SHENZHEN, China, Sept. 17, 2025 /PRNewswire/ — Kexing Biopharm announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Master File (DMF) registration with the U.S. FDA.
Exosomes, as a next-generation bioactive carrier, boast unique advantages such as low immunogenicity, strong tissue penetration, and potential for targeted modification, offering immense promise for medical applications. However, the technical barriers and research challenges in Exosome development place them at the forefront of complexity among bioactive material fields.
This achievement builds on Kexing’s K’Exosome platform, which is built on high-performance GMP-grade exosome “end-to-end” production technology. The platform’s core strengths lie in its “six highs and one low” advantages: high purity, high yield, high efficiency, high recovery rate, high stability, high bioactivity, and low cost. This enables scalable, standardized, and intelligent manufacturing of clinical-grade exosomes. Additionally, the platform offers advanced engineering capabilities for efficient protein/small nucleic acid loading and precise targeted modification, providing a comprehensive solution from molecular design to process scale-up for next-generation delivery therapies.
Kexing Biopharm will continue to advance its “Innovation + Internationalization” strategy, driving the global development and application of exosome technologies and delivering high-quality solutions for broader healthcare needs.
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