CUTIA-B(02487): CU-10201 (Topical 4% Minocycline Foam) has obtained approval from the National Medical Products Administration for marketing.

CUTIA-B(02487) announces that the group's CU-10201 (topical 4% minocycline foam) has obtained approval for marketing from the National Medical Products Administration of the People's Republic of China (NMPA). The indication for CU-10201 is the treatment of non-nodular moderate to severe acne, and it is suitable for use in children aged nine and above as well as adult patients. CU-10201 is the first and only topical minocycline approved for the treatment of acne vulgaris globally, and the first topical minocycline to be granted priority review and approval for marketing by the NMPA in China. Minocycline is a tetracycline antibiotic used to treat various bacterial infections and acne vulgaris. Currently available minocycline products are mainly oral medications. Compared to other major anti-acne antibiotics and traditional oral medications, topical minocycline foam has lower systemic drug exposure, fewer side effects, lower resistance, and potentially higher patient compliance. The approval of CU-10201 for marketing is based on the efficacy and safety results from Phase III clinical trials in China. The results show that CU-10201 significantly improves acne and is well-tolerated, reducing common side effects associated with oral minocycline.