Core Viewpoint - The clinical trial results for CU-20101, an injectable botulinum toxin type A for treating moderate to severe glabellar lines, have shown positive outcomes, indicating its efficacy and safety comparable to BOTOX® [1][2] Group 1: Clinical Trial Results - The clinical trial for CU-20101 is a two-phase study, with the first phase being a randomized, multi-center, double-blind, positive drug-controlled trial, and the second phase being an open-label trial [1] - The trial is set to complete all subject exits by November 2025 and database lock by early January 2026 [1] - Efficacy results indicate that CU-20101 meets non-inferiority standards compared to BOTOX®, with success rates supported by both investigator assessments and independent evaluations [1] Group 2: Safety Profile - CU-20101 demonstrated good overall safety, with no adverse events leading to trial withdrawal or death, and no serious adverse events related to treatment [1] - The safety profile of CU-20101 is comparable to that of BOTOX®, with no new safety signals reported [1] Group 3: Production and Market Potential - CU-20101 will be produced without animal-derived materials, reducing the risk of transmissible spongiform encephalopathy (TSE) infections and related allergic reactions, which is expected to enhance its safety profile [2] - The introduction of CU-20101 will diversify the company's skin product portfolio and create synergies with existing products, potentially increasing market share in the skin treatment market [2]
科笛-B(02487)：CU-20101用于改善中度至重度眉间纹的中国III期临床试验取得积极的顶线结果