Xuanzhu Biopharmaceutical Co., Ltd. (XUANZHUBIO-B) has secured authorisation from China’s Center for Drug Evaluation to begin a multi-centre Phase III study evaluating a bismuth-containing quadruple regimen with Anaprazole Sodium Enteric-coated Tablets (An Jiu Wei) for the eradication of Helicobacter pylori infection.

The double-blind, double-dummy, randomised, active-controlled trial will enrol 556 adult H. pylori-positive subjects. Participants will receive a 14-day course of either the anaprazole-based quadruple therapy or an esomeprazole-magnesium-based control regimen. Efficacy will be measured by the H. pylori eradication rate confirmed through 13C-urea breath test on day 28 post-treatment, alongside assessments of safety and population pharmacokinetics.

H. pylori infects about 44% of China’s population, contributing to gastric ulcers, chronic gastritis and gastric cancer. Frost & Sullivan estimates the country’s H. pylori treatment market at RMB5.50 billion in 2024, with projections of RMB6.80 billion by 2029 and RMB12.60 billion by 2035, underscoring the commercial importance of effective therapies.

First approved in June 2023 for duodenal ulcer, Anaprazole Sodium is a Class 1 domestically developed proton pump inhibitor with only 3.5% metabolism via CYP2C19, reducing drug–drug interaction risk and enhancing suitability for patients on multiple medications or with renal impairment. A separate Phase III trial for reflux esophagitis, initiated in July 2025, has completed patient enrolment.

Regulatory clearance to test Anaprazole Sodium in H. pylori expands the drug’s potential indications and strengthens Xuanzhu Biopharma’s positioning in China’s growing digestive-disease treatment market.