Pharma Focus Asia

Harbour BioMed Accepts Biologics Licence Application of Batoclimab

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.

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024