BJ Bioscience Inc.announced that the world's first tumor-targeted IL-15 fusion protein (product code BJ-001), independently developed by the company and having global patents, was submitted 28 days after submission to the US FDA. Obtained FDA notifications for clinical trials in the United States.
IL-15 is a multipotent cytokine that plays a central role in the development, survival and activation of NK, T and B cells. IL-15 not only increases the number of NK cells and T cells, but also activates NK cells and cytotoxic CD8 + T cells, thereby killing tumors and other pathogens, so IL-15 has tumor and infectious diseases. The higher therapeutic potential is at the top of the list of 20 and oncology immunotherapeutics recommended by the National Cancer Institute (NCI) in 2008, including PD-1.
Although recombinant IL-15 has been shown to have anti-tumor effects in animal studies and has also been shown to be effective in lung metastasis of melanoma in human trials, its short half-life is a major obstacle to its drug-forming properties. . The world's first tumor-targeting IL-15 fusion protein BJ-001, independently developed by BJ Bioscience Inc. and possessing global patents, not only overcomes the shortcomings of short half-life of recombinant IL-15, but more importantly, its tumor targeting can make it IL-15 is enriched in tumors with high target expression, thereby reducing systemic toxicity and enhancing therapeutic effects. In addition, the effect of IL-15 on lymphocyte proliferation in tumors has a "hot tumor" that responds to a "cold tumor" that does not respond to currently used immunosuppressive agents such as anti-PD-1 antibodies. The potential of hot tumor) will greatly increase the effectiveness of existing tumor immunotherapy drugs and benefit more patients. Therefore, Boco biomedical tumor targeting IL-15 is expected to become another rookie in tumor immunotherapy. The product was notified in advance in the United States for clinical trials and also indicated that the FDA recognized the quality and safety of the product.
For the early approval of the BJ-001 by the US FDA, Dr. Zhang Haizhou, co-founder and CEO ofBJ Bioscience Inc., said:
"BJ-001's entry into clinical trials in the United States marks that our company has become a company in the clinical development stage, which is an important milestone for the company. As a biotechnology company based in China, facing the global market and focusing on independent innovation. Our goal is to promote clinical research on a fully self-innovative product every 1-2 years, providing more innovative treatments for patients in China and around the world."
Although it has been in operation for less than two years, and adhering to the concept of only globally independent and innovative drugs, BJ Bioscience Inc. has developed a biopharmaceutical research and development platform that uses its trade secret protection to begin to lay out tumors and infectious diseases. The BJ-001, which was approved for clinical entry, is one of the many innovative products in its R&D pipeline. Prior to this,BJ Bioscience Inc.has started the establishment of the BJ-001 immunohistochemistry test (IHC) method and the development of the accompanying diagnostic kit with partners, hoping to provide more accurate treatment for cancer patients by means of precision medicine.
About BJ Bioscience Inc.
BJ Bioscience Inc.is a biotechnology company dedicated to the research and development of innovative drugs. It is created by a returnee expert with many years of experience in research and development of innovative drugs, including major national special drug review experts, and has trade secrets. The protected antibody discovery platform and top technology at home and abroad currently mainly develop biopharmaceuticals for tumors and infectious diseases. The company's main research and management team has many years of experience in research and development and management of antibody drugs in domestic and foreign R&D companies and national key scientific research institutions, especially European and American multinational companies. Focusing on the global view of R&D and based on strong capital support, Boji Biomedical has a global layout of R&D from a global perspective. It also has two R&D laboratories in San Francisco and Hangzhou, China. It can realize a comprehensive collection of talents, technology, management and capital markets, laying a solid foundation for the company's global positioning and development.
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