SIHUAN PHARM(00460.HK): First Patient Dosed in Phase III Trial of Anaprazole Sodium from Xuanzhu Biologics for Helicobacter Pylori Eradication

NewTimeSpace News: On 22 June 2026, Sihuan Pharmaceutical Holdings Group Ltd. (00460.HK) issued a voluntary announcement disclosing the milestone of first patient enrollment in the Phase III clinical trial of Anaprazole Sodium for the new indication of Helicobacter pylori eradication.

This is a multi-center, randomized, double-blind, double-dummy, positive-parallel-controlled Phase III clinical trial, planning to enroll 556 adult subjects testing positive for Helicobacter pylori. It takes bismuth quadruple therapy with Esomeprazole Magnesium as the control regimen, to assess the efficacy, safety and population pharmacokinetic profiles of 14-day consecutive administration of bismuth quadruple therapy containing Anaprazole Sodium. The primary endpoint is the Helicobacter pylori eradication rate confirmed by the ¹³C urea breath test (¹³C-UBT) on Day 28 post-treatment.

Anaprazole Sodium Enteric-coated Tablets (Anjiuwei®) obtained marketing approval from the National Medical Products Administration (NMPA) in June 2023 for the treatment of duodenal ulcer. Featuring an innovative structural design, the product undergoes both non-enzymatic and multi-enzymatic metabolism with balanced dual intestinal and renal excretion pathways. Only 3.5% of its metabolism relies on CYP2C19, so its efficacy is unaffected by CYP2C19 genetic polymorphisms, making it a proton pump inhibitor (PPI) better suited for Chinese populations.

The Helicobacter pylori infection rate in China stands at approximately 44%. The domestic market size of therapeutic drugs for H. pylori infection reached RMB5.5 billion in 2024 and is projected to hit RMB12.6 billion by 2035.