LEADS BIOLABS-B (09887): LBL-024 is administered to the first patient in the Phase II clinical trial for treating bile duct cancer.

LEADS BIOLABS-B (09887) announced that the first patient in the Phase II clinical trial evaluating the efficacy of the opatlizumab monoclonal antibody (PD-L1/4-1BB bispecific antibody LBL-024) for the first-line treatment of bile duct cancer has successfully received treatment, marking significant progress in expanding the indication for this core product. This open-label, multicenter Phase II clinical study, led by Professor Zhou Jian from Zhongshan Hospital, affiliated with Fudan University, is being simultaneously conducted in multiple hospitals nationwide. The trial aims to evaluate the efficacy and safety of opatlizumab combined with first-line treatment in patients with advanced bile duct cancer. LBL-024 is a bispecific antibody targeting PD-L1 and 4-1BB simultaneously, making it the world's first targeted therapy targeting the 4-1BB receptor to enter the registered clinical stage for extrapulmonary neuroendocrine tumors. LBL-024 is also expected to become the first approved drug for the treatment of advanced extrapulmonary neuroendocrine tumors. Utilizing our proprietary X-bodyTM platform, LBL-024 is designed with the optimal 2:2 structure to relieve PD-1/L1 immune suppression and enhance 4-1BB-regulated T cell activation, achieving a synergistic effect in eliminating tumors, with a broader cancer treatment potential compared to PD-1/L1 inhibitors. In April 2024, the company obtained approval from the National Medical Products Administration (NMPA) to conduct a single-arm registration clinical trial, and in October 2024, received Breakthrough Therapy Designation (BTD) for the treatment of late-stage extrapulmonary neuroendocrine tumors with LBL-024 from the NMPA. In November 2024, the company also received Orphan Drug Designation (ODD) for the treatment of neuroendocrine tumors with LBL-024 from the U.S. Food and Drug Administration (FDA).