And platinum medicine Bartoli single resistance by the National Drug Administration breakthrough treatment drug qualification

And platinum pharmaceutical (stock code: 02142.HK) today announced that its research product Bartoli monoanti (HBM9161) recently obtained the National Drug Administration Drug Review Center (CDE) breakthrough therapeutic drug qualification.
severe muscle weakness (MG) is a neuromuscular disease mediated by pathogenic IgG that seriously affects the quality of life.
in China, about 250,000 patients suffer from severe muscle weakness, existing treatments are not effective in controlling the condition, and new effective and safe treatments are urgently needed.
Bartoli monoanti (HBM9161) is an all-human monoclonal antibody (mAb) that blocks FcRn-IgG from binding to each other and accelerates the removal of IgG in the body, thus effectively treating pathogenic IgG-mediated autoimmune diseases.
available evidence suggests that lower IgG levels in patients with severe muscle weakness are associated with clinical benefits.
early studies have shown that Bartoli monoantigens are well-to-resist and can rapidly reduce total IgG.
study also showed that Bartoli monoantigen was the first anti-FcRn target drug to be shown to continuously reduce IgG after subsethic injection (SC) in Chinese and Caucasian populations.
breakthrough therapeutic drug qualification is designed to accelerate the development of new drugs that target serious diseases and have shown significant advantages over existing treatments in pre-clinical trials.
's access to breakthrough therapeutic drugs can enable the drug to receive CDE rapid review treatment, and can be closely communicated with CDE, access to guidance, thereby speeding up the launch of new drugs, and earlier to address the unseeded clinical needs of Chinese patients.
also approved during the same period are Takeda, AstraZeneta and other pharmaceutical companies.