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 collaborator, Dianthus Therapeutics, Inc. (“Dianthus”; NASDAQ: DNTH), has designated Sjögren’s disease (SjD), systemic lupus erythematosus (SLE), and dermatomyositis (DM) as the initial three priority indications for the clinical development of LBL-047 (referred to as DNTH212 outside Greater China).

Strategic Priority: Advancing Clinical Development of LBL-047

LBL-047 is a bifunctional fusion protein with the potential to be first- and best-in-disease. It targets plasmacytoid dendritic cell (pDC) BDCA2 to lower Type 1 interferon production, while also inhibiting BAFF/APRIL to curb B cell function. This dual-targeted, complementary strategy engages both the innate and adaptive immune systems, offering a differentiated approach that could lead to better outcomes across multiple autoimmune conditions.

As a core asset in its pipeline and a key strategic focus, Dianthus is progressing the clinical development of LBL-047 in SjD, SLE, and DM—three disease areas with significant unmet medical needs. To support the global development of LBL-047, Dianthus secured a strong financial base by completing an upsized underwritten public offering in March 2026, which generated gross proceeds of approximately $719 million.

Phase 1 Data Anticipated in 2H’26

A two-part Phase 1 study commenced in China in December 2025, enrolling healthy volunteers (Part A) and patients with SLE (Part B). Top-line results from the healthy volunteer cohort are anticipated in the second half of 2026. Following the conclusion of the Phase 1 trial, Dianthus intends to announce an update on the subsequent steps for progressing its prioritized indications in clinical development.

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 is designed to selectively deplete pDCs, thereby reducing type 1 interferon production, while concurrently blocking the B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) signaling pathways to inhibit B-cell activation, differentiation, and antibody production. This distinct strategy, which addresses two primary drivers of autoimmune disease pathogenesis, holds promise for treating a range of autoimmune indications. Furthermore, Fc engineering has been used to optimize LBL-047, prolonging its half-life and enabling the potential for a patient-friendly, subcutaneous self-administration regimen with a dosing frequency of once every four weeks (Q4W) or less, bolstering its profile as a potential first-line biologic therapy.

On October 16, 2025, Leads Biolabs formed an exclusive global partnership with Dianthus, a clinical-stage biotechnology company focused on creating next-generation treatments for severe autoimmune diseases. The total potential value of the agreement is up to $1 billion. As per the terms, Dianthus received exclusive global rights to research, develop, manufacture, and commercialize LBL-047 outside Greater China, under the name DNTH212. The two companies are working together to advance the global development of the asset to maximize its clinical and commercial potential.

About Leads Biolabs
Established in 2012, Leads Biolabs is a clinical-stage biotechnology company committed to discovering, developing, and commercializing novel therapies to meet unmet medical needs in oncology, autoimmune disorders, and other serious diseases in China and worldwide.

The company is a leader in next-generation immuno-oncology, with a differentiated portfolio of 14 innovative drug candidates. This pipeline includes four clinical-stage candidates and one asset in the registration stage.

Leads Biolabs employs a science-driven R&D model and has built extensive capabilities covering antibody discovery and engineering, in vivo and in vitro efficacy evaluation, and druggability assessment. The company has also created several proprietary technology platforms, such as the LeadsBody platform (a CD3 T-cell engager platform), the X-body platform (a 4-1BB engager platform), and TOPiKinectics (an ADC platform). These platforms form the foundation for ongoing innovation and their effectiveness has been demonstrated by the clinical results from the company’s bispecific antibody portfolios.

The company possesses integrated capabilities across early discovery, translational medicine, clinical development, CMC, and business development. The innovative quality and competitive advantages of its drug candidates, along with its global outlook, proactive strategy, and efficient clinical validation, have positioned Leads Biolabs as an attractive partner for top-tier industry players and investment institutions. Additional information is available at https://en.leadsbiolabs.com/

CONTACT: Contact:

yizi@leadsbiolabs.com