China Grants Approval to Nucala for COPD Management | iPharmaCenter

China’s National Medical Products Administration has officially cleared Nucala (mepolizumab) as a supplemental maintenance therapy for adults suffering from chronic obstructive pulmonary disease (COPD). This authorization specifically targets patients whose condition remains poorly managed and is linked to elevated levels of eosinophils in the blood.

Nucala: A Milestone in Biological Respiratory Care

Nucala stands as the inaugural monthly biological treatment in China indicated for a broad spectrum of COPD sufferers, including those with blood eosinophil counts (BEC) as low as 150 cells/µL. This is particularly significant given that roughly two-thirds of patients who still struggle with symptoms while on triple-inhaled medication possess these specific inflammatory markers.

Clinical Evidence: The MATINEE and METREX Programs

The regulatory green light was prompted by successful outcomes from two major Phase III international research programs.

• Reduction in Attacks: Both trials proved that adding mepolizumab to standard triple therapy significantly decreased the frequency of moderate to severe flare-ups compared to a dummy drug.

• Emergency Prevention: Specifically, data from the MATINEE study highlighted a decrease in exacerbations that required urgent emergency department visits or inpatient hospital stays.

• Safety Consistency: The frequency of side effects reported by participants receiving the medication was virtually identical to those receiving the placebo.

Addressing a Major Health Crisis in China

With an estimated 100 million individuals living with COPD in China, the nation accounts for nearly one-third of the world's fatalities related to the disease. Recurrent respiratory crises not only damage lung tissue permanently but also increase the risk of death and place an immense strain on the medical system.

Mechanism and Broader Applications

Nucala is a monoclonal antibody designed to intercept interleukin-5 (IL-5). This specific protein acts as a primary signal for type 2 inflammation, driving the activity of eosinophils. By neutralizing this pathway, the drug helps stabilize the airways.

Outside of this new COPD indication, the therapy is already utilized within China to treat:

• Severe eosinophilic asthma.

• Chronic rhinosinusitis with nasal polyps.

• Eosinophilic granulomatosis with polyangiitis (EGPA).

  
  

While already available for COPD in the United States and recently recommended for approval in Europe, mepolizumab continues to undergo regulatory assessment in several other global territories.