China-based Keymed Biosciences announced that the National Medical Products Administration (NMPA) of China has approved its new drug application for Stapokibart.
The drug will be marketed under the trade name Kangyueda to treat moderate-to-severe atopic dermatitis in adults.
Stapokibart is an anti-interleukin-4 receptor a-subunit (IL-4Rα) monoclonal antibody.
NMPA accepted and granted priority review for the new drug application in December last year.
The marketing approval of Stapokibart is based on results from a multi-centre, randomised, double-blind, placebo-controlled Phase 3 study announced in June.
It had co-primary endpoints like achieving at least a 75% improvement in 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 these endpoints at week 16, with long-term treatment showing sustained clinical benefits and a good safety profile.
At week 52, 92.5% of patients on Stapokibart and 88.7% of patients who switched from placebo to Stapokibart achieved EASI-75.
The EASI-90 response rates were 77.1% for Stapokibart and 65.6% for the placebo-to-Stapokibart group.
Achieving an IGA score of 0 or 1 with a reduction of ≥2 points from baseline was observed higher in the Stapokibart group than in the placebo-to-Stapokibart group.
Long-term treatment with Kangyueda consistently improved dermatitis symptoms and quality of life.
Only one subject experienced a relapse during the maintenance period.
Kangyueda was safe and well-tolerated after 52 weeks, with safety profiles consistent with those observed at week 16 and no new safety signals identified.
The drug has shown strong safety and promising efficacy in several clinical trials.
To date, the Chinese health regulator has accepted Keymed Biosciences’ new drug applications for treating seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis.
In May 2023, Keymed Biosciences partnered with China-based Rona Therapeutics, an RNA therapeutics platform firm.
The partnership was intended to jointly discover and develop siRNA therapeutics for glomerulonephritis, a severe type of kidney disease.
