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From "Stem Cell Research" to "Stem Cell Pharmaceutical"-Jiuzhitang is a global leader in regenerative medicine
The Jiuzhitang Yonghe Qihang Fund initiated by the traditional Chinese medicine pharmaceutical company Jiuzhitang signed an investment agreement with Stemedica Cell Technology Co., Ltd. (hereinafter referred to as Stemedica, USA), which has more than ten years of research and development, production and marketing history of stem cells in San Diego, USA. According to the agreement, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereinafter referred to as Jiuzhitang Maker) will introduce stem cell production technology and preparation platform of the world's top stem cell companies, and construction a commercial-grade stem cell production base that meets US and EU cGMP (Dynamic Drug Production Management Practices) standards in 3 to 5 years in Daxing Biomedical Industry Base in Beijing. This marks the 100-year-old Chinese medicine company Jiuzhitang officially entered the field of stem cell drug research and development, clinical research and industrialization. The era of stem cell pharmaceutical is coming in China.
As a pioneer of domestic stem cell medicine, Jiuzhitang has been actively constructing international research and development, production and application layout, and has played an active role in promoting the competitiveness of stem cell medicines and the development of regenerative medicine in China.
Stemedica Inc. is located in San Diego, the nation's biotechnology and pharmaceutical industry. It is the first stem cell drug clinical trial approved for the treatment of Alzheimer's disease in the United States. Its stem cell drug clinical trial for the treatment of Alzheimer's disease is the first one approved in the United States. It is one of the few FDA-certified companies who is permitted to conduct stem cell drug testing in the United States. It is one of the few companies in the world that can produce two kinds of stem cells including human bone marrow mesenchymal stem cells and human neural stem cells.
Making stem cells into medicine is the development strategy of stem cell products selected by Jiuzhitang. By investing in the Stemedica, Jiuzhitang quickly seized the technological frontiers of international stem cell drug research.
Cellular drugs are the most complex drugs in human history, and they are also difficult for scientists in various countries to tackle their problems. In recent years, stem cell drugs have developed by leaps and bounds, bringing revolutionary changes to human health and medicine. It has promoted a revolutionary revolution in the medical, preventive medicine, health care and other industries, and brought the gospel to the healthy life of mankind. With the continuous deepening of scientific research and the continuous development of technology, countries around the world have gained more and more understanding of cellular drugs, and the regulatory system and path are constantly improving. According to incomplete statistics, there are currently 13 approved stem cell drugs worldwide. But unfortunately, there are no approved stem cell drugs in China.
In recent years, the pace of reform of China's pharmaceutical system has continued to increase, and frequent incentive policies for innovative drugs have been introduced. CFDA has successively issued a series of guidelines for stem cell technology, the regulatory system is becoming more and more perfect, and the application for stem cell clinical trials has resumed, and the door to stem cell medicine has been opened.
With the steady transfer of technology, Jiuzhitang will have a production site in Daxing that can industrialize stem cell drugs. All facilities are designed and constructed in accordance with US and EU cGMP standards. After being put into use, the platform has the ability of preparation of 900,000 vials consistent, highly active therapeutic stem cells from a donated bone marrow sample, truly achieving the world-scale stem cell scale-up and solving the key technical problems of stem cell medicine. Jiuzhitang Maker will continue to innovate on the basis of the existing achievements of Stemedica in the United States, and conduct clinical trials in the fields of nervous system, cardiovascular, endocrine, orthopedics. At present, Jiuzhitang Maker is carrying out data preparation and expected to report to CFDA during the year.
Jiuzhitang Maker will also cooperate with top hospitals in China to conduct multi-center clinical trials. Based on the results of clinical trials of Stemedica in the United States, it plans to conduct stem cell clinical research on nervous system and cardiovascular and cerebrovascular diseases, and finally promote the early marketing of stem cell drugs in China.
At the same time, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. also signed a cooperation agreement with Mexico's Novastem Cell Technology and Kazakhstan's ALTACO Cell Technology to jointly establish an internationalized stem cell research and development platform.