January 29, 2021 // -- Harbour BioMed (Harbour BioMed) recently announced that its research product Bartoli monoanti (HBM9161) has recently been awarded breakthrough therapeutic drug qualification by the National Drug Administration (NMPA) Drug Review Center (CDE).
breakthrough therapeutic drug qualification is designed to accelerate the development of new drugs that target serious diseases and have shown significantly superior efficacy or safety over existing treatments in pre-clinical trials.
breakthrough therapeutic drug identification enables the drug to receive CDE rapid review treatment, and can be closely communicated with CDE, access to guidance, so as to speed up the launch of new drugs, earlier to solve the unseeded clinical needs of Chinese patients.
also approved during the same period are Takeda, AstraZeneta and other pharmaceutical companies.
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 monoantigen (HBM9161) mechanism of action - Click on the image to see that the large picture neonatal Fc Subject (FcRn) is a cellular subject that binds to IgG antibodies and guides them through cell transport.
FcRn plays a key role in preventing the degradation of IgG antibodies.
, FcRn inhibition (e.g., by using FcRn targeted antibodies) has been shown to reduce the level of pathogenic IgG antibodies.
clinical trials of other anti-FcRn antibodies in IgG-mediated autoimmune diseases have yielded good clinical results, indicating that FcRn is an important drug target for the treatment of these related diseases.
Bartoli monoanti (HBM9161) is a new all-humanized monoclonal antibody (mAb) targeted at FcRn that blocks FcRn-IgG from binding to each other and accelerates the removal of IgG in the body, thus effectively treating autoimmune diseases mediated by pathogenic IgG.
available evidence suggests that lower IgG levels in patients with severe muscle weakness (MG) are associated with clinical benefits.
early studies have shown that Bartoli monoantitors 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.
and Platinum Pharmaceutical Pipeline - Click on the image to see the greater Tubartoli monoanti (HBM9161) licensed by And Platinum Pharmaceuticals from HanAll Biopharma, and Platinum Pharmaceuticals has the right to develop, manufacture and commercialize the drug in Greater China, including Hong Kong, Macau and Taiwan.
Based on this innovative mechanism and the high medical needs that have not yet been met in China, platinum medicine has initiated a number of clinical studies to evaluate HBM9161 for the treatment of a variety of autoimmune diseases, including: immunothyroidism, thyroid-related eye disease, severe muscle weakness, optic neurospinal genealogy disease, autoimmune hemolytic anemia, chronic epithelial multiple neuropathy.
Jinsong Wang, Founder, Chairman and CEO of
and Platinum Pharmaceuticals, said, "Bartoli monoanti is an important milestone in the first time in platinum history that a product has been eligible for a breakthrough therapeutic drug.
a large number of patients in China are suffering from pathogenic IgG-mediated immunologic diseases, including severe muscle weakness, immunocompromise platelet reduction and optic neurospinal cord disease.
breakthrough therapeutic drug qualification will further accelerate the development of Bartoli monoanti, accelerate the drug market, we look forward to the early development of innovative treatments for patients with severe muscle weakness.
" () Origin: and Platinum Medicine