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Enterprise News | the world's first tumor targeted IL-15 fusion protein of Boji biomedicine has been approved by FDA to enter clinical trials
2019-09-04 00:00:00

Boji biomedical technology (Hangzhou) Co., Ltd. recently announced that the world's first tumor targeted IL-15 fusion protein (product code bj-001), independently developed by the company and with a global patent, was notified by the FDA 28 days after it was submitted to the FDA, and can carry out clinical trials in the United States.


IL-15 is a multifunctional cytokine that plays a central role in the development, survival and activation of NK, t and B cells. IL-15 can not only increase the number of NK cells and T cells, but also activate NK cells and cytotoxic CD8 +t cells, thus killing tumors and other pathogens. Therefore, IL-15 has high therapeutic potential in the field of tumors and infectious diseases, ranking first among the 20 cancer immunotherapeutic drugs including PD-1 recommended by the National Cancer Institute (NCI) in 2008.


Although recombinant IL-15 has been proved to have anti-tumor effect in animal experiments and has been proved to be effective in lung metastasis of melanoma in the first human experiment, its short half-life and other shortcomings are the main obstacles to its drug formation. The world's first tumor targeting IL-15 fusion protein bj-001, independently developed by Boji biomedicine and with a global patent, not only overcomes the shortcoming of short half-life of recombinant IL-15, but also its tumor targeting can enrich IL-15 in tumors with high expression of the target, thus reducing systemic toxicity and enhancing curative effect.
In addition, the effect of IL-15 on lymphocyte proliferation in the local tumor also has the potential to turn the "cold tumor" that does not respond to the current commonly used immunosuppressants such as anti-PD-1 antibody into a reactive "hot tumor", which will greatly improve the efficiency of existing tumor immunotherapy drugs and benefit more patients. Therefore, the tumor targeting IL-15 of Boji biomedicine is expected to become another rookie in tumor immunotherapy. The product has been notified in advance once applied in the United States that clinical trials can be carried out, which also shows that FDA recognizes the quality and safety of the product.


As for the advance approval of bj-001 by FDA, Dr. zhanghaizhou, co-founder and CEO of Boji biomedicine, said:

"The entry of bj-001 into clinical trials in the United States marks that our company has become a company in the stage of clinical development, which is an important milestone for the company. As a biotechnology company located in China, facing the global market and focusing on independent innovation, our goal is to promote clinical research with a completely self-help innovative product every 1-2 years, so as to provide more innovative treatment methods for patients in China and even the world 。”


Although it has been operating for less than two years and adhering to the idea of only making global independent innovative drugs, Boji biomedicine has begun to deploy in tumors and infectious diseases by using its biopharmaceutical R & D platform protected by trade secrets. Bj-001, which was approved to enter the clinic this time, is one of many innovative products in its R & D pipeline. Prior to this, Boji biomedicine has started the establishment of bj-001 immunohistochemical detection (IHC) method and the development of accompanying diagnostic kit with partners, hoping to provide more accurate treatment for cancer patients by means of precision medicine.


About Boji biomedicine

Boji biopharmaceutical is a biotechnology company dedicated to the research and development of innovative drugs. It was founded by overseas experts with many years of experience in the research and development of innovative drugs at home and abroad, including experts in the major special review of science and technology for "major new drug creation". It has an antibody discovery platform protected by trade secrets and top technologies at home and abroad. At present, it mainly researches and develops biological drugs for tumors and infectious diseases. The main scientific research and management team of the company has many years of experience in R & D and management of antibody drugs in domestic and foreign R & D companies and national key scientific research institutions, especially in European and American multinational companies. With a global view of R & D and strong capital support, Boji biomedicine has made a global layout of R & D from a global perspective since its inception. At the same time, it has two R & D laboratories in San Francisco, USA and Hangzhou, China, so that the company can achieve an all-round collection of talents, technology, management and capital markets at the initial stage of entrepreneurship, laying a solid foundation for the company's global positioning and development.