CUTIA-B (02487) announced that the Abbreviated New Drug Application (ANDA) for its self-developed topical finasteride spray, CU-40105, has been accepted by China's National Medical Products Administration (NMPA). The drug is indicated for the treatment of androgenetic alopecia.

Finasteride, as a competitive inhibitor of type II 5α-reductase, suppresses the conversion of testosterone to dihydrotestosterone (DHT) in the scalp, thereby treating androgenetic alopecia. Unlike oral finasteride, the topical formulation allows for precise application directly to the scalp, reducing systemic drug exposure compared to oral administration. The company believes the topical version will be more readily accepted by patients and provide a new treatment option.

CU-40105 will further enrich the company's portfolio of hair disorder treatments. Its formulation, dosage form, strength, indication, route of administration, and dosage are consistent with the reference drug. Key excipients are exclusively supplied by the originator manufacturer to ensure quality and performance match the reference product.

Given the broad therapeutic demand in the androgenetic alopecia market, CUTIA-B expects CU-40105 to support a differentiated commercialization strategy, catering to diverse consumers and expanding coverage among target populations.