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Today, China’s National Food and Drug Administration (NMPA) announced that GlaxoSmithKline (GSK)’s mepolizumab (mepolizumab, formerly known as mepolizumab) injection has been approved for marketing in China
.
Mepolizumab is a "first-in-class" anti-IL-5 humanized monoclonal antibody and the world's first approved anti-IL-5 monoclonal antibody
Mepolizumab is a "first-in-class" anti-IL-5 humanized monoclonal antibody, and it is also the world's first approved anti-IL-5 monoclonal antibody against IL-5 eosinophilic granulomatosis.
Screenshot source: NMPA official website
Mepolizumab is an anti-IL-5 antibody, which can selectively recognize and bind IL-5, block the binding of IL-5 to the receptor on the surface of eosinophils, and reduce the growth of eosinophils It is expected to alleviate a variety of diseases caused by excessive eosinophils
.
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) patients , accompanied by nasal polyps and chronic sinusitis (CRSwNP) patients, and so on
.
In China, the marketing application of mepolizumab was accepted by the CDE in July 2020 and was included in the priority review
.
According to the public information of priority review, the indication for this application of the drug is: it is suitable for adult patients with eosinophilic granulomatous polyangiitis
Suitable for adult patients with eosinophilic granulomatous polyangiitis
Screenshot source: CDE official website
According to the clinical trial data of the drug 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
.
In the 36th and 48th weeks of treatment, the proportion of patients receiving mepolizumab in remission was significantly higher than that in the placebo group
, The accumulation time for patients receiving mepolizumab to achieve remission was significantly prolonged
Eosinophilic granulomatous polyangiitis is a rare autoimmune disease
.
Its symptoms include asthma, high levels of eosinophils, and inflammation of medium and small blood vessels
Reference materials:
Reference materials:[1] On November 19, 2021, the drug approval document pending information is released.
[1] On November 19, 2021, the drug approval document pending information is released.
Retrieved Nov 19, 2021, from https:// ] The FDA today approved the first new drug for rare vasculitis.
Retrieved Dec 13, 2017, from https://mp.
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