Mepolizumab Wins COPD Treatment Approval in China, Expanding GSK's Respiratory Portfolio

quietly_staking · 2026-01-12T17:42:48+00:00

GSK's Nucala received approval in China for COPD maintenance therapy, supported by phase III trials showing significant efficacy. This expands its existing uses in the Chinese market, with ongoing regulatory advancements in other countries.

quietly_staking

2026-01-12 17:42:48

Abstract generation in progress

GSK plc (GSK, GSK.L) has received regulatory clearance from China’s National Medical Products Administration (NMPA) for Nucala (mepolizumab) as an add-on maintenance therapy for adult patients with inadequately controlled chronic obstructive pulmonary disease featuring elevated eosinophil levels. This marks a significant expansion of the medication’s indication in the Chinese market.

Clinical Evidence Supports COPD Treatment Expansion

The approval decision was underpinned by positive results from the MATINEE and METREX phase III clinical trials. Data from these studies demonstrated that mepolizumab delivered a statistically significant and clinically meaningful reduction in the rate of moderate to severe exacerbations on an annualised basis when compared to placebo combined with standard care. The benefit was observed across a diverse patient population with COPD displaying an eosinophilic phenotype.

Broadening Therapeutic Applications

Prior to this COPD treatment milestone, mepolizumab had already secured market access in China for several other indications. The medication was previously approved for use as an add-on maintenance treatment in severe eosinophilic asthma among adults and adolescents aged 12 and above. Additionally, it holds approvals for chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis in the Chinese market.

Global Pipeline Progress

The COPD treatment approval in China follows earlier regulatory momentum in other major markets. Mepolizumab is currently authorized for COPD use in the United States. Meanwhile, the European regulatory pathway continues to advance, with the Committee for Medicinal Products for Human Use (CHMP) recently issuing a positive opinion on mepolizumab for COPD treatment, with additional regulatory submissions under review across global markets.

Market Response

GSK closed trading on January 2 at $49.63, reflecting a gain of $0.59 or 1.20%. Overnight trading saw the stock retreating modestly to $49.43, representing a decline of $0.20 or 0.40%.

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