GSK(US:GSK) 智通财经网·2025-12-17 07:06Core Viewpoint - GlaxoSmithKline (GSK) has received FDA approval for its new asthma treatment, Exdensur (depemokimab), which is expected to pave the way for the drug to become a blockbuster product [1] Group 1: Regulatory Approvals - Exdensur has been approved by the FDA as an additional maintenance therapy for patients aged 12 and older with severe asthma [1] - Earlier this month, the drug received marketing authorization from the European Medicines Agency, and the UK regulatory body has also given it the green light [1] - The drug's applications in China and Japan are currently under review [1] Group 2: Clinical Efficacy - Exdensur is the first ultra-long-acting biologic for respiratory diseases, with a dosing frequency of only twice a year [1] - Clinical trial data indicates that the drug can reduce the risk of acute exacerbations in severe asthma patients by 54% and alleviate nasal congestion symptoms in chronic sinusitis patients while reducing the size of nasal polyps [1] Group 3: Market Potential - Exdensur is considered a key component of GSK's future growth strategy [1] - The company plans to expand the drug's applications across various indications between 2026 and 2027 [1] - GSK anticipates that Exdensur could achieve annual sales of up to £3 billion (approximately $4 billion) [1] Group 4: Target Patient Population - GSK estimates that there are approximately 2 million patients with severe asthma in the United States, with half of these patients still facing frequent exacerbations and hospitalization risks [1]