XuanZhu Biopharma-B (02575.HK) -1.460 (-5.556%) announced that Annerazone Sodium Enteric-coated Tablets (brand name: Anjiuwei?, an innovative drug independently developed by the group, has recently been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China to commence a Phase III clinical study for bismuth-containing quadruple therapy incorporating Annerazone Sodium Enteric-coated Tablets for the eradication of Helicobacter pylori.The study is a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group Phase III clinical trial, planning to enroll 556 adult subjects who tested positive for Helicobacter pylori. Using a bismuth-containing quadruple therapy regimen including esomeprazole magnesium as the control, the trial will evaluate the efficacy, safety, and population pharmacokinetic characteristics of a 14-day continuous treatment with a bismuth-containing quadruple therapy incorporating Annerazone Sodium for Helicobacter pylori eradication. The primary endpoint is the Helicobacter pylori eradication rate confirmed by the 13C-urea breath test (13C-UBT) on Day 28 after completion of treatment.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 infection rate of Helicobacter pylori in China is approximately 44%. The market size for Helicobacter pylori treatment drugs in China has been expanding continuously, reaching RMB5.5 billion in 2024. It is projected to increase to RMB6.8 billion by 2029 and further to RMB12.6 billion by 2035. (ec/w)(HK stocks quote is delayed for at least 15 mins.)
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