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On December 7, 2023, Bio-Thera announced that its bevacizumab biosimilar **ZIVI (BAT1706) has been approved by the U.S. FDA. **Zivi is Bio-Thera's second product to receive U.S. FDA marketing approval, and the second biosimilar product developed by a Chinese pharmaceutical company and approved by the FDA.
On October 8, 2023, Bio-Thera announced that its partners recently received notification from the U.S. FDA that TOFIDENCE (BAT1806 BIIB800), a biosimilar developed by Bio-Thera with reference to Amerol (tocilizumab)), has received marketing approval from the U.S. FDA for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
The competition in the pharmaceutical field, which is at the forefront of technology, is fierce. The first is that drug development is extremely time-consuming and costly. Secondly, the failure rate is high. Finally, the post-marketing commercialization also determines the life cycle of a drug. As the patent term of best-selling drugs enters less than 10 years, the speed of global imitation will inevitably accelerate, further seizing the market share of original products.
*: Huaxin Innovative Drugs.
*: Huaxin Innovative Drugs.
Bevacizumab Injection——
Bevacizumab, a large monoclonal antibody that inhibits the VEGF-VEGFR pathway.
Mechanism of action of antiangiogenic drugsIn fact, there are many studies and explorations on angiogenesis of tumors, which is an important factor and an important feature of tumor growth and proliferation. Drug development for tumor angiogenesis is also a major research area, and the main mechanisms of action of anti-angiogenic drugs include:Facilitates antigen presentation, activating in the process of tumor immune response;Promotes lymphocyte infiltration and migration;Reversal of immunosuppression due to VEGF;Promote normalization of the tumor vascular system;Promotes the activity of T cells and immune effector molecules;Enhance the mechanism of drug delivery, etc.
Tocilizumab injection——
Tocilizumab Injection is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R), which specifically binds to soluble and membrane-bound IL-6 receptors (SIL-6R and MIL-6R) and inhibits signaling mediated by SIL-6R or MIL-6R. Previous studies have shown that IL-6 is a pro-inflammatory cytokine whose release can induce a range of downstream pro-inflammatory responses. Studies have found that IL-6 is also an important pathway to induce cytokine storm in COVID-19 patients, and tocilizumab has the potential to alleviate cytokine storm in COVID-19 patients.
Specifically, some COVID-19 patients have serious complications, including acute respiratory distress syndrome (ARDS), and even admission to the intensive care unit (ICU) and death. Analysis of autopsy biopsy samples showed thatAberrant host immune response and inflammatory cytokine stormIt is the cause of the high mortality rate of new crown pneumonia patients.
Previous studies have shown that pathogenic T cells and inflammatory monocytes trigger an inflammatory storm through large amounts of interleukin-6 (IL-6). Thus, monoclonal antibodies targeting the IL-6 pathway may inhibit the inflammatory storm.
Mechanism of "inflammatory storm" in patients with new coronary pneumonia.
Tocilizumab calms the inflammatory storm by blocking IL-6 receptors.
A total of 4 randomized controlled studies have evaluated the efficacy of tocilizumab in hospitalized patients** COVID-19, including:Oxford University-led recovery testTestand the Roche-sponsored Empacta, Covacta and Remedacta trials. FDA approval was based on the results of the Recovery trial as well as the Empacta trial.