CUTIA-B(02487): CU-40104 (topical finasteride preparation) New drug clinical trial application granted implicit approval by the National Medical Products Administration.

Notice from CUTIA-B (02487): The new drug clinical trial (IND) application for CU-40104 (topical dutasteride formulation) of this group has obtained the clinical trial implied approval from the China National Medical Products Administration (NMPA), for the treatment of androgenetic alopecia. CU-40104 is a topical dutasteride formulation developed independently by this group. Dutasteride, as a specific type I and II 5-reductase competitive inhibitor, inhibits the conversion of testosterone into dihydrotestosterone in the scalp, thus treating androgenetic alopecia. The topical formulation being developed by this group allows dutasteride to be directly applied to the scalp, with the expectation of reducing systemic exposure and side effects compared to oral dutasteride (which has been approved for the treatment of androgenetic alopecia in multiple countries worldwide). This group believes that CU-40104 will further enrich the group's hair disease product portfolio, providing valuable supplementation and synergy with CU-40102 (topical minoxidil spray) which has already obtained NMPA market approval.