SINGAPORE, July 16, 2024 /PRNewswire/ -- Biosyngen, a leading biotechnology company focused on the development of innovative cell therapies, recently announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has approved the initiation of a pivotal Phase ll clinical trial evaluating BRG01, the company's autologous Epstein-Barr virus (EBV) specific chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of patients with recurrent or metastatic EBV-positive nasopharyngeal carcinoma. BRG01 is the world's first CAR-T therapy for solid tumor to obtain clinical trial approvals from China and the U.S. and to advance to a pivotal Phase ll clinical trial, representing a significant milestone in the field of cell-based immuno-therapies for solid cancers.
Biosyngen Announces FDA Fast Track Designation for BST02
SINGAPORE, Oct. 26, 2023 /PRNewswire/ -- On October 26, 2023, Biosyngen's TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA. BST02, a breakthrough product in the field of cell and gene therapy, represents the world's first TIL therapy designed for the treatment of all types of liver cancer to progress into the clinical stage.
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