Teprenone

Insufficient gastric mucosal defense capacity is one of the core inducing factors for the recurrent attacks of peptic ulcer and chronic gastritis. Traditional clinical acid suppression therapy often ignores the long-term value of mucosal repair, while teprenone, as a terpene gastric mucosal protective agent, precisely fills this gap in clinical demand. It has a unique mechanism of action, which can directly promote the synthesis of mucin and prostaglandins in gastric mucosal epithelial cells and repair the damaged mucosal barrier without affecting the normal secretion of gastric acid. It is not only suitable for improving mucosal injury in acute gastritis and acute exacerbation of chronic gastritis, but also can be used as a long-term maintenance treatment for gastric ulcer, with good safety for elderly patients and high-risk groups with underlying gastric diseases.

The current global market size of teprenone is approximately USD 1.28 billion, with a compound annual growth rate of 4.2% in the past three years. The growth momentum mainly comes from the rising prevalence of chronic gastritis and the improved clinical awareness of mucosal repair drugs. The Chinese market accounts for 27% of the global share, making it the fastest growing regional market. At present, the domestic preparation market is dominated by the original research product, and generic preparations from 3 local enterprises have been approved for marketing. In the 2023 provincial-level centralized drug procurement, the average price reduction of teprenone oral regular-release dosage forms was 48%, which further reduced the medication burden of patients, and the demand for upstream API has entered a period of rapid release accordingly.

The original research enterprise of teprenone is Eisai Co., Ltd. from Japan, with the original brand name of Selbex. The core compound patent of teprenone expired globally in 2010. At present, the dosage form of the original research product approved in China is capsule, with a specification of 50mg. This product has been included in the China Listed Drug Catalogue and is used as the reference preparation for domestic generic preparations. In terms of API registration, as of now, there are 8 teprenone registration entries on the CDE API registration platform, 3 of which are in status A and can be used for associated review. A total of 5 specifications of teprenone preparations have been approved for marketing in China. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for teprenone API, fully covering synthetic process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API R&D, quality research and registration declaration.