SHANGHAI, August 7, 2026
Alebund Pharmaceuticals announced that China’s National Medical Products Administration (NMPA) has formally accepted for review the New Drug Application (NDA) for AP301, a novel oral iron-based phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) receiving maintenance dialysis. The NDA is primarily supported by results from the pivotal Phase 3 RESPOND-1 trial, in which AP301 demonstrated sustained phosphate reduction and non-inferiority to sevelamer carbonate over 52 weeks. The regulatory acceptance represents a key step toward potential commercialization of AP301 in China.
AP301 Meets Key Phase 3 Efficacy Endpoints
The RESPOND-1 Phase 3 trial enrolled 474 dialysis patients across 50 sites in China, with participants randomized to AP301 or sevelamer carbonate for 52 weeks. The study met both pre-specified primary efficacy endpoints. AP301 demonstrated clinically and statistically significant superiority over its ineffective low-dose control in reducing serum phosphate levels and achieved non-inferiority to sevelamer carbonate. At Week 52, patients receiving AP301 experienced a mean serum phosphate reduction of 0.76 mmol/L (2.35 mg/dL) compared with 0.72 mmol/L (2.22 mg/dL) for sevelamer carbonate. AP301 also achieved a higher target attainment rate of 66.7% versus 58.6%, while requiring a lower mean daily dose exposure.
Novel Oral Phosphate Binder Designed to Reduce Treatment Burden
AP301 is a fiber-iron-based phosphate binder designed to address several challenges associated with long-term phosphate-lowering therapy. According to Alebund, the drug provides high phosphate-binding capability, does not require chewing, does not expand in the stomach when exposed to gastric fluid, and is not systemically absorbed. These characteristics may help reduce pill burden and improve tolerability and treatment adherence among dialysis patients who require chronic phosphate management. In the RESPOND-1 trial, AP301 was generally safe and well tolerated, with discolored feces and diarrhea among the most common adverse events. No notable iron-overload safety signal was observed during the 52-week treatment period.
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NMPA Review Supports Potential Commercialization in China
The NDA acceptance brings AP301 closer to potential commercialization in China, where hyperphosphatemia remains a significant unmet medical need among patients receiving dialysis. Alebund stated that it will actively support the regulatory review process while accelerating commercial launch preparations using its manufacturing base in Yangzhou, Jiangsu. The company is also continuing the global clinical development of AP301, with the broader program aimed at potentially expanding access to the therapy beyond China.
Source:Alebund Pharmaceuticals, press release
