LEADS BIOLABS-B(09887)LBL-047 has obtained IND approval from the US FDA.

LEADS BIOLABS-B (09887) announced that the US Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for their self-developed drug LBL-047 on September 19, 2025. LBL-047 is a bispecific fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and a modified transmembrane activator and calcium modulator ligand interactor (TACI) extracellular domain. There are currently no approved or clinical stage bispecific fusion proteins targeting both BDCA2 and TACI globally, indicating LBL-047 has the potential to be a first-in-class drug.