Core Viewpoint - The company Codex-B (02487.HK) has announced that its self-developed topical finasteride spray, CU-40105, has received acceptance for a New Drug Application (ANDA) by the National Medical Products Administration of China, aimed at treating androgenetic alopecia [1] Group 1: Product Development - CU-40105 is a topical finasteride spray that acts as a specific type II 5α-reductase competitive inhibitor, preventing the conversion of testosterone to dihydrotestosterone in the scalp, which is effective for treating androgenetic alopecia [1] - Unlike oral finasteride, the topical formulation allows patients to apply the medication directly to the scalp, potentially reducing systemic exposure to the drug [1] - The company believes that the topical finasteride will be more readily accepted by patients suffering from androgenetic alopecia, providing a new treatment option [1] Group 2: Market Strategy - CU-40105 will enhance the company's product matrix for hair diseases, with its formulation, dosage form, specifications, indications, administration route, and usage consistent with the reference formulation [1] - Key excipients for CU-40105 are exclusively supplied by the original manufacturer to ensure product quality and performance align with the reference formulation [1] - Given the broad treatment needs in the androgenetic alopecia market, the company anticipates that CU-40105 will facilitate a differentiated commercialization strategy targeting diverse consumers and patients, thereby expanding the coverage of topical finasteride among the target population [1]
科笛-B(02487.HK)：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