Harbour BioMed Resubmits Batoclimab BLA for Generalized Myasthenia Gravis to NMPA

Harbour BioMed has announced the formal resubmission of the Biologics License Application (BLA) for batoclimab (HBM9161), its lead drug candidate targeting generalized myasthenia gravis (gMG), to the National Medical Products Administration (NMPA) of China. Batoclimab is a fully human monoclonal antibody designed to block the interaction between FcRn and IgG, thereby expediting the elimination of pathogenic IgG. This mechanism offers an effective treatment for autoimmune diseases mediated by pathogenic IgG.

In a Phase III clinical study, batoclimab demonstrated noteworthy efficacy in treating generalized myasthenia gravis. The drug showed rapid and significant improvement in patients’ clinical symptoms, thereby enhancing their quality of life. Furthermore, the trial highlighted a favorable safety profile for the drug. Harbour BioMed has successfully wrapped up the extension study of the Phase III trial without the need for new patient recruitment, thereby gathering additional long-term safety data. These newly acquired safety data were included in the resubmitted BLA.

Dr. Jingsong Wang, the Founder, Chairman, and CEO of Harbour BioMed, expressed satisfaction with the resubmission, emphasizing the company's ongoing communication with the NMPA to expedite the review process. He reiterated the drug's significant efficacy demonstrated in the Phase III trial across both primary and secondary endpoints. Dr. Wang remains optimistic that batoclimab will offer a new treatment option for gMG patients and extend its benefits to a broader patient population.

Previously, Harbour BioMed had announced on December 1, 2023, the withdrawal of the marketing application for batoclimab due to delays in the Phase III study, which necessitated the collection of additional long-term safety data. The company had planned to resubmit the BLA in the first half of 2024, aligning with their current submission timeline.

Batoclimab has received significant recognition, including the "Breakthrough Therapy Designation" by the China National Medical Products Administration in 2021. The same year, the drug completed its proof-of-concept study for Chinese patients with generalized myasthenia gravis. By March 2023, Harbour BioMed reported positive results from the Phase III clinical trial. Additionally, the company has entered into a collaboration with NBP Pharmaceutical Co., Ltd., a subsidiary of CSPC, to co-develop batoclimab in Greater China. This partnership aims to expand treatment options for patients suffering from gMG.

The FcRn antibody drug market is still in its nascent stages with limited players. Currently, marketed FcRn antibodies include Efgartigimod α, developed by Argenx and Zai Lab, and Rozanolixizumab from UCB, while Johnson & Johnson’s Nipocalimab is in Phase III clinical trials. Harbour BioMed’s batoclimab is poised to inject new hope and vigor into this burgeoning field.