LEADS BIOLABS-B Selects Initial Clinical Indications for LBL-047

Stock News
May 06

LEADS BIOLABS-B (09887) announced that its partner, Dianthus Therapeutics (Nasdaq: DNTH), has chosen Sjögren'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 outside Greater China: DNTH212). As a core pipeline asset of strategic focus, Dianthus is advancing the clinical development of LBL-047 to validate its clinical value in these three indications with high unmet medical needs. In March 2026, Dianthus successfully completed an upsized underwritten public offering, raising approximately $719 million in total proceeds, providing solid capital support for advancing the global development of LBL-047. A two-part Phase I clinical study in China was initiated in December 2025, enrolling healthy subjects (Part A) and systemic lupus erythematosus patients (Part B). Top-line data from the healthy subject cohort is expected in the second half of 2026. Following the 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 anti-BDCA2 antibody and a modified extracellular domain of TACI. It works by selectively clearing plasmacytoid dendritic cells (pDCs) to reduce type I interferon production and by inhibiting the BAFF and APRIL signaling pathways to block B-cell activation, differentiation, and antibody production. This differentiated approach targets two key drivers of autoimmune disease pathogenesis, giving it potential for treating a range of autoimmune indications. Furthermore, LBL-047 is further optimized through Fc region engineering to extend its half-life, offering the potential for a patient-friendly subcutaneous self-administration regimen with a dosing frequency of once every four weeks or less, supporting its potential as a first-line biological therapy. On October 16, 2025, the company entered into an exclusive global partnership with Dianthus, with a total potential transaction value 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 (referred to as DNTH212 outside Greater China) outside Greater China, aiming to jointly advance the global development of LBL-047 and maximize its clinical value and commercial potential.

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