CUTIA-B: CU-40102 (topical finasteride spray) has received marketing approval from the National Medical Products Administration
CUTIA-B announced that its CU-40102 (topical finasteride spray) has received marketing approval from the National Medical Products Administration of China, becoming the world's first topical finasteride for the treatment of androgenetic alopecia. The drug works by inhibiting the conversion of testosterone to dihydrotestosterone in the scalp, providing a more convenient method of administration and reducing systemic drug exposure. This approval is based on the results of a Phase III clinical trial conducted in China, which showed that CU-40102 is effective and well-tolerated. The product will enhance the group's presence in the field of dermatological treatments
According to the Zhitong Finance APP, CUTIA-B (02487) announced that the group's CU-40102 (topical finasteride spray) has received marketing approval from the National Medical Products Administration of China. The approved indication for CU-40102 is the treatment of androgenetic alopecia, making it the world's first and only approved topical finasteride for this condition, as well as the first and only approved topical finasteride in China.
Finasteride, as a specific type II 5α-reductase competitive inhibitor, inhibits the conversion of testosterone to dihydrotestosterone in the scalp, which can treat androgenetic alopecia. Unlike oral finasteride, the topical formulation of CU-40102 allows patients to apply the medication directly and precisely to the scalp surface, reducing systemic exposure compared to oral medication. The group believes that CU-40102 as a topical medication will be more easily accepted by patients, providing an alternative solution for those with androgenetic alopecia and becoming a new medication option for patients.
This marketing approval is primarily based on the results of a phase III confirmatory clinical trial completed in China for CU-40102. The results of this clinical trial showed that CU-40102 effectively treats androgenetic alopecia, and the subjects using CU-40102 had good local tolerance at the application site.
As the first product approved by the National Medical Products Administration in the field of hair diseases and care, and the second product approved following CU-10201 (topical 4% minocycline foam), CU-40102 will further strengthen the group's commercialization layout in the treatment and care of a wide range of skin diseases. Additionally, CU-40102 has submitted a new drug application to the Department of Health of the Hong Kong Special Administrative Region government in April 2024
