TY - JOUR
T1 - Therapeutic Efficacy and Safety of Recombinant Botulinum Toxin Type A for Moderate to Severe Glabellar Lines
T2 - A Randomized, Controlled, Double-blind, Phase III Trial in Chinese Adults
AU - Wu, Yan
AU - Long, Xiao
AU - Yu, Nanze
AU - Chen, Jin
AU - Lu, Jianyun
AU - Tan, Lina
AU - Lai, Wei
AU - Li, Li
AU - Wu, Sufan
AU - Wu, Liming
AU - Sun, Jiaming
AU - Bi, Hongsen
AU - Geng, Songmei
AU - Wang, Huiping
AU - Luo, Shengkang
AU - Hu, Zhiqi
AU - Yang, Jianmin
AU - Wang, Baoxi
AU - Yang, Wu
AU - Sun, Xiaoli
AU - Sun, Xiaoyun
N1 - Publisher Copyright:
© The Author(s) 2026. Published by Oxford University Press on behalf of The Aesthetic Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.
PY - 2022/12
Y1 - 2022/12
N2 - Background: Conventional botulinum toxin type A (BoNT/A) products include non-therapeutic accessory proteins vary in composition and manufacturing processes, which may contribute to differences in purity and biochemical characteristics. YY001 (Retoxin®) is a novel recombinant BoNT/A manufactured via E. coli expression to reduce impurities, improve purity, and minimize immunogenic risk. Objectives: To evaluate the efficacy, safety, and immunogenicity of YY001, a recombinant botulinum toxin type A (Chongqing Claruvis Pharmaceutical Co., Ltd., Chongqing, China), in the treatment of moderate-to-severe glabellar lines. Methods: In this multicenter, randomized, double-blind, vehicle- and active-controlled Phase III trial, 529 adults aged 18-65 with moderate to severe glabellar lines were randomized 4:2:1 to receive a single 20 U injection of YY001, Botox®(Allergan Pharmaceuticals Ireland, Westport, Ireland), or vehicle. The primary endpoint was composite response rate (CRR) at Week 4, defined as a ≥2-grade improvement of glabellar line severity assessed by both investigator and participant. Secondary endpoints included onset time, duration, satisfaction, and safety. Results: YY001 achieved a CRR of 86.7% at Week 4, significantly outperforming Botox® (66.7%, P < .0001) and vehicle (1.3%, P < .0001). It showed faster onset, longer median duration (97 days), and high participant satisfaction. Adverse events were mild and comparable across groups. Only one case of anti-drug antibody was observed; no neutralizing antibodies were detected. A 12-week follow-up and ethnically homogenous population may limit generalizability. Conclusions: YY001 demonstrated strong efficacy and a favorable safety profile than Botox®. Longer-term and multicenter studies are needed to assess durability, immunogenicity, and applicability across broader populations. Level of Evidence: 1 (Therapeutic): For image description, please refer to the figure legend and surrounding text.
AB - Background: Conventional botulinum toxin type A (BoNT/A) products include non-therapeutic accessory proteins vary in composition and manufacturing processes, which may contribute to differences in purity and biochemical characteristics. YY001 (Retoxin®) is a novel recombinant BoNT/A manufactured via E. coli expression to reduce impurities, improve purity, and minimize immunogenic risk. Objectives: To evaluate the efficacy, safety, and immunogenicity of YY001, a recombinant botulinum toxin type A (Chongqing Claruvis Pharmaceutical Co., Ltd., Chongqing, China), in the treatment of moderate-to-severe glabellar lines. Methods: In this multicenter, randomized, double-blind, vehicle- and active-controlled Phase III trial, 529 adults aged 18-65 with moderate to severe glabellar lines were randomized 4:2:1 to receive a single 20 U injection of YY001, Botox®(Allergan Pharmaceuticals Ireland, Westport, Ireland), or vehicle. The primary endpoint was composite response rate (CRR) at Week 4, defined as a ≥2-grade improvement of glabellar line severity assessed by both investigator and participant. Secondary endpoints included onset time, duration, satisfaction, and safety. Results: YY001 achieved a CRR of 86.7% at Week 4, significantly outperforming Botox® (66.7%, P < .0001) and vehicle (1.3%, P < .0001). It showed faster onset, longer median duration (97 days), and high participant satisfaction. Adverse events were mild and comparable across groups. Only one case of anti-drug antibody was observed; no neutralizing antibodies were detected. A 12-week follow-up and ethnically homogenous population may limit generalizability. Conclusions: YY001 demonstrated strong efficacy and a favorable safety profile than Botox®. Longer-term and multicenter studies are needed to assess durability, immunogenicity, and applicability across broader populations. Level of Evidence: 1 (Therapeutic): For image description, please refer to the figure legend and surrounding text.
UR - https://www.scopus.com/pages/publications/105038814962
U2 - 10.1093/asj/sjag042
DO - 10.1093/asj/sjag042
M3 - 文章
C2 - 41692601
AN - SCOPUS:105038814962
SN - 1090-820X
VL - 46
SP - 672
EP - 679
JO - Aesthetic Surgery Journal
JF - Aesthetic Surgery Journal
IS - 6
ER -