London, January 6, 2026, 09:03 GMT — Regular session
GSK plc shares rose nearly 1% in early London trade on Tuesday after the drugmaker said Japan had approved its bronchial asthma treatment Exdensur. Shares were up 0.96% at 1,838 pence by 0830 GMT.
The decision lands as investors weigh whether GSK’s next wave of respiratory launches can broaden growth beyond its established portfolio. Long-acting medicines that cut the number of injections can be a commercial lever, but they also have to win reimbursement and persuade patients and doctors to switch.
The Japan approval followed a separate regulatory win in China on Monday, when authorities cleared Nucala for adults with chronic obstructive pulmonary disease (COPD), a lung condition that makes breathing difficult. The back-to-back decisions extend GSK’s reach in inflammatory airway disease, one of the company’s core growth bets.
Japan’s health ministry approved Exdensur, also known as depemokimab, for severe or refractory asthma and for chronic rhinosinusitis with nasal polyps (CRSwNP), a chronic inflammatory sinus disease, GSK said. In late-stage SWIFT trials, the drug cut annualised asthma attacks by 58% and 48% versus placebo, while ANCHOR studies showed improvements in nasal polyp measures, the company said.
“The approval of Exdensur in Japan could set a new standard of care,” Kaivan Khavandi, GSK’s global head of Respiratory, Immunology & Inflammation R&D, said. The treatment is designed for twice-yearly dosing and targets IL-5, an immune messenger linked to eosinophil-driven inflammation. GSK
In China, regulators approved Nucala (mepolizumab) as an add-on maintenance treatment — given on top of standard inhaled therapy — for adults with inadequately controlled COPD and raised blood eosinophils, a type of white blood cell tied to airway inflammation, GSK said. In the MATINEE and METREX phase III trials, Nucala reduced the annualised rate of moderate or severe COPD flare-ups versus placebo, the company said.
Exdensur enters a crowded asthma market. Analysts have said depemokimab’s convenience could help it compete with established biologics such as Sanofi and Regeneron’s Dupixent and Roche and Novartis’ Xolair, but they also cautioned that trial efficacy looked similar to existing options and uptake will matter.
Investors are also watching the next regulatory steps. In Europe, GSK has said a European Commission decision on depemokimab is expected in the first quarter of 2026, after a positive opinion from the European Medicines Agency’s CHMP panel.
A key risk is execution rather than headline approvals. Slower-than-expected reimbursement decisions, cautious prescribers or aggressive discounting by rivals would dull the revenue impact, even if the clinical profile holds up in day-to-day practice.
