Upamostat

In the clinical treatment of acute severe diseases such as acute pancreatitis and disseminated intravascular coagulation, excessive activation of proteases is the core pathological link leading to tissue injury and disease progression. As a broad-spectrum protease inhibitor, ulinastatin can simultaneously inhibit the activities of multiple serine proteases such as trypsin, α-chymotrypsin and elastase, block the inflammatory cascade, and reduce inflammatory injury to the pancreas and systemic organs. Clinically, it is mainly used for the treatment of acute pancreatitis (including mild, severe and postoperative acute pancreatitis), and can also be used for adjuvant intervention of acute circulatory failure and disseminated intravascular coagulation. The applicable population covers adult acute severe patients and pediatric patients who meet the medication indications.

In recent years, the market size of domestic ulinastatin preparations has maintained steady growth. In 2023, the sales volume in sample hospitals was approximately RMB 1.2 billion, with a compound annual growth rate maintained at around 8%. The competitive landscape is dominated by generic drugs. At present, nearly 20 domestic enterprises have obtained approval for ulinastatin preparations. As provincial-level centralized drug procurement gradually covers this variety, the average price reduction of preparations has reached 40%, and the cost control and supply stability of upstream API have become the core competitiveness of downstream preparation enterprises.

The original research enterprise of ulinastatin is Ono Pharmaceutical Co., Ltd. of Japan, with the original brand name "Miraclid". Its core compound patent expired in 2008, and the main Chinese preparation patent also expired in 2019. The original dosage form is ulinastatin for injection, with conventional specifications including 25,000 units, 50,000 units and 100,000 units, which has been included in the China Listed Drug Catalog as a reference preparation. As of now, there are more than 30 ulinastatin API registration entries on the China CDE API Registration Platform, among which nearly 20 have been activated to Status A, which can be associated with domestic preparation declaration or marketing use. All domestic approved ulinastatin preparation products are injection dosage forms. (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 ulinastatin API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations including Chinese Pharmacopoeia and FDA, and can fully meet the needs of API manufacturers for quality research, stability study and compliance declaration.