CUTIA-B (02487): CU-30101 (local anesthetic lidocaine cream) obtained the drug market approval from the National Medical Products Administration.

CUTIA-B (02487) announced that the CU-30101 (topical lidocaine-prilocaine cream) of this group has obtained the drug market approval from the National Medical Products Administration of the People's Republic of China (China NMPA). CU-30101 is a topical lidocaine-prilocaine cream used for local anesthesia during superficial surgical procedures. Due to its unique pharmacokinetic properties, the combination of lidocaine and prilocaine in CU-30101 can provide fast and long-lasting anesthesia effects. Lidocaine diffuses faster and over a wider range than prilocaine, while prilocaine is a long-acting amino ester local anesthetic that is more lipophilic and can concentrate in the stratum corneum of the skin. Additionally, the topical cream formula limits the systemic absorption of the anesthetic ingredients, making it safe for use. The drug market approval of CU-30101 is based on the results of a Phase III clinical trial conducted in China. The results of the clinical trial showed that the analgesic efficacy of CU-30101 is comparable to the reference drug Pliaglis (lidocaine-prilocaine cream), and overall safety is good. The local tolerance of CU-30101 is similar to Pliaglis, and there are no new safety signals compared to the known safety profile of Pliaglis. As the first product in the field of superficial anesthesia to receive approval from the National Medical Products Administration, CU-30101 is also the third product approved by the group after CU-10201 (topical 4% minocycline foam) and CU-40102 (topical finasteride spray). CU-30101 will help the group further expand its sales channels and provide convenience for the commercialization of subsequent products. Therefore, CU-30101 will strengthen the group's commercial layout in the market for the treatment and care of a wide range of skin diseases.