LEADS BIOLABS-B(09887)LBL-047 is prioritizing the development of clinical indications for Sjogren's syndrome, systemic lupus erythematosus, and dermatomyositis.

LEADS BIOLABS-B (09887) announced that its partner Dianthus Therapeutics (Dianthus, Nasdaq code: DNTH) has selected Sjgren's syndrome (SjD), systemic lupus erythematosus (SLE), and dermatomyositis (DM) as the first three priority indications for the clinical development of LBL-047 (development code: DNTH212) in the Greater China region. As a strategic core pipeline asset, Dianthus is advancing the clinical development of LBL-047 to validate its clinical value in the highly unmet needs indications of SjD, SLE, and DM. In March 2026, Dianthus successfully completed a round of oversubscribed public offering, raising approximately $719 million to provide solid capital support for the global development of LBL-047. A two-part Phase I clinical study conducted in China was initiated in December 2025, with healthy volunteers (Part A) and systemic lupus erythematosus patients (Part B) enrolled. The topline data for healthy volunteers is expected to be announced in the second half of 2026. After completion of the Phase I study, Dianthus will update the clinical development plan for the priority indications. LBL-047 is a bifunctional fusion protein composed of a humanized antibody against blood dendritic cell antigen 2 (BDCA2) and a modified transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) extracellular domain, which selectively eliminates plasmacytoid dendritic cells to reduce type 1 interferon production and inhibits the B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) signaling pathways to block B cell activation, differentiation, and antibody production. This differentiated approach targeting two major drivers of autoimmune disease pathogenesis has the potential to treat a variety of autoimmune indications. In addition, LBL-047 has been further optimized by modifying the Fc region to extend half-life, potentially offering a patient-friendly subcutaneous self-administration regimen with dosing frequency of once every four weeks or less, supporting its potential as a first-line biologic therapy. On October 16, 2025, the company entered into an exclusive global partnership agreement with Dianthus, with a total transaction amount of up to $1 billion. Under the agreement, the company granted Dianthus exclusive global rights for the research, development, manufacturing, and commercialization of LBL-047 (known as DNTH212 outside of Greater China), while jointly advancing the global development of LBL-047 to maximize its clinical value and commercial potential.