Shanghai Sai'ao Biotechnology Co., Ltd.

Sai'ao Biotechnology was founded in 2009 and is one of the earliest companies in China dedicated to the cell therapy industry. After years of rapid development, it has now become a leading national high-tech enterprise in cell biotechnology. The company has long been committed to basic research and clinical translational research on stem cells and immune cells; research and development, production, testing, and storage of cell products; and preclinical testing, clinical efficacy evaluation, and prognostic analysis of cell therapy. Sai'ao Biotechnology has established extensive and in-depth cooperation with numerous outstanding domestic and international research institutions and clinical medical institutions, including the Shanghai Institute of Life Sciences of the Chinese Academy of Sciences, School of Medicine of Tsinghua University, College of Life Sciences of Zhejiang University, Peking University Health Science Center, Cancer Institute of Shanghai Jiao Tong University, Second Military Medical University, Third Military Medical University, and CELLEX Co., Ltd. of Japan. Through independent and joint research and development, the company has developed a series of advanced, high-quality standard, and proprietary intellectual property iCELLTM immune cell and stem cell products. Sai'ao Biotechnology has always been dedicated to research and industrialization of cell biotechnology. Relying on outstanding research institutions and experts in the cell biology field domestically and internationally, and through independent R&D and joint development, it actively promotes the clinical translation of the latest cell biotechnology to benefit human health and disease treatment. In cellular immunity, Sai'ao Biotechnology focuses on anti-tumor and anti-viral research of immune cells. Through basic and clinical research on NK, AKT, CTL, CIK, DCCIK, DC cells, it continuously explores immune cell products and therapeutic techniques with better clinical efficacy and is currently committed to the development of CAR-T. In stem cells, Sai'ao Biotechnology has conducted in-depth research on the culture and clinical application of bone marrow mesenchymal stem cells, umbilical cord mesenchymal stem cells, adipose-derived mesenchymal stem cells, amniotic epithelial cells, and embryonic stem cells, and has carried out clinical research in treating nervous system diseases, retinopathy, premature ovarian failure, and autoimmune diseases. Sai'ao Biotechnology adopts the internationally standard cell processing center (CPC) cell production management model. In accordance with the U.S. FDA guidelines for somatic cell therapy products, the Ministry of Health's "Management Standards for Autologous Immune Cell Therapy Technology," and the 2010 GMP requirements of the China Food and Drug Administration, and referencing the highest standards of international cell processing centers in Europe, America, and Japan, the company has designed and constructed four standardized, large-scale GMP-standard clinical-grade cell processing centers in Beijing, Shanghai, Guangzhou, and Chongqing. Center 1: Built in March 2014, covering 800 square meters, located at 1st Floor, Building 12, No. 1 Chaoqian Road, Zhongguancun Changping Science Park, Beijing. It was designed under the guidance of Dr. Hiroshi Shimosaka, Vice President of the International Society for Cell Therapy (ISCT) and President of the Asian Cellular Therapy Organization (ACTO), fully designed according to the highest international CPC standards, achieving an international first-class level. In October 2014, the Beijing Municipal Development and Reform Commission approved Beijing Sai'ao Biotechnology as the first government-recognized "Cell Therapy Beijing Engineering Laboratory." Center 2: Built in December 2010, covering 1,400 square meters, located at 4th Floor, Building 15, No. 879 Zhongjiang Road, Putuo District, Shanghai. It is one of the earliest central-level enterprises for cell preparation production in China. The clean area reached background Grade C and local Grade A in operation zones. Center 3: Built in June 2015, covering 800 square meters, located at 3rd Floor, Building A, No. 191 East Binjiang Road, Haizhu District, Guangzhou. Center 4: Built in September 2015, covering 2,400 square meters, located at 3rd Floor, Building 26, Zone C, Jianqiao Industrial Park, Dadukou District, Chongqing. In cooperation with Southwest Hospital affiliated to Third Military Medical University, the Chongqing Southwest Hospital Stem Cell R&D and Translational Center was established. Sai'ao Biotechnology not only pioneered DCCIK clinical research with Changzheng Hospital affiliated to the Second Military Medical University but also established long-term collaborations with Peking University People's Hospital, International Peace Maternity and Child Health Hospital of China Welfare Association, First Affiliated Hospital of Jiao Tong University, Southwest Hospital affiliated to Third Military Medical University, as well as Japanese institutions like Cellex Corporation, and domestic research institutions such as the Chinese Academy of Sciences, Shanghai Cancer Institute, Tsinghua University, and Zhejiang University. The company also possesses fully proprietary intellectual property over NK cells, AKT cells, CTL cells, CAR-T cells, and mesenchymal stem cells, embryonic stem cells, amniotic epithelial cells, and other products and technologies, showcasing strong technical capabilities. In May 2011, Sai'ao Biotechnology, in collaboration with Changzheng Hospital affiliated to the Second Military Medical University, jointly initiated clinical research on iCELL™ DCCIK cell technology for the treatment of malignant tumors such as lung cancer and renal carcinoma. Based on this, in October 2014, Changzheng Hospital obtained clinical application approval from the Health Department of the General Logistics Department of the People's Liberation Army regarding "Reply on Conducting Clinical Application of Autologous DCCIK Cell Therapy for Lung Cancer and Renal Carcinoma." In 2013, Sai'ao Biotechnology signed a cooperation agreement with Cellex Co., Ltd. of Japan, establishing the "iCELL-Cellex Joint Cell R&D and Preparation Center" in both China and Japan. Sai'ao Biotechnology introduced to China the "High-activity NK Cell Therapy" technology filed with Japan's Ministry of Health, Labour and Welfare, which holds four patents in Japan and the United States. Cellex's New City Osaki Clinic in Tokyo has performed NK cell therapy on over a thousand malignant tumor patients in Japan, yielding good therapeutic outcomes.