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Screenshot source: CDE official website to bead serotonin is a recombinant humanized anti-human leukine 6 (IL-6) receptor monoclonal antibody expressed by mammalian cells (CHO), which works by inhibiting the activity of IL-6 receptors.
IL-6 is an inflammatory cytokine, whose release promotes a range of downstream inflammatory responses.
tobead monotomotics inhibits the transmission of IL-6 signals by blocking IL-6 binding to soluble and membrane-binding IL-6 receptors, thereby reducing the pathological inflammatory response.
globally approved for the treatment of a variety of immunology diseases, tobead monotol is the first human-derived IL-6 receptor antagonist that can be administered by intravenous infusion and subcutaneous injection.
since 2009 in the European Union, the United States, Japan and other countries and regions have been approved for market, approved indications as follows: the use of at least one other improved condition of anti-rheumatism drugs (DMARD) after the effect of moderate to severe active RA adult patients;
active multijoint juvenile isoarthritis, suitable for patients 2 years and older; active systemic juvenile iexclusiveiate arthritis, applicable to patients 2 years and older;
, clinical studies of this product for the treatment of systemic sclerosis have progressed to a later stage.
Tozhu monotorenosis was first approved in China in 2013 for the treatment of RA, a commodity called Yamelo.
2016, the drug was approved for phase 3 clinical form for the treatment of systemic juvenile isoarthritis, making it the first biological agent approved in China for the treatment of systemic juvenile isoarthritis.
according to the drug clinical trial registration and information publicity platform, tozhuzumab has registered a number of studies in China, including systemic juvenile iexclusiveiatre arthritis and RA.
According to Roche's previous announcement, in August 2019, tozhuzumab was officially included in China's national health insurance directory for the treatment of the second-line of systemic juvenile iexclusiveism, as well as the diagnosis of the diagnosis of RA by traditional DMARD treatment of disease activity decreased by less than 50% of the patients.
, China has a number of pharmaceutical companies are carrying out research and development of tozhuzumab biosimilar drugs, including BaiOtai, Jinyu biological and so on.
In May this year, CDE published the Guidelines for Clinical Trials of Tozhusma-Injectable Biosimilars (Draft for Comments) to better promote the development of biosimilars in the product. The results of the phase 3 study
treatment of COVID-19, published this summer, showed that in some patients with severe COVID-19, elevated levels of IL-6 were associated with the occurrence of cytokine storms.
when a "cytokine storm" occurs, it can cause severe lung damage and can endanger the patient's life.
based on this, the tobead monotomatotag, which targets IL-6, is expected to improve inflammation in the lungs.
, a phase 3 study for the treatment of patients with severe neo-coronary pneumonia (COVID-19) is currently under way in several countries and is expected to be released in early 2020, according to Roche's first-quarter results.
note, in April, Roche also received $25 million in support from the U.S. Bureau of Advanced Biomedical Research and Development (BARDA) to accelerate the Phase 3 study of COVID-19 patients with toth-bead monoto-statin resistance therapy.
this time Roche in China submitted to the application for the listing of tozhusm anti-new indications, is expected to expand the scope of the product's indications. In addition to
for systemic juvenile isoarthritis and rheumatoid arthritis, tozhuzumab is also expected to benefit patients with cytomegalocytin, cytokine protrusion syndrome, and active multijoint infant isoarthritis.
wish the product's follow-up registration going well and allow more patients to benefit from the drug at an early date.
References: The Drug Review Center of The State Drug Administration of China. Retrieved July 7, 2020, from Roche's Amero ® (Tozhu monotortagain) is approved by the FDA for the treatment of cytokine protrusion syndrome caused by CAR-T therapy, Retrieved August 31, 2017, from .3. (2018). Review of tocilizumab in the treatment of rheumatoid arthritis. Biologics: Targets and Therapy DOI: 10.2147/BTT. S1828.