Traditional Chinese Medicine company Jiuzhitang introduces international technology into the field of stem cells
Global Stem Cell Industry Development Summit Forum was held in Beijing recently. The event was co-hosted by Jiuzhitang Co., Ltd. and Z-Park Daxing Biomedicine Industry Park and sponsored by Zhongguancun Medical Device Park Co., Ltd. On the forum, Jiuzhitang Yonghe Qihang Fund initiated by Jiuzhitang, a traditional Chinese medicine pharmaceutical company, signed an investment agreement with Stemedica Cell Technologies, Inc. Under the agreement, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. will introduce Stemedica’s stem cell manufacturing technologies and platform into a stem cell manufacturing facility to be constructed in Beijing Daxing Biomedicine Industry Park. This move marks the official entry of Jiuzhitang, a centuries-old Chinese medicine company into the field of stem cell drug production, clinical development and industrialization.
As demonstrated by an increasing number of clinical cases, stem cell technology has an epoch-making significance to the development of healthcare industry. Many countries around the world have listed stem cells development as a strategic emerging industry that helps enhance their international competitiveness in the healthcare sector.
As a century-old pharmaceutical enterprise, Jiuzhitang made a timely decision as early as 2015 to remap the field of regenerative medicine leveraging strengths it has accumulated as a TCM enterprise and proven stem cell technologies from abroad. It will strive to pioneer a road of innovation for Chinese time-honored pharmaceutical companies by combining traditional Chinese medicine with cutting-edge stem cell technologies. In order to shorten the research and development process and seize initiatives of China's stem cell pharmaceutical market, Yonghe Qihang Fund established by Jiuzhitang decided to invest in Stemedica Cell Technologies, Inc. and found Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. as the sole recipient of stem cell technologies developed by Stemedica. By bringing in Stemedica’s technologies and platform, Jiuzhitang Maker is positioned to realize the large-scale expansion of stem cells, thus solving key technical obstacles to the development of stem cell drugs. Maker is now building a US FDA and EU cGMP-compliant facility of allogeneic stem cells in Daxing District of Beijing. This facility will be used for manufacturing of human bone marrow mesenchymal stem cells and neural stem cells. With a total area of 4,500 square meters, the facility is anticipated to be put into use in 2019.
The establishment of Jiuzhitang Maker marks a significant step a representative traditional Chinese medicine company has taken towards medical innovation. In the future, a number of international multi-center clinical trials will be launched to further advance the development of stem cell pharmaceutical technologies.
Formulating stem cells into drugs is the strategy Jiuzhitang has chosen to follow for development of stem cell products. As technology transfer goes on and after Maker’s facility commences operation, 900,000 vials of consistent and highly active therapeutic stem cells will be manufactured out of a donated bone marrow sample, thus achieving scalable expansion of stem cells and solving the key technical problems of stem cell drugs formulation. Jiuzhitang Maker will continue to innovate based on scientific and technical achievements of Stemedica, and launch clinical trials on neurological, cardiovascular, endocrine, and orthopedic indications. The company is now busy preparing for regulatory filing with CFDA, which is expected to occur by end of this year.
In order to bring stem cell drugs into market as early as possible, Jiuzhitang Maker will cooperate with domestic hospitals to conduct multi-center clinical trials. The company plans to carry out clinical program on neurological, cardiovascular and cerebrovascular conditions based on positive data Stemedica received from its clinical trials.
On the forum, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. signed cooperation agreements with Mexico's Novastem Cell Technology Co. and Kazakhstan's ALTACO Cell Technology Co. respectively to co-build internationalized stem cell research and development platform.
Subsequently, Dr. Aaron Ciechanover as 2004 Nobel prize winner, Dr. Joseph Maroon and Dr. Michael Levy as internationally well-known stem cell clinical research specialists, Professor Yuan Baozhu, Director of the China National Institute for Food and Drug Control, Cell Resource Storage and Research Center, Prof. Zhang Yanan from Beijing Tiantan Hospital Affliated to Capital Medical University, Professor Tian Ye from No.1 Hospital Affiliated to Harbin Medical University, and Dr. Alex Kharazi as Chief Technology Officer of Stemedica shared their perspectives on exploration into the frontier domain of stem cells development based on their respective expertise.
Participants witnessed the opening ceremony marking Jiuzhitang’s entry into the field of stem cell pharmaceutical development. Jiuzhitang will continue to contribute actively to the establishment of an internationalized R&D, production and application layout of stem cells development, improvement of China’s competitiveness in terms of making stem cells into drugs, and development of the Chinese regenerative medicine industry.