GSK’s Nucala (Mepolizumab) Gains China NMPA Approval for Eosinophilic COPD

GSK on 05 January 2026 announced that China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who remain inadequately controlled and have raised blood eosinophil levels. The decision introduces the first and only monthly biologic therapy in China evaluated in COPD patients with blood eosinophil counts starting as low as 150 cells per microlitre.​​

Kaivan Khavandi, SVP and Global Head of Respiratory, Immunology and Inflammation R&D at GSK, noted that COPD remains highly prevalent in China and carries a mortality rate above the global average. He said the approval of Nucala provides patients with a monthly add-on option designed to cut exacerbations, including those that lead to emergency visits or hospital stays, which drive a large share of COPD-related healthcare costs.​

COPD affects nearly 100 million people in China, and exacerbations that continue despite optimal inhaled triple therapy are linked with faster disease progression, higher hospitalisation rates, increased mortality, and growing strain on health systems. Among patients still experiencing flare-ups on triple therapy, about 67 percent have blood eosinophil counts above 150 cells per microlitre, highlighting a population with ongoing unmet need.​

Clinical Data

Approval was based on results from two phase III trials, MATINEE (NCT04133909) and METREX (NCT02105948).​

Both trials enrolled adults with COPD receiving optimal inhaled triple therapy. MATINEE followed patients for up to two years and included individuals with chronic bronchitis, emphysema, or both, provided they had evidence of type 2 inflammation. METREX evaluated mepolizumab across eosinophilic and non-eosinophilic phenotype groups, using defined blood eosinophil thresholds for entry.​

• MATINEE: Rate ratio 0.79 (annualised exacerbation rates: 0.80 for mepolizumab vs. 1.01 for placebo).​​
• METREX: Rate ratio 0.82 (annualised rates: 1.40 vs. 1.71).​
• Secondary analysis in MATINEE: Fewer exacerbations requiring emergency department visits or hospitalisation (rate ratio 0.65).​

Across both trials, adverse event rates were similar between mepolizumab and placebo groups, supporting a manageable safety profile.​​

Patient Impact

In China, mepolizumab is already available as an add-on maintenance treatment for severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and eosinophilic granulomatosis with polyangiitis (EGPA). It is also approved for COPD in the United States, with additional regulatory reviews ongoing globally.​​

How Nucala Works

Nucala is a monoclonal antibody that targets interleukin-5 (IL-5), a key cytokine that drives the survival and activation of eosinophils. By lowering eosinophil levels, the therapy aims to reduce inflammation associated with COPD exacerbations in patients with an eosinophilic phenotype.

References

Nucala (mepolizumab) approved in China for use in adults with chronic obstructive pulmonary disease (COPD), 05 January 2025, sea-nucala-approved-in-china-for-copd.pdf

Mepolizumab as Add-on Treatment IN Participants with COPD Characterized by Frequent Exacerbations and Eosinophil Level (MATINEE), ClinicalTrials.gov ID NCT04133909, https://clinicaltrials.gov/study/NCT04133909

Sciurba FC, et al, Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype. N Engl J Med. 2025 May 1;392(17):1710-1720. doi: 10.1056/NEJMoa2413181. PMID: 40305712.

Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients, ClinicalTrials.gov ID NCT02105948, https://clinicaltrials.gov/study/NCT02105948

Pavord ID et al, Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Oct 26;377(17):1613-1629. doi: 10.1056/NEJMoa1708208. Epub 2017 Sep 11. PMID: 28893134. https://pubmed.ncbi.nlm.nih.gov/28893134/