Tegoprazan

Acid-related diseases such as gastroesophageal reflux disease and peptic ulcer have long plagued more than 1 billion patients worldwide. Traditional proton pump inhibitors have clinical limitations such as insufficient nocturnal acid suppression and slow onset of action, and the advent of potassium-competitive acid blockers has filled this treatment gap. Tegoprazan, as a representative variety of this class of drugs, reversibly binds to the potassium ion binding site of H⁺/K⁺-ATPase in gastric parietal cells, is not affected by food intake, and can achieve fast, long-lasting and all-time acid suppression effects. Currently, it has been approved for indications such as reflux esophagitis, Helicobacter pylori eradication, and duodenal ulcer, and is suitable for various adult patients who require long-term acid suppression therapy and have poor response to traditional drugs.

The global market size related to tegoprazan exceeded USD 1.2 billion in 2023, with a compound annual growth rate remaining above 28%. The growth rate of the Chinese market is significantly higher than the global average, and the sales volume in sample hospitals in 2023 increased by more than 150% year-on-year. In terms of competitive landscape, the original research product still occupies a dominant position in the market. Three domestic enterprises have been approved for generic drug preparations, and the generic drug applications of more than 10 other enterprises are in the review stage. With the gradual coverage of the centralized procurement policy, the expansion of the downstream preparation market will directly drive the continuous rise in the demand for active pharmaceutical ingredients.

The original research enterprise of tegoprazan is Chong Kun Dang Pharmaceutical from South Korea, and the original research trade name is "Vocinti". Its Chinese compound patent will expire in 2030. The main dosage form approved by the original research is tablet, with two specifications of 50mg and 25mg. It has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and has also been included as a reference preparation by the FDA. Up to now, there are 11 tegoprazan API registration entries on the Chinese CDE API Registration Platform, among which 7 are in the status of "A" (approved for use in marketed preparations). Tegoprazan tablets from the original research enterprise and multiple domestic generic drug enterprises have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for tegoprazan API, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support the reference standard requirements throughout the whole process of API R&D, quality research and registration.