Treatment of liver cancer, brain cancer, lung cancer and other solid tumors by immune cell preparation dawn in the former in China

 Recently, Keji Biomedical (Shanghai) Co., Ltd. officially opened its biological building. Keji Biomedical (Shanghai) Co., Ltd. is founded by researcher Zonghai Li from Shanghai Cancer Institute of Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, which is China's first CAR-T biomedical enterprise with 30 million US dollars financing. The biological building is equipped with 3100 square meters of cell preparation center in strict accordance with the GMP Standard for Injections of China Food and Drug Administration. This indicates that China has taken substantial steps in the industrialization process of the original scientific research results of CAR-T cell treatment of the solid tumors.

According to Jianren Gu, Academician of Chinese Academy of Engineering, Honorary Director of Shanghai Cancer Institute, tumors have currently become major diseases and public health problems which have serious threat to human life and health, affecting the socio-economic development. According to the statistics from National Cancer Center released in 2015, newly diagnosed cases of cancers in China is expected to be 4.2916 million in 2015, which means that an average of 11.75 thousand people per day and about 8 people per minute were diagnosed with cancers. The number of deaths from cancers is as high as 2.8142 million.

 According to Zonghai Li, an important reason for tumoriogenesis and progression is that tumor cells escape immune system, especially T lymphocyte recognition. CAR-T cells (Chimeric Antigen Receptor, CAR) are T-lymphocytes that are modified by CAR gene, so that T lymphocytes have the ability to accurately identify and destroy tumors. At present, CAR-T cells have significant effects in leukemia and some types of blood tumors. Both Novartis and Cade Pharmaceuticals have submitted applications for new CAR-T drugs for leukemia or lymphoma in recent years and are expected to benefit patients in the near future. However, transformation research of CAR-T cells therapy of solid tumors is still in the initial stage. At present, the cases of CAR-T studies to achieve efficacy of "clinical remission" for solid tumors is very few in the globe. In 2015, Zonghai Li led the research team to carry out the first CAR-T clinical study for hepatocellular carcinoma in the world and the CAR-T clinical study for glioma, with the support of Shanghai Health and Family Planning Commission, Shanghai Cancer Institute and Shanghai Collaborative Innovation Center of Transformational Medicine, and have achieved initial results.

 In 2015, Zonghai Li led the creation of the first domestic CAR-T biomedical enterprises --- Keji Biomedical (Shanghai) Co., Ltd. and established production-study-research cooperation alliance with the Shanghai Cancer Institute. They committed to the original development of CAR-T to promote transformation of scientific research results and benefit cancer patients. The company currently has more than ten original candidates of CAR-T products, covering leukemia, lymphoma, myeloma, liver cancer, lung cancer, gastric cancer, pancreatic cancer, brain glioblastoma, esophageal cancer and other human tumors, among which CAR-T for lung cancer, gastric cancer, pancreatic cancer are international initiative. The company has become the international leading enterprises in the field of CAR-T cell therapy of solid tumors. In 2016 the company successfully received $ 30 million financing, valued at $ 173 million. At present, the company has set up subsidiaries in Hong Kong and the United States. And in the end of 2016 the company officially launched the pre-clinical study in the United States, which is expected to be formally approved by the US FDA to carry out clinical research in 2017. In order to better ensure the quality for the preparation of CAR-T, since March 2016, Keji company established 3100 square meters of cell preparation center in strict accordance with GMP Standard for Injections of the China Food and Drug Administration, and recently completed, which will provide very important facilities to guarantee CAR -T cell products preparation and their safety for the human body.

For the future development, Zonghai Li said that from the company's point of view, as China's leading enterprises in the field of CAR-T cell therapy, Keji is expected to declare documents for at least five clinical research approvals from national CFDA and 1-2 US FDA clinical research approval in 2017-2018. It strives to have the first marketing CAR-T product in 2020. From the perspective of transformation of scientific research, he hopes to develop effective drugs to cure cancers, so that escort for human health.

 Vice president of Renji Hospital and Director of Shanghai Cancer Research Institute Huili Dai said that, as a director of research group in the State Key Laboratory of Oncogenes and Related Genes of Shanghai Cancer institute, and a doctoral tutor of Shanghai Jiao Tong University School of Medicine, Zonghai Li needs to undertake a lot of scientific research and teaching work. Shanghai Cancer Institute retains his work platform on the basis of the similar assessment, to encourage Zonghai Li to explore the foundation of enterprises, and actively promote the transformation of results from research projects. It is reported that Shanghai Cancer Institute and Keji Biomedical (Shanghai) Co., Ltd. signed a strategic cooperation agreement, that Keji Biotechnology Company funds to support the transformation of results from research projects, and both the two sides share the benefits by a certain percentage. "We are still exploring and practicing the cooperation model which can benefit both the society, the community, the research team, the R & D team and the investigators. We hope that the final research results will be transformed and industrialized as soon as possible so that benefit more cancer patients."

 Vice President and Secretary of Party Committee of Shanghai Science and Technology Commission Jianrong Yang, Vice President of Shanghai Jiao Tong University School of Medicine and Dean of Graduate School Hongzhuan Chen, Associate Dean of Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Director of Shanghai Cancer Institute Huili Dai and other relevant leaders attended the ceremony for the completion of the building.(Reporter Shan Tan and Huiyun Yuan / Translator Weiwei Zhang)