From "Stem Cell Research" to "Stem Cell Pharmaceuticals"—Jiuzhitang Aims to Become a Global Leader in Regenerative Medicine


来源:Economic Information Daily

2018-10-12

Jiuzhitang, a traditional Chinese medicine pharmaceutical company, has recently signed an investment agreement with Stemedica Cell Technologies Inc., a U.S.-based company based in San Diego’s renowned Biotech Valley and boasting over a decade of experience in stem cell research, development, manufacturing, and marketing. Under the terms of the agreement, Jiuzhitang Maker (Beijing) Cell Technologies Co., Ltd. will introduce cutting-edge stem cell production technologies and a state-of-the-art preparation platform from one of the world’s leading stem cell firms. Over the next three to five years, Jiuzhitang Maker plans to establish a commercial-grade stem cell production facility at the Daxing Bio-Medical Industry Base in Beijing, adhering to both U.S. and EU cGMP standards. This strategic move marks Jiuzhitang, a century-old Chinese medicine enterprise, officially entering the rapidly growing fields of stem cell drug R&D, clinical applications, and industrialization—signaling that China’s era of stem cell-based pharmaceuticals is on the horizon.

As a pioneer in the development of stem-cell-based pharmaceuticals in China, Jiuzhitang has been actively building an international network for research, development, production, and application, playing a proactive role in enhancing the competitiveness of China’s stem-cell therapies and advancing the growth of the country’s regenerative medicine sector.

U.S.-based Stemedica, located in San Diego—the epicenter of the biotechnology and pharmaceutical industries across America—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-based drug trials, and among the very few companies worldwide capable of producing both human bone-marrow mesenchymal stem cells and human neural stem cells.

Turning stem cells into pharmaceuticals is the stem-cell product development strategy chosen by Jiuzhitang. By investing in the U.S.-based company Stemedica, Jiuzhitang has quickly secured a leading position at the cutting edge of international research on stem-cell-based drug development.

Cell-based therapies are the most complex drugs in human history and remain a significant challenge for scientists worldwide to overcome. In recent years, stem cell-based treatments have seen rapid advancements, ushering in groundbreaking changes that are reshaping healthcare, preventive medicine, and wellness industries—and bringing unprecedented hope for healthier, longer lives. As scientific research continues to deepen and technology evolves, countries around the globe are gaining deeper insights into these innovative therapies, while regulatory frameworks and pathways are steadily improving. According to incomplete statistics, there are currently 13 stem cell-based drugs approved globally. Yet, regrettably, China has not yet approved any stem cell therapies for clinical use.

In recent years, China has steadily accelerated the pace of its pharmaceutical system reform, introducing a series of policies that actively encourage innovation in drug development. The CFDA has progressively released a set of guiding principles specifically tailored to stem cell technologies, further refining the regulatory framework. As a result, the agency has resumed accepting applications for clinical trials involving stem cells, effectively opening the door for stem cell-based drugs to enter the market.

As technology steadily advances, Jiuzhitang has secured a production facility in Daxing capable of industrializing stem-cell-based pharmaceuticals. The facility has been designed and constructed entirely in accordance with U.S. and EU cGMP standards. Once operational, it will enable the preparation of 900,000 consistent, highly active therapeutic-grade stem cells from just one donated bone marrow sample—marking a global breakthrough in scalable stem-cell expansion and addressing a critical technical hurdle in turning stem cells into viable medicines. Building on Stemedica Corporation’s existing expertise, Jiuzhitang Maker will continue to innovate across key therapeutic areas such as neurology, cardiovascular health, endocrinology, and orthopedics, with plans to initiate clinical trials in these fields. Currently, the company is finalizing documentation and making necessary preparations, with an anticipated submission to the CFDA later this year.

Jiuzhitang Maker will also collaborate with top-tier hospitals in China to conduct multi-center clinical trials. Building on the clinical trial results from Stemedica in the U.S., the company plans to advance stem-cell research focused on neurological and cardiovascular diseases, ultimately accelerating the development and timely launch of stem-cell therapies in China.

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 to jointly establish an international stem cell research and development platform.