Alebund Pharmaceuticals (Jiangsu) Limited (HKEX: 09637) announced on August 7, 2026 that China's National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for AP301 capsules, a novel oral fiber-iron-based phosphate binder, for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients receiving maintenance dialysis. The filing rests primarily on results from RESPOND-1, the company's pivotal Phase III trial conducted across 50 sites in China.
The acceptance positions AP301 as a potential new entrant in a market where phosphate control remains poor despite multiple approved therapies. According to data cited by the Shanghai-based company, approximately 76% of dialysis patients in China fail to achieve target serum phosphate levels of 1.13–1.78 mmol/L, a rate materially higher than in the United States (52%) or Japan (39%), according to 2021 Dialysis Outcomes and Practice Patterns Study (DOPPS) data.
RESPOND-1 was a randomized, open-label, active-controlled Phase III trial enrolling 474 patients with hyperphosphatemia on maintenance dialysis, randomized 3:1 to AP301 (355 patients) or sevelamer carbonate (119 patients) over 52 weeks. The trial carried two pre-specified primary endpoints.
At Week 12, AP301 demonstrated non-inferiority to sevelamer carbonate in reducing serum phosphate levels, with least-squares mean reductions from baseline of 0.72 mmol/L versus 0.70 mmol/L, respectively. The upper bound of the 95% confidence interval for the between-group difference was 0.06 mmol/L, below the pre-defined non-inferiority margin of 0.19 mmol/L. At Weeks 24–27, among AP301 responders re-randomized to maintenance dose or an ineffective low dose, the maintenance-dose group achieved statistically significant superiority over the low-dose group, with a between-group difference of −0.58 mmol/L (P<0.001).
At Week 52, the AP301 group showed a greater mean serum phosphate reduction from baseline than the sevelamer carbonate group (0.76 mmol/L versus 0.72 mmol/L), a higher target attainment rate (66.7% versus 58.6%), and a lower mean daily dose (6.52 g/day versus 7.56 g/day). No iron-overload signal was observed over the 52-week period. The most common adverse events were discolored feces and diarrhea; diarrhea was predominantly early-onset, mild, and self-resolving, with a discontinuation rate of 0.6%. Full Phase III results were presented at ASN Kidney Week 2025.