Harbour BioMed Resubmits Biologics License Application for Batoclimab (HBM9161) for the Treatment of Generalized Myasthenia Gravis to NMPA

2024-06-27

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临床3期突破性疗法申请上市临床结果

Harbour BioMed today announced that it has formally resubmitted the Biologics License Application (BLA) for its core drug candidate, batoclimab (HBM9161), a fully human monoclonal antibody (mAb) targeting generalized myasthenia gravis (gMG), to the National Medical Products Administration (NMPA) of China.

Batoclimab (HBM9161), as a fully human monoclonal antibody, works by blocking the interaction between FcRn and IgG, thereby accelerating the clearance of pathogenic IgG, providing an effective treatment for autoimmune diseases mediated by pathogenic IgG. In the Phase III clinical study for generalized myasthenia gravis, batoclimab has demonstrated positive therapeutic effects, rapidly and significantly relieving patients' clinical symptoms and improving their quality of life, with a favorable safety profile.

Based on the rigorous execution of the clinical trial protocol, Harbour BioMed has successfully completed the extension study of the Phase III clinical trial without recruiting new patients and collected more long-term safety data. Therefore, the company has proactively included these safety data and resubmitted the BLA for batoclimab as planned.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, said, "We are pleased to resubmit the BLA as planned and will continue to maintain close communication with NMPA to facilitate the review of this innovative therapy. The results of the Phase III clinical trial have fully demonstrated the significant efficacy of batoclimab in both primary and secondary endpoints, and we are confident that this innovative drug will bring a new treatment option for patients with generalized myasthenia gravis and benefit more patients."

Recalling the previous announcement, Harbour BioMed had announced on December 1, 2023, the withdrawal of the marketing application for batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG), and planned to resubmit it in the first half of 2024. The company stated that this withdrawal was due to the delay in the Phase III study of batoclimab, which required the collection of more long-term safety data.

It is worth noting that batoclimab was granted the "Breakthrough Therapy Designation" by the China National Medical Products Administration in 2021 and completed the proof-of-concept study for Chinese patients with generalized myasthenia gravis in August of the same year. In March 2023, the company announced positive results from its Phase III clinical trial. In addition, Harbour BioMed has reached a collaboration agreement with NBP Pharmaceutical Co., Ltd., a wholly-owned subsidiary of CSPC, to jointly develop batoclimab in Greater China, committed to providing more treatment options for patients with this disease.

In the field of FcRn antibody drugs, the current market is still in the early stage of development, with relatively few participants. Currently, the FcRn antibodies that have been marketed include Efgartigimod α co-developed by Argenx and Zai Lab, and Rozanolixizumab from UCB, while Nipocalimab from Johnson & Johnson is in Phase III clinical trials. Harbour BioMed's batoclimab will bring new hope and vitality to this field.

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