China’s National Medical Products Administration (NMPA) has approved Keymed Biosciences’ supplemental new drug application (NDA) for Stapokibart to treat seasonal allergic rhinitis.
The approval is supported by a multicentre, double-blind Phase III trial that confirmed the safety and efficacy of the injection in adults with seasonal allergic rhinitis that is poorly controlled with nasal corticosteroids or other treatments.
Trial findings also revealed that the therapy, administered for two weeks, effectively controlled symptoms such as runny nose, nasal itching, sneezing, and nasal congestion during the pollen season.
Stapokibart was compared against a standard treatment regimen comprising nasal spray hormones along with antihistamine drugs.
The least-squares mean (LSMean) of the inter-group difference observed in the trial was -1.3, with a 95% confidence interval also at -1.3, representing a significant statistical difference.
This difference surpassed the minimal clinically important difference of 0.23, indicating substantial clinical benefits.
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Apart from an excellent safety profile, the therapy lessened the symptoms of ocular allergy, including eye itching or burning.
Stapokibart is a humanised antibody that targets the interleukin-4 receptor alpha subunit (IL-4Rα). It is the first domestically produced IL-4Rα antibody therapy to receive marketing approval from the NMPA.
The asset is already approved for marketing to treat moderate-to-severe atopic dermatitis and chronic rhinosinusitis with nasal polyposis.
In May 2023, the company entered a collaboration with Rona Therapeutics to discover and develop small interfering RNA therapeutics for glomerulonephritis.
