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From Stem Cell Research to Stem Cell Pharmaceuticals: Jiuzhitang Power Regenerative Medicine


Jiuzhitang Yonghe Qihang fund initiated by Jiuzhitang signed an investment agreement with Stemedica Cell Technology Co., Ltd. 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 centuries old Chinese medicine company Jiuzhitang officially entered the field of stem cell drug development, clinical research and industrialization.

 

Strategic Transformation

According to the industry, stem cell technology has an epoch-making significance for human medical development. Countries around the world have listed stem cells as strategic emerging industries that enhance international competitiveness in the field of human health. In the listed companies listed on NASDAQ alone, the market value of stem cell concept stocks exceeds $30 billion. It is estimated that by 2020, the global stem cell market will reach 400 billion US dollars, and the Chinese stem cell market will reach 120 billion yuan. China also issued the "Healthy China 2030" Planning Outline in 2016. Regenerative medicine represented by stem cell technology is the main direction of future medical development.

Li Zhenguo, chairman of Jiuzhitang Co., Ltd., told the Securities Times reporter that the company, based on the advantages of its own Chinese medicine industry and leverage the advantages of international stem cell technology, hopes to combine traditional Chinese medicine with stem cell frontier biotechnology to create an innovation road of a China's old pharmaceutical company. In order to shorten the research and development process and seize the opportunity of China's stem cell pharmaceutical market, the Yonghe Qihang Fund initiated by Jiuzhitang invested in the United States Stemedica Cell Technology Co., Ltd. At the same time, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. was established as the sole recipient of Stemedica's stem cell technology in China. Through the introduction of Stemedica's world-leading stem cell production technology and preparation platform, Jiuzhitang (Maker) has achieved the world's leading stem cell scale-up and solved the key technical problems of stem cell medicine.

According to incomplete statistics, there are currently 13 approved stem cell drugs worldwide. But there are no approved stem cell drugs in China. However, in recent years, the pace of reform of China's pharmaceutical system has continued to increase, and incentives for innovative drugs have been frequently introduced. CFDA has successively issued a series of guidelines for stem cell technology and the regulatory system is becoming more and more perfect. The application for stem cell clinical trials has resumed, and the door to stem cell medicine has been opened.

 

It is reported that Jiuzhitang is building an allogeneic stem cell production site in accordance with US and EU cGMP standards in Daxing District, Beijing, and the site will be used for the production of human bone marrow mesenchymal stem cells and neural stem cells. The platform has a total area of ​​4,500 square meters and is expected to be put into use in 2019. The platform has the ability of preparation of 900,000 vials of 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, the company is carrying out data preparation work, and is expected to report to CFDA during the year.

Start clinical trials

It is reported that Jiuzhitang (Maker) will cooperate with top hospitals in China to carry out multi-center clinical trials. Based on the results of good clinical trials of Stemedica in the United States, it is planned to conduct stem cell clinical research on nervous system and cardiovascular and cerebrovascular diseases, and finally promote stem cell drugs to the market as soon as possible in China.

At the same time, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. also signed a cooperation agreement with Mexico's Novastem Cell and Kazakhstan's ALTACO Cell Technology to jointly establish an internationalized stem cell research and development platform.

Among them, Kazakhstan is an important node of the “One Belt, One Road” strategy. Kazakhstan ALTACO is a long-term partner of Stemedica in Kazakhstan. ALTACO, as a sponsor, conducted a number of stem cell clinical trials in Kazakhstan using Stemedica's stem cells. Just earlier this month, the Ministry of Health of Kazakhstan signed a document approving a treatment plan for mesenchymal stem cells for acute myocardial infarction, marking the official commercialization of stem cell therapy in Kazakhstan. This is the first approved stem cell treatment program in the five Central Asian countries. The industry believes that this event has important demonstration significance for the future development of stem cell technology in Central Asia and the Middle East.

 

Synchronized with Jiuzhitang officially entering the stem cell field, the “Global Stem Cell Industry Development Summit Forum” was held in Beijing on the same day. Professor Aaron Ciechanover, winner of the 2004 Nobel Prize and Dr. Joseph Maroon, an international stem cell clinical research expert, attended the forum and delivered speeches.