GSK's Mepolizumab Receives NMPA Approval for New Indication in China: Chronic Rhinosinusitis with Nasal Polyps
GSK
Pharmaceutical R&D Manufacturer
On January 2, the NMPA official website showed that GSK's Mepolizumab Injection was approved for a new indication in China. Insight database speculated that the new indication might beChronic Rhinosinusitis with Nasal Polyps。
Screenshot source:NMPA Official Website
Mepolizumab（Mepolizumab）Is a specific targeting of interleukin-5（IL-5）The monoclonal antibody was developed to treat a series of IL-5 mediated diseases associated with type 2 inflammation.
In November 2015, the drug was first approved by the FDA.Approved for Marketing，YesThe world's first approved IL-5 targeted monoclonal antibody. CurrentlyHas been approved for multiple indications in the United States, including eosinophilic asthma, allergic granulomatous vasculitis, and eosinophilic granulomatosis with polyangiitis.（EGPA）、 Eosinophilia Syndrome and Chronic Rhinosinusitis with Nasal Polyps.
Screenshot source: Insight database
In addition, the Phase III clinical trial MATINEE of Mepolizumab for the treatment of adult COPD has achieved positive results in September 2024.
In China, Mepolizumab was approved in November 2021 forTreatment of Eosinophilic Granulomatosis with Polyangiitis in Adults, approved in January 2024 for adults and adolescents aged 12 years and aboveSevere Eosinophilic AsthmaMaintenance Treatment。
Screenshot source: Insight database
In the pivotal SYNAPSE study, researchers compared mepolizumab with placebo in combination with standard therapy in over 400Chronic Rhinosinusitis with Nasal Polyps（CRSwNP）Efficacy and safety in patients.
Results showed that at Week 52 of treatment, compared with the placebo group, patients in the mepolizumab treatment group experienced statistically significant improvements in both nasal polyp volume and nasal congestion; moreover, compared with the placebo group, patients in the mepolizumab treatment groupThe proportion of patients undergoing surgery decreased by 57%.(HR=0.43). In addition, a lower proportion of patients receiving mepolizumab required systemic corticosteroids during the 52-week treatment period.
Latest ReleasedMepolizumab in Japan, China, and RussiaCRSwNP PatientsPhase III MERIT clinical trial results show,Compared with placebo,Mepolizumab significantly improved nasal congestion VAS scores from baseline to weeks 49-52., and correlated with the trend of overall ENPS improvement at Week 52.
The above study concluded that mepolizumab is effective and well-tolerated in patients with CRSwNP/ECRS in Japan, Russia, and China.
Screenshot source: Insight database
Mepolizumab is also the first IL-5 targeted monoclonal antibody approved for marketing in China. According to the Insight database, it has several potential competitors, including those produced in China.3SBioSSGJ-610,Hengrui MedicineSHR-1703 has progressed toPhase III clinical stage, the fastest-progressing domestically produced new drug in China. In addition,Zhengda Tianqing and Bio-Thera are also actively developing a biosimilar of mepolizumab.
