Big news! China's century-old pharmaceutical giant is entering the stem-cell industry, paving the way for a new era in China's stem-cell-based drug development!


来源:Stem Cell Home

2018-09-15

(Stem Cell House News, Beijing) On September 14, 2018, Jiuzhitang Yonghe Qihang Fund—launched by the traditional Chinese medicine pharmaceutical company Jiuzhitang—signed an investment agreement with U.S.-based Stemedica Cell Technologies, Inc., a San Diego-based biopharmaceutical company with over a decade of experience in stem cell research, development, manufacturing, and marketing. Under the terms of the agreement, Jiuzhitang Maker (Beijing) Cell Technology 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 3 to 5 years, Jiuzhitang Maker plans to establish a commercial-grade stem cell production facility meeting both U.S. and EU cGMP standards at the Daxing Biomedical Industry Base in Beijing. This strategic move marks Jiuzhitang, a century-old Chinese medicine enterprise, officially entering the rapidly growing fields of stem cell drug research, clinical applications, and industrialization—a clear indication that China’s era of stem cell-based pharmaceuticals is fast approaching.

Strategic Transformation

Pioneering a New Era in China's Stem Cell Pharmaceutical Industry

As a century-old pharmaceutical company, Jiuzhitang has seized the perfect opportunity to accelerate its R&D process and gain a competitive edge in China’s burgeoning stem-cell drug market. By partnering with U.S.-based Stemedica, Jiuzhitang (Meike) has successfully introduced the company’s globally advanced stem-cell production technology and manufacturing platform, enabling world-class, large-scale expansion of stem cells—thus resolving a critical technical hurdle that has long hindered the development of stem-cell-based therapies. Currently, Jiuzhitang 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 cutting-edge facility will be dedicated to producing human bone marrow-derived mesenchymal stem cells and neural stem cells. With a total area of 4,500 square meters, the site is expected to become operational by 2019.

The establishment of Jiuzhitang (Meike) marks a significant step for this iconic 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.

Seize the forefront

Invest in a globally leading stem cell company

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 manufacturing both human bone marrow mesenchymal stem cells and human neural stem cells.

Given the advanced hypoxic culture production and manufacturing process of the U.S.-based company Stemedica, its stem cell products have demonstrated exceptional safety and therapeutic efficacy in clinical trials. Stemedica has conducted six stem cell therapy clinical trials in the U.S., targeting conditions such as ischemic stroke, chronic heart failure, Alzheimer’s disease, photoaging of the skin, acute myocardial infarction, and traumatic brain injury. Meanwhile, the company has also leveraged clinically graded stem cells to produce stem cell-derived factors, developing a range of health-focused products that are now being applied in areas like cosmetic enhancement, anti-aging treatments, and aesthetic procedures. Currently, Stemedica is further advancing research in tumor vaccines by harnessing its proprietary stem cell technology. Due to the superior key performance indicators of its stem cell products compared to industry peers, Stemedica has been recognized by the renowned life sciences company Life Technology as a "best-in-class" product—and is exclusively entrusted with managing its scientific research and development sales channels.

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 seized a leading position at the cutting edge of international research on stem-cell-based drug development.

As technology steadily advances, Jiuzhitang is building a state-of-the-art production facility in Daxing, designed and constructed entirely in accordance with both U.S. and EU cGMP standards. Once operational, this facility 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 the critical technical challenges that have long hindered the development of stem-cell-based therapies. Leveraging Stemedica Corporation’s existing expertise, Jiuzhitang (Meike) will continue to innovate and push the boundaries of research, with clinical trials already underway in key therapeutic areas such as neurology, cardiovascular and cerebrovascular diseases, endocrinology, and orthopedics. Currently, the company is finalizing documentation and making necessary preparations, with plans to submit its application to the CFDA within the year.

Initiate the clinical trial

Accelerate efforts to bring stem cell therapies to market at the earliest possible date.

Jiuzhitang (Meike) will collaborate with top-tier hospitals in China to conduct multi-center clinical trials. Building on the promising clinical results achieved by Stemedica in the U.S., the company plans to advance stem-cell clinical research focused on neurological and cardiovascular diseases—specifically, conditions like stroke and heart disease. Ultimately, this initiative aims to accelerate the approval and availability of stem-cell therapies in China, enabling the nation’s people to benefit from groundbreaking regenerative medicine advancements.

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

Stemedica's long-term partner in Kazakhstan, ALTACO, the sponsor, has conducted multiple stem cell clinical trials in Kazakhstan using Stemedica's stem cells.

Just earlier this month, Kazakhstan's Ministry of Health signed documents approving a mesenchymal stem cell treatment protocol for acute myocardial infarction, marking the official entry of stem cell therapy into the commercial phase in Kazakhstan. This is the first stem cell treatment 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.

Global Cooperation

Together, let's create a bright future for human health.

Leveraging the momentum of Jiuzhitang's entry into the stem-cell field, Jiuzhitang Co., Ltd. and the Daxing Biomedical Industry Base in Zhongguancun Science Park jointly hosted the "Global Stem Cell Industry Development Summit Forum," with co-organization by the Zhongguancun Medical Device Park. This event was a rich academic feast, bringing together top domestic and international stem-cell experts and attendees. Renowned specialists from both China and the U.S., representing cutting-edge research in stem-cell basics and clinical applications, offered insights from diverse perspectives—including venture capital, fundamental science, clinical translation, and regulatory policies—exploring the entire journey of stem-cell innovation, from R&D to drug development.

Professor Aaron Ciechanover, the 2004 Nobel laureate, delivered a speech titled "The New Medical Revolution: At What Cost Will We Cure All Diseases?"

Dr. Joseph Maroon, an international expert in clinical stem cell research, delivered a compelling talk titled "Can Stem Cells Serve as a Treatment for Traumatic Brain Injury?"

Professor Michael Levy delivered the keynote speech titled "Efficacy Analysis of Stem Cells in Stroke and Other Serious Diseases."

Dr. Alex Kharazi, Chief Medical Officer of Stemedica, presented details about the company's stem cell hypoxia technology and its preparation platform.

Professor Tian Ye from the First Affiliated Hospital of Harbin Medical University presented insights into the promising applications of stem cells in cardiology, as well as the role of exosomes and sonodynamic regulation.

Professor Zhang Yanan from Beijing Tiantan Hospital, Affiliated to Capital Medical University, presented the domestic clinical trial plans and protocols for stem cells in the hospital's Departments of Neurology and Neurosurgery.

Professor Yuan Baozhu, Director of the China Institute of Food and Drug Control and the Cell Resource Storage & Research Center, shared insights on quality control for stem cells with everyone.

Attendees jointly witnessed the launch ceremony marking Jiuzhitang's entry into the stem-cell pharmaceutical sector. As a pioneer in developing stem-cell-based drugs domestically, Jiuzhitang remains steadfast in its commitment to becoming a global leader in regenerative medicine. The company will continue proactively building an international network for research, production, and application, playing a vital role in enhancing China’s competitiveness in stem-cell drug development and driving the growth of the country’s regenerative medicine industry.