SHANDONG XINHUA (00719) announced that it recently received the "Chemical Drug API Marketing Approval Notice" for vonoprazan fumarate ("the product") issued by China's National Medical Products Administration (NMPA).

In March 2024, the company submitted the domestic production registration application for vonoprazan fumarate API to NMPA's Center for Drug Evaluation (CDE), which was subsequently accepted. The approval notice was obtained in November 2025, with the evaluation conclusion approving production of the product.

The product is primarily used for treating reflux esophagitis and is classified as a Category B drug in China's National Reimbursement Drug List (2025). According to relevant statistics, sales of vonoprazan fumarate-related preparations in China's public medical institutions reached approximately RMB 825 million in 2024.