Recently, 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"), for the treatment of peptic ulcer bleeding.

Gastrointestinal ulcer bleeding is a common complication of peptic ulcer disease, with a mortality rate of 4% to 10%, posing a significant risk. Effectively inhibiting gastric acid secretion is a key strategy for treating peptic ulcer bleeding and alleviating symptoms.

Currently, proton pump inhibitors (PPIs) are the first-line drugs for acid suppression therapy in clinical practice in my country. However, in recent years, potassium-competitive acid blockers (P-CABs) have quietly emerged, providing a powerful "new weapon" for the treatment of acid-related diseases and Helicobacter pylori infection. Compared with PPIs, P-CABs have advantages in pharmacodynamics and pharmacokinetics.

Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) that reversibly binds to the K+ binding site of H+,K+-ATPase, inhibiting its conformational change and preventing the exchange of H+ and K+. It inhibits gastric acid secretion in a K+ competitive manner and features rapid onset of action (full effect with the first dose), no effect from meals, minimal individual variability, and strong and long-lasting acid-suppressing effect.

The drug was originally developed jointly by Takeda Pharmaceutical and Otsuka Pharmaceutical in Japan. It was first approved for marketing in Japan in December 2014 and then approved for marketing by the National Medical Products Administration (NMPA) in December 2019, becoming the first P-CAB approved for the Chinese market.

Leveraging its unique mechanism of action and significant clinical efficacy, vonoprazan has rapidly penetrated the domestic market for the treatment of gastric acid-related diseases, establishing its leading position in this field. According to data from PharmNet, the drug's sales in China exceeded 1 billion yuan in 2025.

Dongyangguang Pharmaceutical's vonoprazan fumarate sodium chloride injection is a Class 2 new drug . It is an innovative dosage form developed based on the oral formulation vonoprazan fumarate tablets (trade name: Vocinti®). It effectively fills the clinical gap that oral formulations cannot meet, and is especially suitable for high-risk patients with rebleeding peptic ulcers who cannot 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.

Its Phase I clinical study showed that, compared with PPI injections, vonoprazan injection can rapidly increase gastric pH after administration, achieve maximum acid suppression capacity on the first day of administration, and has no nocturnal acid breakthrough phenomenon.

The results of a multicenter, randomized, double-blind, positive-drug parallel-controlled phase II/III clinical trial showed that vonoprazan injection can effectively control the risk of rebleeding in patients with peptic ulcer bleeding and has good safety .

Digestive system diseases are a key area of focus for Dongyangguang Pharmaceutical in the field of chronic diseases. The company currently has esomeprazole magnesium enteric-coated capsules with annual sales exceeding 100 million yuan.

In January of this year, Dongyangguang Pharmaceutical's generic version of vonoprazan fumarate tablets (Class 4) received NMPA approval for production. The acceptance of the marketing application for vonoprazan fumarate injection signifies that the company's product pipeline in the digestive field is expected to be further enriched and improved.

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