mp.weixin.qq.com· 米内网·· 4 hours agoPickScore70
NMPA Approves CSPC and Harbour BioMed Batoclimab for Generalized Myasthenia Gravis
刚刚！石药集团/和铂医药1类新药获批上市
In brief
On October 22, the NMPA approved batoclimab injection (HBM9161), an imported Class 1 new drug filed by CSPC Pharmaceutical Group and Harbour BioMed, for patients with generalized myasthenia gravis (gMG). Batoclimab is a fully human monoclonal antibody targeting FcRn and was granted breakthrough therapy designation by the CDE in January 2021.
Why it matters
Gives the approved indication and mechanism of the FcRn antibody batoclimab, enabling comparison with other FcRn drugs in gMG.
Source: mp.weixin.qq.com · mp.weixin.qq.com