NMPA Approves Genakumab Injection for Clinical Trial Commencement

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2024-05-26

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May 23rd, 2024, Shanghai - GenSci recently received the Approval Notice from the National Medical Products Administration (NMPA) to initiate the Genakumab Injection(liquid form) clinical trial, which marks the initiation of bioequivalence studies for the new formulation of Genakumab Injection.


GenSci's Genakumab is a Category 1 new biological drug for therapeutic use, produced through genetic engineering and other advanced technologies as an anti-IL-1β antibody medication. Previously, the marketing application for the powder form of Genakumab (anti-IL-1β antibody) for the treatment of acute gouty arthritis has been accepted by the NMPA; The recently approved clinical trial is a bioequivalence study for the new formulation of Genakumab Injection, which offers an additional convenient option to patients, complementing the existing formulations. Additionally, GenSci's Genakumab is currently undergoing clinical research for other indications such as systemic juvenile idiopathic arthritis and interstitial lung disease. 


Relevant research suggests that an overabundance of interleukin (IL) is a pathogenic factor in various inflammatory diseases. Anti-IL-1β antibodies can rapidly and specifically block the binding of IL-1βto its receptor, thereby inhibiting inflammation.