Nanjing Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment

Nanjing Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment

Nanjing Leads Biolabs Co., Ltd, a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its Category 1 drug LBL-034, which is intended for the treatment of multiple myeloma (MM).

LBL-034: A Novel Bispecific Antibody Targeting GPRC5D for Cancer Immunotherapy
LBL-034 is a novel bispecific antibody (BsAb) developed using Leads Biolabs’ proprietary T cell engager antibody technology platform, LeadsBodyTM. According to the company’s announcement, LBL-034 is the world’s third GPRC5D-targeted CD3 T-cell engager to reach the clinical stage. The drug is designed to simultaneously bind to CD3 on T cells and the tumor-associated antigen GPRC5D on cancer cells, bringing T cells into close proximity with cancer cells and effectively activating them to attack and kill the targeted cancer cells.- Flcube.com

Insight, China's Pharmaceutical Industry