China clears GSK's Nucala for COPD

GSK has claimed an important new approval for Nucala in chronic obstructive pulmonary disease (COPD), in China, which is estimated to account for around a quarter of the global patient population.

The National Medical Products Administration (NMPA) has approved IL-5 inhibitor Nucala (mepolizumab) as an add-on maintenance treatment for adults with inadequately controlled COPD, characterised by raised blood eosinophils.

The drug – which is also approved for severe asthma and other indications characterised by eosinophilic inflammation – has previously been cleared for COPD in the US and was also recently recommended for approval in the EU.

According to a 2023 report from the World Health Organization (WHO), China has almost 100 million people living with COPD, and the disease is the third leading cause of death.

Those numbers alone make China an important market for GSK, but in recent years, the Chinese government has ramped up screening programmes and treatment capacity in primary healthcare. COPD is a priority within the government's Healthy China 2030 public health plan.

Between 2020 and 2023, for example, more than 140.000 primary healthcare workers received training in performing lung function tests, ramping up their skills in the early diagnosis of COPD.

In a statement, GSK said that Nucala is the first and only monthly biologic approved in China studied in a wide COPD population with a blood eosinophil count (BEC) starting as low as 150 cells/µL.

It will enter the market there a few months after its main rival – Sanofi and Regeneron's IL-4 and IL-13 inhibitor Dupixent (dupilumab) – which was cleared by the NMPA last September for similar use in people with BEC of 300 or more.

GSK has high hopes for Nucala thanks to its less frequent dosing – once a month, versus every other week for Dupixent – and the broader label. The company has estimated that among people with COPD who need additional treatment on top of inhaled triple therapy, around two-thirds have BECs of 150 or more.

Nucala is already one of GSK's top sellers, with sales of £1.44 billion ($1.94 billion) in the first nine months of 2025, up 13% on the like year-earlier period, and the company has estimated that COPD could add another £500 million to its peak sales potential.

"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 GSK's global head of immunology and inflammation R&D, Kaivan Khavandi.

"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," he added.

Regulatory submissions for Nucala in COPD are also currently under review in Europe and other areas of the world.

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