- GSK
- 05 January 2026 07:41:43
Source: Sharecast
Following the green light from China's National Medical Products Administration, Nucala is the country's first and only monthly biologic for a COPD patient population with a blood eosinophil count of 150 cells/µL or higher.
Of the 100m people in China who have COPD, among those who continue to exacerbate despite inhaled triple therapy, around 67% have a blood eosinophil count above 150 cells/µL, GSK said.
The approval follows positive results from the Matinee and Metrex phase III trials, which showed a "clinically meaningful and statistically significant" reduction in the annualised rate of moderate to severe exacerbations compared with the placebo plus standard of care.
The trials, which GSK said included a wide spectrum of COPD patients with an eosinophilic phenotype, showed a similar incidence of adverse events between both the placebo and Nucala 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 of respiratory in GSK's Immunology & Inflammation R&D division.
"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 hospitalisations which account for a large proportion of annual direct medical costs."