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Ulinastatin is a glycoprotein and serine protease inhibitor derived from human urine, classified as a protein-based biologic therapy. It inhibits multiple proteolytic enzymes including trypsin, chymotrypsin, plasmin, cathepsin G, and neutrophil elastase. Ulinastatin exerts anti-inflammatory effects by suppressing the activity of these enzymes and modulating cytokine production (such as TNF-alpha, IL‑1, IL‑6, IL‑8), thereby reducing inflammation and immune-mediated tissue damage. Clinically, it is used to treat acute pancreatitis and has been widely adopted in China for various critical illnesses such as sepsis, shock states (including septic shock), severe pneumonia, acute respiratory distress syndrome (ARDS), multiple organ dysfunction syndrome (MODS), severe burns/trauma, cardiac arrest resuscitation support, and other acute inflammatory or immune-related conditions. Its mechanisms also include stabilization of lysosomal membranes, protection of vascular endothelium/microcirculation improvement, reduction of apoptosis in tissues under stress or injury conditions. In oncology research settings it has shown potential to inhibit tumor invasion/metastasis by blocking cell-bound plasmin activity and cathepsin B function[2][3][4][6][9].
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