CSPC Pharmaceutical Group Limited’s budesonide enteric-coated capsules and lansoprazole enteric-coated capsules, two Category 4 generic drugs, have been approved for marketing
On May 21, according to the NMPA official website, CSPC Pharmaceutical Group Limited obtained marketing approval for its two Category 4 generic drugs—budesonide enteric coated capsules (4 mg) and Lansoprazole enteric coated capsules—which are deemed to have passed the consistency evaluation.
Budesonide is a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity, and undergoes extensive first pass metabolism. It inhibits the proliferation of mucosal B cells in the ileal Peyer’s patches and their differentiation into plasma cells, thereby suppressing the production of galactose deficient IgA1 antibody (Gd IgA1).
Lansoprazole is a second generation proton pump inhibitor that suppresses gastric acid secretion by inhibiting enzyme activity, making it the current first line treatment for various digestive tract diseases related to gastric acid secretion. In the domestic market, Lansoprazole is available in three dosage forms: injections, tablets, and capsules. Data show that in 2025, the total hospital market (all terminals) in China for Lansoprazole enteric coated capsules exceeded 200 million yuan, with a steady year on year growth of 19.48%, indicating strong market potential.
