Development Space Of Domestic Stem Cell Industry Opens: Favorable Policies, More Flowering, Capital Bet On Upstream Industry

Stem cell research has been rated as one of the top ten scientific achievements in the world by science magazine. The new coronal pneumonia epidemic also prompted the society to pay more attention to cell and gene therapy.

In recent years, under the joint promotion of the country and the local government, the clinical research and transformation application of stem cells in China has stepped into an accelerated development stage.

In 2021, as the first year of the "14th five year plan", stem cell research and organ repair was again listed as a national key R & D plan by the Ministry of science and technology. On May 11, the Ministry of science and technology of the people's Republic of China issued the guidelines for the application of the key special project "stem cell research and organ repair" in 2021, allocated 500 million yuan for stem cell research, deployed five key tasks, and planned to support 17 projects.

In addition, in the Yangtze River Delta and Dawan District, which are leading in the development of stem cell industry in China, the local government is also increasing the development of stem cell industry from the policy. On May 19, Shanghai released several opinions on promoting the high-quality development of the city's biomedical industry, which clearly included high-end biological products such as gene therapy and cell therapy into the support fields of high-quality development; On March 12, the Standing Committee of the Shenzhen Municipal People's Congress held a forum to solicit opinions on the legislation of the "Regulations on the promotion of cell and gene industries in Shenzhen Special Economic Zone (Draft)", aiming to give Shenzhen greater autonomy in the reform of biomedicine.

Stem cells are a kind of cells with self-renewal and multi-directional differentiation potential, which have broad application prospects and market space in the field of life science and medicine. With the deregulation of regulatory policies and the improvement of industrial development environment, the industrial application space will also be opened.

China's stem cell industry started relatively late, but it has developed rapidly. Industrial basic research ranks second in the world. There are about 2500 stem cell patents, and the scale in 2020 is more than 100 billion yuan.

In China's stem cell industry chain, the upstream is the most mature link, and the middle and lower reaches need to be expanded. IC photo

Good policies from nothing to more flowers

For a long time, the research and development of stem cell industry is quite tortuous, once China's relevant departments once stopped stem cell therapy. However, in 2015, China's National Health Commission (formerly the health and Family Planning Commission) officially launched the "management measures for stem cell clinical research (Trial)", breaking the policy barriers. This is the first normative document for the management of stem cell clinical research in China.

Li Jieming, assistant chairman of the board of yingguan biology, pointed out in an interview with the 21st century economic report that the introduction of this new policy has opened a channel for stem cell research in China, "but this management method has no further regulations on how to carry out transformation and landing after stem cell research." At this time, China's stem cells according to the drug, technology, the implementation of the "quasi double track system" supervision. Enterprises are encouraged to apply for stem cell preparations according to the drug application and be supervised by the State Food and drug administration; New biomedical technologies led by medical institutions can be managed according to medical technology and supervised by the health commission. This management method also makes clear that stem cell development follows the drug route“ However, at that time, there was no relevant regulatory rules or measures on drug declaration. "

Since then, on December 22, 2017, the former State Food and Drug Administration issued the technical guidelines for research and evaluation of cell therapy products (Trial Implementation), which pointed out the direction for enterprises to further develop cell therapy products.

Li Jieming pointed out to the reporter of the 21st century economic report that "after the promulgation of this guiding principle, enterprises began to apply for stem cell treatment products according to drugs, which also led to the success of subsequent enterprises applying for clinical trials of car-t therapy according to drugs." It is reported that the first domestic enterprise to successfully apply for car-t therapy clinical trial according to the drug is legendary biology.

In 2019, the National Health Commission has successively issued the regulations on the management of clinical application of new biomedical technologies (Draft for comments) and management measures for clinical research and transformation and application of somatic cell therapy (Trial) (Draft for comments), which further promotes the development of clinical research and transformation of stem cells.

The focus of these two documents is to clarify the main body responsible for stem cell clinical research and regulatory agencies, and point out the direction for the transformation and application of stem cell clinical research technology.

In response, Li Jieming said in an interview with the 21st century economic report that the two documents really opened a way for the commercialization of stem cell clinical technology, but the two new policies have not yet been implemented after soliciting opinions.

Li Jieming believes that this means that there is only one way for the development of stem cells for enterprises, that is to develop in the direction of drug application. However, cell therapy products are different from traditional chemical drugs and have stronger individuation. Some cell types still need one-to-one production mode. Therefore, R & D and production costs for enterprises are higher, which brings survival challenges to many innovative enterprises.

In 2019, cell therapy will be included in the guidance catalogue of China's industrial structure adjustment for the first time, which will guide the cell therapy to accelerate the transformation from laboratory to market.

At the beginning of 2020, stem cell therapy has attracted more and more attention due to its effectiveness and safety in the fight against new crown pneumonia. In 2021, the policy dividend continued to be supported, and relevant policies were issued intensively at the national and local levels to promote the development of stem cell industry.

On February 9, the National Health Commission issued the reply to the recommendation No. 4371 of the third session of the 13th National People's Congress on its official website. In the reply letter, it was clearly pointed out that our commission has always encouraged and supported the research, transformation and industrial development of stem cells and immune cells. At the local level, Yunnan, Jiangsu, Guangdong, Liaoning, Shandong, Beijing, Shanghai and other places have issued policies related to cell therapy, and mentioned to vigorously support the clinical transformation of stem cells. At present, stem cell technology has been approved for clinical research in the treatment of dozens of diseases.

In the reply letter, it is clearly pointed out that the State Council will issue regulations on the administration of clinical research, transformation and application of new biomedical technologies, and the clinical research and transformation and application of stem cell technology will be managed in accordance with the relevant provisions of the regulations.

Up to now, more than 100 stem cell research institutions have been registered by the National Health Commission. The state is also vigorously supporting the clinical transformation of stem cells, and has approved stem cell technology for clinical research on the treatment of dozens of diseases.

According to statistics, as of May 21, this year, nearly 100 stem cell research projects have been recorded, including stem cell therapy for diabetes, leukemia, stroke, Parkinson's disease and spinal cord injury, blood system disease, nervous system disease, limb ischemic disease, cardiovascular and cerebrovascular disease, secretory system disease, surgical disease, skin disease, etc Tumor, immune system and other diseases are the major clinical diseases.

According to the reporter's analysis, as of May 23, the national drug evaluation and Evaluation Center (CDE) has accepted 19 applications for clinical trials of stem cell drugs. At present, 12 items have been approved by implication, all of which are biological products of mesenchymal stem cells. The indications for the treatment include: knee osteoarthritis (3 items), diabetic foot ulcer (1 item), rheumatoid arthritis (1 item), and so on Ischemic stroke (1 item), anti graft host disease (3 items), inflammatory bowel disease (1 item), idiopathic pulmonary fibrosis (1 item), chronic periodontitis (1 item), liver failure (1 item).

In fact, stem cell drug research and development, stem cell therapy and clinical transformation mainly belong to stem cell industry, which is the only way for stem cell industrialization. At present, China is relatively weak in this link. It is reported that there are 21 kinds of stem cell drugs on the market in the world, but there are no mature products in China.

In Li Jieming's view, for the industry, the top priority is to further refine and implement many favorable policies, so that the downstream or application end can be truly converted into income, so that enterprises can enter a virtuous development cycle and see hope. At present, yingguan biology, where Li Jieming works, is also developing stem cell drug ind in the fields of focusing on nervous system, autoimmune system and aging degenerative diseases.

The capital of stem cell upstream industry is the most concentrated

In China, a relatively complete stem cell industry chain has been formed from the upstream stem cell storage, the midstream drug development and the downstream clinical treatment.

In the complete stem cell industry chain, the upstream is the most mature link, and the middle and lower reaches need to be expanded. The related businesses are mainly concentrated in the upstream, while most of the downstream businesses are in the stage of clinical trials or market trials.

According to Li Jieming, the upstream industry of stem cells includes the collection and storage of stem cells. Due to the low technical requirements and early development of this part of the industrial chain, it has become the place with the most mature industrialization and the most concentrated capital in the field of stem cells. In China, Beijing, Shanghai, Shenzhen and other real estate development is relatively leading.

Cell storage the APSC pluripotent cells in the cells are preserved for a certain period of time to ensure that the function and activity of the cells are not significantly affected. It is the most basic and front-end business of stem cell medical industry, and also the place with the most capital accumulation. The main representative companies include: Tianjin umbilical cord blood hematopoietic stem cell bank, China umbilical cord blood bank of Jinwei medical, Shanghai umbilical cord blood hematopoietic stem cell bank of Shanghai stem cell technology company, Shenzhen mesenchymal stem cell bank and human umbilical cord mesenchymal stem cell bank of Shandong Province.

Due to the relatively mature business model and technology application of stem cell acquisition and storage, domestic listed companies are mainly engaged in upstream industry related business. Domestic listed companies such as Nanjing Xinbai and Zhongyuan Xiehe have set up the track early, mainly including neonatal umbilical cord blood collection, peripheral blood collection, adipose tissue stem cell collection and other businesses. Among them, cord blood storage business is the most well-known.

According to Li Jieming, there are "public" and "private" umbilical cord blood banks in China. The public library provides free storage service, which belongs to the free donation of pregnant women, and is open to public inquiry, clinical treatment and scientific research. The private bank of umbilical cord blood preservation requires citizens to pay a certain fee, and the depositor has the right to control. Since the establishment of the first umbilical cord blood bank in 1996, seven public umbilical cord blood banks have been approved in China. Most of these public coffers are operated by enterprises.

According to the 21st century economic report, the reporter inquired about the public information and learned that among the seven National Library licenses, Nanjing Xinbai owns four of Beijing Library, Guangdong library, Zhejiang Library and Shandong library, and the remaining three are respectively under Zhongyuan Xiehe, Zhuxin group and JuKang biology.

Taking the cord blood bank of Guangdong Province as an example, self preservation of cord blood costs 20-50 thousand, and the general storage period is 18-20 years. Children can choose to renew or stop storage when they are adults.

In addition, more storage services for adult adipose derived mesenchymal stem cells and dental pulp mesenchymal stem cells are also sprouting. Stem cell therapy is also actively involved in "brain economy", showing a good trend in the field of stroke.

However, due to the low technical threshold and high gross profit margin of stem cell upstream industry, the related business has already developed and matured. However, there are still private umbilical cord blood banks with profit-making as the main purpose in the market. In order to strengthen market supervision, the general office of the National Health Commission issued the notice on the approval of establishment of umbilical cord blood hematopoietic stem cell bank in January 2021. After study, it was decided that the application for examination and approval of umbilical cord blood bank establishment would not be accepted in 2021.

At present, the overall maturity of the domestic stem cell medical industry is low, and there is no obvious leading enterprise. Among them, the upstream stem cell collection and storage enterprises are developing well, and the middle and lower reaches of R & D and application enterprises are still growing rapidly.

However, the whole stem cell market is huge. According to market research and transparency market research, the global market is expected to exceed 170 billion US dollars in 2020; In terms of market distribution, North America is the largest stem cell market in the world, with Western Europe and Asia Pacific accounting for 38% and 17% respectively.

According to the data of prospective industry research institute, the market scale of China's stem cell therapy industry will exceed 140 billion yuan in 2020, with an annual compound growth rate of more than 30%.

In the future, with the continuous liberalization of policies and the maturity of technology research, more and more enterprises and capital join the stem cell industry, and the development potential of domestic stem cell industry will be fully released.