Cutia Therapeutics (CUTIA-B, 02487) has obtained Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) for CU-40104, its self-developed topical dutasteride formulation aimed at treating androgenetic alopecia.

CU-40104 Overview • Mechanism: Dutasteride inhibits both Type I and Type II 5-alpha reductases, blocking the conversion of testosterone to dihydrotestosterone (DHT) in the scalp—an established pathway in androgenetic alopecia. • Delivery Advantage: The topical formulation is designed to deliver the active ingredient directly to the scalp, potentially lowering systemic exposure and reducing side-effect risk compared with existing oral dutasteride therapies already approved in multiple jurisdictions.

Strategic Fit CU-40104 broadens the company’s scalp-disease portfolio and is positioned as a complementary, synergistic product to CU-40102 (topical finasteride spray), which previously secured NMPA marketing approval.

Regulatory Status and Next Steps With IND approval in hand, Cutia Therapeutics is authorized to initiate clinical trials in China. The company emphasizes that successful development and commercialization are not guaranteed, and shareholders are advised to exercise caution when dealing in its shares.

Corporate Information The announcement was authorized by the Board of Directors, led by Chief Executive Officer and Executive Director Zhang Lele, and released on 16 March 2026 in Hong Kong.