Vonoprazan

Gastroesophageal reflux disease is a highly prevalent chronic digestive system disease. Traditional proton pump inhibitors have clinical limitations such as short duration of acid suppression and poor control of nocturnal acid breakthrough, and the advent of vonoprazan has filled this treatment gap. As a potassium-competitive acid blocker (P-CAB) class of acid-suppressive drugs, it reversibly blocks the potassium ion binding site of H+/K+-ATPase in gastric parietal cells, exerts a rapid acid-suppressive effect without requiring acid activation, and can achieve full efficacy with the first dose. Its acid-suppressive effect is not affected by CYP2C19 gene polymorphism. Clinically, it is mainly used for reflux esophagitis, combination therapy for Helicobacter pylori eradication, and symptom control of non-erosive reflux disease. Its applicable population covers adult patients of all age groups, and it is especially suitable for refractory patients with poor response to traditional PPIs.

At present, the global market size of vonoprazan has exceeded 1.5 billion US dollars, with a compound annual growth rate of more than 18%. The growth rate of the Chinese market is particularly prominent, with an average growth rate of more than 35% in the past three years, and the sales in domestic sample hospitals in 2023 were close to 1.2 billion yuan. In terms of the competitive landscape, the original research product still accounts for about 60% of the market share. With the expiration of patents, generic preparations from 7 domestic enterprises have been approved for marketing, all of which have been included in the national centralized procurement, and the maximum price reduction of the selected products is more than 90% compared with the original research product. On the API supply side, nearly 20 domestic enterprises have completed CDE API registration at present, and the overall market has entered a stage of full competition between original research products and generics.

The original research enterprise of vonoprazan is Takeda Pharmaceutical of Japan, with the original trade name "Vocinti". Its core compound patent in China expired in 2026, and its acid addition salt and crystal form patents will also expire around 2030. The dosage form approved by the original research is oral tablet, with specifications of 10mg and 20mg. It has been included in the Chinese *Catalogue of Reference Preparations of Chemical Drugs* and also included in the FDA Reference Preparation Catalogue. At present, there are 19 vonoprazan API registration numbers in China, among which 13 are in A status and can be legally supplied for preparation production, and 8 enterprises have obtained approval for the marketing of vonoprazan oral preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of vonoprazan impurity reference standards, which can cover the requirements of qualitative and quantitative impurity research in the whole production process of APIs and preparations. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, which can help enterprises accelerate the R&D and registration progress and ensure the reliability of quality research data.