The stem cell industry has received national funding to support the industrialization development of the industry.

The stem cell industry has received national funding to support the industrialization development of the country.

Recently, China’s biotechnology The Development Center issued the "Notice on the Announcement of the 2018 Project Arrangements for the National Key Research and Development Program "Stem Cells and Transformation Research"" (hereinafter referred to as the "Notice"). In 2018, the "Stem Cells and Transformation Research" key project is planned to be established** *A total of 30 projects, with a total funding of 585 million yuan, and the project cycle is 2018-2022.

The general view in the industry is that stem cells are an important technology in the field of regenerative medicine. In addition to national financial support, policies have been continuously favorable in recent years, and the market potential is huge. Many companies have begun to seize the market. According to the "Stem Cell Medical Industry Development Prospects Forecast and Investment Strategic Planning Analysis Report" released by the Qianzhan Industry Research Institute, the revenue of my country's stem cell industry reached 30 billion yuan in 2015, with a compound annual growth rate of more than 50%. It is predicted that by 2020, the industry market size will reach about 80 billion yuan.

However,

Compared with 43 projects and a total funding of 940 million yuan in 2017, there are 13 fewer planned projects in the "Stem Cell and Translational Research" key special project in 2018, with a total funding of 940 million yuan. Shrunk by 37.77%. In this regard, on June 5, the relevant person in charge of the China Biotechnology Development Center told a reporter from the 21st Century Business Herald that this is how the project was arranged.

“Projects have cycles, and all those that should have been supported in the last round were supported.” Regarding the shrinkage of funds, a biomedical company’s R&D director analyzed the reporter of the 21st Century Business Herald: “It is worth noting that Now stem cells are moving towards industrialization, industry quality standards have been released, and more than 100 clinical trial bases have been approved. The most important thing is to do industrialization."

Recently, Boya Holding Group ( Xu Xiaochun, chairman of Boya (hereinafter referred to as "Boya"), also said that since 2015, the country has invested a lot of energy in supporting the development of the stem cell industry, and our country is in the transition stage from stem cell research to industrialization. "However, the clinical transformation and industrialization of basic stem cell research in my country still face bottlenecks and require further breakthroughs."

Received national funds

According to the "Notice", the above-mentioned received central financial support There are ***30 projects. The project lead undertaking units include hospitals, such as the First Affiliated Hospital of Suzhou University, as well as universities and research institutes, such as Sun Yat-sen University and the Institute of Basic Medicine, Chinese Academy of Medical Sciences. The funding support for a single project is 920,000. yuan to 29.81 million yuan.

As early as the end of 2014, the State Council issued the "Plan on Deepening the Management Reform of Central Fiscal Science and Technology Plans (Special Projects, Funds, etc.)", which regulates scientific research in public welfare industries managed by 13 departments including the Ministry of Science and Technology and the National Development and Reform Commission. Special projects were integrated to form a national key R&D plan, and "stem cell and translational research" was listed as one of the national key R&D plans.

In 2016-2017, "Stem Cell and Translational Research" has received two central financial funding supports. In 2016, 25 proposed projects (including young scientist projects) received approximately 488 million yuan in financial support; in 2017, 43 proposed projects received 940 million yuan in financial support.

In the opinion of industry insiders, in addition to financial support, in recent years, policies in the field of stem cells have also continued to be favorable. Xu Xiaochun told a reporter from the 21st Century Business Herald that since 2015, the country has invested a lot of energy in supporting the development of the stem cell industry and frequently issued supporting policies.

For example, on May 10, 2017, the Ministry of Science and Technology issued the "Thirteenth Five-Year Plan for Biotechnology Innovation", proposing to focus on strengthening the applied basic research and translational research of stem cells, strengthening stem cells, and biomedical research. The cross-integration of materials and tissue engineering guides the technological upgrading of my country's biomedical materials industry and the standardized clinical application of new treatments such as cell therapy.

In June of the same year, six departments including the Ministry of Science and Technology, the State Sports General Administration, and the former National Health and Family Planning Commission jointly issued a document stating that it is necessary to carry out directional induction and differentiation of embryonic stem cells, induced pluripotent stem cells and adult stem cells, and scale Chemical culture and other basic and clinical research.

The important reason why stem cells have gained policy favor may be their extensive medical value. Stem cells are considered to be another disease treatment method in addition to drug treatment and surgical treatment, and are expected to lead the regenerative medicine revolution. Guangzheng Hengsheng Research Report stated that due to the replication and differentiation capabilities of stem cells, their application prospects are immeasurable and can be used in fields such as beauty, organ transplantation, biorepair and disease treatment.

With policy support and potential medical application value, the stem cell industry has been given high market expectations. Many institutions predict that the scale of the global stem cell industry will reach 400 billion yuan in 2020. Currently, China’s stem cell industry The market size has exceeded 40 billion yuan, with a compound annual growth rate of more than 50%.

Searching for beachfront layout

The potential market size has attracted many companies to plan for the stem cell industry.

The stem cell industry consists of three parts: upstream stem cell collection and storage, midstream stem cell preparation production research, and downstream stem cell clinical treatment and application. At present, upstream collection and storage are relatively mature areas of my country's stem cell industry.

“Umbilical cord blood is an important source of hematopoietic stem cells. Hematopoietic stem cells are indeed the most mature stem cells in clinical application at present and have therapeutic effects on blood system diseases and some immune system diseases.” Xu Xiaochun told a reporter from the 21st Century Business Herald explain.

Zhongyuan Xiehe also stated in its 2017 annual report that the upstream of the domestic stem cell industry is the most mature industrialization project. According to Market Research&Transparency

Market Research estimates that the current overall stem cell storage in the country The rate ratio is still less than

1%, and regional storage rates are also unbalanced, with a large gap compared with developed countries. With reference to developed countries, my country's stem cell storage market is expected to exceed 30 billion yuan.

Take the well-known umbilical cord blood storage as an example. Many listed companies have already laid out plans. For example, after reviewing the 2017 annual report of Nanjing Xinbai, a reporter from the 21st Century Business Herald found that this company, which was once mainly engaged in the department store business, officially acquired 76% of Shandong Qilu Stem Cell Engineering Co., Ltd. for 3.42 billion yuan on February 1, 2017. Equity, the latter is a high-tech enterprise whose main business is the storage of umbilical cord blood hematopoietic stem cells.

In addition, Zhongyuan Xiehe’s main business includes cell preparation and storage services, genetic testing, sales of in vitro diagnostic reagents, beauty and anti-aging, etc. Its cell testing preparation and storage business achieved operating income of 492 million yuan in 2017, a year-on-year increase of 16.98%, and its gross profit margin reached 82.7%.

However, many industry insiders said in interviews with reporters from the 21st Century Business Herald that although the upstream storage market for stem cells has matured, the application of midstream and downstream products is the main area of ??competition among enterprises. The middle and lower reaches of the stem cell industry are also gradually deployed.

Zhongyuan Xiehe mentioned in its 2017 annual report that the share of stem cell storage in the entire industry dropped from 20.9% in 2010 to 15.2% in 2018. The global stem cell industry is gradually moving towards downstream applications such as drug research and development and manufacturing. The market is tilted.

“In the clinical application field downstream of the industry, the clinical trial of stem cell treatment for progeria jointly conducted by Boyaa and Peking University Third Hospital is the world’s first attempt to reverse aging through placental stem cells; Boyaa’s stem cell treatment has already It has entered Phase II and III clinical trials in the United States, and the Phase III clinical stem cell treatment is for lower limb lesions caused by peripheral vasculitis," Xu Xiaochun told a reporter from the 21st Century Business Herald.

Industrialization needs to be promoted

Xu Xiaochun pointed out that judging from the current domestic clinical development status, the research and development of stem cell drugs is highly repetitive. Stem cells face high investment, high risk but low return in the clinical field. Moreover, in recent years, state investment has been biased towards scientific research institutes, and the development of the stem cell industry requires not only financial allocations, but also practical transformation. To achieve the sustainable development of stem cell regenerative medicine, it lies not in scientific research institutions and hospitals, but in enterprises.

In the view of the above-mentioned R&D director, stem cells are currently clearly moving towards drug development. "Industry quality standards have been released, and more than 100 clinical trial bases have been approved. The most important thing later is to do industrialization."

"In recent years, the development of my country's stem cell industry has shown good signs. , the country has frequently issued supporting policies, the industry has gradually developed in the direction of standardization, and the standards for stem cell application as a drug have also been clarified - it will not be too far away for my country's stem cell drugs to obtain clinical approval. "Xu Xiaochun also believes that the industrialization of stem cells has ushered in good news. .

Just in May, the China Medical and Biotechnology Association announced that as of May 2018, following the first batch of 8 stem cell clinical research projects filed by 7 institutions, 12 more have been filed by 10 institutions. A stem cell clinical research project has been registered in accordance with the provisions of the "Stem Cell Clinical Research Management Measures (Trial)".

According to the above announcement, the registered projects include clinical research on human umbilical cord mesenchymal stem cells in the treatment of psoriasis (Central South University Xiangya Hospital), and a randomized blind parallel comparison of umbilical cord mesenchymal stem cells in the treatment of lupus nephritis. 12 clinical research projects including multi-center research (Nanjing Drum Tower Hospital).

In addition, in December 2017, the former State Administration of Food and Drug Administration issued the "Technical Guiding Principles for Research and Evaluation of Cell Therapy Products (Trial)", which made stipulations on the stage design and trial data of cell therapy clinical research. The new guiding principles are considered by the market to be beneficial to the time required for product clinical trials and to speed up the pace of marketing.

However, Xu Xiaochun took marketed products as an example. Since 2009, more than a dozen stem cell drugs have been approved for marketing around the world, but no stem cell drug has been approved for marketing in China. However, in recent years, there have been more than 100 registered stem cell clinical research institutions in China, with about 20 registered stem cell clinical research projects, growing rapidly.

In this regard, Xu Xiaochun pointed out that my country’s stem cell therapy research and development level is no worse than that of foreign countries, but the clinical transformation and industrialization of basic research face bottlenecks. "Judging from the current development situation, factors restricting the development of industrialization can be considered from the technical level and the policy level. The technical level includes the lack of original scientific research results, large-scale standardized preparation, high quality control requirements, etc. The policy level includes policy supervision and The industrialization process cannot be synchronized, etc.

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