XUANZHUBIO-B(02575): Omeprazole enteric-coated tablets (Anjiuwei) completed the enrollment of all subjects in the Phase III clinical trial for the treatment of reflux esophagitis in China.

XUANZHUBIO-B (02575) announced that the Phase III clinical trial of the innovative drug Anailazol sodium enteric-coated tablets (trade name: Angewei) developed independently by the company for the treatment of adult reflux esophagitis (RE) in China has recently been successfully completed with all 500 subjects enrolled. The Phase III clinical trial is a key study that is multicenter, randomized, double-blind, double-dummy, and parallel-controlled with positive drugs, aimed at evaluating the efficacy and safety of Anailazol sodium enteric-coated tablets in treating Chinese adult reflux esophagitis subjects. The primary clinical endpoint of the trial is the cure rate of reflux esophagitis in endoscopic subjects after a predetermined treatment cycle compared to the positive control drug (within 8 weeks of treatment); secondary endpoints include the cure rate of reflux esophagitis in endoscopic subjects (at the 4th week of treatment), severity and frequency of main symptoms (heartburn and reflux) compared to baseline (at the 4th and 8th week of treatment), and other multidimensional efficacy indicators. Safety endpoints mainly include the types, incidence, and severity of adverse events.