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Fighting! Battle of 100 regiments at the CGT CDMO track

 Last Update: 2022-11-04
 Source: Internet
 Author: User

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In recent years, investment and financing in the field of gene and cell therapy (CGT) have shown a blowout trend, and venture capital, private equity investment, and IPO are very active, which has also driven the development of
the CGT CDMO industry.

For example, on September 27, Yiming Cell, which focuses on CGT's one-stop CDMO service, completed hundreds of millions of yuan in Series C financing, led by Kingstone Investment and CLSA Capital, followed by BGI Win-Win, Xingxing Investment, etc.
, and old shareholders Huagai Capital, Fangfu Capital, IDG Capital, etc.
continued to increase their weight
.

In addition to the primary market, CDMO listed companies such as WuXi AppTec, Heyuan Biologics, Kanglong Chemical, and Porton have also opened fierce market competition
in the secondary market.

Obtained hundreds of millions of yuan in financing to build a one-stop CDMO service platform for CGT

Founded in October 2015, Yiming Cell is a leading CGT one-stop CDMO service platform in China, which can provide GMP plasmids, AAVs, lentiviruses, adenoviruses, oncolytic viruses and other viral vectors as well as cell and gene therapy drug development services, and provide product process development program CRO services, GMP system translation and other services, which can meet customers from early research and development, new drug clinical trial application (pre-IND) and phase I/II clinical trials (IND), Requirements for
commercial production.

It can meet the requirements
of customers from early research and development, new drug clinical trial application (pre-IND) and phase I/II clinical trial (IND), and commercial production.

Through the development of viral vectors and large-scale production processes, Yiming Cell can provide customers in the field of gene therapy with integrated CRO front-end + CDMO solutions from process development, small-scale test, pilot test to clinical sample production in an all-round way to assist customers in accelerating the research and development, clinical and marketing
of gene drugs.

Integrated CRO front-end + CDMO solution

After 7 years of development, Yiming Cell has an outstanding R&D team composed of a group of returnee doctors and a strong scientific research network alliance, with a total of more than 400 employees, of which 20% are doctoral degrees and 40% are master degrees
.

The total number of employees in the company exceeds 400, of which 20% are doctoral degrees and 40% are master's degrees
.

Yiming Cell's expert team comes from professors or researchers from internationally renowned universities such as the Cancer Institute of the National Institutes of Health, Harvard University, Hopkins University, University of Maryland, Columbia University (UBC) in Canada, and has more than ten years of industrial experience
in the field of CGT.

He has more than ten years of industry experience
in the field of CGT.

At present, Yiming Cell has established two production bases
in Jinan and Suzhou.
Among them, the GMP plant area of Jinan base is 5000 square meters, with a number of plasmid, virus, cell therapy drug production lines, filling using absolute A isolator filling, can provide CGT field customers GMP plasmid, AAV, lentivirus, adenovirus, CAR-T and other products development and production services
.

Yiming Cell has established two production bases
in Jinan and Suzhou.

Suzhou base GMP plant area of 9000 square meters, using large-scale disposable production technology for plasmid and recombinant virus production, and the production line is further expanded, including prokaryotic cell culture scale of 10L-50L-200L, eukaryotic cell culture scale of 50L-200L-500L-2000L, prokaryotic fermentation scale of 10L-50L-200L, and equipped with advanced purification technology to meet the diversified needs
of customers.
Since it was put into operation in March 2022, the company has reached a number of strategic cooperation
with many customers.

Since the production line was further expanded in March 2022, it has operated steadily, and the company has reached a number of strategic cooperation
with many customers.

From the project results, since 2019, Yiming Cell has undertaken/delivered more than 60 batches of
IND and IIT products in China.
In 2022, the two AAV gene drugs cooperated by the company obtained the clinical implicit license of CDE, and the other one AAV gene drug IND application was accepted by CDE, establishing a differentiated competitive advantage
in the field of large-scale preparation of AAV vectors and the industry.

Since 2019, Yiming Cell has undertaken/delivered more than 60 batches of
IND and IIT products in China.

On September 27, Yiming Cell announced the completion of hundreds of millions of yuan in Series C financing, which will further accelerate the global layout, accelerate the construction of CMC R&D center platforms in the United States and Canada, continue to promote the development and innovation of CGT carrier technology and process, continuously enhance the company's leading position in one-stop CDMO services in the field of CGT, and improve GMP in an all-round way The production capacity of AAV, plasmid, lentivirus, adenovirus, CAR-T, iPSC and other products strongly empowers the development and industrial transformation
of new CGT drugs at home and abroad.

On September 27, Yiming Cell announced the completion of hundreds of millions of yuan in Series C financing

The production is difficult and the outsourcing penetration rate is high, which has achieved the CGT CDMO 10 billion track

Cell and gene therapy (CGT) is at the forefront of next-generation biotechnology
with its unique and excellent therapeutic effects and the opportunity to heal patients.

However, due to the difficulty of CGT drug production and high outsourcing demand, CGT has been driven Development of
the CDMO industry.
As Dr.
Sun Xiulian, Chairman and CTO of Yiming Cell, said, "The CGT industry has entered a golden age of
industrialization.
”

Due to the difficulty of CGT drug production and high outsourcing demand, CGT has been driven Development of
the CDMO industry.

In contrast, due to the essential differences between traditional drugs and CGT drugs in terms of mechanism of action and clinical treatment, there are obvious differences
in the business scope of CRO and CDMO between the two.

Gene therapy CDMO provides related process development and manufacturing services
in the preclinical research stage, clinical research stage, and commercial production stage.
Among them, the preclinical research stage mainly includes production material research, preparation process development and process control, stability research, quality research and control and other services; The clinical research phase mainly includes GMP production services for clinical-grade samples; The commercial production phase mainly includes large-scale GMP production services
.
In addition, CDMO also provides CMC material writing services
.

First of all, unlike traditional drugs, the gene therapy production process is complex, involving process development and quality control method development of plasmid transfection and purification, large-scale production cell culture, plasmid transfection, virus purification and other links, with low fault tolerance, very strict requirements for process control, and overall
difficulty.

The requirements for process control are very strict and the overall difficulty is greater
.

Therefore, the production process and quality control are the core development content of gene therapy, and it is also the main competitiveness of
gene therapy CDMO enterprises.

Secondly, compared with traditional drugs, gene therapy is closely related to basic biomedical research, and the transformation mechanism is also different: gene therapy pilot research is mainly promoted by universities, research institutes and medical institutions, and the technology incubation of gene therapy drugs usually comes from laboratory research
.

Compared with traditional drugs, gene therapy is closely related to basic biomedical research, and the transformation mechanism is also different:

Therefore, the lack of industrial management experience has become one of the important factors restricting the transformation of gene therapy drugs, and also makes the field more dependent on outsourcing services
.

It also makes the sector more dependent on outsourcing services
.

▲Gene therapy CDMO industry chain Source: Heyuan Biologics prospectus

Moreover, the field of gene therapy has not been developing for a long time, and except for a few large pharmaceutical companies that have deployed gene therapy business in recent years, most of the participants are start-ups
.
Moreover, gene therapy products are difficult, long-cycle and costly
.

The R&D and production of gene therapy products are difficult, long-cycle and costly
.

According to the ARM report and Frost & Sullivan's analysis, as of July 20, 2021, 75% of the 48 gene therapy companies with gene therapy product clinical trials announced by CDE in China are start-ups
.
For example, the major domestic gene therapy drug R&D companies are Legend Biologics, JW Therapeutics, Fosun Kate, Boya Gene, Newforth and so on
.

For example, the major domestic gene therapy drug R&D companies are Legend Biologics, JW Therapeutics, Fosun Kate, Boya Gene, Newforth and so on
.

In particular, gene therapy start-up innovative drug companies rely more on professional R&D and production outsourcing services
due to the limitations of process development capabilities, GMP production experience, and knowledge of relevant regulations for clinical declaration in the process of drug development, clinical application and commercial production.
According to J.
P.
Morgan, the outsourcing penetration rate of gene therapy exceeds 65%, far exceeding the 35%
of traditional biologics.

More reliance on professional R&D and production outsourcing services
.

Based on this, the cell and gene therapy CDMO industry has shown a good market prospect.

According to Frost & Sullivan's analysis, the global gene therapy CDMO market size grew from $770 million to $1.
72 billion from 2016 to 2020, with a compound annual growth rate of 22.
4%, and is expected to reach $7.
86 billion
by 2025.

Based on this, the cell and gene therapy CDMO industry has shown a good market prospect.

In addition, from 2018 to 2022, the domestic cell and gene therapy CDMO market will grow from 870 million yuan to 3.
26 billion yuan, with a compound annual growth rate of 39.
3%, and is expected to grow to 19.
74 billion yuan
by 2027.

The compound annual growth rate is 39.
3%, and it is expected to grow to 19.
74 billion yuan
by 2027.

WuXi, Heyuan, Kanglong, Porton.
.
.
Compete in the CGT CDMO track

Globally, the gene therapy CDMO industry in developed regions in Europe and the United States is relatively more mature, with a larger market scale and a more formed industry structure.
The domestic gene therapy CDMO industry is in the early stage of development, but in recent years, it has accelerated growth, and the market scale has expanded rapidly and the growth trend is good
.

Currently, the world's major companies in the gene therapy CRO/CDMO field include Lonza, TMO, Oxford BioMedica, Catalent, Charles River、BrammerBio、CELL for CURE, Wuxi Biobase Pharmaceutical, a subsidiary of WuXi AppTec, Heyuan Biologics, GenScript Biotechnology subsidiary Boom Biologics, Kanglong Chemical, Porton Biologics, a subsidiary of Porton, etc
.

WuXi AppTec's subsidiaries Wuxi Shengji Pharmaceutical, Heyuan Biologics, GenScript Biotechnology subsidiaries Boom Biologics, Kanglong Chemical, Porton Biologics, subsidiaries of Porton, etc.

According to Research and According to Markets, there are 130+ players making viruses and pDNA worldwide: 90+ mainly make viral vectors, 30+ companies mainly make DNA plasmids, and 14 companies do
both.
Due to a large number of clinical trials in North America, more than half of the current factories are in North America; 80% of players at clinical scale, 40% from academic institutions and non-profit organizations have been the main source of supply, but none have expertise in industrial scale-up; CGT is in its early stages, and the market is generally fragmented, with only 20% of players having commercial-scale capacity
.

CGT is in its early stages, and the market is generally fragmented, with only 20% of players having commercial-scale capacity
.

From the perspective of competitive landscape, according to WuXi Biologics data, the concentration of CGT CMO/CDMO industry is relatively high, and the market share of the top four companies has reached 75%:

Overseas first echelon: including Catalent, Lonza, Thermo Fisher, the top three, account for about 70% of the market share
.
Among them, Catalent is the world's largest CGT CMO/CDMO market player, CGT The CDMO market share reached about 40%.

The industrial chain layout and capability platform construction of the three leading overseas enterprises are relatively perfect, all of which have preclinical/clinical/commercial production capabilities, and cover the mainstream drugs
of cell gene therapy.

Overseas first echelon:

Overseas second echelon: including WuXi AppTec (Wuxi Biobase Pharmaceutical WuXi ATU), Charles River, Oxford Biomedica, three companies account for about 15% of the market
.
Overseas second-tier suppliers have high-barrier technical capability platforms in some links of cell and gene therapy, and then gradually complete the layout
of the entire industry chain through acquisition or increased investment.

Overseas second echelon:

In terms of the domestic market, WuXi Biologics occupied the domestic CGT with a market share of 55.
86% in 2020 CDMO half of the country; Secondly, the market shares of Heyuan Biologics and GenScript are 7.
65% and 3.
1%
respectively.

From the perspective of operating performance, in the first half of 2022, WuXi AppTec's cell and gene therapy CTDMO (contract testing, R&D and production) business achieved revenue of 615 million yuan, a year-on-year increase of 35.
73%, accounting for 3.
47% of revenue, providing development and production services for 67 projects, including 51 preclinical and phase I clinical trial projects, 9 phase II clinical trial projects, and 7 phase III clinical trial projects (4 of which are in the marketing application preparation
。

In the first half of 2022, WuXi AppTec's cell and gene therapy CTDMO (contract testing, R&D and manufacturing) business achieved revenue of 615 million yuan, a year-on-year increase of 35.
73%

Heyuan Biotech's gene therapy CDMO business achieved revenue of 107 million yuan in the first half of the year, an increase of 47.
98% over the same period of the previous year, accounting for 79.
25% of the company's total revenue, and the gene therapy CRO business achieved revenue of 24.
3837 million yuan, accounting for 18.
08%
of revenue.
As of the end of the reporting period, the cumulative number of new orders for CDMO in 2022 exceeded 130 million yuan, with more than 350 million yuan
of unexecuted orders in hand.

Heyuan Biotech's gene therapy CDMO business achieved revenue of 107 million yuan in the first half of the year, an increase of 47.
98% over the same period of the previous year.

Kanglong Chemical's macromolecule and cell and gene therapy services achieved revenue of 95.
4698 million yuan in the first half of the year, a year-on-year increase of 33.
22%, a gross profit margin of 19.
82%, and a revenue proportion of 2.
06%.

Among them, North American customers, European customers (including the United Kingdom) and Chinese customers accounted for 84.
17%, 14.
51% and 1.
25%
of the company's macromolecular and cell and gene therapy service revenue, respectively.

Kanglong Chemical's macromolecule and cell and gene therapy services achieved revenue of 95.
4698 million yuan in the first half of the year, a year-on-year increase of 33.
22%

Porton's biological CDMO business (ie gene cell therapy CDMO business) achieved revenue of 11.
2671 million yuan in the first half of the year, an increase of 80% year-on-year, mainly providing customers with plasmid, viral vector and cell therapy CDMO services, serving 32 customers, a year-on-year increase of 167%, introducing 31 new projects, a year-on-year increase of 244%, and signing new orders of about 92.
08 million yuan, a year-on-year increase of 68%, mainly involving TiL, Car-NK cells, mRNA and other related projects process development, analysis and testing, GMP batch production, IND package and other different types of services
.

Porton's biological CDMO business (i.
e.
gene cell therapy CDMO business) achieved revenue of 11.
2671 million yuan in the first half of the year, a year-on-year increase of 80%

【Reference】

【Reference】【Reference】

1.
Financial reports, announcements, official websites, and prospectuses of each company

2.
"CGTCDMO Industry Report: Riding the New Wave of CGT Drugs, Rapidly Rising Potential Market", Haitong International

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