Harbour BioMed’s Batoclimab granted Breakthrough Therapy designation in China
pharmafile | January 28, 2021 | News story | | Harbour BioMed
Harbour BioMed (HBM) has announced that China’s Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab, a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG).
Myasthenia Gravis is a severely debilitating condition that causes skeletal muscle contraction and weakness resulting in limited movement, and can lead to fatal respiratory failure. In China, an estimated 250,000 patients suffer from this condition, and current therapies are limited due to inadequate efficacy, safety issues, or limited availability.
Batoclimab treats pathogenic immunoglobulin G (IgG)-mediated autoimmune diseases by blocking FcRn-IgG interactions, accelerating the degradation of autoantibodies. Earlier studies demonstrated that the drug is well tolerated and can rapidly reduce total IgG, making Batoclimab the first anti-FcRn to demonstrate a sustained IgG reduction in both Chinese and Caucasian populations when administered via subcutaneous injection.
According to CDE guidelines, Breakthrough Therapy designations are reserved for drugs that treat serious or life-threatening diseases or conditions, while demonstrating a substantial improvement over existing therapies. The designation also indicates that the development and review of Batoclimab in adults with MG will be expedited in order to address patients’ unmet needs quicker.
Dr Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, said: “This is the first Breakthrough Therapy designation granted to HBM, highlighting the unmet needs and the potential opportunity for our expanding immunology portfolio.
“In China, large numbers of patients suffer IgG-mediated autoimmune diseases including MG, ITP, NMOSD, among others. This Breakthrough Therapy designation will enable the accelerated development of Batoclimab for MG, thereby bringing this life-changing innovative drugs to patients in China sooner.”
Darcy Jimenez
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