CSPC PHARMA (01093): Budesonide Enteric-coated Capsules (4mg) Obtain Drug Registration Approval

CSPC PHARMA (01093) announced that the group's developed Budesonide Enteric-coated Capsules (4mg) has obtained the drug registration approval from the National Medical Products Administration of the People's Republic of China. Budesonide is a corticosteroid with potent glucocorticoid activity and weaker mineralocorticoid activity, with high first-pass metabolism. Budesonide can inhibit the proliferation of mucosal B cells in the Peyer's patches in the ileum and their differentiation into plasma cells, thereby suppressing the production of IgA1 antibodies with galactose deficiency (Gd-IgA1). By reducing the levels of Gd-IgA1 antibodies and immune complexes in the circulation, it reduces the deposition of immune complexes in the mesangial area of the glomerulus that lead to glomerulonephritis and renal function decline. This product is used to treat adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression to reduce kidney function loss. Compared to other drugs, this product is a targeted therapy for IgA nephropathy, using a dual delayed-release and sustained-release process to achieve targeted treatment with low systemic exposure and high safety. The approval of this product will further enrich the group's product line in the field of kidney diseases and enhance the group's competitiveness in this area.