Group 1 - The company SiHuan Pharmaceutical (00460) announced that its non-wholly owned subsidiary, XuanZhu Biotechnology Co., Ltd. (stock code: 02575.HK), has successfully completed the enrollment of 500 participants in the Phase III clinical trial for its innovative drug, Anaprazole Sodium Enteric-Coated Tablets (brand name: Anjiuwei), aimed at treating adult reflux esophagitis (RE) in China [3] - The Phase III clinical trial is a multi-center, randomized, double-blind, double-dummy, positive drug parallel-controlled key study designed to evaluate the efficacy and safety of Anaprazole Sodium Enteric-Coated Tablets in adult participants with reflux esophagitis in China [3] - The primary clinical endpoint of the trial is the cure rate of reflux esophagitis in participants assessed by endoscopy after the treatment period, compared to a positive control drug within 8 weeks of treatment; secondary endpoints include the cure rate at week 4, severity and frequency of primary symptoms (heartburn and reflux) compared to baseline at weeks 4 and 8, among other multidimensional efficacy indicators [3]
四环医药: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