Zhitong Finance App News, Sihuan Pharmaceutical (00460) announced that the results of the Phase III registered clinical study of the national Class 1 innovative drug, amneprazole sodium enteric tablets for the treatment of reflux esophagitis, independently developed by Xuanzhu Biotechnology Co., Ltd. (Xuanzhu Biotech, stock code: 02575.HK), a non-wholly-owned subsidiary of the group, were conducted in the form of an oral report at the 34th European Digestive Disease Week (LB25) conference held recently in Barcelona, Spain Exhibit.
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 Los Angeles grade (LA), this study only included LAB-D grade patients with severe erosive esophagitis, and the prospective requirement that no less than 20% of the subjects were LAC/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 value was higher than the positive control drug rabeprazole sodium at week 8, showing a trend of efficacy advantages:
—Full analysis set (FAS): aneprazole sodium group 88.4%, rabeprazole sodium group 84.6%, correction risk difference 3.8% (95% CI: -2.3% ~ 10.0%);
—Complying with the 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 of the PPS set reached 81.6% in week 4, indicating the potential for early benefit; the efficacy trend of each preset subgroup was consistent, 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 UEGWEEK2026 late-breaking session, indicating that the evidence-based evidence chain of aneprazole sodium has received attention and recognition from international academic platforms, and is expected to bring new treatment options to patients around the world.