Zhitong Finance App News, Xuanzhu Bio-B (02575) issued an announcement. The results of the Phase III registered clinical study on the treatment of reflux esophagitis, a national Class 1 innovative drug independently developed by the Group, were presented in the form of a Late-Breaking Abstract (LB25) oral report at the 34th European Digestive Disease Week (UEG Week 2026) conference held in Barcelona, Spain recently.
This study was a multi-center, randomized, double blind, double simulation, and parallel control of positive drugs. A total of 500 subjects were randomly enrolled. Of these, 467 were included in the full analysis set (FAS). The subjects were grouped 1:1 and treated with aneprazole sodium or rabeprazole sodium once a day, respectively. It is worth noting that unlike previous studies that have included a large number of patients with grade A mild in LA grade (LA), this study only included patients with severe LA B-D grade erosive esophagitis, and the prospective requirement is that no less than 20% of the subjects are LA C/D grade. The selection criteria are the strictest among the currently published registration studies for similar products. The extent of esophageal mucosal damage in the study population was more severe and treatment was more difficult. The efficacy data obtained in this context is of great clinical reference value.
Research results showed that amneprazole sodium not only achieved the main pre-set end point, but in the full analysis set and compliance protocol set (PPS), the endoscopic healing rate was higher than that of the positive control drug rabeprazole sodium at week 8, showing a trend of efficacy advantages:
Complete analysis set (FAS): aneprazole sodium group 88.4%, rabeprazole sodium group 84.6%, correction risk difference 3.8% (95% CI: -2.3% ~ 10.0%);
Compliance protocol set (PPS): amneprazole sodium group 93.9%, rabeprazole sodium group 89.4%, correction risk difference 4.8% (95% CI: -0.4% ~ 10.0%).
The lower confidence interval limits of both groups (-2.3% and -0.4%) were far above the pre-set non-poor efficacy threshold of -10%, and the non-poor results were stable; among them, the lower confidence interval limit of the PPS set was close to zero. In the context of strictly selected severe patients, all efficacy indicators of aneprazole sodium were higher than rabeprazole sodium, showing a trend of efficacy advantage. Furthermore, the healing rate in week 4 of the PPS set reached 81.6%, indicating the potential for early benefit; the efficacy trend was consistent for each preset subgroup, and the results were steady. In terms of safety, treatment-related adverse events were all grade 1-2, and there were no adverse events related to drugs of grade 3 or above.
Clinical data on the treatment of reflux esophagitis was presented academically during the UEG Week 2026 Late-Breaking session. The evidence-based evidence chain labeling aneprazole sodium received attention and recognition from international academic platforms, which is expected to bring new treatment options to patients around the world.
Anneprazole sodium enteric tablets (trade name: Anjiuwei) were approved for marketing by the China National Drug Administration in June 2023 for the treatment of duodenal ulcers. Aneprazole sodium has an innovative structural design. It has characteristics such as non-enzymatic polyenzyme metabolism and balanced intestinal and renal dual-channel excretion. Only 3.5% is metabolized by CYP2C19, which makes it unaffected by CYP2C19 gene polymorphisms. Compared with previous generations of proton pump inhibitors, there is less risk of using aneprazole sodium in combination. It will be a safer medication choice for patients with multiple medication and people with renal insufficiency, and it is a more suitable proton pump inhibitor for Chinese people. As a national Class 1 innovative drug, amneprazole sodium fills the gap in domestic self-developed proton pump inhibitors, bringing a treatment plan with better efficacy and safety to Chinese patients. In addition to duodenal ulcers that have been approved and reflux esophagitis for which applications for marketing of new drugs have been accepted, phase III clinical studies of amneprazole sodium enteric tablets to eradicate Helicobacter pylori are also progressing simultaneously in China.