Apr, 2023. AstraZeneca’s Gefurulimab injection(ALXN1720) obtains the Implied License from CDE for generalized myasthenia gravis clinical trial.
According to public information, Gefurulimab injection is a third-generation C5 inhibitor. AstraZeneca acquired Alexion for US$39 billion in 2020 to obtain ALXN1720, which is being developed by the latter.
Myasthenia gravis is a chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles. https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravisMechanism of action for Gefurulimab is related to Complement C5. Gefurulimab is an investigational, anti-C5 albumin-binding humanized bispecific VHH antibody that binds C5 and blocks its activation. This antibody has a molecular weight of only 25 kD, so it is with has better permeability, and can bind to albumin to extend its half-life.
Because of the optimization for sub-cutaneous delivery, Gefurulimab is expected to become a once-weekly subcutaneous injection therapy that can be self-administered by the patient, greatly improving the convenience of treatment for generalized myasthenia gravis patients.
Previous programs about Gefurulimab have demonstrated safety and efficacy of C5 inhibitors in generalized myasthenia gravis. Gefurulimab is conducting phase 3 clinical research overseas for the treatment of generalized myasthenia gravis, and to assess safety and efficacyhttps://www.aan.com/MSA/Public/Events/AbstractDetails/53615. Clinical research for treatment of generalized myasthenia gravis in China will start after approval this time.