November 29th, Gelonghui-Science-B (02487.HK) announced that the group's potential Class 1 new drug CU-20401 (recombinant mutated collagenase) has obtained top-line data from phase II clinical trials for the treatment of submental fat accumulation in China. The data shows that the clinical trial has achieved the main research endpoint, with results that have statistical significance and clinical importance.
The clinical trial is a multicenter, randomized, double-blind, and placebo-controlled trial aimed at evaluating the efficacy and safety of CU-20401 in patients with moderate to severe submental fat accumulation, with a total of 108 subjects enrolled.
The analysis results show that in terms of efficacy, the main efficacy endpoint data show that the treatment efficacy rates of both the low-dose CU-20401 group and the high-dose CU20401 group are higher than those of the placebo control group, and the differences in efficacy rates are statistically significant. Secondary efficacy endpoint data also demonstrate similar efficacy advantages. In terms of safety, throughout the entire clinical trial period, the CU-20401 group (including the low-dose and high-dose groups) did not experience any adverse events graded ≥3 according to the Common Terminology Criteria for Adverse Events (CTCAE), leading to drug adjustments, study withdrawals, serious adverse events (SAE), or other adverse events. Overall, CU-20401 demonstrates significant and robust efficacy advantages and good safety.
