Jiuzhitang Bolsters Regenerative Medicine, Stepping Up Investment in the Stem-Cell Pharmaceutical Sector
来源:Securities Daily
2018-09-18
Our reporter, Zhang Min
On September 14, the Jiuzhitang Yonghe Qihang Fund—established by Jiuzhitang—signed an investment agreement with U.S.-based Stemedica Cell Technologies Inc. (referred to as U.S. Stemedica hereafter), a company located in San Diego's Biotech Valley that boasts over a decade of experience in stem cell research, development, manufacturing, and marketing.
As stipulated in the agreement, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereinafter referred to as Jiuzhitang Maker) will introduce cutting-edge stem cell production technologies and preparation platforms from world-class stem cell companies. Over the next 3 to 5 years, the company plans to build a commercial-grade stem cell production facility meeting U.S. and EU cGMP standards at the Daxing Biomedical Industry Base in Beijing.
A representative from Jiuzhitang stated that this move marks the company's official entry into the research, clinical development, and industrialization of stem-cell therapies—solidifying Jiuzhitang, a century-old traditional Chinese medicine enterprise, as a pioneer in this cutting-edge field.
Jiuzhitang's Strategic Transformation
Increasingly, clinical cases demonstrate that stem cell technology holds groundbreaking significance for the advancement of human medicine. As a result, countries around the world are positioning stem cells as a strategic emerging industry aimed at enhancing their international competitiveness in the field of human health. Data indicates that by 2020, the global stem cell market is projected to reach US$400 billion, while China’s stem cell market is expected to grow to as much as 120 billion RMB.
In May of this year, Jiuzhitang released an announcement regarding the investment progress of its merger and acquisition fund.
It is understood that the Yonghe Qihang Fund, initiated by Jiuzhitang, has invested in Stemedica Cell Technology Co., Ltd. of the United States. Simultaneously, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. was established as the sole Chinese partner entrusted with taking over Stemedica's stem cell technology from the U.S. company. By introducing Stemedica's globally advanced stem cell production technology and manufacturing platform, Jiuzhitang (Meike) has achieved world-class scalability in stem cell expansion, effectively addressing a critical technical hurdle in turning stem cells into viable pharmaceutical products. Currently, the company is constructing a cGMP-compliant allogeneic stem cell production facility in Beijing’s Daxing District—meeting both U.S. and EU standards—that will be dedicated to producing human bone marrow mesenchymal stem cells and neural stem cells. The facility will span a total area of 4,500 square meters and is expected to become operational in 2019.
Jiuzhitang stated that the establishment of Jiuzhitang (Meike) marks a significant step for a leading traditional Chinese medicine enterprise toward pharmaceutical innovation. Looking ahead, the company will launch several international, multi-center clinical trials to further advance the development of stem-cell-based drug technologies.
It is understood that Jiuzhitang, a time-honored pharmaceutical company with over a century of history, strategically announced in 2015 its intention to leverage its strong traditional Chinese medicine industry expertise while capitalizing on the global advancements in stem cell technology. The company is making a significant move to establish a robust presence in the regenerative medicine sector, aiming to seamlessly integrate China's rich heritage of traditional medicine with cutting-edge stem cell-based biotechnology—and ultimately pave the way for an innovative growth trajectory tailored specifically for this iconic Chinese pharmaceutical enterprise.
Invest in a globally leading stem cell company
Jiuzhitang introduces that Stemedica, based in San Diego—the epicenter of the U.S. biotechnology and pharmaceutical industry—has become the first U.S. company approved to conduct clinical research using stem cells for Alzheimer’s disease treatment. It is also one of only a handful of U.S. biotech firms certified by the FDA to carry out stem-cell drug trials, and one of the world’s rare companies capable of producing both human bone marrow mesenchymal stem cells and human neural stem cells. Since its establishment in 2005, Stemedica has invested heavily—over $100 million over 13 years—in cutting-edge R&D, successfully developing an oxygen-deprived stem-cell production platform that boasts independent intellectual property rights and has earned U.S. FDA cGMP certification. This state-of-the-art platform not only ensures the highest quality of stem cells but also enables large-scale, standardized, and fully traceable production processes, achieving unprecedented efficiency in stem-cell expansion. In addition to its headquarters in San Diego, Stemedica maintains operations in the region…
In addition to its production facilities, the company also has branches in Singapore and Lausanne, Switzerland.
U.S.-based Stemedica Corporation has conducted six clinical trials in the U.S. using stem cell therapy, targeting conditions such as ischemic stroke, chronic heart failure, Alzheimer’s disease, photoaging of the skin, acute myocardial infarction, and traumatic brain injury. Among these, the trials for ischemic stroke and chronic heart failure have already completed Phase IIa clinical studies and have been backed by several high-profile academic publications. Notably, Stemedica’s clinical research on Alzheimer’s disease marks the first-ever FDA-approved stem cell therapy trial in the U.S. specifically for this condition. In addition, Stemedica has initiated 10 more clinical studies in countries including Switzerland, Kazakhstan, and Mexico. Meanwhile, the company is leveraging stem cell-derived secretomes—biomolecules naturally produced by clinical-grade stem cells—to develop a range of health-focused products, which are being applied in areas like cosmetic enhancement, anti-aging treatments, and aesthetic procedures. Currently, Stemedica is also advancing groundbreaking research in the field of cancer vaccines, utilizing its proprietary stem cell technology to pave the way for innovative therapeutic approaches.
Currently, China does not have any approved stem-cell drugs.
Jiuzhitang stated that, from an industry perspective, governments worldwide are increasingly boosting policy support for stem cells and regenerative medicine, indicating immense future market potential. The market is expected to grow rapidly over the next five years, with broad prospects for industry development. Meanwhile, most domestic companies in China remain focused primarily on stem cell storage and offering medical aesthetic services—few have yet prioritized developing stem-cell-based pharmaceuticals. Stemedica, however, boasts viable and cutting-edge stem-cell preparation technology. Its advanced technological edge positions it as a strong candidate for advancing stem-cell therapies targeting conditions like cardiovascular diseases, spinal cord injuries, and Alzheimer’s disease, making Stemedica a company well worth investing in.
Additionally, Jiuzhitang announced that Jiuzhitang (Meike) will collaborate with top-tier domestic hospitals to conduct multi-center clinical trials. Building on the promising clinical results achieved by Stemedica in the U.S., these trials will focus on stem-cell research targeting neurological and cardiovascular diseases—specifically, conditions related to the nervous system and cerebrovascular disorders. The ultimate goal is to accelerate the development and eventual approval of stem-cell therapies in China, enabling the nation to benefit from groundbreaking advances in regenerative medicine. Meanwhile, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. has also signed cooperation agreements with Mexico’s Novastem Cell Technology Company and Kazakhstan’s ALTACO Cell Technology Company, jointly establishing an international stem-cell research and development platform.
A source from Jiuzhitang revealed that earlier this month, Kazakhstan’s Ministry of Health signed documents approving a mesenchymal stem cell therapy protocol specifically for acute myocardial infarction, marking the official entry of stem-cell treatment into the commercialization phase in Kazakhstan. This is the first stem-cell therapy regimen approved among the five Central Asian countries, and it sets an important precedent for the future development of stem-cell technology across Central Asia and the Middle East.
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