By Fineline Cube 
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced today that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its self‑developed bispecific fusion protein LBL‑047. The approval allows the company to advance LBL‑047 into clinical trials in the United States.
What Is LBL‑047?
- Dual Targeting Design – LBL‑047 fuses a humanized anti‑BDCA2 antibody with a modified extracellular domain of TACI (transmembrane activator and calcium‑modulating ligand interactor).
- Mechanism of Action – By simultaneously engaging BDCA2 on plasmacytoid dendritic cells (pDCs) and BAFF/APRIL pathways via TACI, the molecule suppresses interferon‑α (IFN‑I) secretion and blocks B‑cell and plasma‑cell differentiation.
- Enhanced ADCC – Glycosylation modifications boost antibody‑dependent cell‑mediated cytotoxicity, potentially increasing therapeutic potency.
Therapeutic Potential
LBL‑047’s unique dual blockade offers broad suppression of aberrant immune responses, positioning it as a promising candidate for a spectrum of autoimmune disorders in which B cells and/or pDCs are central drivers. Early pre‑clinical data suggest activity in:
- Systemic lupus erythematosus
- Dermatomyositis
- IgA nephropathy
- Sjögren’s syndrome
No other agent has simultaneously targeted BDCA2 and TACI with an IND‑approved platform, giving LBL‑047 first‑in‑class advantage.
Market and Regulatory Outlook
- Regulatory Pathway – The FDA IND clearance paves the way for Phase I safety studies, with potential rapid progression to Phase II efficacy trials if early results are favorable.
- Commercial Opportunity – Successful clinical development could unlock a sizable market across multiple autoimmune indications, potentially positioning Nanjing Leads Biolabs as a key player in next‑generation immunotherapies.-Fineline Info & Tech