CUTIA-B (02487) Receives NMPA Approval for CU-30101, a Topical Lidocaine-Tetracaine Cream

Stock News
05/07

CUTIA-B (02487) announced that its CU-30101, a topical lidocaine-tetracaine cream, has obtained drug marketing authorization from the National Medical Products Administration (NMPA) of China. CU-30101 is a compound topical anesthetic cream indicated for superficial anesthesia during dermatological procedures. Due to the unique pharmacokinetic properties of its components, the combination of lidocaine and tetracaine in CU-30101 provides rapid and long-lasting anesthetic effects. Lidocaine diffuses more quickly and extensively than tetracaine, while tetracaine, a long-acting amino ester local anesthetic, is more lipophilic than lidocaine, allowing it to concentrate in the stratum corneum. Furthermore, the topical cream formulation limits systemic absorption of the anesthetic agents, resulting in a favorable safety profile. The marketing approval for CU-30101 was primarily based on results from a Phase III clinical trial conducted in China. Trial results demonstrated that the analgesic efficacy of CU-30101 was comparable to the reference drug Pliaglis® (lidocaine-tetracaine cream), with an overall good safety profile. Local tolerability assessments for CU-30101 were similar to those for Pliaglis® and consistent with the known safety characteristics of Pliaglis®, with no new safety signals observed. As the first product from the group to receive NMPA approval in the field of superficial anesthesia, and the third product approved following CU-10201 (topical minocycline foam 4%) and CU-40102 (topical finasteride spray), CU-30101 is expected to help the group further expand its sales channels and facilitate market access for subsequent products. Consequently, CU-30101 will strengthen the group's commercialization strategy in the broad dermatological treatment and care market.

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