--- title: "CUTIA-B: CU-20101 (Injectable Type A Botulinum Toxin) used for improving moderate to severe glabellar lines has completed Phase III clinical trials in China" type: "News" locale: "en" url: "https://longbridge.com/en/news/282463532.md" description: "CUTIA-B announced the completion of the Phase III clinical trial in China for CU-20101 (injectable type A botulinum toxin) aimed at improving moderate to severe glabellar lines. The trial showed that CU-20101 is similar to BOTOX® in terms of efficacy and safety, with no serious adverse events reported. The production process of CU-20101 does not use animal-derived materials, and it is expected to have a good safety advantage" datetime: "2026-04-13T00:22:02.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/282463532.md) - [en](https://longbridge.com/en/news/282463532.md) - [zh-HK](https://longbridge.com/zh-HK/news/282463532.md) --- # CUTIA-B: CU-20101 (Injectable Type A Botulinum Toxin) used for improving moderate to severe glabellar lines has completed Phase III clinical trials in China According to the Zhitong Finance APP, CUTIA-B (02487) announced that the group has completed the Phase III clinical trial in China for CU-20101 (injectable type A botulinum toxin) for the improvement of moderate to severe glabellar lines (the clinical trial). This clinical trial is a two-phase study. The first phase is a randomized, multi-center, double-blind, positive drug-controlled clinical trial, while the second phase is an open-label clinical trial. The purpose of this clinical trial is to evaluate the efficacy and safety of single and repeated injections of CU-20101 in treating severe glabellar lines. The clinical trial uses the reference formulation Botox® injectable type A botulinum toxin (BOTOX®) as a control. The clinical trial completed the exit of all subjects in November 2025 and locked the database in January 2026, obtaining positive top-line results. The results of the clinical trial show that in terms of efficacy, using the Facial Wrinkle Scale (FWS), the treatment success rate for frowning based on the assessments of on-site researchers and participants met the non-inferiority standard. The treatment success rate for frowning based on the independent assessment committee (IAC) further supports the non-inferiority conclusion of the primary efficacy endpoint, indicating that CU-20101 is comparable to BOTOX® in efficacy, achieving both primary and secondary endpoints. In terms of safety, CU-20101 demonstrated overall good safety, with no adverse events leading to premature withdrawal from the trial or resulting in death, and no treatment-related serious adverse events occurred. The safety assessment of CU-20101 is similar to that of BOTOX®, with no new safety signals identified. The efficacy and safety profile of CU-20101 after multiple repeated injections is similar to that of a single administration. CU-20101 will not use animal-derived materials and human serum albumin in its production process, thereby eliminating the risk of transmissible spongiform encephalopathy (TSE) infection and related allergic reactions, and is expected to have good safety advantages. CU-20101 will further enrich the group's skin product matrix and facilitate synergistic effects with the group's existing products. With the broad demand in the skin treatment market, the diversified product layout is expected to help the group gain a larger market share ### Related Stocks - [159506.CN](https://longbridge.com/en/quote/159506.CN.md) - [159892.CN](https://longbridge.com/en/quote/159892.CN.md) - [159859.CN](https://longbridge.com/en/quote/159859.CN.md) - [560600.CN](https://longbridge.com/en/quote/560600.CN.md) - [02487.HK](https://longbridge.com/en/quote/02487.HK.md) - [513120.CN](https://longbridge.com/en/quote/513120.CN.md) - [516820.CN](https://longbridge.com/en/quote/516820.CN.md) - [510660.CN](https://longbridge.com/en/quote/510660.CN.md) - [513060.CN](https://longbridge.com/en/quote/513060.CN.md) - [159615.CN](https://longbridge.com/en/quote/159615.CN.md) - [516930.CN](https://longbridge.com/en/quote/516930.CN.md) - [520880.CN](https://longbridge.com/en/quote/520880.CN.md) - [512290.CN](https://longbridge.com/en/quote/512290.CN.md) - [516500.CN](https://longbridge.com/en/quote/516500.CN.md) - [588860.CN](https://longbridge.com/en/quote/588860.CN.md) - [512010.CN](https://longbridge.com/en/quote/512010.CN.md) - [588250.CN](https://longbridge.com/en/quote/588250.CN.md) - [588130.CN](https://longbridge.com/en/quote/588130.CN.md) - [159837.CN](https://longbridge.com/en/quote/159837.CN.md) - [159849.CN](https://longbridge.com/en/quote/159849.CN.md) - [513700.CN](https://longbridge.com/en/quote/513700.CN.md) - [159316.CN](https://longbridge.com/en/quote/159316.CN.md) - [159992.CN](https://longbridge.com/en/quote/159992.CN.md) - [520690.CN](https://longbridge.com/en/quote/520690.CN.md) - [159102.CN](https://longbridge.com/en/quote/159102.CN.md) ## Related News & Research - [China’s Clinical Trial Registrations Surpass 5,000 for First Time in 2025](https://longbridge.com/en/news/290539713.md) - [Cutia Therapeutics AGM resolutions passed in shareholder vote](https://longbridge.com/en/news/290935117.md) - [China closing in but US still leads in biotech innovation, survey finds](https://longbridge.com/en/news/290431706.md) - [Ab&B Bio-Tech Starts Early-Stage Trials for High-Yield RSV Vaccine as Trading Remains Suspended](https://longbridge.com/en/news/286268861.md) - [CStone Launches Nationwide Supply of Locally Made Pralsetinib as China Sales Surge](https://longbridge.com/en/news/285858047.md)