GSK's Monthly-Dosed Mepolizumab Receives CDE Acceptance for New COPD Indication in China

Recently, the CDE official website showed that GSKTheThe new indication application for Mepolizumab Injection has been accepted. Based on clinical trial progress, the Insight database speculates that the indication isChronic Obstructive Pulmonary Disease（COPD）。

Mepolizumab isThe world's first approved IL-5 monoclonal antibody, administered once a month, has currently been approved for multiple indications in the United States, includingEosinophilic asthma, Allergic granulomatous vasculitis, Eosinophilia syndrome, Chronic rhinosinusitis with nasal polyps,Eosinophilic Chronic Obstructive Pulmonary Disease.

In China, the product has also been approved for three indications, used for treatingTherapyAllergic Granulomatosis Angiitis,EosinophilAsthma andChronic Rhinosinusitis with Nasal Polyps。

Since its first launch in November 2015, Mepolizumab has seen a surge in sales, breaking into the blockbuster category for the first time in 2020 with $982 million in revenue. In 2024, the product generated $2.279 billion in income and maintained double-digit growth in the first half of this year.Reached $1.225 billion。

Recommended reading:Once a Month! GSK's "Mepolizumab" Approved Again, Aiming at the Blue Ocean Track of COPD

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Disclaimer:This article is for information sharing only, and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.

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