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科笛-B(02487):CU-20401(重组突变胶原酶)治疗颏下脂肪堆积完成中国II期临床试验

CUTIA-B (02487): CU-20401 (recombinant mutant collagenase) treatment for submental fat accumulation has completed Phase II clinical trials in China.

Zhitong Finance ·  Dec 31, 2024 07:36

CUTIA-B (02487) announced that the group has completed the Phase II clinical trial (the clinical trial) of the potential Class 1 new drug CU-20401 (recombinant mutant collagenase) conducted in China for the treatment of submental fat accumulation. This clinical trial shows that CU-20401 demonstrates significant and robust therapeutic advantages with good safety.

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. A total of 108 subjects were enrolled in the trial and randomly assigned to three groups in a 1:1:1 ratio, namely the low-dose group of CU-20401 (low-dose group), the high-dose group of CU-20401 (high-dose group), and the placebo control group (placebo group). All groups received a single dose, with a medication adherence rate of 100% among the subjects.

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