NMPA Approves Batoclimab for Generalized Myasthenia Gravis
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China's NMPA has approved batoclimab injection (HBM9161), an imported Class 1 new drug filed by CSPC Pharmaceutical Group and Harbour BioMed, for patients with generalized myasthenia gravis (gMG). Batoclimab is a fully human monoclonal antibody targeting FcRn, a mechanism aimed at reducing pathogenic IgG antibodies underlying the disease. The drug received breakthrough therapy designation from the CDE in January 2021, and the approval marks the culmination of that accelerated pathway. What remains open is how the therapy will be positioned in Chinese clinical practice, including pricing and access arrangements, which have not yet been disclosed.
Written by a model from the reports · updated 2 hours ago
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- mp.weixin.qq.comPickNMPA Approves CSPC and Harbour BioMed Batoclimab for Generalized Myasthenia Gravis
On October 22, the NMPA approved batoclimab injection (HBM9161), an imported Class 1 new drug filed by CSPC Pharmaceutical Group and Harbour BioMed, for patients with generalized myasthenia gravis (gMG). Batoclimab is a fully human monoclonal antibody targeting FcRn and was granted breakthrough therapy designation by the CDE in January 2021.
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