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Recently, Roche's toad monoantigen injection (trade name: Jaromero) was approved by the State Drug Administration for severe or life-threatening cytokine release syndrome (CRS) caused by chisellular antigens (CAR) T cells in adult and children 2 years of age and older.
is also the third indication it has been approved in China, after Ameero was approved for rheumatoid arthritis (RA) and systemic young idlytic arthritis (sJIA) in 2013 and 2016, respectively.
August 2019, Jamero was included in the National Health Insurance Directory for systemic secondary treatment of early childhood idiotic arthritis, as well as for patients with a reduced activity of less than 50% in patients with a well-diagnosed RA-by-traditional DMARD treatment for 3 to 6 months.
It is understood that during the treatment of CAR-T cells, cytokine release syndrome (CRS), neurotoxicity, tumor dissolution syndrome, blood cell reduction/infection, low immunoglobulinemia and hepatitis B virus activation and other adverse reactions, of which CRS is one of the most frequent and prominent acute toxic reactions, research data show that up to 70% of patients will have severe cytokine release syndrome.
The approval of this free clinical trial for the treatment of CRS allergy is based on the clinical trial data of CAR-T cell therapy for blood system diseases provided by two CAR-T companies worldwide, which effectively evaluates the efficacy of toad monotherapy CRS.
At present, in China, there are a number of enterprises in the development of tozhu single anti-biosynthic drugs, according to the pharmaceutical Rubik's Cube PharmaGO database, including Baiotai, Haizheng Pharmaceuticals, Hengrui Pharmaceuticals, Tagg Pharmaceuticals, Yanxin Bio, Jinyu Biology, Maybotenko Pharmaceuticals, etc., the development progress from the first phase of clinical trials and phase iii clinical trials.
May of this year, CDE issued guidelines for clinical trials of toads of biosynthic drugs (draft for comments) to better promote the development of biosynthic drugs for the product.
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