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Batoclimab HBM9161

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Batoclimab (HBM9161) is a novel, fully human anti-FcRn mAb blocking FcRn-IgG interactions and accelerating the degradation of autoantibodies. We believe that this product has the potential to address a variety of pathogenic IgG-mediated autoimmune diseases. 


Batoclimab is being evaluated for the treatment of patients with severe autoimmune diseases mediated by pathogenic immunoglobulin G (IgG), including generalized myasthenia gravis (gMG), thyroid eye disease (TED), neuromyelitis optica spectrum disorder (NMOSD) and immune thrombocytopenic purpura (ITP). Phase 2 study in generalized myasthenia gravis showed that batoclimab can quickly and significantly alleviate patients’ symptoms and improve quality of life. Completed studies demonstrated that batoclimab is well tolerated and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases. 


Harbour BioMed licensed batoclimab (HBM9161) from HanAll Biopharma and has the right to develop, manufacture and commercialize in Greater China (including Hong Kong, Macau and Taiwan).


On October 10, 2022, Harbour BioMed announced that it has entered into an agreement with CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited (CSPC), to transfer the exclusive rights to develop, manufacture and commercialize batoclimab (HBM9161) in Greater China (including mainland China, Hong Kong, Macau and Taiwan) to NBP Pharma. According to the agreement, Harbour BioMed will potentially receive a total of over RMB 1 billion, including an upfront payment of RMB 150 million and other potential milestone payments. In addition, the Company will receive tiered royalties based on annual net sales of batoclimab in Greater China.

Mechanism of Action

The neonatal Fc receptor (FcRn) is a cellular receptor that binds IgG antibodies and guide their transport through cells. FcRn plays a pivotal role in preventing the degradation of IgG antibodies. Therefore, inhibition of FcRn, such as through use of an FcRn targeting antibody, has been shown to reduce levels of pathogenic IgG antibodies. Completed clinical trials of other anti-FcRn antibodies in IgG-mediated autoimmune diseases have generated promising results, suggesting that FcRn is a therapeutically important pharmaceutical target to treat these relevant pathogenic conditions.