Rebang Pharmaceutical-B (09637): AP301 capsule application for the marketing of a new drug for hyperphosphatemia in patients with chronic kidney disease undergoing dialysis was accepted by the China Drug Administration

According to Zhitong Finance App, Libang Pharmaceutical-B (09637) announced that the company's AP301 capsule (a novel oral ferrophosphate binder) marketing application for treating hyperphosphatemia in patients with chronic kidney disease undergoing maintenance dialysis was officially accepted by China's State Drug Administration today. The marketing application for this new drug is mainly based on the results of the key phase III clinical trial RESPOND-1 completed by AP301 in China and other cumulative clinical data.

RESPOND-1 is a randomized, open-label, positive drug-controlled key phase III clinical trial conducted at 50 clinical centers in China, led by Professor Zuo Li, Director of Nephrology at Peking University People's Hospital. A total of 474 patients with hyperphosphatemia receiving maintenance dialysis were randomly assigned to the AP301 group (355) or sevillam carbonate group (119) at a ratio of 3:1. The treatment period was 52 weeks. The two groups adjusted the dose based on the same serum phosphorus target value.

The study reached the two predetermined primary efficacy endpoints. The maintenance dose of AP301 has significant clinical and statistical efficacy in reducing serum phosphorus levels compared to an ineffective low dose, and the curative effect of AP301 is stable and long-lasting throughout the 52-week treatment period, reaching the end point of the test design that is not inferior to sevelam carbonate in reducing serum phosphorus levels. AP301 is safe and well tolerated. The most common adverse events are stool discoloration and diarrhea. Diarrhea usually occurs early in treatment and can be relieved without adjusting the treatment plan.