The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), has received tacit approval for a Category 1 biologic preparation, GCK-01, to proceed with clinical trials. The therapeutic candidate is intended for the treatment of recurrent or refractory follicular lymphoma.
GCK-01 is a universal off-the-shelf CAR-NK cell therapy that targets CD20 and is under development for the treatment of B-cell chronic lymphocytic leukemia. The product utilizes CellBri’s Gentle Flex Pro high-throughput fully enclosed automated cell processing system and Gentle P-Pac high-precision automatic packaging system for its development.
Recently, GCK-01 initiated a Phase III clinical study in combination with rituximab for the treatment of recurrent or refractory B-cell non-Hodgkin’s lymphoma.- Flcube.com
