XUANZHUBIO-B(02575): The new indication of esomeprazole sodium has been approved to conduct Phase III clinical trials.

XUANZHUBIO-B(02575) announced that the innovative drug Anairazol sodium enteric-coated tablets (trade name: Anjiuwei) independently developed by the group recently received approval from the China National Medical Products Administration's Drug Evaluation Center (CDE) to conduct a Phase III clinical study on the eradication of Helicobacter pylori with a quadruple therapy containing Anairazol sodium enteric-coated tablets. This study is a multicenter, randomized, double-blind, double-simulation, positive drug parallel-controlled Phase III clinical trial, planned to enroll 556 Helicobacter pylori-positive adult subjects. The efficacy, safety, and population pharmacokinetic characteristics of the quadruple therapy containing Anairazol sodium will be evaluated for 14 days as compared to the quadruple therapy containing esomeprazole magnesium bismuth, with the main endpoint being the eradication rate of Helicobacter pylori confirmed by the 13C-urea breath test (13C-UBT) on the 28th day after treatment. Helicobacter pylori is a Gram-negative microaerobic pathogen closely associated with various gastric diseases, including gastric ulcers, chronic progressive gastritis, and gastric cancer. According to Frost & Sullivan, the infection rate of Helicobacter pylori in China is approximately 44%, and the market size for the treatment of Helicobacter pylori infection is continuously expanding. By 2024, the market size for the treatment of Helicobacter pylori infection in China has reached RMB 5.5 billion, projected to increase to RMB 6.8 billion by 2029, and reach RMB 12.6 billion by 2035. The approval of this Phase III clinical trial application for the new indication of Anairazol sodium will help expand the product's indications and enhance the company's influence in the field of digestive disease treatment, which is of great significance for the company's long-term development and commercial layout.