Core Viewpoint - The announcement highlights the successful completion of the Phase III clinical trial for Anaprazole Sodium Enteric-Coated Tablets (brand name: Anjiuwei®) developed by Xuan Zhu Bio-Tech Co., Ltd., a non-wholly owned subsidiary of Sihuan Pharmaceutical (00460), for the treatment of adult reflux esophagitis in China [1] Group 1 - The Phase III clinical trial involved a total of 500 participants and was designed as a multi-center, randomized, double-blind, parallel-group study [1] - The primary clinical endpoint of the trial was the cure rate of reflux esophagitis in participants, assessed via endoscopy after an 8-week treatment period compared to a positive control drug [1] - Secondary endpoints included the cure rate at week 4, changes in the severity and frequency of primary symptoms (heartburn and reflux) from baseline at weeks 4 and 8, and various efficacy indicators [1] Group 2 - Safety indicators focused on the types, incidence, and severity of adverse events occurring during the trial [1]
四环医药(00460)：安奈拉唑钠肠溶片(安久卫®)治疗反流性食管炎中国III期临床试验完成全部受试者入组