The Center for Drug Evaluation (CDE) of China has indicated that Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) is on track to receive Breakthrough Therapy Designation (BTD) for its bispecific antibody GR1803. This designation is for the treatment of recurrent refractory multiple myeloma (RRMM) in patients who have previously undergone at least three lines of treatment, including a protease inhibitor, an immune modulator, and an anti-CD38 monoclonal antibody.
GR1803 is designed to target both BCMA and CD3, effectively recruiting and activating cells to eliminate tumor cells while minimizing non-specific T cell activation typically associated with CD3 antibodies. This innovative approach aims to balance therapeutic efficacy with safety. In a Phase I study, GR1803 demonstrated an overall objective response rate (ORR) of 85% when administered intravenously once weekly. Notably, the drug achieved a baseline ORR of 100% in subjects with extramedullary plasmacytoma (EMM), showcasing its potential in addressing this challenging disease.- Flcube.com
