Medigen Biotechnology Corp. (Medigen) and its subsidiary, TBG Biotechnology Corp. (TBG), recently signed a licensing agreement with National Taiwan University (NTU) to develop and commercialize a genetic test designed to assess adverse reactions to antithyroid drugs. Under the agreement, TBG and Medigen obtained the exclusive global rights to apply this invention in in vitro diagnostics. The test is designed to help prevent severe adverse drug reactions in patients with Graves' disease undergoing antithyroid therapy.
NTU has already obtained a Taiwan patent for the licensed technology (Application No. 105104441) and filed patent applications in Mainland China and Hong Kong. This licensing collaboration enables TBG to become the first diagnostic company to commercialize and sell the products of the patented technology in the Greater China region.
Graves' disease, a leading cause of hyperthyroidism, has a prevalence of approximately 1%–1.6% in the general population. Standard treatment involves thionamide-class antithyroid drugs, which are known to carry the risk of causing severe, and potentially fatal, adverse reactions such as agranulocytosis.
To mitigate the risk of antithyroid drug-induced agranulocytosis (TiA), a research team led by NTU College of Medicine Honorary Professor Dr. Tien-Chun Chang, Professor Wei-Shiun Yang of the Institute of Clinical Medicine, Dr. Shyang-Rong Shih of the Department of Internal Medicine, Associate Professor Pei-Lung Chen of the Institute of Medical Genomics and Proteomics, and Research Fellow Dr. Cathy S.-J. Fann of Academia Sinica's Institute of Biomedical Sciences identified two human leukocyte antigen (HLA) alleles associated with TiA. Their findings were published in the prestigious journal Nature Communications and subsequently patented. Following the licensing agreement with NTU, TBG has begun developing genetic tests and providing testing services to assist clinicians in assessing patients' risk of adverse drug reactions.
Professor Tien-Chun Chang, a pioneer in Graves' disease research in Taiwan, commented:
“Over the past several years, we have conducted HLA-related genetic screening studies in patients at NTU Hospital, which significantly reduced the incidence of TiA. To further reduce this risk globally, we are collaborating with Medigen and TBG to commercialize this genetic test.”
Mr. Eugene Cheng, CEO of TBG, stated:
“For nearly a decade, TBG has focused on the development, manufacturing, and global sales of HLA and in vitro diagnostic products, applied in fields such as organ transplantation, transfusion medicine, tissue typing, and autoimmune diseases. The addition of this companion diagnostic product fully aligns with our corporate development goals and enhances our product portfolio. With NTU Hospital being one of the leading medical centers in Asia, we believe this close collaboration will contribute to reducing the incidence of TiA across Asia.”