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    Home > Active Ingredient News > Drugs Articles > Another biosimilar is recognized for its R&D strength overseas

    Another biosimilar is recognized for its R&D strength overseas

    • Last Update: 2021-07-26
    • Source: Internet
    • Author: User
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    On April 8, Biogen and Biotech jointly announced that the two parties have signed a license agreement for BAT1806.
    BAT1806 is Biogen's development of a targeted interleukin-6 receptor ( IL-6R) recombinant humanized monoclonal antibody is currently in the global phase III clinical trial stage
    .

    RoActemra/Actemra (generic name: tocilizumab, tocilizumab) is a blockbuster anti-inflammatory drug developed by Roche Genentech.
    It is the first drug that can be injected intravenously (IV) and subcutaneously (SC).
    The humanized anti-IL-6R monoclonal antibody administered in two ways has been approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis ( sJIA), giant cell arteritis (GCA), cytokine release syndrome (CRS), Castleman disease, aortic arteritis
    .

    BAT1806 is a tocilizumab injection developed by Biotech in accordance with the relevant guidelines of China's NMPA, US FDA, and EU EMA biosimilars.
    It is a recombinant humanized monoclonal antibody targeting IL-6R.
    It can be combined with soluble and Membrane-bound IL-6 receptors (sIL-6R and mIL-6R) specifically bind to and inhibit signal transduction mediated by sIL-6R or mIL-6R.
    In January 2019, the global phase III clinical treatment of RA was initiated.
    Experiment
    .

    According to the agreement, Biogen will obtain exclusive rights related to the registration, production and commercialization of BAT1806 in all countries around the world except China (including Hong Kong, Macau and Taiwan)
    .


    Under the conditions of satisfactory results in the BAT1806 Phase III clinical trial, Bojian will pay Biotech a down payment of US$30 million


    Innovative drugs and biosimilars are in parallel, and Biotech's two drugs are reported for production

           Biotech is a biopharmaceutical company dedicated to the development of a new generation of innovative drugs and biosimilars.
    It has established a rich product pipeline for autoimmune diseases, tumors, cardiovascular diseases and ophthalmological diseases
    .


    Among them, Biotech’s adalimumab biosimilar (BAT1406, Glorious) is a fully human monoclonal antibody targeting TNF-α.


    From Biotech's official website

           In addition, Biotech has several biosimilars in clinical trials
    .

           ► BAT1806, the biosimilar of tocilizumab, is a monoclonal antibody targeting IL-16R
    .

           ► BAT2506, the biosimilar of golimumab, is a fully humanized anti-tumor necrosis factor (TNF-α) monoclonal antibody
    .

           ► BAT2206, the biosimilar of Usinuzumab, is a humanized monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23.
    It is intended for the treatment of psoriasis, silver Autoimmune diseases such as squamous arthritis, Crohn’s disease and ulcerative colitis
    .

           ► BAT2306, the biosimilar of Skuchiyuumab, is a monoclonal antibody that targets IL-17A
    .

           ► BAT1706, the biosimilar of bevacizumab, is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF)
    .


    At present, Biotech has submitted a domestic marketing application for BAT1706 for the treatment of advanced, metastatic or recurrent NSCLC and metastatic colorectal cancer, and in November 2020, it submitted a marketing authorization application for BAT1706 to the US FDA and European EMA


           It is worth mentioning that in recent years, Biotech has reached cooperation with many companies on biosimilars
    .

           ► In January 2019, Biotech reached a licensing and commercialization agreement with Cipla Limited, a world-renowned pharmaceutical company, granting Cipla the exclusive commercialization of BAT1706 in some emerging country markets
    .

           ► In July 2020, Biotech signed an exclusive license agreement with Pharmapark LLC, authorizing Pharmapark to exclusively commercialize BAT2506 in Russia and other CIS countries
    .

           ► In August 2020, Biotech and BeiGene signed an authorization, distribution, and supply agreement for BAT1706 in China
    .


    According to the agreement, BeiGene obtains the development, production and commercialization rights of BAT1706 in China (including Hong Kong, Macao and Taiwan), and Biotech reserves the relevant rights on a global scale outside the above-mentioned regions


           ► In December 2020, Biotech and Biomm signed a license agreement in Brazil to exclusively license the marketing rights of BAT1706 in Brazil to Biomm
    .

           In addition, Biotech Pharmaceuticals has three innovative drugs that are making rapid progress, namely BAT2904, BAT5906 and BAT4306F
    .

           ► BAT2904, namely Batifiban, is a Class 1 new drug with independent intellectual property rights independently developed by Biotech.
    It is a synthetic platelet glycoprotein IIb/IIIa receptor antagonist
    .


    It can specifically bind to platelet glycoprotein receptor IIb/IIIa to inhibit its binding to fibrinogen, and at the same time prevent glassy protein from binding to endothelial cells and smooth muscle cell integrin ανβ3, which makes BAT2904 not only preventive The formation of thrombus (blood clot) induced by platelet aggregation may also prevent integrin ανβ3 from inducing the adhesion and spread of platelets and endothelial cells, and prevent re-blocking of blood vessels


           ► BAT5906, a recombinant anti-VEGF humanized monoclonal antibody, mainly improves the permeability of the retinal blood vessel barrier by blocking the binding of VEGF to its corresponding receptor
    .

           ► BAT4306F, a recombinant Fc glycosylated modified anti-CD20 humanized monoclonal antibody, has stronger antibody-dependent cytotoxicity (ADCC) and is expected to become the best-in-class therapy
    .


           

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