科兴制药外泌体原料通过美国FDA DMF备案

Core Insights - Company has successfully registered its exosome raw materials with the FDA under the Type II Drug Master File (DMF), marking a significant achievement in meeting international standards for exosome technology [1] - The exosome technology is recognized for its low immunogenicity, strong penetration capabilities, and potential for targeted modification, making it applicable in various fields including drug delivery, regenerative medicine, and consumer markets such as aesthetics and anti-aging [1][2] - The successful DMF registration indicates that the company has passed rigorous international reviews regarding production processes, quality control, and safety data, which is a testament to its R&D capabilities and will facilitate market entry in high-end segments and other overseas markets [1] Company Developments - The exosome project is based on the K'Exosome delivery technology platform, which enables the large-scale and standardized manufacturing of clinical-grade exosomes, along with efficient loading of proteins/small nucleic acids and precise targeting capabilities [2] - The global market for exosome diagnostics, therapeutics, and research tools reached $227.5 million in 2023 and is projected to grow to $1.3 billion by 2028, reflecting a compound annual growth rate (CAGR) of approximately 42.2% [2] - The company is committed to an "innovation + internationalization" strategy, with significant progress in its overseas business and ongoing efforts to advance "R&D internationalization," positioning itself to penetrate the European, American, and emerging markets effectively [2]