Sivelestat sodium

Acute lung injury is a common fatal complication of critical illnesses such as severe infections and surgical trauma, and there has been a lack of targeted therapeutic approaches in clinical practice in the past. Sivelestat sodium is a selective neutrophil elastase inhibitor, which can specifically block the damage of neutrophil elastase to lung tissue, reduce alveolar capillary permeability, and decrease inflammatory exudation. It is the world's first drug approved for the treatment of acute lung injury associated with systemic inflammatory response syndrome, providing a key medication option for respiratory support therapy for critically ill patients in the ICU.

Relevant data show that the global market size of sivelestat sodium was approximately USD 120 million in 2023, and it is expected to expand steadily at a compound annual growth rate of 6.8% from 2024 to 2030. The growth drivers mainly come from the improvement of diagnosis and treatment capabilities in critical care medicine and the continuous release of demand for perioperative lung protection. The domestic market is currently in the stage of rapid volume growth. In 2023, the terminal sales in public medical institutions exceeded RMB 270 million, with a year-on-year growth of 42%. The existing market competitors consist of the original research manufacturer and 3 local generic drug enterprises, and the drug has not yet been included in the scope of national centralized procurement, so there is a large market gap in the supply demand of API.

The original research enterprise of this drug is Ono Pharmaceutical Co., Ltd. of Japan, with the original brand name "Elaspol". Its core compound patent expired in Japan in 2007, and the compound patent in China expired in 2009. The original dosage form is injection with a specification of 100mg per vial, which has been included in the China Listed Drug Catalogue as the reference listed drug. In terms of domestic API registration, at present, 6 enterprises have obtained A-status registration numbers for sivelestat sodium APIs after approval by the CDE, and 5 generic varieties of sivelestat sodium for injection have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for sivelestat sodium, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference standard support for API R&D, quality research and consistency evaluation work.