Alebund Wins FDA IND Clearance for AP308, First-in-Class IgAN Protease
Shanghai – September 11, 2026 -- Alebund Pharmaceuticals (Jiangsu) Limited (HKEX: 09637) has received U.S. FDA clearance of its Investigational New Drug application for AP308, a first-in-class engineered recombinant IgA protease targeting IgA Nephropathy (IgAN), moving the candidate from preclinical research into clinical development.
AP308 targets a disease affecting 9.5 million people worldwide
IgAN is the most common primary glomerulonephritis globally, with an estimated 9.5 million patients in 2025, including 5.1 million in China, more than half of the global total, according to China Insights Consultancy. Under current treatment strategies, median kidney survival is approximately 11 to 12 years, and roughly 60% of patients in a Chinese cohort progressed to end-stage renal disease within 15 years of diagnosis, per long-term studies in China and the UK.