SIHUAN PHARM(00460): The Phase III clinical study data of Xuanzhu Biopharm(02575)'s anlazole sodium for the treatment of reflux esophagitis was presented at UEG Week 2026

SIHUAN PHARM (00460) announced that the Phase III registered clinical study results of anlazole sodium enteric-coated tablets, a National Class 1 innovative drug independently developed by its non-wholly-owned subsidiary Xuanzhu Biopharm Co., Ltd. (Xuanzhu Biopharm, stock code: 02575.HK), for the treatment of reflux esophagitis were recently presented in an oral presentation as a Late Breaking Abstract (LB25) at the 34th United European Gastroenterology Week (UEG Week 2026) held in Barcelona, Spain. This study was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group non-inferiority trial. A total of 500 subjects were randomized, of whom 467 were included in the full analysis set (FAS). Subjects were assigned 1:1 to receive once-daily treatment with either anlazole sodium or rabeprazole sodium. Notably, unlike previous studies that enrolled a large number of patients with mild Los Angeles (LA) Grade A disease, this study enrolled only patients with moderate-to-severe erosive esophagitis of LA Grades BD, and prospectively required that no less than 20% of subjects be LA Grades C/D. The inclusion criteria were the most stringent among currently published registered studies of similar products. The study population had more severe esophageal mucosal injury and higher treatment difficulty, and the efficacy data obtained in this context are of great clinical reference value. The results showed that anlazole sodium not only met the prespecified primary endpoint, but also achieved higher Week 8 endoscopic healing rates than the active comparator rabeprazole sodium in both the full analysis set and the per-protocol set (PPS), showing a trend toward efficacy advantage: Full analysis set (FAS): 88.4% in the anlazole sodium group vs. 84.6% in the rabeprazole sodium group, with an adjusted risk difference of 3.8% (95% CI: -2.3% to 10.0%); Per-protocol set (PPS): 93.9% in the anlazole sodium group vs. 89.4% in the rabeprazole sodium group, with an adjusted risk difference of 4.8% (95% CI: -0.4% to 10.0%). The lower limits of the confidence intervals in both groups (-2.3% and -0.4%) were well above the prespecified non-inferiority margin of -10%, and the non-inferiority conclusion was robust; the lower limit of the confidence interval in the PPS was close to zero. In the context of a trial with strict enrollment of moderate-to-severe patients, all efficacy indicators of anlazole sodium were higher than those of rabeprazole sodium, showing a trend toward efficacy advantage. In addition, the Week 4 healing rate in the PPS reached 81.6%, suggesting potential for early benefit; efficacy trends were consistent across prespecified subgroups, and the results were robust. In terms of safety, treatment-related adverse events were all Grade 12, and no Grade 3 or higher drug-related adverse events occurred. The presentation of these clinical data for the treatment of reflux esophagitis in the Late-Breaking session of UEG Week 2026 marks that the evidence chain for anlazole sodium has gained attention and recognition from an international academic platform and is expected to bring a new treatment option to patients worldwide.