NANJING, China — May 6, 2026 — Leads & Copy — Nanjing Leads Biolabs Co., Ltd. (9887.HK) announced that Dianthus Therapeutics, Inc. (NASDAQ: DNTH), its partner, 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).
Dianthus is prioritizing the clinical development of LBL-047 in SjD, SLE, and DM, three indications with high unmet medical need. 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. This complementary approach targets both the innate and adaptive immune systems, potentially addressing multiple autoimmune indications with improved outcomes.
Dianthus completed an upsized underwritten public offering in March 2026, raising approximately $719 million in gross proceeds to support the global development of LBL-047.
A two-part Phase 1 study in China, involving healthy volunteers (Part A) and patients with SLE (Part B), was initiated in December 2025, with top-line results in healthy volunteers expected in the second half of 2026. Dianthus plans to provide an update on the next steps for advancing its prioritized indications in clinical development upon completion of the Phase 1 study.
LBL-047 is composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain. The protein 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. The drug has been optimized with Fc engineering to extend its half-life, offering potential for subcutaneous self-administration with a dosing frequency of Q4W or less.
Leads Biolabs entered into an exclusive global partnership with Dianthus on October 16, 2025, 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.
Founded in 2012, Leads Biolabs is focused on developing and commercializing therapies for oncology, autoimmune, and other severe diseases. The company has a pipeline of 14 drug candidates, including four in clinical stages.
Leads Biolabs has established R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, and druggability assessment. It has also developed proprietary technology platforms, including LeadsBody platform, X-body platform, and TOPiKinectics.
Leads Biolabs has capabilities across early discovery, translational medicine, clinical development, CMC, and business development.
Source: Leads Biolabs
