XuanZhu Bio-B (02575) announced that its self-developed innovative drug, Anaprazole Sodium Enteric-Coated Tablets (brand name: Anjiuwe®), has recently received approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration to conduct a Phase III clinical study. The trial will evaluate a bismuth-containing quadruple therapy including Anaprazole Sodium Enteric-Coated Tablets for the eradication of Helicobacter pylori. This multicenter, randomized, double-blind, double-dummy, active-controlled Phase III clinical trial plans to enroll 556 adult subjects with H. pylori infection. Using esomeprazole magnesium-containing bismuth quadruple therapy as the control, the study will assess the efficacy, safety, and population pharmacokinetics of the Anaprazole Sodium-containing bismuth quadruple therapy administered for 14 consecutive days. The primary endpoint is the H. pylori eradication rate confirmed by 13C-urea breath test (13C-UBT) on day 28 after treatment completion. Helicobacter pylori is a Gram-negative microaerophilic pathogen closely associated with various gastric diseases, including gastric ulcers, chronic progressive gastritis, and gastric cancer. According to Frost & Sullivan data, China's H. pylori infection rate is approximately 44%, with the treatment market continuously expanding. The market size for H. pylori infection treatments in China reached RMB 5.5 billion in 2024 and is projected to increase to RMB 6.8 billion by 2029, reaching RMB 12.6 billion by 2035. The approval of this Phase III clinical trial application for the new indication of Anaprazole Sodium will help expand the product's indication scope, enhance the company's influence in the digestive disease treatment field, and holds significant importance for the company's long-term development and commercial strategy.
Comments