HBM Holdings Limited announced that based on the results of the Phase III clinical trial, which demonstrated that the efficacy in the primary and secondary endpoints of batoclimab (HBM9161), and given the safety profile was favorable and consistent with historical data, the Company has completed the communication with the Center for Drug Evaluation of the National Medical Products Administration of China (the "NMPA") for the biologics license application ("BLA") for batoclimab (HBM9161) for treatment of generalized myasthenia gravis. In accordance with the clinical trial protocol, the Group is currently in the extension period for the Phase III clinical trial for the collection of other long-term safety data. No additional patients have been enrolled during this extension period.

As a result, the Company voluntarily plans to include additional long-term safety data and re-submit the BLA for batoclimab (HBM9161). The Company has been actively communicating with the NMPA regarding the BLA for batoclimab (HBM9161), and subsequent submission-related interactions and processes are currently ongoing. The Company expects to re-submit the BLA for batoclimab (HBM9161) to the NMPA in the first half of 2024.

Batoclimab is designed as a fully human monoclonal antibody that selectively binds to and inhibits the neonatal FcRn. FcRn plays a pivotal role in preventing the degradation of IgG antibodies. High levels of pathogenic IgG antibodies drive many autoimmune diseases.

As the most clinically advanced FcRn inhibitor being developed in Greater China, batoclimab has the potential to be a breakthrough treatment for a wide spectrum of autoimmune diseases in Greater China.