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.
The drug directly clears deposited IgA immune complexes, a mechanism distinct from existing therapies
AP308 is derived from an IgA protease sourced from Thomasclavelia ramosa, a human commensal bacterium. It cleaves IgA1, galactose-deficient IgA1, polymeric IgA and IgA immune complexes, directly removing IgA complexes and complement C3 already deposited in the glomeruli. In preclinical studies, it acted within minutes without affecting IgG or IgM, while most existing and emerging IgAN therapies act on IgA production or downstream inflammation rather than clearing existing renal deposits.
Preclinical data showed an 80% reduction in circulating IgA complexes over eight weeks
In a humanized mouse model, once-weekly subcutaneous dosing of AP308 over eight weeks reduced circulating human IgA and IgA immune complexes by approximately 80% versus controls. Histological analysis at treatment end confirmed glomerular IgA deposits were almost completely cleared, proteinuria decreased significantly, and kidney pathology improved, with no signals of liver or kidney toxicity and no significant rise in anti-drug antibody titers. In a separate paired design, a single dose fully cleared pre-existing chronic glomerular IgA and complement C3 deposits within seven days. The findings were published in May 2026 in Kidney International, the official journal of the International Society of Nephrology.
Alebund holds global rights following a 2022 license deal with Peking University First Hospital
Alebund entered a license agreement with Peking University First Hospital in January 2022 to develop IgA proteases as a potential IgAN treatment, subsequently nominating AP308 as a drug candidate using its proprietary Long-Acting Protease Engineering Platform. The platform extends circulating half-life, reduces renal clearance and lowers immunogenicity while preserving cleavage activity against IgA1, enabling long-acting, low-frequency dosing. Alebund holds global rights to develop, manufacture and commercialize AP308.