SIHUAN PHARM(00460): Xuan Bamboo Biotech (02575) completes the first patient enrollment in the Phase III clinical trial of Anantrezole Sodium for new indications for the eradication of Helicobacter pylori.

SIHUAN PHARM (00460) announced that its non-wholly owned subsidiary, Xuanzhu Bio-Technology Co., Ltd. (Xuanzhu Bio, stock code: 02575.HK), has successfully completed the enrollment of the first patient in the phase III clinical study of the innovative drug Anailazone Sodium enteric-coated tablets (trade name: Anjiuwei), which is independently developed by Xuanzhu Bio and used in the quadruple therapy regimen containing Anailazone Sodium for the eradication of Helicobacter pylori (Hp). This milestone marks the formal entry of the key registration clinical study into the substantial implementation stage. The study is a multicenter, randomized, double-blind, double-simulation, positive drug parallel-controlled phase III clinical trial, planning to include 556 Hp-positive adult subjects. It will evaluate the effectiveness, safety, and population pharmacokinetic characteristics of the quadruple therapy regimen containing Anailazone Sodium for 14 days of continuous administration for the eradication of Hp compared to the quadruple therapy regimen containing Esomeprazole Magnesium. The primary endpoint is the Hp 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 microaerophilic pathogen closely related to various gastric diseases, including gastric ulcers, chronic progressive gastritis, and gastric cancer. According to Frost & Sullivan, the infection rate of Hp in China is approximately 44%, and the market size of drugs for the treatment of Hp infection is continuously expanding. By 2024, the market size of drugs for the treatment of Hp infection in China has reached RMB 5.5 billion, and it is predicted to increase to RMB 6.8 billion by 2029 and reach RMB 12.6 billion by 2035. The phase III clinical study for Hp eradication indication was approved by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) in April 2026. After quickly completing the enrollment of the first patient, Xuanzhu Bio's clinical development team's efficient execution capabilities were fully demonstrated, marking the official entry of the project into the critical clinical execution stage. If this indication is successfully approved for market launch in the future, it is expected to further expand the target patient population for Anailazone Sodium, accelerate product market growth, and create a new performance growth point in the digestive field for the group and Xuanzhu Bio.