Authors: Yan Wu, MD , Xiao Long, MD , Nanze Yu, MD , Jin Chen, MD , Jianyun Lu, MD , Lina Tan, MD , Wei Lai, MD , Li Li, MD , Sufan Wu, MD , Liming Wu, MD, Jiaming Sun, MD , Hongsen Bi, MD , Songmei Geng, MD , Huiping Wang, MD , Shengkang Luo, MD , Zhiqi Hu, MD , Jianmin Yang, MD , Baoxi Wang, MD , Wu Yang, PhD , Xiaoli Sun, MS , Xiaoyun Sun, MD, PhD
Abstract: 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. This study aims 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. 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. 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. 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.
