Alebund Pharmaceuticals (Jiangsu) Limited announced that the National Medical Products Administration of China (NMPA) has accepted for review the New Drug Application (NDA) for AP301, a novel oral iron-based phosphate binder developed to treat hyperphosphatemia in chronic kidney disease (CKD) patients undergoing maintenance dialysis.

The NDA is primarily supported by results from RESPOND-1, a randomized, open-label, active-controlled Phase III trial conducted across 50 sites in China. In the study, 474 dialysis patients with hyperphosphatemia were randomized 3:1 to receive AP301 (355 patients) or sevelamer carbonate (119 patients) over 52 weeks, with dose titration to identical serum phosphate targets.

Key efficacy outcomes: • Week 12: AP301 achieved non-inferiority to sevelamer carbonate in lowering serum phosphate, showing least-squares mean reductions of 0.72 mmol/L (2.22 mg/dL) versus 0.70 mmol/L (2.17 mg/dL). The upper bound of the 95% confidence interval for the between-group difference was 0.06 mmol/L, well below the non-inferiority margin of 0.19 mmol/L. • Weeks 24–27: Among responders re-randomized to maintenance versus low-dose AP301, the maintenance group achieved a further 0.58 mmol/L (1.8 mg/dL) greater reduction in serum phosphate (P<0.001). • Week 52: AP301 delivered a larger mean serum phosphate reduction than sevelamer carbonate (0.76 mmol/L vs. 0.72 mmol/L), a higher response rate (66.7% vs. 58.6%), and a lower mean daily dose (6.52 g vs. 7.56 g).

Safety profile: AP301 was generally well tolerated over 52 weeks. The most common adverse events were discoloured faeces and diarrhea; diarrhea typically occurred early and resolved without treatment modification. No signs of iron overload were detected.

Clinical context: Hyperphosphatemia affects about 95% of end-stage renal disease patients on dialysis. Despite existing phosphate binders, 76% of Chinese dialysis patients and over half of U.S. and Japanese hemodialysis patients fail to achieve target serum phosphate levels, highlighting a persistent need for effective, better-tolerated therapies with lower pill burden.

Regulatory note: In line with Hong Kong Listing Rule 18A.08(3), Alebund Pharmaceuticals cautions that successful development and commercialization of AP301 are not guaranteed, and shareholders and potential investors should exercise caution when dealing in the company’s shares.