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

(SeaPRwire) –   NANJING, China, May 05, 2026 — Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs”; Stock Code: 9887.HK) announced today that its partner, Dianthus Therapeutics, Inc. (“Dianthus”; NASDAQ: DNTH), has identified Sjögren’s disease (SjD), systemic lupus erythematosus (SLE), and dermatomyositis (DM) as the initial three priority indications for the clinical advancement of LBL-047 (branded as DNTH212 outside Greater China).

Strategic Focus: Moving Forward with LBL-047 Clinical Development

LBL-047 is a potential first- and best-in-disease bifunctional fusion protein designed to target plasmacytoid dendritic cell (pDC) BDCA2 to decrease Type 1 interferon production, while concurrently blocking BAFF/APRIL to inhibit B cell function. By addressing both the innate and adaptive immune systems, this complementary and distinct approach offers the potential to treat multiple autoimmune conditions with enhanced therapeutic outcomes.

Treating LBL-047 as a key pipeline asset and strategic focus, Dianthus is progressing the clinical development of LBL-047 in SjD, SLE, and DM — three areas characterized by high unmet medical needs. Following an upsized underwritten public offering in March 2026, Dianthus raised approximately $719 million in gross proceeds, creating a solid financial base to fund the global development of LBL-047.

Phase 1 Results Expected in 2H’26

A two-part Phase 1 study was launched in China in December 2025, enrolling healthy volunteers (Part A) and SLE patients (Part B), with top-line data from the healthy volunteer group expected in the second half of 2026. After the Phase 1 study concludes, Dianthus intends to announce the next steps for the clinical progression of its prioritized indications.

About LBL-047
LBL-047 is a bifunctional fusion protein consisting of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain. Its mechanism involves selectively depleting pDCs to lower type 1 interferon levels, while simultaneously inhibiting B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) signaling pathways to curb B-cell activation, differentiation, and antibody generation. By targeting two critical factors in autoimmune disease pathology, this differentiated approach holds promise for treating various autoimmune indications. Moreover, LBL-047 features Fc engineering to prolong its half-life, enabling a convenient subcutaneous self-administration regimen with a dosing frequency of Q4W or less, which supports its potential as a first-line biologic therapy.

On October 16, 2025, Leads Biolabs secured an exclusive global partnership with Dianthus, a clinical-stage biotechnology company focused on developing next-generation treatments for severe autoimmune diseases, with the total potential deal value estimated at up to $1 billion. According to the agreement, Dianthus obtained exclusive global rights to research, develop, manufacture, and commercialize LBL-047 outside Greater China, where it is designated as DNTH212, collaborating to advance its global development and maximize clinical and commercial value.

About Leads Biolabs
Established in 2012, Leads Biolabs is a clinical-stage biotechnology entity committed to the identification, creation, and commercialization of cutting-edge therapies to meet unaddressed medical necessities in oncology, autoimmune diseases, and other serious conditions within China and internationally.

We stand at the forefront of next-generation immuno-oncology therapies, boasting a diverse pipeline of 14 novel drug candidates, which includes four in clinical stages and one in the registration stage.

We utilize a science-centric R&D methodology and have built extensive R&D competencies covering antibody discovery and engineering, in vivo and in vitro efficacy testing, and druggability analysis. Additionally, we have created several proprietary technology platforms, such as the LeadsBody platform (a CD3 T-cell engager platform), X-body platform (a 4-1BB engager platform), and TOPiKinectics (ADC platform). These platforms form the foundation of our ongoing innovation and are confirmed by the clinical data from our bispecific antibody portfolios.

We have built integrated strengths spanning early discovery, translational medicine, clinical trials, CMC, and business development. The inventive character and competitive edge of our drug candidates, combined with our international outlook, forward-thinking strategy, and rapid clinical validation, have established us as a sought-after partner for top-tier industry entities and investment groups. For further details, please visit https://en.leadsbiolabs.com/

CONTACT: Contact:

yizi@leadsbiolabs.com