P.S.K Biosciences Completes FDA DMF Type II and INCI Filings for Exosome Subpopulations S1 and S2

In May 2025, P.S.K Biosciences completed Drug Master File Type II (DMF Type II) filings with the U.S. FDA for its proprietary human umbilical cord mesenchymal stem cell-derived exosome subpopulation materials, S1 and S2. The DMF numbers are 041763 for S1 and 041762 for S2.

The completion of the DMF Type II filings marks an important milestone in P.S.K Biosciences’ process development, quality research, critical quality attribute characterization, and technical documentation system for MSC-derived exosome subpopulations. The Company has established a systematic framework covering manufacturing process, quality control, batch-to-batch consistency, and product characterization, supporting future development of natural exosome therapeutics, international collaboration, and global expansion.

Recently, P.S.K Biosciences further completed the International Nomenclature Cosmetic Ingredient (INCI) filing for its S1 and S2 exosome subpopulations. The ingredient has been listed under the INCI name Human Umbilical Mesenchymal Stem Cell Extracellular Vesicles, with the INCI number 40148.

The completion of both FDA DMF Type II and INCI filings further reflects P.S.K Biosciences’ continued progress in standardization, industrialization, and international documentation for exosome subpopulation technologies. Moving forward, the Company will continue to advance its engineered exosome delivery platform and natural exosome therapeutics platform, while exploring broader applications in innovative medicines, international collaboration, and high-value bioactive ingredients.

P.S.K Biosciences
Corporate Communications
October 1, 2025