GSK Submits Fourth Indication Application in China for Mepolizumab (Nucala) Targeting COPD

On February 11, the CDE website showed that GSK's Mepolizumab（Mepolizumab，Nucala）New indication marketing application accepted. Based on clinical trial progress, the Insight database speculates that the indication isChronic Obstructive Pulmonary Disease (COPD). This is Mepolizumab.Item 4Indications for regulatory submission in China.

Source: CDE Official Website

Mepolizumab is a monoclonal antibody that specifically targets interleukin-5 (IL-5). It was the first IL-5 targeted monoclonal antibody to be approved by the FDA, gaining approval in November 2015.

Currently, the product has been approved for multiple indications in the United States, including eosinophilic asthma, allergic granulomatous vasculitis, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps. In China, mepolizumab also has...Three Indications Approved for Marketing, namely allergic granulomatous vasculitis, eosinophilic asthma, and chronic sinusitis with nasal polyps.

Source: Insight Database

In December 2024, GSK announced that the FDA had accepted the submission for a new indication of mepolizumab as an add-on maintenance treatment for patients with eosinophilic phenotype COPD.PDUFA Date: May 7, 2025. The press release shows that Mepolizumab has the potential to becomeThe First Biologic Approved for Monthly Administration in COPD Patients。

The listingApplicationBased on the data from the MATINEE studyThis is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to investigate the use of mepolizumab as an add-on therapy for patients with frequent COPD exacerbations characterized by eosinophil levels. The study results showed that, compared with placebo, in patients receiving 52-104 weeks of treatment,The annualized rate of moderate/severe exacerbations was significantly reduced., with statistical and clinical significance.

Since its launch, Mepolizumab has performed well in the market, with sales reaching $2.283 billion in 2024. With the expansion into new indications in the future, it is expected to achieve even more.