The stem cell industry has been supported by state funds, and the industrialization development results are gratifying.
Recently, China Biotechnology Development Center issued the Notice on Announcing the 20 18 Annual Project Arrangement of the National Key R&D Program "Stem Cell and Transformation Research" (hereinafter referred to as the Notice). In 20 18, 30 key projects of "stem cell and transformation research" were put forward, with a total funding of 585 million yuan and a project cycle of.
It is generally believed in the industry that as an important technology in the field of regenerative medicine, in addition to the support of state funds, the policy of stem cells has continued to be favorable in recent years, and the market potential is huge. Many enterprises have begun to seize the beach layout. According to the data of "Analysis Report on the Development Prospect and Investment Strategic Planning of Stem Cell Medical Industry" issued by Prospective Industry Research Institute, the income of stem cell industry in China has reached 30 billion yuan in 20 15, with a compound annual growth rate of over 50%. It is predicted that by 2020, the industry market scale will reach about 80 billion yuan.
however
Compared with 43 projects in 20 17, with a total funding of 940 million yuan, the number of key special projects of "stem cell and transformation research" in 20 18 decreased by 13, and the total funding decreased by 37.77%. In this regard, on June 5th, the relevant person in charge of China Biotechnology Development Center told the reporter of 2 1 Century Business Herald that the project was arranged like this.
"The project is cyclical, and everything that should be supported in the last round was supported." Regarding the problem of shrinking funds, the R&D director of a biomedical company told 2 1 Century Business Herald: "It is worth noting that stem cells have been industrialized, industry quality standards have been released, and 100 clinical experimental bases have been approved. What is important later is industrialization. "
Recently, Xu Ye, chairman of Boya Holding Group (hereinafter referred to as Boya Holding Group), said that since 20 15, the state has invested a lot of energy to support the development of stem cell industry, and China is in the transitional stage from stem cell research to industrialization. "However, the clinical transformation and industrialization of basic stem cell research in China still face bottlenecks and need further breakthroughs."
Obtain state funds
According to the circular, the above 30 projects supported by the central government are led by two hospitals, such as the First Affiliated Hospital of Soochow University, and universities and research institutions, such as Sun Yat-sen University and the Institute of Basic Medicine of China Academy of Medical Sciences. The financial support for a single project ranges from 920,000 yuan to 29,865,438 yuan.
As early as the end of 20 14, the State Council issued the Plan on Deepening the Management Reform of the Central Fiscal Science and Technology Plan (Special Projects, Funds, etc.). ) ",integrated the scientific research projects of public welfare industries managed by the Ministry of Science and Technology, the National Development and Reform Commission and other departments 13, and formed a national key R&D plan." Stem cell and transformation research "was listed as one of the national key R&D plans.
From 20 16 to 20 17, "stem cell and transformation research" has been supported by the central government twice. In 20 16, 25 projects to be funded (including young scientists' projects) received funding of about 488 million yuan; In 20 17, 43 proposed projects were supported by 940 million yuan.
In the eyes of the industry, in addition to financial support, in recent years, the policies in the field of stem cells are constantly improving. Xu told the reporter of 2 1 Century Business Herald that since 20 15, the state has invested a lot of energy to support the development of the stem cell industry, with frequent policy support.
For example, in May 17 and 10, the Ministry of Science and Technology issued the "Thirteenth Five-Year Plan for Biotechnology Innovation", proposing to focus on strengthening the basic research and transformation research of stem cell application, strengthening the cross-integration of stem cells, biomedical materials and tissue engineering, and guiding the technological upgrading of biomedical materials industry in China and the standardized clinical application of new treatment methods such as cell therapy.
In June of the same year, the Ministry of Science and Technology, the State Sports General Administration and the former State Health Planning Commission jointly issued a document, proposing to carry out basic and clinical research such as embryonic stem cells, induced pluripotent stem cells, directional induced differentiation of adult stem cells and large-scale culture.
The important reason why stem cells can be favored by policies is their extensive medical value. Stem cells are considered as another disease treatment besides drug therapy and surgical treatment, which is expected to lead the revolution of regenerative medicine. Zheng Guangheng's research report said that because stem cells have the ability of replication and differentiation, their application prospects are immeasurable, and they can be used in the fields of beauty, organ transplantation, bioremediation 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 global stem cell industry will reach 400 billion yuan in 2020. At present, China's stem cell market has exceeded 40 billion yuan, with a compound annual growth rate of over 50%.
Beach-rushing layout
The potential market size has attracted many companies to lay out the stem cell industry.
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 preservation is a relatively mature field of stem cell industry in China.
"Umbilical cord blood is an important source of hematopoietic stem cells. Hematopoietic stem cells are indeed the most mature stem cells in clinical application, and have therapeutic effects on blood system diseases and some immune system diseases. " Xu told the reporter of 2 1 Century Business Herald.
Zhongyuan Concord also stated in the 20 17 annual report that the upstream of domestic stem cell industry is the most mature industrialization project. According to market research &; transparency
Market research estimates that the proportion of stem cell storage rate in China is still insufficient.
1%, and the regional storage rate is also unbalanced, which is far from developed countries. Referring to developed countries, China's stem cell storage market is expected to exceed 30 billion yuan.
Take the well-known cord blood storage as an example, many listed companies have already laid out. For example, after consulting the annual report of Nanjing Xinbai 20 17, the reporter of 2 1 Century Business Herald found that this company, which is mainly engaged in department stores, officially acquired 76% equity of Shandong Qilu Stem Cell Engineering Co., Ltd. for 3.42 billion yuan on February 17, which is a high-tech enterprise with cord blood hematopoietic stem cell storage as its main business.
In addition, Zhongyuan Concord's main business is cell preparation and storage services, genetic testing, in-vitro diagnostic reagent sales, beauty and anti-aging. Its 20 17 cell detection, preparation and storage business achieved an operating income of 492 million yuan, a year-on-year increase of 16.98%, and its gross profit margin reached 82.7%.
However, many people in the industry said in an interview with 2 1 Century Business Herald that although the upstream storage market of stem cells has matured, the application of products in the middle and lower reaches is the main field of competition among enterprises, and related enterprises are gradually laying out in the middle and lower reaches of the stem cell industry.
Sheikh Zhongyuan mentioned in the annual report of 20 17 that the share of stem cell storage in the whole industry decreased from 20.9% in 20 10 to 15.2% in 20 18, and the global stem cell industry gradually tilted to the downstream application market such as drug research and development and manufacturing.
"In the clinical application field downstream of the industry, the clinical experiment of stem cell treatment for premature aging carried out by Boya and Peking University Third Hospital is the first attempt in the world to reverse aging through placental stem cells; Boya's stem cell therapy has entered the second and third phase clinical trials in the United States. The third phase clinical stem cell therapy is aimed at lower extremity lesions caused by peripheral vasculitis. " Xu introduced to the reporter of 2 1 century business herald.
Industrialization needs to be promoted
Xu pointed out that from the current clinical development in China, the research and development of stem cell drugs is repetitive. Stem cells face the risks of high investment, high risk and low return in the clinical field. Moreover, in recent years, the state investment has been biased towards scientific research institutes, and the development of stem cell industry needs not only financial allocation, but also transformation. The sustainable development of stem cell regenerative medicine depends not on scientific research institutions and hospitals, but on enterprises.
According to the above-mentioned director of R&D, stem cells are now clearly moving in the direction of drug development. "Industry quality standards have been released, and more than 100 clinical experimental bases have been approved. What is important later is industrialization. "
"In recent years, there have been good signs of the development of stem cell industry in China. The state has frequently issued policy support, and the industry has gradually developed in the direction of standardization. The standard for stem cells to be declared as drugs has also been made clear-it will not be too far for China stem cell drugs to obtain clinical approval. " Xu also believes that the industrialization of stem cells has ushered in good results.
Just in May, China Pharmaceutical Biotechnology Association announced that as of 2065438+May 2008, after the first batch of eight stem cell clinical research projects of seven institutions were filed, the stem cell clinical research projects of 12 institutions were filed in accordance with the provisions of the Administrative Measures for Stem Cell Clinical Research (Trial).
According to the above announcement, the registered projects include the clinical study of human umbilical cord mesenchymal stem cells in the treatment of psoriasis (Xiangya Hospital of Central South University), the randomized blind parallel controlled multicenter study of umbilical cord mesenchymal stem cells in the treatment of lupus nephritis (Nanjing Gulou Hospital) and other 12 clinical research projects.
In addition, on February 20 17, 17, the former US Food and Drug Administration issued "Technical Guiding Principles for Research and Evaluation of Cell Therapy Products (Trial)", which made new guiding principles for clinical research design and experimental data of cell therapy, and was considered by the market to be conducive to shortening the time required for clinical trials of products and speeding up the pace of listing.
However, take listed products as an example. Since 2009, more than a dozen stem cell drugs have been approved for marketing in the world, but no stem cell drug has been approved for marketing in China. However, in recent years, there are more than 100 registered stem cell clinical research institutions in China, and there are about 20 registered stem cell clinical research projects, which are growing rapidly.
In this regard, Xu pointed out that the research and development level of stem cell therapy in China is not worse than that in foreign countries, but the clinical transformation and industrialization of basic research are facing bottlenecks. "From the current development situation, the 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, and the policy level including policy supervision and industrialization cannot be synchronized. "