Recently, the FDA Oncology Drug Expert Advisory Committee approved the approval of Novartis CAR-T therapy CTL-019 for a 10:0 vote to use for children or adolescents with acute lymphoblastic leukemia who did not respond to standard treatment. The FDA will make a final approval decision by October 3, based on the opinion of the committee. This means that the world's first CAR-T therapy is only one step away from the market.
At present, tumor immunotherapy represented by monoclonal antibody-type immunological checkpoint inhibitors (Anti-PD-1/PD-L1, etc.), CAR-T cell therapy, and tumor vaccine has become a well-deserved focus of the biomedical industry. According to data released by the global business intelligence agency GBI, it is estimated that by 2022, the global immunotherapy market will exceed 74.2 billion US dollars, which is expected to occupy half of the cancer treatment.
In recent years, there has been a hot spot in the field of tumor immunity. In 2010, the FDA approved the prostate cancer vaccine Provenge. In 2011, the first immune checkpoint inhibitor was launched. Now, the CAR-T field has ushered in a new breakthrough. It is believed that in the near future, the field of tumor immunotherapy will spawn a large number of biomedical industry giants, bringing safer and more effective treatments to patients.
CAR-T stands for "Chimeric Antigen Receptor T Cell", which is based on the principle of isolating T lymphocytes from patients and then using genetic engineering techniques to confer T cells recognition of specific tumor cells and specificity. The ability to kill the tumor cells is finally returned to the patient by autologous.
Different from the traditional new drug research and development, CAR-T therapy has strong technical attributes and high reproducibility. For the new drug research and development, China has the possibility of overtaking in the corner. Currently, China is in ClinicalTrials. The number of CAR-T-related clinical studies registered by gov is second only to the United States and has become the first echelon in this field.
This paper selects some representative Chinese companies that have been deployed in the CAR-T field for your reference.
Nanjing Legend Biotechnology
Founded in 2014, Nanjing Legend is a wholly-owned subsidiary of Kingsray Biotech, which specializes in CAR-T cell technology research. At the 2017 American Society of Clinical Oncology Annual Meeting, Nanjing Legend became the big black horse of this year with its breakthrough in the CAR-T field.
According to data released by Nanjing Legend, 33 (94%) of 35 patients with multiple myeloma who had relapsed after treatment were obtained 2 months after receiving the company's experimental anti-BCMA CAR-T cells (LCAR-B38M). Clinical remission showed significant clinical remission of myeloma (complete response or very good partial response) with an objective response rate of 100%. In clinical practice, 85% of patients have short-term adverse reactions such as fever, myalgia, hypotension, and dyspnea, but most patients have mild symptoms and no serious adverse reactions or fatal events.
Multiple myeloma is the second most common malignancy in the blood system, with an incidence of about 100,000. There are currently about 60,000 to 70,000 patients in China. According to a treatment sample of more than 10 RMB, the Chinese market is about 10 billion in market size.
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