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According to the announcement of the National Food and Drug Administration (NMPA) of China, the listing application status of the anti-IL-5 monoclonal antibody mepolizumab (mepolizumab) injection of GlaxoSmithKline (GSK) has been updated to "under approval".
Screenshot source: NMPA official website
Mepolizumab is a "first-in-class" anti-IL-5 humanized monoclonal antibody, which can selectively recognize and bind IL-5.
In the United States, the FDA has approved a number of indications for mepolizumab, including severe asthma, adult patients with eosinophilic granulomatous vasculitis, adults and children over 12 years of age with eosinophilia (HES), chronic sinusitis with nasal polyps (CRSwNP) patients, and so on
In China, the marketing application of mepolizumab was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in July 2020 and was included in the priority review.
According to the clinical trial data of mepolizumab approved in the United States for the treatment of this indication, compared with placebo, patients receiving mepolizumab have a significantly longer accumulation time for remission
Eosinophilic granulomatous polyangiitis is a rare autoimmune disease
Reference materials:
[1] Inquiry about the progress of drug registration in the State Drug Administration of China.
[1] Inquiry about the progress of drug registration in the State Drug Administration of China.
[2] The FDA today approved the first new drug for rare vasculitis.
Retrieved Dec 13.
2017.
from https://mp.
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