On May 21, CSPC Pharmaceutical Group (1093.HK) announced that its budesonide enteric-coated capsules (4mg) (hereinafter referred to as "the product") have obtained a drug registration certificate issued by the National Medical Products Administration of the People's Republic of China.

Budesonide is a corticosteroid with potent glucocorticoid activity and relatively weak mineralocorticoid activity, exhibiting extremely high first-pass metabolism. Budesonide inhibits the proliferation of mucosal B cells and their differentiation into plasma cells in the Peyer's patchy lymph nodes of the ileum, thereby suppressing the production of galactose-deficient IgA1 antibodies (Gd-IgA1). It reduces the deposition of immune complexes in the glomerular mesangial area, leading to glomerulonephritis and decreased renal function, by reducing the formation of Gd-IgA1 antibodies and immune complexes in systemic circulation. This product is used to treat adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression to reduce renal function loss. Compared to other drugs, this product is a causal treatment for IgA nephropathy, employing a dual-stage formulation with both delayed and sustained release for targeted therapy, resulting in low systemic exposure and a high safety profile.

The approval of this product will further enrich the group's product line in the field of nephrology and enhance the group's competitiveness in this field.

https://mp.weixin.qq.com/s/3F4m-UnO9SjmBDXOqT5EAw