Xuanzhu Biopharmaceutical Co., Ltd. (XUANZHUBIO-B) released detailed Phase III results for its Class 1 innovative proton-pump inhibitor, Anaprazole Sodium Enteric-coated Tablets, at the 34th UEG Week 2026 in Barcelona.
The multicentre, randomised, double-blind, double-dummy, active-controlled non-inferiority study enrolled 500 patients with Los-Angeles (LA) Grade B–D reflux esophagitis; 20% or more were LA Grade C/D, reflecting a more severe population than in most published comparator trials. A total of 467 patients were assessed in the Full Analysis Set (FAS).
Key efficacy read-outs: • Week 8 endoscopic healing rate (primary endpoint) – FAS: 88.4 % for Anaprazole vs 84.6 % for Rabeprazole; adjusted risk difference +3.8 % (95 % CI: –2.3 % to +10.0 %). – Per-Protocol Set (PPS): 93.9 % vs 89.4 %; adjusted risk difference +4.8 % (95 % CI: –0.4 % to +10.0 %). Both confidence-interval lower bounds were well above the pre-specified non-inferiority margin of –10 %, confirming non-inferiority and indicating a numerical efficacy advantage for Anaprazole.
• Week 4 PPS healing rate reached 81.6 %, suggesting early therapeutic benefit.
Safety profile: All treatment-related adverse events were Grade 1–2; no Grade 3 or higher drug-related events were reported.
Regulatory and development status: Anaprazole Sodium (trade name “An Jiu Wei”) has been approved in China since June 2023 for duodenal ulcer. The new drug application for reflux-esophagitis is under review, while a parallel Phase III trial for Helicobacter pylori eradication is ongoing.
Mechanistic highlights: The molecule employs a novel structure with non-enzymatic plus multi-enzymatic metabolism and dual intestinal–renal excretion. Only 3.5 % is metabolised via CYP2C19, minimising gene polymorphism impact and drug–drug interaction risk, offering a potentially safer option for patients on multiple medications or with renal impairment.
The favourable Phase III data, disclosed voluntarily by XUANZHUBIO-B, have garnered international attention and reinforce Anaprazole Sodium’s potential as a differentiated treatment for patients with moderate-to-severe reflux esophagitis.
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