Recently, Xuanzhu Biotech achieved a significant milestone in its R&D efforts: the marketing registration application for Anairaazole Sodium Enteric-Coated Tablets (brand name: Anjiuwei®), a nationally approved Class 1 innovative drug independently developed by the company for the treatment of adult reflux esophagitis, has been officially accepted by the National Medical Products Administration. This marks renewed authoritative recognition of the clinical value of anairaazole sodium in the field of digestive disease therapy and brings new therapeutic hope to millions of patients with reflux esophagitis in China.

Evidence-based and highly effective

This application is based on the results of a domestic multicenter Phase III clinical study. Conducted under the leadership of Academician Li Zhaoshen and Director Du Yiqi at the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), the study enrolled a total of 500 participants and represented a pivotal registration trial characterized as multicenter, randomized, double-blind, double-blinded simulation, with a positive drug as the parallel control. The study outcomes demonstrated that antrazole sodium exhibited superior efficacy, with an endoscopic lesion healing rate within 8 weeks exceeding that of the control group, successfully meeting all predefined clinical endpoints. It also demonstrated encouraging clinical value in both primary efficacy endpoints and secondary endpoints such as symptom improvement.

As a prevalent chronic digestive system disorder, reflux esophagitis causes significant impairment to patients' quality of life due to symptoms such as heartburn and gastroesophageal reflux. Prolonged disease progression may further lead to severe complications including ulcers and esophageal strictures, creating an urgent clinical demand in China. The acceptance of the new indication application for Anagliptide Sodium will provide this substantial patient population with a novel therapeutic option that combines high efficacy and safety.

Innovative solutions that precisely meet the needs of China's patients

Antrazole sodium enteric-coated tablets were the first to be approved in 2023 for the treatment of duodenal ulcers. Leveraging innovative molecular structure design, antrazole sodium exhibits significant characteristics such as non-enzymatic and multi-enzyme metabolism, as well as balanced excretion through both intestinal and renal pathways. Only 3.5% is metabolized by CYP2C19, making it less susceptible to the influence of CYP2C19 gene polymorphisms and reducing the risk associated with polypharmacy. It demonstrates outstanding safety profiles in patients undergoing multiple medications or with renal impairment, better meeting the practical needs of Chinese patients with complex medication regimens.

From "filling gaps" to "continuously leading the way"

As an innovative drug that fills the gap in domestically developed proton pump inhibitors, Anagliptide Sodium has provided Chinese patients with a highly effective and safe novel treatment option. Currently, its Phase III clinical study for Helicobacter pylori eradication has completed administration to the first patient, with its indications continuing to expand.

With the official acceptance of new indication applications for reflux esophagitis, this innovative drug is expected to benefit millions of patients with digestive diseases, inject innovative momentum into clinical treatment, and continuously advance the independent innovation process in China's field of digestive disease therapy.