Lafutidine

Acid-related diseases such as peptic ulcer and reflux esophagitis have long plagued more than 1 billion people worldwide. Traditional H2 receptor antagonists have clinical shortcomings such as short duration of acid suppression and insufficient control of nocturnal acid breakthrough, and the advent of lafutidine has filled the medication gap in this field. As a second-generation long-acting H2 receptor antagonist, it can persistently inhibit gastric acid secretion, and also has a gastric mucosal protective effect, which can promote the repair of ulcer wounds and reduce the risk of recurrence. Clinically, it is mainly used for the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis and Zollinger-Ellison syndrome, and is suitable for adult patients with acid-related diseases, especially those who need long-term control of gastric acid secretion and have poor response to traditional drugs.

At present, the global market size of lafutidine is about 1.27 billion yuan, with a compound annual growth rate of 4.6% in the past 3 years. The growth momentum mainly comes from the improved diagnosis rate of acid-related diseases in primary medical institutions and the long-term medication demand of middle-aged and elderly patients. In terms of the domestic market, generic drugs dominate. There are more than 15 approved preparation manufacturers. The winning price in provincial centralized procurement in 2022 was about 68% lower than that of the original research drug, which further promoted clinical accessibility, and the proportion of the primary market has risen from 21% in 2019 to 39% in 2023.

The original research enterprise of lafutidine is Fujifilm Wako Pure Chemical Corporation, Japan, with the original brand name Storga. Its core compound patent expired in the Japanese market in 2011, and the Chinese compound patent also expired in 2011. The main dosage form approved for the original research is tablet, with specifications of 5mg and 10mg. The original research tablet has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. At present, the lafutidine APIs of more than 30 domestic enterprises have completed registration with the CDE and obtained A status publicity, and more than 20 lafutidine oral preparation varieties have been approved for marketing. (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 lafutidine API. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in the whole process of R&D, quality research and production.