The application rests on findings from the RESPOND-1 study, a multicenter Phase III clinical trial led by Professor Li Zuo of Peking University People's Hospital. In the 52-week study, 474 dialysis patients were randomized to receive either AP301 or sevelamer carbonate. The trial met its primary efficacy endpoints, demonstrating that AP301 was not only non-inferior to the active comparator but also provided sustained phosphate control throughout the year-long treatment period.
In section Releases
China’s NMPA to Review Alebund’s AP301 for Kidney Disease
Alebund Pharmaceuticals has moved its oral iron-based phosphate binder, AP301, closer to market after China’s National Medical Products Administration formally accepted its New Drug Application. The treatment aims to address hyperphosphatemia in dialysis patients, a persistent challenge where existing therapies often struggle with high pill burdens and patient adherence.
Data from the study showed that patients taking AP301 achieved a higher target attainment rate at 66.7% compared to 58.6% for those on sevelamer carbonate, while requiring a lower daily dose. Safety profiles remained consistent across the cohort, with common side effects such as diarrhea resolving without clinical intervention. No significant risk signals regarding iron overload were reported during the trial. Alebund, which operates a manufacturing facility in Yangzhou, plans to leverage these results to accelerate its commercialization strategy as it navigates the regulatory review process.
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