Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel monoclonal antibody, SHR-1819. This injectable treatment can now proceed to Phase Ib/II studies, focusing on atopic dermatitis (AD) in children and adolescents aged 6-17 years old.
SHR-1819: A Potential New Treatment for Type 2 Inflammation-Related Diseases
SHR-1819 is designed to bind human IL-4Rα (hIL-4Rα) and inhibit both IL-4 and IL-13 signaling pathways, which are key in the development of type 2 inflammation-related diseases. This mAb is currently under development for the treatment of AD and other conditions associated with type 2 inflammation. Previous clinical approvals for SHR-1819 in China cover a range of indications, including nodular prurigo, chronic sinusitis with nasal polyps, and adult AD.
Comparative Products in the Market
A comparable product in the market, as cited by Hengrui, is Sanofi’s (NASDAQ: SNY) Dupixent (dupilumab), which is used to treat a variety of conditions, including AD, chronic sinusitis with nasal polyps, asthma, nodular prurigo, and eosinophilic esophagitis. Additionally, Keymed Biosciences Inc.’s (HKG: 2162) stapokibart, another IL-4Rα mAb drug, was approved in China in September this year for use in adult moderate to severe AD, indicating a growing focus on targeted therapies for these conditions.-Fineline Info & Tech
