Renal-focused biopharmaceutical company Alebund Pharmaceuticals (Jiangsu) Limited (HKEX:09637) announced on Friday that China's National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for AP301 capsules, a novel oral iron-based phosphate binder for chronic kidney disease patients receiving maintenance dialysis.

The NDA is supported by results from the RESPOND-1 Phase III clinical trial in China and additional clinical data.

AP301 is designed to provide high phosphate-binding capability without requiring chewing, expanding in gastric fluid or systemic absorption, with the aim of reducing pill burden and improving patient adherence.

The 52-week RESPOND-1 trial enrolled 474 dialysis patients with hyperphosphatemia across 50 sites in China and met both primary efficacy endpoints. The study showed AP301 was non-inferior to sevelamer carbonate in reducing serum phosphate levels and demonstrated sustained efficacy throughout the treatment period.

Alebund reported that AP301 was generally safe and well tolerated, with the most common adverse events being discoloured faeces and diarrhoea.

Results from RESPOND-1 were presented at the American Society of Nephrology (ASN) Kidney Week 2025.