Another major breakthrough has been reported in China's stem cell therapy field.

On September 14, traditional Chinese medicine pharmaceutical company Jiuzhitang announced that Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereafter referred to as Jiuzhitang Maker) will partner with U.S.-based Stemedica Cell Technology Co., Ltd., which boasts over a decade of experience in stem cell R&D and manufacturing. Together, they plan to build a commercial-grade stem cell production facility meeting both U.S. and EU cGMP standards within three to five years.

This move marks Jiuzhitang's official entry into the stem-cell field. "Our goal is to develop stem-cell-based pharmaceuticals," Jiuzhitang Maker CEO Gao Yansong told a reporter from Science and Technology Daily.

Previously, companies like Tasly, Shiyao Group, and Haier Group have all announced their entry into the stem cell market. Yet at the same time, high-profile incidents such as the "Wei Zexi" case and headlines like "Billionaire Spends 600,000 Yuan on Embryonic Stem Cell Injection" have continuously fueled skepticism surrounding stem cells. As this cutting-edge industry navigates through ongoing controversy, where will it ultimately head? And what does the future hold for China's first stem-cell-based drug?

The global stem cell market is projected to reach $400 billion in 2020.

Increasingly, clinical cases demonstrate that stem cell technology is poised to revolutionize the future of human medicine. At the Global Stem Cell Industry Development Summit held on the 14th, experts from institutions such as the School of Medicine at UC San Diego in California and Beijing Tiantan Hospital affiliated with Capital Medical University shared compelling case studies showcasing the application of stem cells in areas like stroke treatment, neurology, and cardiology.

Data from the world's largest publicly registered stem cell database reveal that nearly 6,000 clinical stem cell studies are currently registered globally—compared to just 800 a decade ago.

With breakthroughs in basic research and advancements in clinical applications, stem cell technology is giving rise to a massive market. Data indicates that the global stem cell market is projected to reach $400 billion by 2020, while China's stem cell market is expected to grow to as much as 120 billion RMB.

Clinical translation is the bottleneck.

Precisely for this reason, countries around the world are increasingly positioning stem cells as a strategic emerging industry aimed at enhancing international competitiveness in the field of human health.

The stem cell industry consists of three main components: stem cell collection and storage, stem cell product development and research, and clinical treatment and application. Gao Yansong noted that China currently has more than 140 stem cell-related enterprises, with the vast majority focused on collection, storage, and stem cell product development and research—while clinical application remains a key area that requires greater emphasis and investment.

Gao Yansong analyzed that there are two main pathways for stem cell applications: developing cell-based drugs and conducting clinical trials. "Globally, 13 stem cell drugs have already been approved, but China remains a blank slate in this area. Currently, stem cell applications in China primarily fall into two categories: clinical trials and clinical research," he said.

"Although health authorities require that stem-cell technologies used in clinical treatments undergo approval, unauthorized stem-cell therapy programs remain widespread. 'Some companies, driven by commercial interests, are directly administering injections to patients through various channels,' says Gao Yansong. 'Many hospitals have already started offering stem-cell-based clinical treatments, attracting a growing number of individuals eager to participate—and willing to spend substantial sums of money in the process. This chaotic situation is significantly undermining the healthy development of the stem-cell industry.'"

To address the chaos, at the end of 2011, the Ministry of Health (now the National Health Commission) and the State Food and Drug Administration issued a ban mandating that China cease using any unapproved stem cells in treatments and clinical trials by July 1, 2012—and also halt the acceptance of new applications for stem cell-based clinical projects.

In August 2015, the National Health and Family Planning Commission (now the National Health Commission) and the State Food and Drug Administration jointly issued the "Administrative Measures for Clinical Research on Stem Cells (Trial)." This, China's first regulatory document specifically targeting stem cell clinical research, sparked a new wave of industry enthusiasm.

Large corporations join to accelerate the advancement of stem cell technology applications

"Research and development applications of stem cells require massive financial investments, and the involvement of major corporations will undoubtedly accelerate this process—while also driving the refinement of a comprehensive stem cell quality standards system," analyzed Yuan Baozhu, Director of the Cell Resource Preservation Research Center at the Institute of Biological Products Testing, China National Institute for Food and Drug Control.

Yuan Baozhu stated that all stem cell preparations—from preparation and in vitro testing to in vivo animal studies, clinical research involving implantation into humans, and ultimately clinical treatment—must undergo rigorous research and quality control measures to ensure the cells meet high standards of quality, safety, and biological efficacy.

"We have already established a preliminary quality control and evaluation system for stem cells, but the regulations and oversight in this field still need further improvement. At the same time, pharmaceutical review experts and R&D personnel should deepen their understanding of these regulations," said Yuan Baozhu.

"Yuan Baozhu highlighted that large-scale stem cell preparation and standardized storage are precisely the issues Jiuzhitang Maker is committed to addressing. 'We’ve introduced Stemedica’s globally advanced stem cell production technology and manufacturing platform, enabling world-leading scalable expansion of stem cells—and ultimately resolving the critical technical challenges that have long hindered the development of stem-cell-based therapies,' said Gao Yansong."

"By the end of this year, the company plans to submit its stem cell clinical trial application to the National Medical Products Administration, aiming to accelerate the launch of China's first stem cell-based drug," said Gao Yansong.