London, March 30, 2026, 14:08 (BST). 1
GSK said on Monday China approved its asthma drug Exdensur and accepted its hepatitis B candidate bepirovirsen for regulatory review, handing the British drugmaker two fresh regulatory wins in China on the same day. A company filing showed Exdensur was cleared for patients aged 12 and older with severe eosinophilic asthma, while GSK said China had opened formal review of bepirovirsen for adults with chronic hepatitis B. 2
The timing matters. GSK is leaning on new launches to sustain growth as it works through looming patent expiries in HIV medicines, and CEO Luke Miels said in February, “We need to accelerate what we have,” while outlining a plan to speed development and add assets through smaller deals. China has also become a bigger draw for multinational drugmakers as licensing activity picks up. 3
Exdensur, or depemokimab, is a twice-yearly injected biologic — a targeted antibody medicine — for severe eosinophilic asthma, a form of the disease driven by high levels of eosinophils, a type of white blood cell that can inflame the airways. That schedule is unusual in a market where many rival biologics are dosed far more often. 4
GSK said the China approval rested on late-stage SWIFT trials in which Exdensur cut annualised asthma attacks by 58% and 48% against placebo over 52 weeks. Kaivan Khavandi, GSK’s respiratory research head, said the approval could “redefine care in just two doses a year.” 5
But the commercial test may be harder than the regulatory one. Exdensur will face Sanofi and Regeneron’s Dupixent and Roche and Novartis’ Xolair, and analysts have said its efficacy looked broadly similar to existing options in trials, leaving uptake likely to hinge on whether patients and doctors value the twice-yearly dosing enough to switch. 6
Bepirovirsen is further from market, but the China filing gives GSK a formal route into a disease area with few curative options. The gene-targeting medicine aims for what doctors call a functional cure — when hepatitis B viral DNA and surface antigen remain undetectable for at least 24 weeks after treatment stops — in a disease where standard therapies are often taken for life and clear the virus in only a small share of patients. 7
Jefferies analyst Michael Leuchten said in January the consistency of the phase-three bepirovirsen data was “encouraging” and could “open blockbuster potential,” though he added investors still need the full dataset. GSK has said the medicine could generate more than 2 billion pounds in peak annual sales. 8
China adds to an already broad rollout for Exdensur. The drug has approvals in the United States, the European Union and the United Kingdom for severe asthma, although the U.S. regulator in December did not clear it for chronic rhinosinusitis with nasal polyps, a form of long-running sinus inflammation. 6
For GSK, Monday’s twin China updates add momentum to a launch cycle Miels has singled out as central to hitting the group’s goal of more than 40 billion pounds in annual sales by 2031. Exdensur and blood cancer drug Blenrep are among the medicines expected to do much of that work. 3
