GSK Submits Mepolizumab BLA in China, Marking First IL-5 Inhibitor Filing in the Country

Text | Baihuawen

On July 6, the Center for Drug Evaluation (CDE) accepted GlaxoSmithKline’s marketing application for mepolizumab injection in China, marking the first IL-5 monoclonal antibody to be submitted for marketing approval in the country.

Mepolizumab was approved by the FDA for market launch in November 2015 under the brand name Nucala. The drug has been approved for the indications of eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. Indications currently under development include chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps, and chronic eosinophilic leukemia/hypereosinophilic syndrome. In 2019, Nucala’s sales amounted to £768 million.

Currently, two IL-5 monoclonal antibodies have been approved for marketing worldwide: mepolizumab and reslizumab (Teva). Additionally, one IL-5 receptor (IL-5R) monoclonal antibody, benralizumab from AstraZeneca, has been approved. In China, 3SBio’s IL-5 monoclonal antibody is in Phase I clinical trials, while Mabpharm’s biosimilar of mepolizumab is in the preclinical stage.

The FDA has currently approved five monoclonal antibodies targeting the Th2 pathway for marketing, with global sales revenue exceeding $7 billion in 2019. Among these, omalizumab and dupilumab have been approved for marketing in China, with indications for asthma and atopic dermatitis, respectively.

Source: NextPharma