Sihuan Pharmaceutical Holdings Group Ltd. reported that its non-wholly-owned subsidiary, Xuanzhu Biopharm, has enrolled the first patient in a Phase III, multi-centre, randomised, double-blind, double-dummy trial of Anaprazole Sodium Enteric-coated Tablets (trade name: An Jiu Wei) as part of a bismuth-containing quadruple therapy targeting Helicobacter pylori (Hp) infection.

The study will randomise 556 Hp-positive adults to receive a 14-day regimen containing either anaprazole sodium or the active control, esomeprazole magnesium, alongside bismuth, an antibiotic and an antimicrobial agent. Primary endpoint is Hp eradication confirmed by 13C-urea breath test on day 28 post-treatment. Regulatory clearance for the trial was granted by China’s National Medical Products Administration (CDE/NMPA) in April 2026.

Hp infection affects roughly 44% of China’s population and is linked to gastric ulcer, chronic gastritis and gastric cancer. Frost & Sullivan estimates place China’s Hp-treatment drug market at RMB5.50 billion in 2024, with projections of RMB6.80 billion by 2029 and RMB12.60 billion by 2035, underscoring the commercial potential of new therapies.

Anaprazole Sodium, approved by the NMPA in June 2023 for duodenal ulcer, is a Class 1 innovative proton-pump inhibitor (PPI). Its non-enzymatic plus multi-enzymatic metabolism and dual intestinal–renal excretion limit reliance on CYP2C19 (3.5% metabolism), reducing drug–drug interaction risk and widening applicability to patients on multiple medications or with renal impairment.

Successful approval of the Hp eradication indication would broaden An Jiu Wei’s addressable patient base and strengthen Sihuan Pharmaceutical and Xuanzhu Biopharm’s digestive-disease portfolio, aligning with the Group’s “two-wheel” strategy of expanding medical aesthetics and biopharmaceutical operations.