Friday, June 30, 2023
Harbour BioMed announced the acceptance of the Biologics Licence Application (BLA) of batoclimab (HBM9161) by the National Medical Products Administration (NMPA) of China for the treatment of generalised myasthenia gravis (gMG).
Batoclimab, an anti-FcRn treatment, has successfully completed clinical development and demonstrated positive results in the treatment of generalised myasthenia gravis (gMG) in the Chinese population. This groundbreaking therapy has been confirmed to be both effective and safe. Its introduction into clinical practise is expected to establish a new standard of care for gMG treatment.
Batoclimab (HBM9161) is a fully human anti-FcRn monoclonal antibody that works by blocking the interaction between FcRn and IgG molecules. In a Phase III study conducted in patients with myasthenia gravis, batoclimab showed promising results. The positive results of the Phase III study indicated that batoclimab was able to quickly and significantly alleviate the symptoms of myasthenia gravis, leading to an overall improvement in their quality of life.
Myasthenia gravis (MG) is an autoimmune disease that is characterised by the presence of antibodies such as anti-acetylcholine receptor (AChR) immunoglobulin G (IgG) and anti-muscle-specific tyrosine kinase (Anti-MuSK) IgG. These antibodies target and affect the postsynaptic membrane of the neuromuscular junction.
Current main treatments for MG include cholinesterase inhibitors and glucocorticoids and other immunosuppressive drugs, but their efficacy and safety do not meet the clinical needs of many patients.
