On April 8, 2026, the National Medical Products Administration (NMPA) accepted the marketing authorization application (NDA) for Dongyangguang Pharmaceutical's independently developed improved new drug, vonoprazan fumarate sodium chloride injection (hereinafter referred to as "vonoprazan injection"). The indication for this drug is: treatment of peptic ulcer bleeding.
The vonoprazan injection submitted for approval this time is an innovative dosage form developed based on the oral formulation vonoprazan fumarate tablets (trade name: Vocinti® ) , and is classified as a Class 2 new drug. The introduction of this injectable formulation effectively fills a clinical gap that oral formulations cannot meet, and is particularly suitable for high-risk patients with rebleeding peptic ulcers who are unable to take oral medication due to the severity of their condition.

In addition, this drug is a ready-to-use large-volume infusion, which eliminates the need for on-site preparation in clinical use, effectively reducing the risk of contamination by pathogens and insoluble particles, while also avoiding preparation errors and significantly improving the safety and convenience of medication.

The novel acid-suppressing drug vonoprazan is a potassium-competitive acid blocker (P-CAB). It inhibits the conformational change of H+,K+-ATPase by reversibly binding near the K+ binding site, thus preventing the exchange of H+ and K+. It inhibits gastric acid secretion in a K+ competitive manner and has the characteristics of rapid onset of action (full effect of the first dose), no effect of meals, small individual differences, and strong and long-lasting acid-suppressing effect [1] . The oral tablets of this drug were approved for marketing in China in December 2019, and the domestic sales volume exceeded RMB 1 billion by 2025.

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