Recently, the multicenter, randomized, double-blind, positive drug-controlled Phase III clinical study (Registration Number: CTR20252165) of Anagliptide Sodium Enteric-Coated Tablets, an innovative drug independently developed by Xuanzhu Biotech for the treatment of reflux esophagitis, has officially completed enrollment of all participants. This milestone achievement signifies that the pivotal study has fully entered the data collection and analysis phase, laying a solid foundation for the application of a new indication for reflux esophagitis.

This pivotal Phase III clinical study was led by Shanghai Changhai Hospital, with Academician Li Zhaoshen and Professor Du Yiqi serving as co-Leading Principal Investigators (PIs). The enrollment efforts received joint support from 31 authoritative institutions, including the First Affiliated Hospital of Gannan Medical University, Yichun People's Hospital, Zhengzhou First People's Hospital, Hainan Provincial People's Hospital, Pingxiang People's Hospital, and the First Affiliated Hospital of Zhengzhou University. Since the first participant enrollment in July 2025, investigators and project teams at all centers have collaborated closely, strictly controlled quality standards, and efficiently advanced the enrollment process. Here, Xuanzhu Biotech extends its sincerest gratitude to all participants and their families who supported this study, as well as to all experts, scholars, and clinical research staff.

look forward to the future

With the successful enrollment of the final patient, the Phase III clinical study of Anirazole Sodium Enteric-Coated Tablets for the treatment of reflux esophagitis has entered its final sprint phase. Xuanzhu Biotech will continue to allocate resources to ensure the smooth progress of subsequent follow-up and data analysis, aiming to obtain positive clinical outcomes in the near future and strive for early approval of this indication to benefit a wide range of patients.

In the future, Xuanzhu Biotech will continue to deepen its expertise in the field of digestive disease treatment, committed to delivering more high-quality and accessible therapeutic options for the vast global population suffering from digestive disorders through continuous innovation. This demonstrates our corporate mission of "promoting the development of new drugs in China and serving human health" through concrete actions.