XUANZHUBIO-B's stock soared 6.13% at the market open on Wednesday, following the announcement of a significant regulatory milestone for its key drug candidate.

The biopharmaceutical company received approval from China's Center for Drug Evaluation to initiate a Phase III clinical trial evaluating its drug, Anaprazole Sodium Enteric-Coated Tablets, for the eradication of Helicobacter pylori infection. The multicenter trial plans to enroll 556 adult subjects and will assess the efficacy and safety of a bismuth-containing quadruple therapy regimen.

This development represents a major expansion opportunity for Anaprazole Sodium, which was initially approved for duodenal ulcer treatment in June 2023. The H. pylori treatment market in China represents a substantial commercial opportunity, with infection rates around 44% of the population and market projections showing growth from RMB 5.5 billion in 2024 to RMB 12.6 billion by 2035.