Xuanzhu Biology: the application for the new indication of esomeprazole sodium for the treatment of reflux esophagitis has been accepted by the National Medical Products Administration.

Announcement from Xuanzhu Bio: The new indication for the company's independently developed national Class 1 innovative drug Annalrazole sodium enteric-coated tablets for the treatment of adult reflux esophagitis has recently been officially accepted for market application by the National Medical Products Administration. This acceptance is based on the results of a multicenter, randomized, double-blind, double-simulation, positive drug parallel-controlled Phase III clinical trial conducted in China. The study was a randomized controlled trial with rabeprazole sodium as the positive control, with the primary efficacy endpoint being the cure rate of reflux esophagitis evaluated by the researchers within 8 weeks. The results showed a cure rate of 88.4% for the Annalrazole sodium 60 mg group and 84.6% for the rabeprazole sodium 20 mg group, with a difference of 3.8% between the two groups. The trial results met the pre-specified primary endpoint, with the cure rate numerically higher in the Annalrazole sodium group compared to the control group.