XUANZHUBIO-B(02575): Phase III Clinical Study Data of Anlanzole Sodium for the Treatment of Reflux Esophagitis Presented at UEG Week 2026

XUANZHUBIO-B(02575) announced that the Phase III registered clinical study results of Anlanzole Sodium Enteric-Coated Tablets, a National Class 1 innovative drug independently developed by the Group, 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 Anlanzole Sodium or Rabeprazole Sodium once daily. Notably, unlike previous studies that largely enrolled patients with mild Los Angeles (LA) Grade A disease, this study only enrolled patients with moderate-to-severe erosive esophagitis of LA Grade BD, and prospectively required that no less than 20% of subjects be LA Grade 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 Anlanzole 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 superior efficacy: Full analysis set (FAS): Anlanzole Sodium group 88.4%, Rabeprazole Sodium group 84.6%, adjusted risk difference 3.8% (95% CI: -2.3% to 10.0%); Per-protocol set (PPS): Anlanzole Sodium group 93.9%, Rabeprazole Sodium group 89.4%, adjusted risk difference 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%, demonstrating robust non-inferiority conclusions; the lower limit of the confidence interval in the PPS was close to zero. In the context of a trial with stringent enrollment of moderate-to-severe patients, all efficacy indicators for Anlanzole Sodium were higher than those for Rabeprazole Sodium, showing a trend toward superior efficacy. 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 above 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 international academic recognition of and attention to the evidence chain for Anlanzole Sodium, which is expected to bring a new treatment option to patients worldwide. Anlanzole Sodium Enteric-Coated Tablets (trade name: Anjiuwei) was approved for marketing by China's National Medical Products Administration in June 2023 for the treatment of duodenal ulcers in patients. Anlanzole Sodium features an innovative structural design, with characteristics including non-enzymatic plus multi-enzymatic metabolism and balanced dual-channel intestinal and renal excretion. Only 3.5% is metabolized via CYP2C19, making it unaffected by CYP2C19 genetic polymorphisms. Compared with previous generations of proton pump inhibitors, Anlanzole Sodium carries a lower risk of drug interactions and will become a safer medication option for patients on multiple medications and those with renal insufficiency, making it a proton pump inhibitor more suitable for Chinese people. As a National Class 1 innovative drug, Anlanzole Sodium fills the gap in domestically developed proton pump inhibitors and brings Chinese patients a treatment regimen with both better efficacy and safety. In addition to the approved duodenal ulcer indication and the reflux esophagitis indication for which the new drug application has been accepted, a Chinese Phase III clinical study of Anlanzole Sodium Enteric-Coated Tablets for Helicobacter pylori eradication is also progressing in parallel.