Sihuan Pharmaceutical Holdings Group Ltd. (Sihuan Pharm) announced that its non-wholly-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd., has received clearance from China’s Center for Drug Evaluation to begin a Phase III clinical study of Anaprazole Sodium Enteric-coated Tablets (brand: An Jiu Wei) as part of a bismuth-containing quadruple therapy targeting Helicobacter pylori infection.

The randomized, double-blind, multi-centre trial will enroll 556 adult subjects who test positive for H. pylori. Participants will receive 14-day treatment regimens comparing Anaprazole-based therapy with an esomeprazole-based control, with the primary endpoint being H. pylori eradication confirmed by a 13C-urea breath test on Day 28 post-treatment.

Market context underscores the opportunity: Frost & Sullivan estimates China’s H. pylori infection rate at 44%, driving a therapeutic market that reached RMB5.50 billion in 2024 and is projected to expand to RMB6.80 billion by 2029 and RMB12.60 billion by 2035. Successful development of the new indication would broaden Anaprazole Sodium’s commercial scope beyond its current approval for duodenal ulcer, enhancing Xuanzhu Biopharm’s presence in gastrointestinal therapeutics.

Anaprazole Sodium—classified as a Class 1 innovative drug in China—features a distinctive metabolic profile with only 3.50% CYP2C19 involvement, reducing potential drug–drug interactions and positioning it as a proton pump inhibitor well suited to the Chinese population.

Sihuan Pharm highlighted that this trial approval aligns with its long-term strategy to strengthen innovative drug pipelines within its dual engines of medical aesthetics and biopharmaceuticals. Xuanzhu Biopharm continues to leverage its small-molecule and biologics R&D platforms to advance a diversified product pipeline across digestion, oncology and non-alcoholic steatohepatitis.