Xinhua Pharmaceutical (HKEx: 00719, SZSE: 000756) Gains Approval for Vonoprazan Fumarate API

Bulletin Express2025-11-17

Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical, HKEx: 00719, SZSE: 000756) announced that it has received approval from the National Medical Products Administration for its domestically produced Vonoprazan Fumarate active pharmaceutical ingredient. The product is primarily indicated for the treatment of reflux esophagitis and is listed as a Category B product in the National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2025).

According to the announcement, sales of Vonoprazan Fumarate-related preparations in China’s public medical institutions reached approximately RMB 825 million in 2024. The new approval is expected to enrich the company’s product line and strengthen its competitiveness, although the pharmaceutical sales business remains vulnerable to policy changes, market fluctuations, and procurement processes. The company affirms that all information in the announcement is accurate and complete.

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