GSK’s Nucala (mepolizumab) has recently received approval in China as add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD), expanding the shift in treatment access by allowing use at a lower blood eosinophil threshold. The decision broadens eligibility for biologic therapy, strengthens competition in China’s emerging precision COPD market, says GlobalData, a leading intelligence and productivity platform.
The National Medical Products Administration (NMPA) has approved Nucala for patients with blood eosinophil counts (BEC) of 150 cells/µL or higher, a lower threshold that expands treatment eligibility and positions it competitively in the evolving precision COPD market, through broader patient access and convenient monthly administration.
GlobalData’s Pharmaceutical Intelligence Center reveals that the total prevalent COPD cases in China are estimated to increase at an annual growth rate of 2.14%* from 111 million in 2025 to 130 million in 2033.
According to Chinese Center for Disease Control and Prevention (China CDC), COPD ranks as the third most prevalent non-communicable disease in the country. COPD accounts for 10% of China’s healthcare expenditures, with hospitalizations representing the largest cost component. Studies project China’s economic losses from COPD will reach $1.4 trillion over the next three decades, representing nearly 30% of the global economic burden.
The COPD treatment landscape in China has evolved rapidly with the approval of the first biologic for COPD, Sanofi’s dupilumab in September 2024. It is indicated for COPD patients with BEC ≥300 cells/µL threshold.
Nucala’s approval advances precision medicine by offering a distinct therapeutic approach. Mepolizumab selectively targets IL-5 to reduce eosinophil production and survival, while dupilumab blocks both IL-4 and IL-13 signaling pathways. Furthermore, Nucala is administered as a 100 mg subcutaneous injection monthly versus 300mg dupilumab’s bi-weekly dosing.
Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “Nucala represents a precision medicine approach that uses blood tests to identify which patients need targeted treatment. This approach uses biomarker testing to guide treatment decisions rather than trial-and-error, matching patients to therapies based on their inflammation phenotype.”
The approval was supported by pivotal Phase III trials showing statistically significant reductions in moderate or severe COPD exacerbations when mepolizumab was added to triple inhaled therapy. The data also demonstrated reductions in exacerbations requiring emergency department visits or hospitalization.
Sahu concludes: “As a new challenger to the only biologic previously approved in China, Nucala’s lower eosinophil threshold and monthly dosing provide differentiation advantages. In China’s healthcare context, where COPD exacerbations impose catastrophic costs on families and strain hospital capacity, mepolizumab’s ability to reduce emergency visits and hospitalizations addresses both clinical and economic imperatives.”
*Recalculated growth rate for 2025-2033 based on data from 2023-2033 forecast.
