Core Viewpoint - The company has announced positive topline results from the Phase III clinical trial of CU-20101, an injectable botulinum toxin type A, for the treatment of moderate to severe glabellar lines in China [1][2] Group 1: Clinical Trial Results - The clinical trial consists of two phases: a randomized, multicenter, double-blind, positive-controlled trial followed by an open-label trial to assess the efficacy and safety of CU-20101 [1] - The trial compared CU-20101 to the reference product BOTOX, with results indicating that CU-20101 met non-inferiority standards for treatment success rates based on both investigator and participant assessments [1] - Safety results showed that CU-20101 had a good overall safety profile, with no adverse events leading to trial withdrawal or death, and no new safety signals compared to BOTOX [1] Group 2: Production and Market Potential - CU-20101 will be produced without the use of 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 is anticipated to enrich the company's skin product portfolio and create synergies with existing products, addressing the broad demand in the skin treatment market [2] - The diversified product layout is expected to help the company capture a larger market share in the skin treatment sector [2]
科笛-B：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