LEADS BIOLABS-B (09887) announced that on November 25, 2025, its self-developed investigational drug LBL-047 received Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA). LBL-047 is the world's first bispecific fusion protein to achieve simultaneous clinical trial approvals in both China and the U.S. It consists of a humanized anti-BDCA2 (blood dendritic cell antigen 2) antibody and a modified extracellular domain of transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI). Currently, no drugs targeting both plasmacytoid dendritic cells (pDC) and B cells have been approved for clinical trials globally. With this unique mechanism, LBL-047 holds first-in-class and best-in-class potential. The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study involving both healthy adults and systemic lupus erythematosus (SLE) patients. It will evaluate LBL-047's safety, tolerability, and preliminary clinical efficacy in SLE patients. The healthy volunteer study will be led by Professor Meng Xianmin from Shanghai Public Health Clinical Center, while the SLE patient study will be conducted by Professors Ye Shuang and Chen Sheng from Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine. On October 16, 2025, the company entered an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH), a clinical-stage biotech firm focused on developing transformative therapies for severe autoimmune diseases. Dianthus was granted exclusive global rights (excluding Greater China) for the development, manufacturing, and commercialization of LBL-047 (known as DNTH212 outside Greater China), aiming to accelerate its global development and maximize its clinical and commercial potential.
Comments