Xuanzhu Bio-B (02575) has announced that its self-developed innovative drug, Anaprazole Sodium Enteric-coated Tablets (brand name: Anjiuwei®), has successfully enrolled the first patient into a Phase III clinical study for eradicating Helicobacter pylori (Hp) using an anaprazole sodium-containing bismuth quadruple therapy. This milestone marks the official commencement of the substantial execution phase for this key registration clinical study.

The study is a multicenter, randomized, double-blind, double-dummy, active-controlled parallel-group Phase III clinical trial. It plans to enroll 556 adult subjects who are Hp-positive. Using an esomeprazole magnesium-containing bismuth quadruple therapy as the control, the trial will evaluate the efficacy, safety, and population pharmacokinetic characteristics of the anaprazole sodium-containing bismuth quadruple therapy administered for 14 consecutive days for Hp eradication. The primary endpoint is the Hp eradication rate confirmed by a 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, the Hp infection rate in China is approximately 44%. The market for Hp infection treatment drugs is continuously expanding, reaching RMB 5.5 billion in 2024 in China. It is projected to grow to RMB 6.8 billion by 2029 and reach RMB 12.6 billion by 2035.

Following approval from the China National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) in April 2026, this Phase III clinical study for the Hp eradication indication rapidly completed its first patient enrollment. This demonstrates the high execution efficiency of the company's clinical development team and signifies the project's formal entry into a critical clinical execution phase.

If this new indication is successfully approved for market launch in the future, it is expected to further expand the target patient population for Anaprazole Sodium, accelerate product market penetration, and create a new performance growth driver for the company in the digestive disease field.