Virtus Biotech-B (09887.HK): LBL-047 obtains approval for US FDA's IND.

Wisdom Financial News App News, Vilitz Bio-B (09887.HK) announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for the 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. Currently, there are no approved or clinical-stage fusion proteins that target both BDCA2 and TACI globally, indicating that LBL-047 has the potential to be a first-in-class drug.