Core Insights - The company, Maiwei Biotech, achieved a "zero defect" compliance conclusion during a GMP inspection by INVIMA in Colombia, marking its first successful audit by an overseas regulatory body [1][2] - This inspection evaluated the entire production process of two biosimilar drugs, Prolia® (9MW0311) and Xgeva® (9MW0321), confirming the company's production capabilities and quality management system meet international standards [1][2] Group 1 - The inspection lasted for five days and covered various aspects including facilities, quality systems, production, storage, testing, and release processes [1] - Colombia is recognized as a strategic market in Latin America, with a population of approximately 50 million and a stringent drug regulatory system that aligns closely with international standards such as those from the FDA, EMA, and WHO [1] - The successful audit is expected to enhance the accessibility of Maiwei Biotech's products to more patients and lays a solid foundation for future commercialization in additional countries [2] Group 2 - The company’s Vice President, Hu Huiguo, emphasized that the "zero defect" result is a significant international recognition of its quality management and production capabilities [2] - This achievement demonstrates that Maiwei Biotech's production system can meet high international standards, providing a core competitive advantage for its products in global markets [2]