XUANZHUBIO-B(02575): The application for a new indication for the treatment of reflux esophagitis with esomeprazole sodium has been accepted by the National Medical Products Administration.

XUANZHUBIO-B (02575) announced that the new indication market application (NDA) for the company's self-developed Class 1 innovative drug Anairazole sodium enteric-coated tablets (trade name: Anjiuwei) for the treatment of adult reflux esophagitis (RE) has been officially accepted by the National Medical Products Administration (NMPA) recently. This acceptance is based on the results of a multicenter, randomized, double-blind, double-simulation, positive drug parallel-controlled Phase III clinical study conducted in China. The study was a randomized controlled trial with rabeprazole sodium as a positive control, and the primary efficacy endpoint was the cure rate of endoscopic reflux esophagitis evaluated by researchers within 8 weeks. The results showed that the cure rate for the Anairazole sodium 60 mg group was 88.4% (95% CI: 84.3% - 92.5%), while the rabeprazole sodium 20 mg group was 84.6% (95% CI: 80.0% - 89.2%), resulting in a difference of 3.8% (95% CI: -2.4% - 10.0%). The trial results met the pre-specified primary endpoint, with the cure rate numerically higher in the Anairazole sodium group compared to the control group. Reflux esophagitis is a common type of gastroesophageal reflux disease with erosions and ulcers of the esophageal mucosa. Typical symptoms include heartburn and reflux, which significantly affect patients' quality of life. Long-term recurrent episodes can lead to complications such as esophageal stricture and Barrett's esophagus. According to Zhoushi Consulting data, the prevalence of reflux esophagitis in China has increased from 36.7 million in 2018 to 38.3 million in 2024, and is expected to reach 42.4 million by 2032, indicating a large and growing clinical demand. The indication for RE is the second market application submission for Anairazole sodium after duodenal ulcer, which is of great significance for fully realizing its clinical value as a new generation proton pump inhibitor. Upon approval, it is expected to provide new and effective acid suppression treatment options for RE patients, further strengthening product market competitiveness and commercial potential. Anairazole sodium enteric-coated tablets (trade name: Anjiuwei) were approved for marketing by the NMPA in June 2023 for the treatment of duodenal ulcers in patients. Anairazole sodium features innovative structural design, with characteristics such as non-enzyme-mediated metabolism, balanced intestinal and renal dual channel excretion, and only 3.5% metabolism through CYP2C19, making it unaffected by CYP2C19 gene polymorphism. Compared to previous generations of proton pump inhibitors, Anairazole sodium has a lower risk of combined medication, making it a safer choice for patients with multiple medications and renal impairment, and is a proton pump inhibitor more suitable for the Chinese population. As a Class 1 innovative drug, Anairazole sodium fills the gap in domestically developed proton pump inhibitors, bringing Chinese patients a treatment option with superior efficacy and safety. In addition to the approved indication for duodenal ulcers and the RE indication accepted in this NDA, a Phase III clinical study in China for the eradication of Helicobacter pylori using Anairazole sodium enteric-coated tablets recently successfully enrolled the first patient for treatment.