China Clears Mepolizumab for COPD

Editor's note: this story was originally published on BioPharmInternational.com.

China’s National Medical Products Administration has approved the monoclonal antibody (mAb) mepolizumab (brand name Nucala) as an add-on maintenance therapy for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils, GSK announced on Jan. 5, 2026 (1). The approval marks a regulatory milestone for biologics in respiratory disease management in the country and reflects growing regulatory acceptance of targeted immunologic approaches for a condition historically managed with inhaled therapies alone (1,2).

The approval was supported by data from two Phase III trials (MATINEE and METREX), which evaluated the mAb in patients with COPD who continue to experience exacerbations despite optimal inhaled triple therapy. According to GSK, these studies demonstrated statistically significant reductions in moderate and severe exacerbations compared with placebo, with a safety profile comparable between treatment groups.

“Given the high incidence of COPD in China and a mortality rate that is above the global average, there is a clear need for novel options to address COPD,” said Kaivan Khavandi, senior vice-president and global head, Respiratory, Immunology & Inflammation R&D, GSK, in a company press release (1). “The approval of Nucala offers patients in China a monthly add-on maintenance treatment to reduce exacerbations, including those leading to emergency department visits and/or hospitalizations, which account for a large proportion of annual direct medical costs.”

What does China’s approval mean for biologics in COPD treatment?

With this approval, mepolizumab becomes the first monthly biologic approved in China for COPD and the first evaluated across a broad patient population with blood eosinophil counts starting at 150 cells/µL, GSK stated in its release (1). The company noted that this threshold is clinically relevant because a substantial proportion of patients with persistent exacerbations fall into this category, despite receiving combination inhaled therapy.

COPD affects an estimated 100 million people in China, where the disease accounts for more than 30% of global mortality attributed to the disease (3). Recurrent exacerbations are associated with accelerated lung function decline, increased hospitalization and readmission rates, and higher healthcare costs, creating both clinical and economic pressures on health systems (4,5).

How did the Phase III trials shape regulatory confidence?

In both pivotal trials, mepolizumab met primary endpoints by reducing the annualized rate of moderate or severe exacerbations when added to inhaled triple therapy. In the MATINEE study, the rate ratio was 0.79, while the METREX study demonstrated a rate ratio of 0.82, indicating consistent benefit across study populations with an eosinophilic phenotype (1).

Importantly for regulators and payers, the MATINEE study also showed reductions in exacerbations requiring hospitalization or emergency department visits, outcomes that drive a disproportionate share of COPD–related costs. The incidence of adverse events was similar between treatment and placebo groups, reinforcing the therapy’s safety profile in long-term use (1).

The trial designs reflected real-world heterogeneity, enrolling patients with chronic bronchitis, emphysema, or overlapping presentations, according to GSK. This breadth may have contributed to confidence in generalizability, particularly in a healthcare environment managing large, diverse patient populations (1).

Why does eosinophil stratification matter to the industry?

This approval underscores the increasing role of biomarker-driven stratification in respiratory drug development. Approximately 67% of patients with COPD who remain uncontrolled on triple inhaled therapy have blood eosinophil counts above 150 cells/µL, identifying a sizable subgroup that may benefit from targeted biologic intervention, according to GSK (1).

In addition, this decision highlights a shift toward precision medicine in chronic respiratory diseases and may influence development strategies, trial design, and regulatory engagement for future biologics. It also signals a growing willingness by regulators to expand biologic use beyond traditional indications such as asthma, potentially reshaping treatment paradigms for COPD globally (1,2).

References

1. GSK. Nucala (mepolizumab) Approved in China for Use in Adults with Chronic Obstructive Pulmonary Disease (COPD). Press Release. Jan. 5, 2026.
2. Jia, N.; Jin, M.; Liu, Y.; et al. The Management of Type 2 Inflammatory Respiratory Diseases: A Chinese Expert Consensus [2024]. J. Thorac. Dis. 2025, 17 (4).
3. Wang, C.; Xu, J.; Yang, L.; et al. Prevalence and Risk Factors of Chronic Obstructive Pulmonary Disease in China (the China Pulmonary Health [CPH] Study): A National Cross-Sectional Study. Lancet 2018, 391(10131), 1706–1717. DOI: 10.1016/S0140-6736(18)30841-9
4. Yin, P.; Wang, H.; Vos, T.; et al. A Subnational Analysis of Mortality and Prevalence of COPD in China From 1990 to 2013: Findings from the Global Burden of Disease Study 2013. Chest 2016, 150 (6), 1269–1280. DOI: 10.1016/j.chest.2016.08.1474
5. WHO. Advancing COPD Care in China Through a Comprehensive Approach. who.int, Nov. 15, 2023.