Teprenone

The prevalence of gastric mucosal injury diseases such as gastritis and gastric ulcer remains high globally for a long time, and under the influence of factors such as irregular diet and Helicobacter pylori infection, the proportion of young and middle-aged patients is increasing year by year. Teprenone is a terpene gastric mucosal protective agent, which is different from traditional acid-suppressive drugs. Its mechanism of action is to promote the synthesis and secretion of mucus in gastric mucosal epithelial cells, increase gastric mucosal blood flow, and accelerate the repair and regeneration of damaged mucosal epithelium, so as to improve mucosal barrier function from the defense level. Clinically, it is mainly used to improve gastric mucosal lesions in acute gastritis and the acute exacerbation stage of chronic gastritis, as well as the treatment of gastric ulcer, and the applicable population covers gastric mucosal injury patients of all ages with no history of drug allergy.

At present, the global market size of teprenone is about USD 180 million, and the annual growth rate of the domestic market maintains at around 7%, with stable overall growth. Its original research product was developed by Eisai Co., Ltd. of Japan and entered the Chinese market in 2003. Currently, there are less than 10 domestic generic drug enterprises that have obtained approval, and the market concentration is relatively high. In 2023, the oral regular-release dosage form of teprenone was included in the seventh batch of national centralized drug procurement, and the winning bid price has dropped by more than 60% compared with the price of the original research product. The market substitution rate of generic drugs is rising rapidly, and the demand for corresponding APIs and supporting quality control products is also increasing accordingly.

CATO can provide a full set of impurity reference standards for teprenone API. All products meet the quality requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, with complete qualification documents and sufficient in-stock inventory. It can quickly respond to the demands related to quality research and registration declaration of API manufacturers, drug inspection institutions and R&D units, and provide reliable support for the product compliance and R&D efficiency of customers.