LEADS BIOLABS-B (09887): LBL-047 Receives IND Approval from US FDA

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Sep 22

LEADS BIOLABS-B (09887) announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its proprietary 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 extracellular domain of transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI). Currently, there are no fusion proteins targeting both BDCA2 and TACI that have been approved or are in clinical stages globally, indicating LBL-047's potential as a first-in-class treatment.

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