The U.S. Food and Drug Administration has cleared Nanjing Leads Biolabs' Investigational New Drug application for LBL-047, a novel bispecific fusion protein that targets two distinct pathways involved in autoimmune disease pathogenesis. The approval, granted on September 19, 2025, enables the Hong Kong-listed biotechnology company to proceed with first-in-human clinical trials for what could be the first therapeutic to simultaneously target both BDCA2 and TACI.
Dual-Target Mechanism Addresses Core Autoimmune Pathways
LBL-047 combines a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody with an engineered transmembrane activator and CAML interactor (TACI) ectodomain. This dual-targeting approach addresses two central drivers of autoimmune disease: B cells and plasmacytoid dendritic cells (pDCs).
The TACI component functions as a trap for BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand), key cytokines that promote B cell and plasma cell differentiation, maturation, and function. Meanwhile, the BDCA2-targeting portion inhibits pDCs, which can produce large amounts of type I interferons and activate T and B cells in autoimmune pathogenesis.
"By targeting both BDCA2 and BAFF/APRIL, LBL-047 is designed to simultaneously inhibit pDC activity and B-cell maturation, providing a synergistic approach to treating autoimmune diseases," according to the company's description of the mechanism.
Broad Therapeutic Potential Across Multiple Conditions
The bispecific protein is being developed for treatment of several autoimmune conditions, including systemic lupus erythematosus, dermatomyositis, IgA nephropathy, and Sjögren's syndrome. The drug has been further optimized with glycosylation modifications to enhance antibody-dependent cellular cytotoxicity (ADCC) and Fc engineering for extended half-life.
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, emphasized the clinical need addressed by this approach: "Autoimmune diseases often require lifelong management and represent the third most common chronic illness after cardiovascular diseases and cancer, underscoring the urgent need for safe and effective long-term therapies."
Strategic Pipeline Expansion
The IND clearance represents a significant milestone for Leads Biolabs as it expands beyond its core oncology focus. Dr. Xiaoqiang Kang, Founder, Chairman and CEO, noted that LBL-047, along with another autoimmune candidate LBL-051, reflects the company's strategy of developing bi- and tri-specific antibody modalities.
"Our approach to antibody-based therapeutics is guided by a deep understanding of disease pathogenesis and powered by our advanced engineering platforms," Kang stated.
Founded in 2012, Leads Biolabs has established itself as a clinical-stage biotechnology company with a differentiated pipeline of 14 innovative drug candidates, including six clinical-stage programs. The company has developed proprietary technology platforms including LeadsBody™ (CD3 T-cell engager), X-body™ (4-1BB engager), and TOPiKinectics™ (ADC platform).
The company has not disclosed specific details about the trial design or timeline for LBL-047, but the FDA clearance enables progression to clinical studies evaluating safety, tolerability, and potential therapeutic effects in humans.
