ALEBUND-B (09637.HK): FDA Clears IND for First-in-class IgA Protease AP308 in IgA Nephropathy; First-in-human Trial to Commence

NewTimeSpace News: On 8 September 2026, Alebund Pharmaceuticals (Jiangsu) Limited (stock code: 09637) issued a voluntary announcement stating that the US Food and Drug Administration (FDA) had approved its investigational new drug (IND) application for AP308, a first-in-class engineered recombinant IgA protease, and that the company will initiate a first-in-human clinical trial of AP308 for the treatment of IgA nephropathy (IgAN). To the company's knowledge, AP308 is the first IgA protease-based IgAN candidate drug to receive clinical trial clearance.

According to the announcement, AP308 was developed based on an IgA protease derived from the human commensal bacterium Thomasclavelia ramosa. It cleaves IgA1, galactose-deficient IgA1 (Gd-IgA1), polymeric IgA and IgA immune complexes, and directly removes IgA immune complex and complement C3 deposits in the glomeruli; preclinical studies showed activity within minutes without affecting other immunoglobulins such as IgG and IgM. Alebund entered into cooperation and licensing agreements with Peking University First Hospital in January 2022 to develop the IgA protease as a potential IgAN therapy, and subsequently developed AP308 as the candidate drug on its proprietary long-acting protease engineering platform, holding global development, manufacturing and commercialisation rights.

Preclinical data showed that in a humanised IgA nephropathy mouse model, weekly subcutaneous dosing of AP308 for eight weeks reduced circulating human IgA and IgA immune complex levels by approximately 80% versus the control group, with near-complete clearance of glomerular IgA deposits, significant reduction of proteinuria and no liver or kidney toxicity signals on repeated dosing. In a paired pre- and post-treatment design, a single dose completely cleared established glomerular IgA and complement C3 deposits within seven days. The findings were published in Kidney International (Volume 110, pages 463-476) in May 2026. Citing CIC data, the announcement noted that there were approximately 9.5 million IgAN patients globally in 2025, of whom approximately 5.1 million were in China, accounting for more than half of the global total.

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