NMPA Approves Keymed's Stapokibart for Seasonal Allergic Rhinitis

China's National Medical Products Administration (NMPA) has granted approval for Keymed Biosciences' supplemental new drug application for Stapokibart, a treatment designed for managing seasonal allergic rhinitis. This approval is based on robust data from a multicentre, double-blind Phase III clinical trial, which validated the safety and efficacy of this injection in adults whose seasonal allergic rhinitis symptoms are inadequately managed by nasal corticosteroids or other conventional treatments.

The clinical trial's findings highlighted that Stapokibart, when administered over a two-week period, was effective in alleviating symptoms associated with seasonal allergic rhinitis such as runny nose, nasal itching, sneezing, and nasal congestion specifically during pollen seasons. These results were achieved by comparing Stapokibart's efficacy against a standard treatment regimen that included nasal spray hormones and antihistamine medications.

The trial revealed a statistically significant difference in symptom control between Stapokibart and the standard treatment, with a least-squares mean (LSMean) inter-group difference calculated at -1.3. This measurement, supported by a 95% confidence interval also at -1.3, indicated a pronounced statistical significance. Notably, this difference substantially exceeded the minimal clinically important difference of 0.23, underscoring the clinical benefits that Stapokibart offers.

Beyond controlling nasal symptoms, Stapokibart also demonstrated efficacy in reducing symptoms related to ocular allergies, such as itching or burning sensations in the eyes. The therapy maintained an excellent safety profile throughout the trial, further endorsing its suitability for widespread use.

Stapokibart is characterized as a humanized antibody specifically targeting the interleukin-4 receptor alpha subunit (IL-4Rα). This specificity marks it as the first IL-4Rα antibody therapy to be domestically produced and receive marketing approval from the NMPA in China. Prior to this approval, Stapokibart had already been authorized for treating other conditions, namely moderate-to-severe atopic dermatitis and chronic rhinosinusitis with nasal polyposis.

In addition to its advancements in allergic rhinitis treatment, Keymed Biosciences has been active in broadening its research and development horizons. In May 2023, the company embarked on a collaborative endeavor with Rona Therapeutics. This partnership aims to explore and develop small interfering RNA therapeutics, particularly targeting conditions such as glomerulonephritis, further diversifying Keymed Biosciences' portfolio in the therapeutic arena.