Xuanzhu Bio-B (02575) has announced that the Phase III registrational clinical study results for its independently developed national Class 1 innovative drug, Anlaluzole Sodium Enteric-Coated Tablets, in the treatment of reflux esophagitis were recently presented as a Late-Breaking Abstract (LB25) oral presentation 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, with 467 included in the Full Analysis Set (FAS). Subjects were divided 1:1 to receive either Anlaluzole Sodium or Rabeprazole Sodium once daily.
Notably, unlike previous studies that predominantly enrolled patients with mild Los Angeles Classification (LA) Grade A disease, this study exclusively enrolled patients with moderate-to-severe erosive esophagitis classified as LA Grade B-D, with a prospective requirement that no less than 20% of subjects be LA Grade C/D. The inclusion criteria were the most stringent among all published registrational studies of similar products to date. The study population had more severe esophageal mucosal damage and higher treatment difficulty, making the efficacy data obtained under these circumstances highly valuable for clinical reference.
The results showed that Anlaluzole Sodium not only met the pre-specified primary endpoint, but also achieved higher endoscopic healing rates at Week 8 compared to the active control Rabeprazole Sodium in both the Full Analysis Set and the Per-Protocol Set (PPS), demonstrating a trend toward efficacy advantage. In the Full Analysis Set (FAS): Anlaluzole Sodium group 88.4% vs. Rabeprazole Sodium group 84.6%, adjusted risk difference 3.8% (95% CI: -2.3% to 10.0%). In the Per-Protocol Set (PPS): Anlaluzole Sodium group 93.9% vs. 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 pre-specified non-inferiority margin of -10%, confirming a robust non-inferiority conclusion. Notably, the lower limit of the confidence interval in the PPS set approached zero. Against the backdrop of stringent enrollment of moderate-to-severe patients, Anlaluzole Sodium demonstrated higher efficacy across all efficacy measures compared to Rabeprazole Sodium, showing a trend toward efficacy advantage.
Additionally, the Week 4 healing rate in the PPS set reached 81.6%, suggesting potential for early clinical benefit. Efficacy trends were consistent across all pre-specified subgroups, demonstrating robust results. Regarding safety, all treatment-related adverse events were Grade 1-2, with no Grade 3 or above drug-related adverse events reported.
The presentation of these clinical data for reflux esophagitis treatment at the Late-Breaking session of UEG Week 2026 signifies that the evidence chain for Anlaluzole Sodium has garnered attention and recognition from the international academic community, potentially bringing new treatment options to patients worldwide.
Anlaluzole Sodium Enteric-Coated Tablets (trade name: Anjiuwei) was approved by China's National Medical Products Administration in June 2023 for the treatment of duodenal ulcers. Anlaluzole Sodium features an innovative structural design with characteristics including non-enzymatic plus multi-enzymatic metabolism and balanced dual-channel excretion through both intestinal and renal pathways. Only 3.5% is metabolized via CYP2C19, making it unaffected by CYP2C19 genetic polymorphisms. Compared with earlier generations of proton pump inhibitors, Anlaluzole Sodium carries a lower risk of drug interactions and is expected to become a safer medication option for patients on multiple medications and those with renal impairment, making it a proton pump inhibitor better suited for Chinese patients.
As a national Class 1 innovative drug, Anlaluzole Sodium fills the gap in domestically developed proton pump inhibitors in China, bringing Chinese patients a treatment option with both superior efficacy and safety. In addition to the approved indication for duodenal ulcers and the accepted New Drug Application for reflux esophagitis, a Phase III clinical study of Anlaluzole Sodium Enteric-Coated Tablets for Helicobacter pylori eradication is also being advanced in China.
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