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Today, Baxter Biogroup announced an exclusive license agreement with Pharmapark to license Pharmapark to commercialize its Golimu monoantithing biosimilar drug BAT2506 exclusively in Russia and other CIS countries.
expects to launch the International Multicenter Phase 3 clinical trial of BAT2506 in the fourth quarter of this year, and submit listing applications to the National Drug Administration of China (NMPA), the European EMA and the FDA after completing Phase 3 clinical trials.
golimumab is an all-humanized anti-tumor necrosis factor (TNF-alpha) monoclonal antibody.
Johnson and Johnson's original research drug, Himponi, has been approved in China in 2018 for the treatment of active hyperthyroidism, and can also be combined with methotrexate to treat moderate to severe active rheumatoid arthritis, which improves the efficacy of anti-rheumatoid drugs, including methotrexate, and is the first approved monthly injection of anti-rheumatoid biologics in China.
, Johnson and Johnson's Goliath is also approved outside China for treatment of diseases such as active psoriasis arthritis, moderate to severe ulcerative colitis.
BAT2506 is a Golimu monoto-antibiotic drug developed by BaiOta.
under the cooperation agreement, Baxter will be responsible for the development of BAT2506 and the supply of commercial products to Pharmapark.
Pharmapark will be responsible for the administration and commercialization of BAT2506 in Russia and other CIS countries.
through this cooperation, Baxter will expand the international market with Pharmapark's extensive market and sales system in Russia and other CIS countries.
expects to launch the International Multicenter Phase 3 clinical trial of BAT2506 in the fourth quarter of this year and recruit patients in China, Russia and several other countries, according to a press release.
the company plans to submit listing applications to NMPA, European EMA and FDA in China after completing Phase 3 clinical trials. Founded in 2003,
, Baxter is an innovative biopharmaceutical company with innovative and biosimilars at its core.
the company developed the Adamu singofa biosimilar drug Gleonte was approved in China in November 2019 to treat autoimmune diseases such as aggressive spina bifida, rheumatoid arthritis and psoriasis, and is the first approved Chinese-made Adamu zuma biosimilar drug.
, there are a number of biosimilars in the Baiathai product pipeline, including bevalo zuma biosimilars (originally known as Roche's Anvitin), tozhuzumab biosimilars (originally known as Roche's Amero), golimzumab biosimilars, and so on.
January 2019, Biotech has reached an agreement with Cipla Limited to license Cipla to exclusively commercialize its belaval zuma serobic biosimilar drug BAT1706 in some emerging markets.
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