This approval is based on results from a multicentre, randomised, double-blind, placebo-controlled Phase III trial.
The study’s co-primary endpoints were achieving a minimum of a 75% improvement in the Eczema Area and Severity Index (EASI-75) from baseline, and an Investigator’s Global Assessment (IGA) score of 0 or 1 with a reduction of ≥2 points from baseline at week 16.
The trial met its co-primary endpoints at week 16, with long-term treatment demonstrating sustained clinical benefits and a favourable safety profile.
At week 52, the Stapokibart group and the placebo-to-Stapokibart group achieved EASI-75 rates of 92.5% and 88.7%, respectively.
EASI-90 response rates were reported to be 77.1% and 65.6%, respectively.
The rates of attaining an IGA score of 0 or 1 with a decline of ≥2 points from baseline were observed to be 67.3% and 64.2%, respectively for the Stapokibart and placebo arms.
Furthermore, long-term treatment with Stapokibart demonstrated to improve dermatitis symptoms and quality of life in moderate-to-severe AD patients, with a subject experiencing a relapse during the maintenance period.
In the trial, the therapy was found to be safe and well-tolerated after 52 weeks of dosing, with a safety profile in line with those seen at week 16.
No new safety concerns linked to the treatment were reported in the trial.
A humanised, highly potent antibody, Stapokibart targets the interleukin-4 receptor alpha-subunit (IL-4Rα).
It is said to be the first domestically produced IL-4Rα antibody asset to receive marketing approval from the NMPA.
By targeting IL-4Rα, Stapokibart provides a dual blockade of interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling, both critical cytokines in initiating type II inflammation.
It has shown promising safety and efficacy in multiple clinical trials earlier.
The NMPA has also accepted the new drug applications of the company for the asset to treat seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis.