XUANZHUBIO-B(02575): The first patient has been enrolled in the Phase III clinical trial of new indications for eradication of Helicobacter pylori with esomeprazole sodium.

XUANZHUBIO-B(02575) announced that the company's independently developed innovative drug Annilazone sodium enteric-coated tablets (trade name: Anjiuwei) for the eradication of Helicobacter pylori ("Hp") in the III phase clinical study has successfully completed the enrollment of the first patient, marking the official entry of the key registration clinical study into the substantive implementation phase. The study is a multicenter, randomized, double-blind, double-simulation, positive drug parallel-controlled III phase clinical trial, planning to include 556 Helicobacter pylori-positive adult subjects. It will evaluate the effectiveness, safety, and population pharmacokinetic characteristics of the Annilazone sodium-containing bismuth quadruple therapy administered for 14 days for the eradication of Helicobacter pylori. The primary endpoint is the Helicobacter pylori eradication rate confirmed by the 13C-urea breath test ("13C-UBT") on the 28th day after the end of treatment. Helicobacter pylori is a gram-negative microaerobic pathogenic bacterium closely associated with various gastric diseases, including gastric ulcers, chronic progressive gastritis, and gastric cancer. According to Frost & Sullivan, the Helicobacter pylori infection rate 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 had reached RMB 5.5 billion, and it is predicted to increase to RMB 6.8 billion by 2029 and to RMB 12.6 billion by 2035. After receiving approval from the China National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) to conduct the III phase clinical study for Helicobacter pylori eradication indication in April 2026, the enrollment of the first patient was quickly completed, demonstrating the efficient execution capabilities of the company's clinical development team and marking the official entry of the project into the key clinical execution stage. If this indication is successfully approved for market, it is expected to further expand the target patient population for Annilazone sodium, accelerate product market growth, and create a new growth point for the company in the field of digestion.