A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)

Part I (randomized double-blind controlled study) Study Part 1 consisted of a 1-day baseline/treatment period (randomized and received 1 dose of study treatment) and a 12-week post-treatment follow-up period. It is proposed to enroll 554 subjects with moderate to severe glabellar lines. Subjects eligible for inclusion were randomized in a 1: 1 ratio to CU-20101 or Botox® according to the stratification factors. Stratification factors were severity of glabellar lines at baseline (moderate vs. severe) when trying to frown as assessed on site by the investigator.

After completing the dosing of Part I and assessments of relevant examinations, subjects will return to the study site on Day 29 ± 7 days (Week 4), Day 57 ± 7 days (Week 8), and Day 85 ± 7 days (Week 12) for follow-up of efficacy, safety, and immunogenicity assessments (Figure 1).

Part II (open-label study) For subjects who completed Part I of the study, they automatically entered Period 2 of the study. To evaluate the safety, efficacy, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar striae if they meet the criteria for repeat treatment (at least 12 weeks apart from each test drug injection). If repeat treatment criteria are not met at follow-up, follow-up may continue after 4 weeks until the next treatment is met. The last study treatment was no later than Day 253 ± 7 days (Week 36).

Criteria for repeat therapy are (all of the following criteria must be met): 1.The severity of glabellar lines was assessed by the investigator on-site when the subject tried to frown, with an FWS score of 2 or 3 points; 2.The subjects self-assessed the severity of glabellar lines on the spot when they frowned with an FWS score of 2 or 3; 3.Meets the wishes of the subject; 4.All other inclusion criteria were met and none of the exclusion criteria were met.