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Multiple large-sized companies embark on stem cells development – time to launching stem cells drugs in China market shortened
High-impact news drew attention of stem cells therapeutics industry insiders
Jiuzhitang, a traditional Chinese medicine pharmaceutical company, announced on September 14 that Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereinafter referred to as Jiuzhitang Maker) will cooperate with Stemedica Cell Technologies, Inc., an US biomedical company with more than 10 years’ history of stem cells research and development to build an FDA and EU cGMP-compliant commercial-grade stem cell manufacturing base in 3-5 years.
This marks the official entry of Jiuzhitang into the stem cell field. "Our goal is to develop stem cell drugs." Gao Yansong, CEO of Jiuzhitang Maker told the Science and Technology Daily reporter.
Previously, Tasly, CSPC Pharmaceutical Group and Haier Group had announced their entry into the stem cell market. However, Wei Zexi’s story, news that billionaires would pay 600,000 yuan for one shot of embryonic stem cells have raised doubts on rationality of stem cells development. Where is this frontier industry going forward amid controversies, and what is the prospect for China's first stem cell drug?
The global stem cell market is estimated to reach 400 billion US dollars by 2020
An increasing number of clinical cases have demonstrated that stem cell technologies are of epoch-making significance to the development of healthcare industry. On Global Stem Cell Industry Development Summit held on Sept.14, experts from medical institutions such as University of California San Diego School of Medicine, Beijing Tiantan Hospital affiliated to Capital Medical University and others shared with audience applications of stem cells in fields of stroke, neurology and cardiology.
Data from world's largest stem cell research database shows there are nearly 6,000 stem cell clinical studies registered worldwide, while the number was 800 ten years ago.
As breakthroughs in basic research and advancement of clinical applications are achieved, development of stem cell technologies will create a huge market. Statistics indicates that by 2020, the global stem cell market value will hit 400 billion dollars, while size of the Chinese stem cell market will reach as big as 120 billion RMB.
Clinical transformation is the bottleneck
As a result, many countries around the world have listed stem cells development as a strategic emerging industry that helps enhance their international competitiveness in the healthcare sector.
Operation of the stem cell industry can be classified into three aspects: stem cell collection and storage, manufacturing of stem cell preparations, and clinical treatment and applications. As noted by Gao Yansong, there are currently over 140 Chinese enterprises involved in stem cell business, most of which are focused on collection, storage and production of stem cells. Clinical application is the area that requires huge efforts.
There are two paths leading to application of stem cells: development of stem cell drugs and use in clinical trials, commented by Gao Yansong. "13 stem cell drugs have been approved globally, while the number in China is zero. Clinical trials and clinical studies are two major ways that help bring stem cells into use." he said.
Although the health sector requires stem cell technology for clinical treatment to be approved, unapproved stem cell treatment programs are still widespread. “Some companies directly sell stem cells to patients through various channels for interests. Many hospitals have carried out clinical treatment of stem cells, and many people who want to participate are willing to pay a high price for this. This confusion has brought tremendous negative impacts to development of the stem cell industry." explained Gao Yansong.
In order to terminate the chaos, at the end of 2011, the Ministry of Health (now the National Health Care Commission) and the State Food and Drug Administration issued a ban in China that prohibited any unapproved stem cell trials in treatment and clinical trials before July 1, 2012, and stop accepting new stem cell clinical project applications.
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 "Stem Cell Clinical Research Management Measures (Trial)". This China's first normative document on stem cell clinical research has driven a new round of industry boom.
Joining of large enterprises accelerates the pace of stem cell technology application
"Research and development of stem cell technologies require huge capital investment. The joining of large enterprises will undoubtedly accelerate this process, and will also promote the improvement of stem cell quality standards." Prof. Yuan Baozhu, Director of the Cell Resource Conservation Research Center, National Institute for Food and Drug Control analyzed.
According to Prof. Yuan, stem cell formulations include preparation, in vitro trials, in vivo animal trials, to clinical studies and clinical implanted into human bodies. The quality, safety and biological effects should be studied and controlled during the whole process.
"We have initially established a stem cell quality control and evaluation system, but the regulations and supervision in this field still need to be improved. At the same time, medical review experts and R&D personnel should strengthen their understanding of the regulations," said Yuan Baozhu.
The large-scale stem cell preparation and standardized storage emphasized by Yuan Baozhu are the problems that Jiuzhitang Maker is committed to solve. “We will introduce Stemedica's world leading stem cell production technology and preparation platform to achieve superior stem cell scalability and solve the key technical problems of making stem cells into drugs” said Gao Yansong.
"We expect to submit application of stem cell clinical trials to the State Food and Drug Administration this year, hoping to promote the development of the first stem cell drug in China." Gao Yansong said.