LBL-047 Prioritized for Clinical Development in Sjögren's Disease, Systemic Lupus Erythematosus, and Dermatomyositis

NANJING, China, May 05, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs"; Stock Code: 9887.HK) today announced that its partner, Dianthus Therapeutics, Inc. (“Dianthus”; NASDAQ: DNTH), has selected Sjögren's disease (SjD), systemic lupus erythematosus (SLE), and dermatomyositis (DM) as the first three priority indications for clinical development of LBL-047 (known as DNTH212 outside Greater China).

Strategic Priority: Advancing Clinical Development of LBL-047

LBL-047 is a potential first- and best-in-disease bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes.

As a core pipeline asset and strategic priority, Dianthus is advancing the clinical development of LBL-047 in SjD, SLE, and DM — three indications with high unmet medical need. In March 2026, Dianthus completed an upsized underwritten public offering, raising approximately $719 million in gross proceeds, providing a strong capital foundation to support the global development of LBL-047.

Phase 1 Data Anticipated in 2H’26

A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with SLE (Part B) was initiated in December 2025, with top-line results in healthy volunteers expected in 2H’26. Upon completion of the Phase 1 study, Dianthus plans to provide an update on next steps for advancing its prioritized indications in clinical development.

About LBL-047
LBL-047 is a bifunctional fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain. It is designed to selectively deplete pDCs to reduce type 1 interferon production, while simultaneously inhibiting B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) signaling pathways to suppress B-cell activation, differentiation, and antibody production. By targeting two key drivers of autoimmune disease pathogenesis, this differentiated approach has the potential to address multiple autoimmune indications. Additionally, LBL-047 has been optimized with Fc engineering to extend its half-life, offering the potential for a patient-friendly subcutaneous self-administration regimen with a dosing frequency of Q4W or less, supporting its potential as a first-line biologic therapy.

On October 16, 2025, Leads Biolabs entered into an exclusive global partnership with Dianthus, a clinical-stage biotechnology company developing next-generation therapeutics to address severe autoimmune diseases, with the total potential deal value reaching up to $1 billion. Under the agreement, Dianthus was granted exclusive global rights to research, develop, manufacture, and commercialize LBL-047 outside Greater China, where it is known as DNTH212, jointly advancing its global development to maximize clinical and commercial potential.

About Leads Biolabs
Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally.

We are a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 14 innovative drug candidates, including four clinical-stage drug candidates and one registration-stage asset.

We adopt a science-driven R&D approach and have successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. We have also developed multiple proprietary technology platforms, including LeadsBody platform (a CD3 T-cell engager platform), X-body platform (a 4-1BB engager platform), TOPiKinectics (ADC platform), which serve as the cornerstone for our continued innovation and have been validated by the clinical outcomes of our bispecific antibody portfolios.

We have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of our drug candidates, coupled with our global perspectives, proactive strategy, and efficient clinical validation, have made us an attractive partner for leading industry players and investment institutions. For more information, please visit https://en.leadsbiolabs.com/

Contact:

yizi@leadsbiolabs.com

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