Cutia Therapeutics (Cutia-B) has received drug marketing authorization from China’s National Medical Products Administration (NMPA) for CU-30101, a localized lidocaine and tetracaine compound cream developed for topical anesthesia procedures.

The formulation combines the rapid-diffusion properties of lidocaine with the long-acting, highly lipophilic profile of tetracaine, aiming to deliver both fast onset and sustained analgesia while limiting systemic absorption and supporting a favorable safety profile.

Approval was supported by a China-based Phase III clinical trial demonstrating non-inferiority to the reference product Pliaglis lidocaine and tetracaine cream in pain management, with comparable local tolerance and no new safety signals.

CU-30101 represents Cutia’s first NMPA-cleared product in topical anesthesia and the Group’s third overall approved asset following CU-10201 (topical 4% minocycline foam) and CU-40102 (topical finasteride spray). Management expects the expanded product portfolio to broaden distribution channels and reinforce Cutia’s position in the dermatology treatment and care market.

The company cautions that market launch and commercial success are not yet guaranteed, and advises shareholders and potential investors to exercise prudence when dealing in its shares.