Nucala® is the commercial brand name of Mepolizumab Injection, a humanized anti-IL-5 monoclonal antibody developed by GSK. It binds to interleukin-5 (IL-5) to block the maturation and survival of eosinophils, lower eosinophil levels in tissues and blood, and relieve inflammatory damage caused by eosinophil overactivation.
Main Indications
Add-on maintenance treatment for patients aged 6 years and older with severe refractory eosinophilic asthma to reduce asthma exacerbations;
Maintenance remission treatment for adult eosinophilic granulomatosis with polyangiitis (EGPA);
Long-term control treatment for patients aged 12 years and older with idiopathic hypereosinophilic syndrome lasting over 6 months;
Adjunctive treatment for adult chronic rhinosinusitis with nasal polyps;
Add-on maintenance therapy for adult eosinophilic chronic obstructive pulmonary disease to reduce acute exacerbations.
Clinical Research
Global Phase III MENSA double-blind placebo-controlled pivotal trials proved that 100mg subcutaneous administration of mepolizumab significantly cut annual asthma exacerbation rates and helped reduce long-term oral hormone dosage;
Compared with placebo, long-term extension trials verified continuous efficacy and low cumulative adverse reaction incidence for EGPA and hypereosinophilic syndrome indications;
Domestic multicenter registration clinical trials in China confirmed that the efficacy and safety profile of mepolizumab in Chinese patients matched global clinical trial data.
Common Side Effects
Serious risks: Severe anaphylactic shock, angioedema, herpes zoster infection, severe local injection site inflammatory reaction (rare but severe);
Common mild adverse reactions: Headache, back pain, injection site redness, swelling and soreness, fatigue, upper respiratory tract infection, urinary tract infection, joint pain, skin rash and itching.
Approval Status in China
Original drug Nucala® (Mepolizumab Injection) was officially approved for marketing in China in 2024, with the specification of 100 mg (1ml)/single-dose pre-filled autoinjector. It is currently a prescription biological drug included in China’s category B medical insurance.
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