Sanofi leads, Hengrui, Baiji, Roche, Merck layout, "organ" has become a must -have for research and development!

The name organ, as the name suggests, is the simulation of the real organs and physiological systems of the human body. As one of the important achievements of stem cell research, it has extraordinary value for clinical precision medical treatment (formulating individualized therapy programs for patients) and preclinical drug research and development. Therefore, it has also become TOP Pharmaceutical companies must win the stronghold.

In this Pfizer, Albervi, Johnson & Johnson, Roche, Merck, Novartis, BMS, Sanofi, GSK, Astrakan, Takeda Pharmaceutical and other global TOP20 pharmaceutical companies are competing for the future field of the layout. Get the head up.

Recently, FDA approved the world's first new drug (NCT04658472) to obtain preclinical data based on "organ chip" research. This milestone incident means that the "organ -type chip" experiment for the first time replaced traditional animal experiments and was officially recognized.

This new drug experiment was cooperated with Sanofi and organ chip company HesperOS to treat two rare autoimmune derivation neuropathy. Prior to this, due to the lack of ideal animal models, it was impossible to develop these diseases. Research.

At this point, Sanofi later ranked up. Although it was not the first layout, it was ahead of the field in the field of "organ" practice.

If the project is progressing smoothly, it may completely subvert the various restrictions on clinical development and change the rules of global drug research and development.

1

Why does the United States and the European Union technology technology

Promote to national strategic height?

There are more than 7,000 rare diseases in the world without treatment. Only about 400 of them are undergoing research. A lot of reason is that there is no animal model that simulates these diseases, and major diseases such as tumors and cardiovascular diseases are also facing the same dilemma.

If a technology is expected to bring new drugs to the era of "low risk, low investment, and high return", then "organ chip" may be one of them.

From "organ" to "organ chip"

In 1907, 44 -year -old Professor Wilson at the University of Becrolena found that the sponge cells separated through mechanical separation can be re -aggregated and self -arranged to become a new normal -function sponge organic body. The results of its research were published in 1910 and became the earliest "organ type". The concept prototype.

Since then, with the rapid development of stem cell technology, it has brought key opportunities for organ research. In 2009, the Dutch scientist Hans Clevers team successfully cultivated LGR5+intestinal stem cells into three -dimensional structures with hidden nest and fluffy epithelium area in vitro, and the first small intestinal organs were born.

From 2009 to the present, 3D organ training technology has successfully cultivated most of the tissue and organs with some key physiological structures and functions, including: kidney, liver, lung, intestine, brain, heart, prostate, pancreatic, retina, etc. It was rated as one of the 10 major science and technology of the year by Science magazine.

At the same time, another organ chip technology based on micro -current control technology has begun to study complex cell behavior on the chip and build three -dimensional human organs.

Organ chip

Organoid has high simulation and highly similar histological characteristics and functions to human organs;

Organ-on-A-chip has an advantage in modeling and standardization of modeling, and can realize the construction of more complex models.

However, they are all constructed by a single type of cells, which are still not enough for biological bionicism.

In 2019, the schedule of Science magazine proposed the concept of organ chip for the first time.

Organoids-on-chips integrates the advantages of organ and organ chip technical lines; build an organ physiological microchemical system on the chip to reproduce the interdependent organ function, so as to predict that the human body or different stimulation of drugs or external stimuli reaction. It shows that it is almost an simulated human body, not a single organ.

Class organ chip simulation human physiological microchaser

"Low risk, low investment" new drug research and development? The United States and the European Union introduced support plans

According to statistics, the average cost of developing a new drug in 2021 has fallen to the lowest of nearly seven years, still as high as about 2 billion US dollars. In addition, the failure rate of new drugs in the clinical development stage is still nearly 90%.

The above pain points are mainly due to the insufficient animal model and the animal model cannot accurately predict the human response.

The "organ chip" can be customized as a disease modeling because it is directly constructed by human tissue; therefore, it can be fully evaluated by the price of price before clinical experiments, so as to increase the success rate of drug research and development. Reduce the cost of pharmaceutical development and do not harm animals. In addition, the fusion of Organic chip superimposed AI technology will also make drug screening more efficient and accurate.

For the above reasons, in 2011, the United States NIH, FDA and the US Department of Defense led the launch of the "Micro Physiology System" program (MPS program), and for the first time, the technology chip technology was raised to the national strategic level.

At the same time, the European Union is also optimistic about the development prospects of organ chip technology in the field of new drug research and development, precision medical care, and AI pharmaceuticals. One of the goals of large -scale R & D alliance (IMSAVAR) that they support is to cooperate with large pharmaceutical companies to develop organ chip models.

However, in the next ten years, most of the organ chips are in the laboratory research stage, and there are relatively few clinical applications in drug development. In addition to its high technical barriers and involving multiple disciplines, the biggest "obstacles" still lies in the lack of recognition of regulations; this "obstacle" has been cleared today. 2

Global Market: TOP20 pharmaceutical companies have already entered the field directly

At present, the commercialization of global organ chip markets mainly comes from two aspects: equipment sales and testing services; compound annual growth rate of about 29%; the US market accounts for about 41%, about 38%in Europe.

As an important assistance for the development of new drugs, the downstream customers of organ chip companies mainly include CRO and pharmaceutical companies.

The main business model of organ chip companies

Hubrechtorganoid Technology (HUB) established by HUBRECHTORGANOID Technology (HUB), the originator of organic ancestors, is the world's first organ R & D center. HUB has also helped the first batch of organ companies such as Epistem, Cellesce, Crown BiosCiences, STEMCELL Technology.

In addition, the technology company established by the university research institute is also the main force of this type of organ chip company. For example, EmulaTe, a biotechnology company established by the Harvard University of Wyss Biological Engineering in 2013.

Earlier organ chip companies mostly provided services to pharmaceutical companies by selling products to CROs. After 2015, more and more pharmaceutical companies have directly entered the venue through purchase of products, cooperation authorization, and investment, becoming another force in this field.

In 2015, Johnson & Johnson purchased the thrombosis chip of Emule Company to detect its blood coagulation in the listing drugs or in researching drugs.

In 2016, Merck, Seres therapeutics, etc. purchased EmulaTe company organ chips for new drug research and development tests.

In 2018, Astraikan reached an agreement with Emule to combine its organ chip technology to Astrick's IMED Drug Safety Lab; Astraikon is also the first TOP drug to integrate organ chip technology into the internal laboratory. Enterprise.

In May 2018, Pfizer and HUB cooperated with HUB to develop human intestinal organs to study Crohn's disease, ulcerative colitis and other diseases.

In September 2018, System1 Biosciences, a neurotherapy startup led by Pfizer, received a $ 25 million Series A financing of $ 25 million. Its self -developed brain organs were used to develop new methods of neurotherapy.

In 2021, Sanofi cooperated with HeSperos to conduct NCT04658472 preclinical research.

In January 2022, Belief Schimingbao reached a cooperation with Prellis to create high -affinity human antibodies against human protein based on its human lymph node organ platform.

In March 2022, Sanofi reached a cooperation with Prellis to use its platform to reconstruct an immune response in vitro to provide antibodies with significant genetic diversity.

In addition, more than 20 TOP pharmaceutical companies such as Albervi, Merck, and Novartis have jointly established the Innovationand Quality Consortium to promote the standardized application of organ chips to accelerate the process of drug research and development. At present, a series of industry standards have been published for models such as liver, kidney, lungs.

IQ League member pharmaceutical company

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Chinese market: Hengrui, Baiji; Roche and Merck have led the layout

Since 2021, China has formally promoted the development of organized organ chip technology from scientific research and regulatory levels.

On January 28, 2021, the Ministry of Science and Technology issued the "Notice on the Six Key Specials of the" Fourteenth Five -Year Plan "National Key R & D Plan for the 2021 Project Declaration Guide", and listed the "Modeling Model -based Organ -like Models" as The first batch of key special tasks of the "14th Five -Year Plan" national key R & D plan.

In November 2021, China CDE first included organs into genetic treatment guidelines for gene therapy and cell therapy for non -clinical pharmacological research.

In July 2022, China's first organ guidance of the experts of accurate drug treatment of tumor was released.

Although the development of Chinese organ chips is about ten years than the United States, it has improved rapidly.

The accumulation of Chinese scientific research accelerates the process of related industrialization.

2009-2019, 8%of published documents in the field of organ technology related to organized organs were located in the world's 6th; by 2020, the published documents from China have reached 14%, second only to the United States, located in the 2nd world.

China's capital market has begun to pay attention to organ enterprises.

Since 2019, Chinese organ companies have begun to win capital concerns, completed angel round financing, and completed Series A financing in 2021.

Chuangxin International completes nearly 100 million yuan in Series A financing, led by fun assets;

Danwang Medical completed a round A financing of 120 million yuan, led by the national capital, followed by German Capital and Kunlun Capital, and the organ "originator" Hans Clevers joined as a co -founder and chief consultant scientist;

Big Meak Technology completed tens of millions of yuan in Series A financing, led by Dinghui VGC (Dinghui Innovation and Growth Fund), and invested in the creative altar. Investment; from the perspective of pharmaceutical companies, China has developed the "one brother" and the former "one brother" in the fields of organs related areas.

Baiji Shenzhou is the only Chinese pharmaceutical company in the IQ Alliance. In December 2021, it signed a strategic cooperation agreement with Chuangxin International to jointly establish a new organic research and development technology platform.

Hengrui Pharmaceutical's transformation medical department has established Organoid Culture, which can conduct drug research in the simulated human organs and tumor microenvironment;

Transnational pharmaceutical companies have also expanded the project of China Innovation Center to "organ" related fields.

In 2020, Merck China Innovation Center began to explore the innovation "organ" platform.

One of the key projects of the Roche China Pharmaceutical Department is to apply the human model system (organ and micro physiology system) to the drug discovery product pipeline.

As the FDA's milestone is approved, China NMPA may also be approved by the "organ chip" data in the future. Who is the first approved company?

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