The board of directors of Cutia Therapeutics announced that the New Drug Application (the "NDA") for CU-40102 (topical finasteride spray) was accepted by the National Medical Products Administration of the PRC. The indication of CU-40102 is for the treatment of androgenetic alopecia. CU-40102 is the first and only topical finasteride product approved for androgenetic Alopecia treatment globally and the first topical finasteride to have its NDA accepted by the NMPA of the PRC.

Finasteride can treat androgenetic alopecIA in male patients by acting as a competitive and specific inhibitor of Type II 5-alpha reductase to inhibit the conversion of testosterone to dihydrotestosterone in the scalp. Unlike oral finasteride, CU-40102's topical formulation allows patients to apply the drug directly to the surface of the scalp, thereby maintaining a high concentration at the affected site while possibly reducing the side effects commonly associated with oral formulations. Results of the registrational Phase III clinical trial data analysis in the PRC showed that CU-40102 has a significant efficacy for the treatment of androgenetics alopecia, and patients of the CU-40102 group showed favourable local tolerance to the administration area.

Meanwhile, a Phase I pharmacokinetic study of CU-40102 in Chinese male adult patients with androgenetic alopecium conducted in the same period showed that after the administration of finasteride spray, systemic absorption was minimal in the group of Chinese androgenetic alopecian patients.