AbbVie (ABBV.US) class 1 new drug granted domestic market approval.

On October 13th, the official website of the China Drug Evaluation (CDE) showed that the market application for AbbVie's injectable type E botulinum toxin (TrenibotE) has been accepted, with a registration classification of Class 1. According to public information and the progress of clinical trials, the Insight database speculates that the indication is for moderate to severe glabellar lines. Source: CDE official website TrenibotE is a novel type E botulinum neurotoxin of the same class. In April 2025, AbbVie submitted the first marketing application for this product to the FDA, which was supported by clinical research data from over 2100 patients treated with TrenibotE, including two critical Phase III clinical studies (M21-500 and M21-508) evaluating the treatment of moderate to severe glabellar lines with TrenibotE, as well as an open-label safety study (M21-509). All primary and secondary endpoints of the Phase III studies have been met, with a rapid onset of action within 8 hours (the earliest assessment time) and a duration of effect of 2-3 weeks. Additionally, adverse events occurring during treatment with TrenibotE were similar to placebo, whether administered as a single treatment or up to three consecutive treatments.