Sihuan Pharmaceutical Holdings Group Ltd. (Sihuan Pharmaceutical) announced that its non-wholly-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd., presented positive Phase III data for Anaprazole Sodium Enteric-coated Tablets in reflux esophagitis during the Late-Breaking session at UEG Week 2026 in Barcelona.
The multicentre, randomised, double-blind, double-dummy, active-controlled, non-inferiority study enrolled 500 patients, with 467 included in the Full Analysis Set (FAS). Participants were randomised 1:1 to receive Anaprazole Sodium or Rabeprazole Sodium once daily. Unlike prior trials that focused on mild Los-Angeles (LA) Grade A disease, this study restricted enrolment to LA Grade B–D moderate-to-severe erosive esophagitis, with at least 20 % of subjects required to be Grade C/D.
Key efficacy results demonstrated that Anaprazole Sodium met the primary endpoint and delivered numerically higher Week 8 endoscopic healing rates than Rabeprazole: • FAS: 88.4 % vs. 84.6 %; 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 remained well above the predefined –10 % non-inferiority margin, confirming robust non-inferiority. In the PPS, the lower bound (–0.4 %) approached zero, underscoring a trend toward therapeutic benefit. Week 4 healing in the PPS reached 81.6 %, indicating potential for earlier mucosal recovery. Efficacy trends were consistent across all prespecified subgroups.
Safety outcomes were favourable: all treatment-related adverse events were Grade 1–2, and no Grade 3 or higher drug-related events were reported.
Anaprazole Sodium, approved in China in June 2023 for duodenal ulcer, is characterised by minimal CYP2C19 metabolism (3.5 %), balanced intestinal-renal excretion, and low drug-interaction risk, features that align with the metabolic profile of Chinese patients. Beyond reflux esophagitis, a Phase III trial for Helicobacter pylori eradication is ongoing.
Xuanzhu Biopharm, listed on the Hong Kong Stock Exchange in 2025, focuses on gastroenterology, oncology and metabolism, leveraging integrated small-molecule, biologic and AI-driven platforms. Sihuan Pharmaceutical, listed since 2010, continues to pursue a dual-engine growth strategy in medical aesthetics and biopharmaceuticals.
The voluntary disclosure provides an update on the group’s R&D progress; it does not constitute promotional material for any medical product.