By Fineline Cube 
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for LBL047, its self-developed bispecific fusion protein for systemic lupus erythematosus (SLE).
Regulatory Milestone & Drug Profile
| Attribute | Details |
|---|---|
| Company | Nanjing Leads Biolabs Co., Ltd. (9887.HK) |
| Product | LBL047 (DNTH212 outside Greater China) |
| Approval | NMPA IND approval |
| Milestone | World’s first bispecific fusion protein targeting both pDCs and B cells to receive IND approval in China and US |
| Mechanism | Anti-BDCA2 antibody + engineered TACI ectodomain |
Unique Mechanism of Action
LBL047 is a bispecific fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain:
- Selective pDC Depletion: Reduces type 1 interferon production
- B-Cell Inhibition: Blocks BAFF and APRIL signaling to suppress B cell activation, differentiation, and antibody production
- Dual Targeting: Addresses two key drivers of autoimmune disease pathogenesis
- Fc Engineering: Optimized for extended half-life
Clinical Trial Design
| Parameter | Details |
|---|---|
| Study Type | Double-blind, randomized, placebo-controlled, dose-escalation Phase 1 |
| Population | Healthy adults and SLE patients |
| Primary Endpoints | Safety, tolerability |
| Secondary Endpoints | Preliminary clinical efficacy in SLE patients |
| Status | Trial initiation expected Q1 2026 |
Global Partnership & Commercial Rights
On October 16, 2025, Leads Biolabs entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH):
- Dianthus granted exclusive rights outside Greater China
- LBL047 known as DNTH212 in ex-China markets
- Jointly advancing global development to maximize clinical and commercial potential
Strategic Outlook & First-in-Class Potential
- Market: No approved drugs targeting both pDCs and B cells globally
- Indication Expansion: Potential to address multiple autoimmune diseases beyond SLE
- Competitive Edge: First and best-in-class potential in emerging bispecific autoimmune space
- China-US Parallel Development: IND approvals in both major markets enable synchronized clinical development
Forward‑Looking Statements
This brief contains forward‑looking statements regarding LBL047 development timelines, clinical outcomes, and partnership execution. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech