Phase III trial of HBM 9161 meets primary endpoint in myasthenia gravis.- HanAll Biopharma/Harbour BioMed

This marks the first positive Phase III trial outcome for batoclimab worldwide. The study met its primary endpoint as well as key secondary endpoints, and batoclimab was found to be well-tolerated with no new safety signals identified. Batoclimab is the first anti-FcRn treatment confirmed efficacious and safe in Chinese gMG population.

This multicenter, randomized, double-blind, placebo-controlled Phase III study enrolled 132 adult patients with gMG in China. Patients were randomized to receive batoclimab or placebo as subcutaneous injections by cycle. Each cycle consisted of a treatment period that includes six weekly injections, followed by four weeks of observation period. Harbour BioMed and CSPC plan to submit a Biologics License Application to the National Medical Products Administration (NMPA) for batoclimab based on the study results.

Batoclimab is a fully human, subcutaneously administered antibody originated from HanAll, which selectively binds to and inhibits the neonatal Fc receptor (FcRn). It has demonstrated high potential as a new treatment option for gMG patients in China from the Phase II study, and received Breakthrough Therapy Designation from the NMPA in 2021.