SIHUAN PHARM (00460): The Phase III clinical trial of Esmoprazole Sodium Enteric-Coated Tablets (Anjiuwei) for the treatment of reflux esophagitis in China has completed the enrollment of all subjects.

SIHUAN PHARM (00460) announced that its non-wholly owned subsidiary, Xuanzhu Biotech Co., Ltd. (Stock Code: 02575.HK), has successfully completed the China Phase III clinical trial with all 500 subjects enrolled for its innovative drug Anilazol Sodium enteric-coated tablets (trade name: Anjiuwei) for the treatment of adult patients with reflux esophagitis (RE). The Phase III clinical trial is a key study that is multicenter, randomized, double-blind, and positive drug parallel-controlled, aiming to evaluate the efficacy and safety of Anilazol Sodium enteric-coated tablets in the treatment of Chinese adult patients with reflux esophagitis. The primary clinical endpoint of the trial is the cure rate of reflux esophagitis in endoscopic subjects after a predetermined treatment period, compared to the positive control drug, within 8 weeks of treatment; secondary endpoints include cure rate of reflux esophagitis in endoscopic subjects after 4 weeks of treatment, severity and frequency of major symptoms (heartburn and reflux) compared to baseline at 4 and 8 weeks of treatment, and other multidimensional efficacy indicators. Safety endpoints mainly focus on the types, rates, and severity of adverse events.