Core Viewpoint - The company has received acceptance from the National Medical Products Administration of China for its new drug application for CU-40105, a topical finasteride spray aimed at treating androgenetic alopecia, which is expected to provide a new treatment option for patients [1] Group 1: Product Development - CU-40105 is a self-developed topical finasteride spray that inhibits the conversion of testosterone to dihydrotestosterone in the scalp, addressing androgenetic alopecia [1] - Unlike oral finasteride, the topical formulation allows for precise application on the scalp, potentially reducing systemic exposure to the drug [1] - The product's formulation, dosage form, specifications, indications, administration route, and usage are consistent with the reference preparation [1] Group 2: Market Strategy - The company believes that the topical finasteride will be more readily accepted by patients suffering from androgenetic alopecia, providing a new treatment choice [1] - CU-40105 will enhance the company's product matrix for hair diseases, targeting a diverse consumer and patient base with a differentiated commercialization strategy [1] - The company anticipates that CU-40105 will expand the coverage of topical finasteride among the target population, addressing the broad treatment needs in the androgenetic alopecia market [1]
科笛-B(02487)：CU-40105(自研外用非那雄胺喷雾剂)简略新药上市申请获得国家药监局受理