Alebund Pharmaceuticals received FDA IND clearance for its AP308 engineered recombinant IgA protease application.
Published
Signal category
Legal & Regulatory
Quote
“Alebund Pharmaceuticals (09637.HK) today announced that it has recently received clearance from the U.S. Food and Drug Administration (#FDA) of its Investigational New Drug (#IND) application for #AP308, a first-in-class engineered recombinant IgA protease.”
— Alebund Pharmaceuticals team
Company
Alebund Pharmaceuticals
Follow the Science, Serve the Patients | Advancing innovative therapies for kidney disease patients worldwide
- Industry
- Biotechnology Research
- Company size
- 16 employees
Alebund Pharmaceuticals (09637.HK) is a biopharmaceutical company focused on kidney disease and related chronic conditions, aiming to bring better therapies to patients worldwide. We have one of the broadest renal-focused pipelines and an integrated platform spanning R&D, manufacturing and commercialization. Our portfolio comprises seven investigational drug candidates and one commercialized product, Mircera®. Three of the candidates are at the clinical stage: AP301 (Phase III; China Pivotal Phase III trial completed, global MRCT ongoing), AP306 (Phase II) and AP303 (Phase I). Together they address chronic kidney disease (CKD) and its complications, including hyperphosphatemia, renal anemia, IgA nephropathy, diabetic kidney disease, FSGS and ADPKD. We have built a manufacturing site in Yangzhou, Jiangsu to support the future commercial manufacturing of AP301 and other pipeline products and has obtained a Drug Manufacturing License (Category B) issued by the Jiangsu Provincial Drug Administration. The Company has also established a dedicated nephrology sales team responsible for the commercialization of relevant products in China.
Founded 2018