London, March 30, 2026, 14:08 BST.
GSK notched up two regulatory milestones in China on Monday: the country gave the green light to Exdensur, its asthma therapy, and kicked off a formal review for bepirovirsen, a hepatitis B hopeful. According to a company filing, Exdensur is now approved in China for severe eosinophilic asthma in patients 12 and up. The bepirovirsen filing covers chronic hepatitis B in adults, GSK said.
The clock’s ticking for GSK, with new product launches now key as the company faces looming HIV drug patent cliffs. Back in February, CEO Luke Miels laid it out: “We need to accelerate what we have,” describing a push for faster development and fresh assets, mostly via smaller acquisitions. And on top of that, China’s role is rising fast for global pharma, as licensing deals start stacking up. Reuters
Exdensur, also known as depemokimab, is a targeted antibody therapy given by injection just twice a year for people with severe eosinophilic asthma—a variant characterized by elevated eosinophil counts, those white blood cells that ramp up airway inflammation. The infrequent dosing stands out, since competing biologics in the segment usually require much more regular shots.
GSK pointed to results from its SWIFT late-stage trials in China, where Exdensur managed to cut annualised asthma attacks by 58% and 48% compared to placebo over the 52-week period. Kaivan Khavandi, who leads GSK’s respiratory research, said the green light from regulators could “redefine care in just two doses a year.” GSK
The tougher challenge for Exdensur could be winning over the market, not just regulators. The drug steps into a crowded field against Sanofi and Regeneron’s Dupixent and Roche and Novartis’ Xolair. Analysts point out Exdensur’s trial results showed efficacy on par with what’s already out there, so adoption might come down to whether patients and doctors see enough value in the twice-yearly dosing to justify making a switch.
Bepirovirsen isn’t close to hitting the market yet, but GSK’s regulatory filing in China hands the company an official way in to a field short on curative treatments. This gene-targeted therapy is designed to achieve what physicians refer to as a functional cure — hepatitis B viral DNA and surface antigen stay undetectable for 24 weeks post-treatment — a sharp contrast to current treatments, which most patients take indefinitely and rarely fully clear the virus.
Back in January, Jefferies analyst Michael Leuchten called the phase-three bepirovirsen results “encouraging” and flagged “blockbuster potential,” but pointed out investors are waiting on the complete dataset. GSK, for its part, believes the drug could eventually top 2 billion pounds a year in peak sales. Reuters
Exdensur’s reach keeps expanding—China just joined the list. The asthma drug is already cleared for severe cases in the U.S., EU, and UK. However, the U.S. FDA last December stopped short of approving it for chronic rhinosinusitis with nasal polyps, a persistent sinus inflammation.
Monday brought a pair of China announcements for GSK, boosting a rollout push that CEO Miels has described as key for reaching the company’s target—over 40 billion pounds in yearly revenue by 2031. The heavy hitters: Exdensur and Blenrep, a blood cancer therapy, both expected to shoulder a significant share.
