China's First Approved Fully Human Anti-IL-5 Biologic Launched in Beijing for Long-Term Control of Severe Asthma

China Finance Network January 12th — The National Medical Products Administration (NMPA) recently approved GSK's innovative targeted biologic Nucala (Mepolizumab Injection) for the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above.

Yesterday, the first prescription for Mepolizumab Injection was issued in Beijing. "As a clinician, I am very pleased to issue the first prescription in the Beijing area. I also look forward to this innovative drug helping patients with severe eosinophilic asthma to breathe easily during the day, not feel suffocated at night, reduce the risk of acute attacks, and return to a normal life," said Professor Su Nan, Director of the Department of Respiratory and Critical Care Medicine at China-Japan Friendship Hospital.

Data shows that about 46 million adults in China suffer from asthma, of which 6% are patients with severe asthma. Among patients with severe asthma, there is a subtype whose lung inflammation is caused by an excessive number of eosinophils (EOS, a type of white blood cell), and these are referred to as patients with severe eosinophilic asthma.

The largest international registry study on severe asthma (ISAR*) indicates that the proportion of severe eosinophilic asthma can be as high as 83.8%. China's first multicenter cohort study on adult severe asthma also reached a similar conclusion, with the eosinophilic phenotype accounting for up to 76.8%.

"Clinically, asthma patients with high eosinophil levels are more difficult to treat, experience greater fluctuations, have poorer lung function, and are more likely to visit the emergency room or be hospitalized. Such severe asthma patients with poor control are also prone to secondary issues caused by long-term, high-dose steroid use, including side effects from steroids and increased medical costs." Professor Su Nan stated that Mepolizumab Injection, as the first fully human anti-IL-5 biologic approved in China, specifically inhibits key inflammatory pathways and represents a significant medical advancement in the treatment of severe asthma.

According to reports, as the first approved monoclonal antibody biologic targeting human anti-interleukin-5 (IL-5), Mepolizumab directly binds to and inhibits the IL-5 molecule, achieving symptom improvement within one week (significant improvement in ACQ-5 score within two weeks) and zero severe acute exacerbations throughout the year (up to 96.6% of patients experienced no exacerbations leading to hospitalization or emergency visits over 52 weeks).

To date, Nucala has been approved in the United States, the European Union, and more than 25 other markets as a maintenance treatment for patients with severe eosinophilic asthma. Nucala has now been approved in China for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) and was included in the National Reimbursement Drug List in January 2023.

Professor Su Nan reminded that patients with severe asthma should not only undergo standardized and long-term treatment but also have regular follow-ups and reexaminations of eosinophil levels in blood tests as well as other auxiliary examinations for asthma, including the assessment of lung function. "For every asthma patient, doctors need to provide individualized treatment so that patients can achieve the greatest clinical benefits."