Sihuan Pharmaceutical (00460): Annerazole Sodium Enteric-Coated Tablets ( Anjiuwei® ) Completed enrollment of all subjects in Phase III clinical trial for the treatment of reflux esophagitis in China

LootboxPhobia · 2026-03-22T12:56:41+00:00

Sihuan Pharmaceutical announced that its subsidiary Xuanzhu Biotechnology has completed a Phase III clinical trial of sodium anelazole enteric-coated tablets for gastroesophageal reflux disease (GERD) in adults, involving 500 subjects, aimed at evaluating its efficacy and safety. The trial employed a randomized, double-blind design, with primary focus on the treatment's impact on endoscopic healing rate, as well as monitoring symptom changes and adverse events.

LootboxPhobia

2026-03-22 12:56:41

Abstract generation in progress

CN Finance App News, Four Rings Medical (00460) announced that its wholly owned subsidiary, Xuanzhu Biotechnology Co., Ltd. (Stock Code: 02575.HK), has successfully completed all 500 participants in the Phase III clinical trial of the innovative drug Annerazol sodium enteric-coated tablets (brand name: Ankuwei®) for the treatment of adult reflux esophagitis (RE) in China.

This Phase III clinical trial is a multicenter, randomized, double-blind, double-dummy, positive-controlled pivotal study designed to evaluate the efficacy and safety of Annerazol sodium enteric-coated tablets in treating Chinese adults with reflux esophagitis. The primary clinical endpoint is the healing rate of reflux esophagitis under endoscopy after the treatment period (within 8 weeks of treatment) compared to the positive control drug. Secondary endpoints include the healing rate at week 4, changes in the severity and frequency of main symptoms (heartburn and reflux) from baseline at weeks 4 and 8, and other multidimensional efficacy indicators. Safety assessments mainly focus on the types, incidence, and severity of adverse events.

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