Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that its drug candidate BDB-001 has been granted breakthrough therapy designation (BTD) status in China for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Research indicates that the downstream activation of C5a, a product of the complement system, is a pivotal factor in the pathogenesis of AAV, with C5a binding to its receptors and triggering a range of biological effects. BDB-001 is a monoclonal antibody that targets C5a, capable of efficiently and specifically inhibiting the C5a signaling pathway, which is implicated in numerous inflammatory and immune-mediated diseases. Staidson licensed BDB-001 from InflaRx, and the molecule is said to be similar to InflaRx’s vilobelimab (IFX-1), derived from the same cell line. Vilobelimab has completed Phase II studies for AAV in Europe and the United States and has received emergency use approval for COVID-19.- Flcube.com
