Alebund Pharmaceuticals (Jiangsu) Limited

Alebund Pharmaceuticals announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for AP308, a first-in-class engineered recombinant IgA protease for the treatment of IgA nephropathy, and the company plans to initiate clinical trials in the near term. This clearance marks the transition of AP308 from preclinical research into clinical development. AP308 is designed to cleave and clear pathogenic IgA and IgA immune complexes deposited in the glomeruli, potentially offering a functional cure for IgAN. In preclinical studies, once-weekly dosing over eight weeks reduced circulating IgA and immune complexes by approximately 80%, nearly completely cleared glomerular IgA deposits, and improved kidney pathology without toxicity. Alebund, a renal-focused biopharmaceutical company listed on the Hong Kong Stock Exchange under code 09637, holds global rights to develop, manufacture, and commercialize AP308, which was developed using its proprietary Long-Acting Protease Engineering Platform.

Alebund Pharmaceuticals announced its 2026 interim results, reporting a 761.2% surge in revenue to RMB104.2 million, driven by licensing revenue of RMB79.3 million from its AP306 deal with R1 Therapeutics and Mircera sales of RMB24.8 million, up 105% year-on-year. The company's net loss narrowed 22.5% to RMB162.6 million, while adjusted net loss fell 12.6% to RMB130.1 million. During the period, Alebund completed enrollment in the global Phase III trial for AP301, and the NMPA accepted its New Drug Application for review in August 2026. The company also listed on the Hong Kong Stock Exchange in June, raising net proceeds of approximately HK$1,355.8 million, including the over-allotment option. Cash and equivalents stood at RMB1,392.8 million as of June 30, 2026.