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China Approves GSK’s Nucala as First Biologic for COPD Maintenance Therapy

Prime Highlight

  • China approved GSK’s Nucala (mepolizumab)for adults with poorly controlled COPD and high blood eosinophil levels.
  • It becomes the country’s first monthly biologic therapyfor COPD, helping patients who still experience flare-ups.

Key Facts

  • Trials MATINEE and METREXshowed Nucala reduces moderate and severe COPD flare-ups and is as safe as standard therapy.
  • COPD affects around 100 million people in China, and the drug supports precision treatment using biomarkerslike blood eosinophils.

Background

China’s drug regulator has approved GSK’s monoclonal antibody mepolizumab, sold as Nucala, as an add-on maintenance treatment for adults with poorly controlled chronic obstructive pulmonary disease (COPD). The approval applies to patients with raised blood eosinophil levels who continue to suffer flare-ups despite using standard inhaled triple therapy.

The decision by the National Medical Products Administration marks a major step for biologic medicines in respiratory care in China. Until now, COPD treatment in the country has relied mainly on inhaled drugs. Nucala becomes the first monthly biologic approved in China for COPD and offers a new option for patients who remain at high risk of repeated exacerbations.

GSK said the approval was based on results from two late-stage trials, MATINEE and METREX. In both studies, patients receiving Nucala had fewer moderate and severe COPD flare-ups compared with those given a placebo. The trials also showed that the safety profile of the drug was similar to standard treatment.

Importantly, the MATINEE trial showed that the drug reduced flare-ups that sent people to the hospital or emergency room. These flare-ups put a heavy strain on patients and the healthcare system. Researchers tested the drug in many types of patients, including those with chronic bronchitis and emphysema, showing that it can work well in real-world use.

COPD affects an estimated 100 million people in China and accounts for a large share of global deaths linked to the disease. Many patients continue to worsen even with advanced inhaled therapies.

The approval shows a growing focus on targeted treatment based on markers like blood eosinophil levels. Experts say this step could drive the development of more precise medicines for COPD and change how doctors treat the disease in China and other countries.