Ji Yan Biomedical today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its umbilical cord-derived mesenchymal stem cell (UC-MSC) program. The clearance, issued by the Center for Biologics Evaluation and Research (CBER), allows the company to proceed with a first-in-human study under IND number 031083.0.

Ji Yan Biomedical announced today the successful submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its dendritic cell-derived exosome platform. This DMF, assigned Number 041487, provides comprehensive manufacturing and quality control information for investigational use of exosomes obtained from human dendritic cells.

Ji Yan Biomedical announced today the successful submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its dendritic cell-derived exosome platform. This DMF, assigned Number 041487, provides comprehensive manufacturing and quality control information for investigational use of exosomes obtained from human dendritic cells.

February 2025 — Taipei Ji Yan Biomedical today announced the expansion of its research collaboration with Taipei Medical University (TMU)...

Ji Yan Biomedical today announced the establishment of a targeted research collaboration with Taipei Medical University (TMU) to explore the potential of mesenchymal stem cells (MSCs) in addressing Parkinson’s disease, a leading neurodegenerative disorder worldwide.

Ji Yan Biomedical announced today the successful submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its human umbilical cord-derived mesenchymal stem cell (UC-MSC)-derived exosome product. The DMF, assigned Number 041203, documents the manufacturing processes, quality controls, and storage protocols for Ji Yan Biomedical’s investigational exosome platform.

Ji Yan Biomedical announced today the successful submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its umbilical cord-derived mesenchymal stem cell (UC-MSC) product. This filing supports the company’s efforts to align with international regulatory standards for cell-based research materials and investigational development.

Ji Yan Biomedical announced today the submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA), detailing the manufacturing process, quality controls, and facility compliance for its unmodified gamma delta T cell (Vδ2+ γδT) platform.

January 2025 — Kanagawa-ken Ji Yan Biomedical today announced its active participation in an international biomedical delegation to Japan...

Ji Yan Biomedical announced the filing of a U.S. Provisional Patent Application for a novel method aimed at the optimized expansion and activation of gamma delta T (γδT) cells for immunotherapy applications.

Ji Yan Biomedical today announced the initiation of a targeted research collaboration with Taipei Medical University (TMU) to advance preclinical development activities in glioblastoma with its gamma delta T cell (γδT) immunotherapy platform.

According to a market research report, approximately 19.05 million deaths worldwide were attributed to cardiovascular disease (CVD) in 2022. Data from the American Heart Association (AHA) indicates that the global vascular stent market is expected to reach $22.69 billion by 2030, with a compound annual growth rate (CAGR) exceeding 6.0%.

HeXun Biosciences and JY BioMedical have signed an exclusive licensing agreement for “Human-Derived Umbilical Cord Mesenchymal Stem Cell Drug Production Technology.” Following the licensing of related production technology for human umbilical cord mesenchymal stem cells (UC-MSCs) to JY BioMedical, both parties will collaborate to develop specific MSC-derived exosomes using specialized techniques and data.

HeXun Biosciences (6986), a company listed on the Emerging Stock Market, has recently reached a new milestone in its operations. HeXun has signed a "Mesenchymal Stem Cell Drug - Production Technology" licensing agreement with JY BioMedical. HeXun will provide JY BioMedical with its umbilical cord-derived mesenchymal stem cell (UC-MSC) culture technology and exosome production technology.

HeXun Biosciences and JY BioMedical have signed an exclusive licensing agreement for “Human-Derived Umbilical Cord Mesenchymal Stem Cell Drug Production Technology.” Following the licensing of related production technology for human umbilical cord mesenchymal stem cells (UC-MSCs) to JY BioMedical, both parties will collaborate to develop specific MSC-derived exosomes using specialized techniques and data.

Dendritic cells (DCs) are powerful antigen-presenting cells crucial for initiating immune responses. DC-based tumor vaccines have been shown to safely stimulate anti-tumor-associated antigen (TAA) responses, as exemplified by Sipuleucel-T (Provenge), an FDA-approved autologous DC vaccine for castration-resistant prostate cancer. However, such vaccines have generally shown limited clinical efficacy, necessitating strategies to improve their effectiveness.