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JY BioMed's HCAb-ADC Technology Earns National Innovation Award, Advancing International Licensing
JY BioMed ADC Technology Wins Innovation Award, Eyes Global Licensing. Taiwan's JY BioMed has earned the 22nd National Innovation Award for its HCAb-ADC platform, secured FDA Orphan Drug Designation for pancreatic cancer, and published findings in Cancer Letters, as it advances international licensing partnerships across lung, pancreatic, and colorectal cancers.
May 15


JY BioMed Secures Dual FDA Recognition, Establishing Early Leadership in the Exosome Space
JY BioMed announces dual FDA Type II Drug Master File acceptance in January 2025, covering UC-MSC and UC-MSC-derived Exosomes. Establishing a fully traceable, vertically integrated regulatory platform, JY BioMed is advancing toward IND submission and positioning as an early leader in the exosome therapeutics space.
Apr 29


JY BioMed’s GDT Platform Published in International Journal; Secures US$38M Licensing and Expands into Nasdaq Cell Therapy Ecosystem
JY BioMed Co., Ltd. is proud to announce the publication of its latest research in the internationally renowned journal Cancer Letters, highlighting a novel antibody-drug conjugate (ADC) platform targeting CEACAM6 for the treatment of aggressive cancers, including brain metastases.
Apr 10


JY BioMed Receives FDA “Study May Proceed” Notification for Phase 1 Clinical Trial of MSC Therapy in Frailty Syndrome
Ji Yan Biomedical Co., Ltd. (JY BioMed) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s Investigational New Drug (IND) application for Stemis™, an investigational mesenchymal stem cell (MSC) therapy, and has issued a “Study May Proceed” notification. This clearance allows JY BioMed to initiate its Phase 1 clinical trial evaluating Stemis™ in elderly participants with mild to moderate frailty syndrome.
Jan 18


JY BioMed and YC Biotech Submit FDA Pre-IND Meeting Request for ExoVeris™ Exosome Therapy — A New Milestone for Taiwan’s Regenerative Medicine Advancement
JY BioMed Co., Ltd. (集研生醫股份有限公司) and YC Biotech Co., Ltd. (昱君生技股份有限公司) have jointly submitted a Pre-Investigational New Drug (Pre-IND) Meeting request to the U.S. Food and Drug Administration (FDA) for ExoVeris™, an exosome-based therapeutic candidate, marking another important step forward in the international development of Taiwan’s regenerative medicine sector.
Oct 23, 2025


JY BioMed and YC Biotech Initiate a New Phase in Stemis™ Clinical Development — FDA Pre-IND Meeting Application Submitted
JY BioMed Co., Ltd. (集研生醫股份有限公司) and YC Biotech Co., Ltd. (昱君生技股份有限公司) jointly announced that they have officially submitted a Pre-Investigational New Drug (Pre-IND) Meeting request to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for Stemis™, a human umbilical cord-derived mesenchymal stem cell (hUC-MSC) therapy.
Sep 17, 2025


JY BioMed Receives FDA Orphan Drug Designation for Anti-CEACAM6 ADC Targeting Pancreatic Cancer
JY BioMed (Ji Yan Biomedical Co., Ltd.), a biotechnology company focused on next-generation immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational therapy, an anti-CEACAM6 humanized heavy chain antibody-drug conjugate (HCAb-ADC), for the treatment of pancreatic cancer.
Jul 24, 2025


JY BioMed Collaborates with YC Biotech to Advance Stem Cell-Based Clinical Trial for Alzheimer’s Disease at Taipei Medical University
JY BioMed is pleased to announce that, in collaboration with our clinical development partner YC Biotech, we have officially initiated preparations for a stem cell-based clinical trial targeting Alzheimer’s disease at Taipei Medical University. The trial protocol has been commissioned and is progressing steadily toward regulatory submission and formal IRB review.
Jun 13, 2025


JY BioMed Receives FDA IND Clearance for Umbilical Cord-Derived MSC Investigational Study
JY BioMed 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.
Apr 23, 2025


JY BioMed and YC Biotech Submit Parkinson’s Disease Regenerative Medicine Trial Proposal to TMU Joint IRB
JY BioMed Co., Ltd. and YC Biotech Co., Ltd. are pleased to announce the formal submission of a regenerative medicine clinical research proposal for Parkinson’s disease to the Joint Institutional Review Board (IRB) of Taipei Medical University and its affiliated hospitals.
Apr 11, 2025


JY BioMed Files Type II Drug Master File (DMF) with U.S. FDA for Dendritic Cell-Derived Exosome Platform
JY BioMed 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.
Mar 18, 2025


JY BioMed Submits Type II Drug Master File (DMF) to U.S. FDA for Hair Follicle Mesenchymal Stem Cell-Derived Exosomes
JY BioMed 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.
Mar 18, 2025


JY BioMed and Taipei Medical University Expand Academic Collaboration to Explore Gamma Delta T Cell Research in Liver Cancer
JY BioMed announced the expansion of its research collaboration with Taipei Medical University (TMU) to investigate the application of gamma delta T cells (γδT) in hepatocellular carcinoma (HCC), the most common form of liver cancer.
Feb 1, 2025


JY BioMed and Taipei Medical University Launch Research Collaboration on MSC/Exosome Applications in Parkinson’s Disease
JY BioMed 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.
Feb 1, 2025


JY BioMed Submits Type II Drug Master File (DMF) to U.S. FDA for UC-MSC-Derived Exosome Manufacturing
JY BioMed 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.
Jan 23, 2025


JY BioMed Submits Type II Drug Master File (DMF) to U.S. FDA for Umbilical Cord-Derived Mesenchymal Stem Cells
JY BioMed 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.
Jan 20, 2025


JY BioMed Submits Type II Drug Master File (DMF) to U.S. FDA for Gamma Delta T Cell
JY BioMed 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.
Jan 15, 2025


JY BioMed Partners with YC Biotech and TMU Delegation to Advance Taiwan–Japan Collaboration in Regenerative and Precision Medicine
JY BioMed announced its active participation in an international biomedical delegation to Japan aimed at fostering cross-border collaboration in regenerative medicine and precision healthcare.
Jan 11, 2025


JY BioMed File U.S. Provisional Patent for Novel Gamma Delta T Cell Expansion Technology
JY BioMed 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.
Jan 7, 2025


JY BioMed and Taipei Medical University Initiate a Targeted Collaboration on Gamma Delta T Cell in Glioblastoma Preclinical Research
JY BioMed 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.
Dec 1, 2024
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