100 billion market size, organ regeneration, regenerative materials, stem cells... Regenerative medicine is in full bloom

Organs can regenerate, human bodies can live forever.

Regenerative medicine refers to the use of biological and engineering theoretical methods to create lost or functionally impaired tissues and organs, promote the body's self-repair and regeneration, so that it has the structure and function of normal tissues and organs, bringing new hope for cardiovascular diseases, tumors, diabetes, congenital genetic defects, nervous system diseases, rare diseases and other diseases, and is expected to completely cure certain diseases

According to ARM, the American Regenerative Medicine Alliance, the regenerative medicine sector will raise up to $23.

The concept of regenerative medicine is broad and comes in many forms

At present, subdivision scenarios such as stem cells, bioregenerative materials, and organ regeneration are already potential tracks in the medical field, with many layout enterprises and rapid

From repair to organ regeneration, the path to regenerative medicine

Tissue defect repair and regeneration is one of the major topics in the field of

The main pathways of regenerative medicine include drug therapy, which promotes diseased cells through drugs and produces more signaling factors needed by the body, such as FGF protein growth factor to promote dopamine production in the brain and treat Parkinson's disease; Cell therapy, the repair of traumatized tissue through cells, such as the application of cell therapy in orthopedics, through autologous chondrocyte transplantation, repair of cartilage trauma; Gene therapy, through genetic modification and gene editing, transplanting animal organs to human beings, has been approved for clinical approval in 2019 to enter human trials; Biomaterial-in-combination cell therapy, through biomaterial binding to growth factors and then combining stem cells, builds a living tissue – peripheral nerves – in vitro for tissue repair

In addition, cutting-edge research directions such as exosomes, synthetic biology, mRNA, and microecology are also being gradually applied to the

Regenerative Medicine Technology Pathway

In this paper, Arterial Network divides regenerative medicine into three major sections: bioregenerative materials, stem cell repair, and organ regeneration, and analyzes

■ Bio-renewable materials: A number of products have been listed, and the effect of import substitution has emerged

Bioregenerated materials, different from traditional biomedical materials, are new high-tech materials

Bioregenerative materials have excellent tissue induction, the implantation of bioregenerative materials into the human body, can induce defective tissues and organs for regenerative repair, used in orthopedics, neurosurgery, cardiovascular, ophthalmology, stomatology, medical aesthetics and other fields, including skin defect repair, soft tissue repair, joint cartilage repair, vascular and catheter coating applications, medical beauty, etc

Bioregenerative materials are a subdivision track

Some new bio-renewable materials enterprises

Zhenghai Biological, Guanhao Biological, Maipu Medical three enterprises have been successfully listed

Zhenghai biological soft tissue repair series products oral prosthetic membrane, absorbable hard brain (chiropractic) membrane patch, skin repair membrane, etc.

Guanhao Bio's listed products include biotype hard brain (chiropractic) membrane mesh, B-type dural mesh, thoracic surgical repair membrane (B/P), sterile biological invasive membrane, Ereo breast patch, Youdeqing cell corneal implant, and Zhuhai Xiangle agent's intraocular lens products, which are used in neurosurgery, thoracic surgery, ophthalmology, dermatology, orthopedics, plastic surgery and cosmetology

Maipu Medicine is the only enterprise
in the field of neurosurgery in China that also has implanted medical device products such as artificial hard brain (chiroman) membrane patch, craniomaxillofacial repair products, absorbable and recycled oxidized cellulose hemostasis products.
In the first half of 2022, the company achieved operating income of 95.
0249 million yuan, an increase of 38.
24% over the same period of the previous year; The net profit attributable to the shareholders of the listed company was 21.
2406 million yuan, an increase of 1.
52%
over the same period of the previous year.

Next, bio-recycled materials will continue to innovate and further enrich
the product range.
It is worth noting that bio-renewable materials provide a renewable environment for human tissues, and still need to rely on the body's renewable capabilities
.
For non-renewable tissues and organs such as cornea, nerve cells, and hearts, more technologies such as stem cells need to be relied upon for repair and regeneration
.

■ Stem cell repair: universal cells, which can differentiate into specific types of cells to repair damaged tissues and organs

Stem cells are a class of cells from embryos, fetuses or adults with unlimited self-renewal and proliferation and differentiation capabilities under certain conditions, which can produce daughter cells with the same genotype as themselves and can also produce specialized cells that make up body tissues and organs, and can also differentiate into progenitor cells, also known as "universal cells"
.

Stem cells can be induced to differentiate into specific types of cells, such as cardiomyocytes, blood cells, or nerve cells, for the repair and regeneration
of lesions and damaged tissues in humans.
Stem cell therapy is at the heart of
regenerative medicine research in recent years.
The Special Administrative Measures for Foreign Investment Access (Negative List) (2019 Edition) points out that the development and application of foreign investment in the field of human stem cells is explicitly prohibited, which shows that stem cell technology has become the focus of
competition in various countries.

At present, the layout of domestic enterprises in the stem cell repair and regeneration track has been relatively extensive
.

Partially laid out the stem cell repair business

According to statistics, the current application of regenerative medicine products based on stem cell repair includes spinal cord injury, type I diabetes, Parkinson's disease, Alzheimer's disease, heart disease, stroke, burns, cancer and osteoarthritis
.

Among them, Hematologics is the third company in the world after Japan's Megakaryon and the United States' PlateletBio, and the first company in China to focus on platelet regeneration in vitro, solving the urgent shortage of platelet needs in cancer, liver disease, acute critical illness, blood diseases and other diseases, as well as developing innovative drugs
for various platelet abnormalities-related diseases.

Elp regenerative medicine uses iPSC technology for cell therapy research and development and production, and iPSC technology therapy for the treatment of moderate and severe heart failure has entered many authoritative centers across the country to carry out large-scale randomized controlled human clinical trials
.
On December 17, 2021, Nanjing Elp Regenerative Medicine Technology Co.
, Ltd.
independently developed human iPSC-derived cardiomyocyte injection was accepted by
the Drug Evaluation Center.

Shize Bio is committed to providing large-scale, low-cost stem cell therapy solutions for a series of major diseases such as Parkinson's disease that do not yet have clinical solutions, preparing functional cell types through in vitro induced differentiation of human pluripotent stem cells, and using cell transplantation to replace functional impairment or degeneration of cells in human body to solve major human diseases
.

However, at present, stem cells are limited to the repair of tissues and organs, and have not yet achieved real organ regeneration
.

■ Regenerated organs: artificial organs "pyramid tip", layout enterprises are few, industrialization is remote

Regenerating organs is considered the ultimate solution
to cracking the pain points of traditional organ transplantation.

Tissue and organ defects and functional defects caused by trauma, disease, and aging are common, and organ transplantation is the treatment of choice
.
However, there are two major problems in organ transplantation, one is the serious shortage of allogeneic transplant donors, data show that the number of waiting organ transplant patients in China is growing, about 300,000 people are waiting for organ transplantation in 2020, but the number of organs available for transplantation in China is less than 20,000
.
The second is the problem of rejection, after transplantation surgery need to take a large number of immunosuppressive drugs, such as after kidney transplantation, patients may have to take 20 or 30 capsules of various anti-rejection drugs per day, the cost of each month is as high as 5,000 yuan -7,000 yuan, and it is prone to infection
.

The concept of regenerative organs differs from
that of artificial organs.
Artificial organs include mechanical artificial organs, non-biologically active polymer materials or alloys and other materials imitation of organs, powered by batteries, and semi-mechanical and semi-biological artificial organs, refers to the combination of electronic technology and biotechnology to manufacture organs
.

Regenerated organ refers to the use of cells, the production of biologically active artificial organs, do not need external power such as batteries, long use cycle, will not allow patients to transplant organs after rejection reaction, is the "pyramid tip"
of artificial organs.

At present, most regenerative medicine companies focus on the repair of tissues and organs, and there are few enterprises that lay out regenerative organs
.
Arterial network statistics to the current layout of regenerative organs in the domestic enterprises there are 6, the layout direction of artificial blood vessels, artificial pancreas, artificial kidneys, artificial liver
.

Regenerative organ related enterprises

Huawei Hengyuan has cooperated with Novo Nordisk to develop a diabetic immune exemption artificial pancreas product, diabetic islet protection vector #isletSC-1, which is currently in the preclinical research stage
.
Under the traditional insulin treatment method, patients need daily insulin injection, constant blood glucose monitoring, daily life is completely innervated by insulin, and artificial pancreatic cells transplant immune rejection
.
Diabetic immunity exempts the artificial pancreas, allowing islet transplanted cells to survive in the patient's body for a long time and continuously produce insulin to regulate blood sugar
.

Huayuan Regenerative Medicine uses stem cells and tissue engineering technology to manufacture human-derived biosynthetic organs suitable for human transplantation, treats end-stage organ diseases and transplantation is developing biosynthetic artificial pancreas, in vitro artificial kidneys, biosynthetic implantable artificial kidneys, etc
.

Zhixinhao is focusing on the in vitro reconstruction of human tissues and organs, and the primary pipeline is regenerative islets that can be used for transplantation and treatment of diabetes
.
Thousands of clinical cases have proved that the cancellary tissue donated by the deceased is transplanted into the liver through blood vessels, and nearly 70% of diabetic subjects can completely withdraw from insulin for a long time, showing the great potential of islet transplantation to cure insulin-dependent diabetes; However, the severe scarcity of donors and the need for lifelong use of immunosuppressants greatly limit the promotion and universality
of this therapy.
Zhixin Haozheng is using stem cells to reconstruct islet tissue in vitro to solve the bottleneck
of islet transplantation.

In general, regenerative organs are still in the early stage of development in China and the world, and the pipelines of domestic enterprises are generally in the preclinical stage, and have not achieved scale and commercialization, and still need to undergo a long period of development
.

Financing is early, and regenerative medicine is still in its very early stages

According to the statistics of Arterial Network, there have been 70 financing events in the field of regenerative medicine in China, with a total financing of more than 1.
5 billion yuan
.

Financing of regenerative medicine companies

The financing situation in the field of regenerative medicine in China is relatively considerable, showing an overall upward trend, attracting many top investment institutions
in the medical field.
Eli Lilly Asia Fund and Sequoia Seed Fund invested in Shize Biologics, and Sequoia China invested in Nop Regeneration and Blood Ji Biologics
.

The financing round of China's regenerative medicine enterprises

From the perspective of the financing rounds in which the enterprises are located, the corporate financing rounds are in the early stage, with 11 in the A round financing stage, 5 in the angel round financing stage, and 4 IPO/New Third Board listings
.
Combined with the business of the enterprise, all the subdivisions have received high attention from the capital, the current IPO of enterprises belong to the bioregenerative materials subdivision track, stem cell repair, regenerative organ track started late, the enterprise is in the early stage
.

To be sure, there is still a great potential in the field of regenerative medicine that has not exploded
.

From the perspective of coverage scenarios, the key application scenarios of regenerative medicine such as medical beauty, orthopedics, stomatology, cardiovascular disease, and nerves have been financed by a number of enterprises, which shows that regenerative medicine has received extensive and in-depth attention
from capital.
In the future, there is room for
further growth in these key scenarios.

Among them, the scale of China's medical beauty market continued to grow from 2018 to 2021, about 227.
4 billion yuan in 2021, an increase of 15.
10%
over 2020.
According to the "More Beauty 2021 Medical Beauty Industry White Paper" released by Gengmei APP, the scale of China's medical aesthetic market will continue to maintain rapid growth in 2022, with a growth rate of more than 16%, and the market size may reach 264.
3 billion yuan.

Medical aesthetic injection is moving from the filling era to the "regeneration era", three medical aesthetic products based on recycled materials in China have been approved for listing, and the number of cooperative hospitals signed by East China Pharmaceutical's "Yiyanshi" has exceeded 500 in one year of listing
.

In the orthopedic market, the demand for orthopedic clinical surgeries, which is highly related to age in recent years, has continued to rise, and the market size of orthopedic implants in China has increased from 11.
7 billion yuan in 2013 to 36 billion yuan in 2020, with a compound annual growth rate of 17.
14%, which has become the world's second largest orthopedic implant market
.
Under the background of the continuous increase in orthopedic incidence, the application of orthopedic regenerative medicine products will become more and more extensive
.

From a policy point of view, the global aging continues to intensify, the traditional treatment mode is difficult to solve the tissue and organ defect repair, regeneration and many other problems, regenerative medicine through the creation of functional living cells, tissues or organs to achieve aging, disease, damage and other factors caused by the repair and replacement of tissues, organs or functions, has great strategic significance, is the long-term encouragement of the policy of the general direction
.

Regenerative medicine related policy review

But it is unavoidable that the development of China's regenerative medicine field is still in an extremely early stage
.
Bone restoration, regenerative medical beauty, oral repair and other products have been commercialized, regenerative organs and other high-tech barriers products still stay at the scientific research level, it is reported that regenerated kidneys, regenerative heart in the world have no products into the clinic, artificial pancreas has 2 laboratories into phase II clinical, 5-6 into phase I clinical
.

In the future, the further development of regenerative medicine in China depends on continuous breakthroughs
in policy supervision, capital, product research and development, and upstream and downstream collaboration.