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Jiuzhitang Enters the Stem Cell Pharmaceutical Sector
来源：China Health Media Group – China Food and Drug Network
2018-09-18
Recently, the Jiuzhitang Yonghe Qihang Fund—established by traditional Chinese medicine pharmaceutical company Jiuzhitang—signed an investment agreement with U.S.-based Stemedica Cell Technology Inc. (referred to as Stemedica) in Beijing. Under the agreement, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (referred to as Jiuzhitang Maker) will introduce cutting-edge stem-cell production technology and a state-of-the-art preparation platform from a world-leading stem-cell company. Over the next 3 to 5 years, Jiuzhitang Maker plans to build a commercial-grade stem-cell production facility at the Daxing Biomedical Industry Base in Beijing, adhering to both U.S. and EU cGMP (current Good Manufacturing Practice) standards. This strategic move marks Jiuzhitang's official entry into the research, clinical development, and industrialization of stem-cell therapies.
Currently, regenerative medicine—centered around stem cell therapy—has emerged as an alternative treatment approach for diseases, complementing traditional methods like drug therapy and surgery. It is also one of the key directions for the future of medical advancement. According to incomplete statistics, there are currently 13 stem cell-based drugs approved globally. In 2004, China's National Medical Products Administration issued the first clinical trial approval for a stem cell drug; however, to date, no stem cell-based medication has yet been authorized for market release.
In recent years, China has made significant and rapid progress in both basic stem cell research and technological development. In February 2015, the Ministry of Science and Technology released the "Implementation Plan for the National Key R&D Program—Key Special Project on Stem Cells and Translational Medicine (Draft for Comments)." Later that year, in July, the former National Health and Family Planning Commission issued the "Measures for the Administration of Clinical Research on Stem Cells (Trial)" along with the "Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research (Trial)." As a result, stem cell research has once again been elevated to the level of national strategy, paving the way for more robust regulation and streamlined approval processes for clinical applications of stem cells in the future.
Since 2015, Jiuzhitang has been strategically expanding into the regenerative medicine sector. To accelerate its R&D process and gain a competitive edge in the stem-cell pharmaceutical market, Jiuzhitang initiated the establishment of the Yonghe Qihang Fund to invest in Stemedica—a move that also led to the creation of Jiuzhitang Maker, the company’s exclusive Chinese partner for Stemedica’s cutting-edge stem-cell technology. Jiuzhitang Maker is set to leverage Stemedica’s globally recognized stem-cell production technologies and advanced manufacturing platforms, enabling large-scale, scalable expansion of stem cells—critical for overcoming key technical hurdles in turning stem cells into viable therapeutic products. Currently, the company is constructing a state-of-the-art allogeneic stem-cell production facility in Beijing’s Daxing District, designed to meet both U.S. and EU cGMP standards. This facility will focus on producing human bone marrow-derived mesenchymal stem cells and neural stem cells. The new production site spans a total area of 4,500 square meters and is expected to become operational by 2019. Once fully operational, it will enable the company to transform a single donated bone marrow sample into as many as 900,000 consistent, highly active therapeutic-grade stem cells—ready for clinical applications.
It is reported that Jiuzhitang Maker will collaborate with domestic hospitals to conduct multi-center clinical trials in fields such as neurology, cardiovascular and cerebrovascular health, endocrinology, and orthopedics, building on Stemedica's promising clinical trial results. Currently, Jiuzhitang is busy organizing documentation and making preparatory arrangements, with plans to submit its application to the National Medical Products Administration within the year. (Tong Fei)
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