CUTIA-B (02487) has announced the completion of its Phase III clinical trial in China for CU-20101 (Botulinum Toxin Type A for Injection), aimed at improving moderate to severe glabellar lines. The trial was conducted in two stages. The first stage was a randomized, multicenter, double-blind, active-controlled study, while the second stage was an open-label trial. The objective of the clinical trial was to evaluate the efficacy and safety of both single and repeated injections of CU-20101 in treating moderate to severe glabellar lines. The trial used the reference product BOTOX® (Botulinum Toxin Type A for Injection) as a comparator.

All participants completed the trial in November 2025, and the database was locked in January 2026, yielding positive topline results. According to the trial results, efficacy was assessed using the Facial Wrinkle Scale (FWS). Both investigator and participant assessments of maximum frown treatment success rates met non-inferiority criteria. Additionally, photographic evaluations by an Independent Assessment Committee (IAC) further supported the non-inferiority conclusion for the primary efficacy endpoint, indicating that CU-20101 demonstrated efficacy comparable to BOTOX® and met both primary and secondary endpoints.

In terms of safety, CU-20101 exhibited a favorable overall safety profile. No adverse events led to early trial withdrawal or death, and no treatment-related serious adverse events were reported. The safety assessment of CU-20101 was similar to that of BOTOX®, with no new safety signals observed. The efficacy and safety profile following repeated injections of CU-20101 were consistent with those observed after a single administration.

Notably, CU-20101 is manufactured without the use of animal-derived materials or human serum albumin, thereby eliminating risks associated with transmissible spongiform encephalopathy (TSE) infection and related allergic reactions. This is expected to provide a significant safety advantage.

CU-20101 is anticipated to further enrich the company’s dermatology product portfolio and create synergies with its existing products. Given the broad demand in the skin treatment market, a diversified product lineup is expected to help the company capture a larger market share.