Great News! YSK recently received a confirmation letter from the U.S. Food and Drug Administration (FDA) stating that "Immun-Ex Immune cell serum-free medium"—an immune cell culture medium independently developed and manufactured by Yishengke—has successfully completed its Type II Drug Master File (DMF) filing (DMF No.: 044009).

The DMF filing documentation includes details such as the medium's formulation, raw materials, manufacturing processes, and processing steps. It can be utilized to support Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biologics License Applications (BLA), thereby significantly shortening the drug review and approval timeline.

List of YSK Products with DMF Filings

If you are using the four products listed above for research on antibody drugs, protein-based drugs, or gene therapy projects, and need to submit an IND, NDA, ANDA, another DMF, or an export application to the FDA, please contact your sales representative or reach out via our official WeChat account to request authorization. We will provide a Letter of Authorization (LOA) allowing the FDA to directly review the relevant DMF technical content during the drug application review process, thereby accelerating the FDA's review timeline.