Clinical-stage biotechnology company Nanjing Leads Biolabs Co Ltd (HK:9887) announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for its first-in-human Investigational New Drug (IND) application for LBL-047.

The product is a bispecific fusion protein composed of a humanised anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain independently developed by Leads Biolabs.

It is the company's first autoimmune therapeutic candidate to enter the clinic.

LBL-047 is aimed at both BDCA2 and BAFF/APRIL and is designed to simultaneously inhibit pDC activity and B-cell maturation. It is further optimised with glycosylation modifications to enhance antibody-dependent cellular cytotoxicity (ADCC) and Fc engineering for an extended half-life.