U.S. FDA Drug Master Files (DMFs)
At JY BioMedical, we have filed Drug Master Files (DMFs) with the U.S. FDA for a growing portfolio of advanced cell and exosome-based therapies. These include our UC-MSC, UC-MSC-derived exosomes, Gamma Delta T cells, dendritic cell-derived exosomes, and hair follicle mesenchymal stem cell-derived exosomes (HF-MSC-derived). Each DMF submission represents a rigorous and confidential documentation process, detailing the manufacturing, processing, and quality control of our products in alignment with FDA regulatory expectations.
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These filings reflect more than just regulatory compliance—they underscore our unwavering commitment to delivering safe, high-quality, and scalable therapeutic platforms. By meeting these stringent standards, our products are well-positioned to serve as reliable raw materials for partners in biotechnology and pharmaceutical development, supporting new drug applications and clinical research worldwide. This milestone highlights JY BioMedical’s dedication to scientific excellence, innovation, and meaningful collaboration in the evolving landscape of regenerative medicine.
Gamma Delta T
Our Vδ2+ Gamma Delta T cell product offers potent anti-tumor activity and is manufactured under cGMP standards to ensure high quality and consistency. Key manufacturing data has been submitted to the U.S. FDA and is available for reference under DMF #041080.
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With broad potential across solid tumors and immune-related conditions, this product provides a versatile and reliable platform for clinical and therapeutic development.
UC-MSC
Our UC-MSC product is a cGMP-manufactured cell therapy derived from umbilical cord tissue, known for its strong immunomodulatory and regenerative capabilities. Key information has been submitted to the U.S. FDA and is available under DMF #041078.
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Designed for use in neurological and anti-aging applications, this product offers a safe and versatile platform for advancing clinical research in regenerative medicine.
MSC-Exosome
Our UC-MSC-derived exosomes offer a cutting-edge, cell-free approach to regenerative medicine. Sourced from umbilical cord mesenchymal stem cells, these extracellular vesicles are rich in bioactive molecules—such as proteins, lipids, and miRNAs—that support tissue repair, immune modulation, and cell signaling.
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Manufactured under cGMP conditions, and with data submitted to the U.S. FDA (DMF #041203), this product provides a scalable and stable platform for applications in neurological disorders, anti-aging, and skin rejuvenation.
DC-Exosome
Our dendritic cell-derived exosomes represent a novel, cell-free immunotherapeutic approach designed to enhance immune system activation and modulation. Derived from professional antigen-presenting dendritic cells, these extracellular vesicles are naturally enriched with immunologically active molecules—such as MHC complexes, co-stimulatory proteins, and cytokines—that play a pivotal role in immune signaling and tumor surveillance.
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Produced under strict cGMP conditions, and with data submitted to the U.S. FDA (DMF #041487), this product offers a highly stable and scalable platform for applications in cancer immunotherapy, vaccine enhancement, and immune-related disease modulation.
