-grade PHA and solidifying the supply chain for medical-grade materials [4]. Group 4: Industry Impact - The completion of the main document registration provides a high-standard raw material solution for medical device companies, promoting the independent development of high-end medical materials in China [5]. - Maide Biological aims to break the overseas technology monopoly through innovation, with the large-scale application of PHA microspheres expected to foster a new wave of domestic high-end medical devices in fields such as tumor intervention and aesthetic repair [5].