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Whether it is the entry of new players or the transformation of old players to land in the capital market, the CXO track has always been in the
spotlight.
In recent months, Arterial New Medicine has noticed that most of the pharmaceutical IPOs are directly and indirectly related
to the CXO business.
On August 25 this year, Sinotherapeutics officially landed on the Science and Technology Innovation Board, and Sinothe's main business includes high-end generic drugs and preparation CRO services; On October 11, Bede Pharmaceutical, a self-owned brand supplier of pharmaceutical molecular building blocks, officially landed on the science and technology innovation board, and the molecular building blocks are closer to the upstream CDMO business, which is also a major direction for its future transformation; On November 1, Hongbo Pharma officially landed on the Growth Enterprise Market, a typical local small and medium-sized CXO enterprise starting with APIs, which is now facing transformation, which is both an opportunity and a challenge
.
At the same time, there is a group of new players
worth watching on the CXO track.
Some of these start-up CXO companies stand at a high starting point, such as Sherpa Biologics, founded by Innovent CMC team; Some focus on more cutting-edge service tracks, such as oligonucleotide CDMO start-up Oli Biologics
.
But regardless of the starting point, everyone is looking for space where they can survive and develop, hoping to get a piece of the vast
CXO track.
In the past two months, Arterial New Medicine has planned CXO topics and interviewed a number of distinctive CXO companies, and we found that in the seemingly crowded CDMO track, new industrial opportunities are still emerging
.
According to the results of recent interviews and some desk work, Arterial New Medicine will take stock of 7 representative start-up CDMO companies established around 2020 in this article, mainly covering three subdivisions
of CGT, oligonucleotide and peptide.
The current situation and technical characteristics of the start-up CDMO enterprises established in the past two years can help us get a glimpse of the characteristics of the relevant tracks, the current development stage, and the new direction
of the industry.
of CGT, oligonucleotide and peptide.
The current situation and technical characteristics of the start-up CDMO enterprises established in the past two years can help us get a glimpse of the characteristics of the relevant tracks, the current development stage, and the new direction
of the industry.
Where do start-up CDMO companies come from?
Where do start-up CDMO companies come from?Among the 7 companies, in addition to Sherpa Biologics will involve antibodies, fusion proteins, CGT, ADC and other fields, the other 6 start-ups have their own focus on subdivisions, of which 3 focus on the CGT field, and the remaining 3, Oli Biotech focuses on the nucleic acid drug track that is still before commercial production in China, Xiushi Bio is in the peptide drug track, and Kaituo Biotech chooses the layout strategy
of CGT and nucleic acid drugs.
From the perspective of the founding team, these start-up CDMO companies have their own characteristics
.
In addition to Huaji Biotechnology, which is a typical university (Tsinghua University) scientific research fruit transformation enterprises, the founding teams of the remaining 6 enterprises are mainly from the CMC departments of universities, large biopharmaceutical companies, or domestic and foreign CDMO leading enterprises
.
Among them, Sherpa Biotech and Xiji Biotechnology are more special, they are derived from Biotech companies and both were established in 2022, which reflects the development trend
of domestic Biotech companies expanding CDMO.
of domestic biotech companies expanding CDMO.
Sherpa Biologics spun off Innovent Biologics' CMC team to form a process development team of more than 1,000 people, and accumulated process development and industrialization experience
at Innovent Biologics.
Lu Xian'an, the founder of Xiji Biotechnology, is also the co-founder of Yimiao Shenzhou, which has been developing new cell therapy drugs since 2015 and has grown into a leader in the field of CGT, which allows Xiji Biotechnology to have the earliest team
in China to carry out the research and development of CAR-T new drugs.
We observed that 5 CDMO companies entered different stages
of financing.
The financing progress of the relatively mature CGT track is the fastest, and the earliest established Huaji Biotechnology has entered the B round stage, and both Kaituo Biotech and Yuanjian Youke have completed the A round of financing
.
The start-up CDMO company in the peptide and nucleic acid drug track is still in its infancy, and the latest disclosed financing round of Xiushi Bio is in the seed round, and is currently conducting a round of financing, which is expected to be completed by the end of 2022; Oli Biotech completed the pre-A round of financing
.
CDMO is an asset-heavy investment, which requires government resources in terms of land acquisition, GMP plant landing, and policy support for investment attraction in the park, so it has a closer
relationship with local governments.
relationship with local governments.
Among these financing events, there are many local government funds
.
In the Series B financing of Huaji Biotechnology, CICC Qiyuan National Emerging Industry Venture Capital Guidance Fund is eye-catching, which is the first state-level fund in China focusing on investing in emerging industry venture capital funds and enterprises, jointly invested and established
by the National Development and Reform Commission, the Ministry of Finance and other social investors.
Similarly, among the investors in Kaituo's Series A financing, we also see Suzhou localized funds
such as Yuanhe Holdings.
The investment of these investment institutions has made CDMO enterprises more closely connected with local industries
.
Huaji Biotech chose its headquarters and production base in Beijing, and Kaituo Biotech also established a production workshop
in Suzhou.
From a geographical point of view, 6 CDMO companies chose to deploy in the Yangtze River Delta region
.
The Yangtze River Delta is an important place in the domestic biomedical industry, Suzhou, Hangzhou and Shanghai have become popular locations, and Huaji Biotechnology, which only has the background of Tsinghua University, has its headquarters in Beijing
.
In addition, the construction of plants in a single area can no longer meet the capacity layout needs of CDMO, even if it is a start-up CDMO company, it has directly opened a multi-place layout, Kituo Biologics chose to have a dual layout in Suzhou and Wuhan, and Sherpa Biologics not only built a factory in Suzhou, but also built a production workshop
in Hangzhou.
Don't worry about orders, expanding production capacity is still the main theme,
Don't worry about orders, expanding production capacity is still the main theme,Why?
Why?During the interview, Arterial New Medicine found that most of these CDMO companies that started after 2020 did not have to worry about not receiving orders, and most of them had orders of more than 100 million yuan, and a few had tens of millions of yuan in order signings
.
Some companies no longer have the capacity to undertake new orders, and some companies' CDMO orders have basically filled the R&D line
.
.
Taking Xiji Biotech as an example, it was established in January this year, began to receive orders in April, and recently signed orders, and the revenue scale has reached nearly 100 million
.
At present, this year's production capacity has been fully used up, and new capacity is under construction
.
Having obtained CDMO orders from large enterprises, expected to have better cash flow, expand production capacity, increase R&D equipment, introduce high-level professional and technical personnel, and gradually open up the international market, which is still the main theme
of these start-up CDMO enterprises.
of these start-up CDMO enterprises.
There are many new opportunities in the CDMO space, especially for start-up companies
.
Among them, CGT CDMO is relatively ahead, the track is constantly refined, and the vertical segmentation opportunities of the industry are increasing
.
This is reflected in the emergence of a new generation of CDMO companies
similar to Huaji Biotechnology in 2018.
Huaji Biology is a typical project for the transformation of
scientific and technological achievements in colleges and universities.
The original research technology, microcarrier technology and 3D cultivation process technology of Huaji Biotechnology all come from the transformation
of achievements of Tsinghua University.
At present, multinational and local CGT CDMO companies generally use plasmids and viruses as their main service content, and cell service capabilities need to be solved
urgently.
Huaji Biotech emphasizes the 3D cell culture process and how to put 3D
The cultivation technology is applied to the entire CGT field, and even the traditional CDMO industry
.
Although Xiji Biotech is a CDMO company that provides plasmids, viruses, and cells from IIT to commercialization, it also emphasizes its outstanding cell service capabilities
.
In addition, Xiji Biotech has found a differentiated positioning in the geographical layout, and at present, the domestic CGT
CDMO companies are mostly concentrated in the Yangtze River Delta, very few in the north, Xiji Biotech is located in Beijing Daxing Biomedical Industry Base, with the help of Beijing's education and medical resources, will gradually start
from the north.
CGT CDMO track, the development space of start-ups is to emphasize the advantages of more segmented fields, whether it is technical, or geographical and resource service advantages
.
.
In the field of oligonucleotides, the current industrial ecology is still in its infancy, and "one-stop" CDMO services such as discovery of oligonucleotide drugs, process development, CMC services, API production, and drug registration are still the most popular
in the market.
Only by helping downstream R&D enterprises to advance nucleic acid drugs to the clinic and advance to the commercialization stage can the domestic oligonucleotide industry ecology truly break out
.
At present, domestic oligonucleotide drugs are basically in various stages
of pre-commercial production, pre-clinical and clinical research.
According to Arterial New Medicine, the demand of enterprises is basically concentrated in 10
mg to 10 kg, compared to small molecules and peptides, the demand for capacity is not large
.
However, relevant companies are always paying attention to the progress of
oligonucleotide drugs.
Once there are products that are advancing quickly and have great hope to enter the commercial production stage, enterprises will also increase production capacity
in a timely manner.
Taking Oli Biotech as an example, Oli Biotech entered the nucleic acid drug CDMO track in 2021, because the company found that in the domestic market, professional nucleic acid CDMO companies are relatively scarce, but the CDMO demand of nucleic acid pharmaceutical companies is constantly expanding
.
At present, Oli Biotech is equipped with 5 production lines with a capacity of 10 mg to 100 grams, and will have two production lines
with a capacity of 10 grams to 100 kilograms by the end of the year.
At present, Oli Biologics not only undertakes early orders for nucleic acid drugs, but also has two main block businesses, the primer and probe business of IVD companies, and the CpG adjuvant business
of vaccine companies.
More than a year after its establishment, Oli Biotech has delivered more than 22 million
orders.
The peptide track is a typical revitalized track, and this vitality is slowly transmitted to the upstream CDMO business
.
.
In order to save costs and reduce R&D risks, peptide pharmaceutical companies often choose to cooperate with professional CRO/CDMO companies in the early stage of R&D, so the peptide CDMO track has a long history of development, but there are fewer
entrants.
Domestic peptide CDMO enterprises Peptide Biochemical and Chengdu Sirnaomics were established in 2001, Hanyu Pharmaceutical was established in 2003, Angbo Pharmaceutical was established in 2005, and Nuotech Biotech was established in 2009, all of which have a development history
of more than 10 years or even more than 20 years.
With the emergence of a number of "blockbuster" drugs such as somarutide, the peptide track is returning to the public's vision, and peptide drug CDMO companies will also receive more attention
.
With the emergence of a number of peptide innovation enterprises in China, the demand for innovation has been further released to the upstream industry
.
For example, traditional peptide CDMO companies often adopt chemical synthesis or classical genetic engineering methods, which generally have higher costs and low
synthesis efficiency.
Xiushi Bio is a rare peptide CDMO established in recent years, established at the end of 2020, which claims that they are one of the very few start-ups
that truly and effectively use synthetic biology technology to solve the problem of peptide drug industrialization development.
It is understood that Xiushi Bio in the GLP-1 receptor agonist analogue drug project, the production efficiency has reached 5-10 times of traditional genetic engineering technology, and the gross profit of APIs has reached more than 85%, and many leading companies in this field are discussing cooperation
with it.
Guided by innovative products and technologies, going upstream
Guided by innovative products and technologies, going upstreamAfter years of development, CDMO companies with full-process services for drug development and marketization are not lacking in China, and most CDMOs in China also provide related products and services around the whole process of drug development, these companies are better at the establishment of drug development systems, drug declaration and other links, and a large number of CDMO companies have relevant experience
in declaring drugs before this.
"In the early stage of industry development, everyone is more concerned about how to make a drug, how to successfully promote the drug from early development, to IND approval into the clinic, and then to the final commercial production, that is, the opening of the drug development process
.
" Dr.
Liu Wei, co-founder and CEO of Huaji Biologics, told Arterial New Medicine, "But as the industry matures, everyone begins to pay attention to every detail
of drug development.
For example: what is the production process of raw materials, reagents, and equipment required for a drug? ”
of drug development.
For example: what is the production process of raw materials, reagents, and equipment required for a drug?
Guided by innovative products and technologies, the development to the upstream is the most important development space
for start-up CDMO enterprises.
for start-up CDMO enterprises.
Based on product- and technology-oriented business models, BD level, emerging CDMO companies are also innovating business models
.
Huaji Biotech said that in addition to emerging CGT pharmaceutical companies, it can also use its 3D cell culture process to reduce costs and increase efficiency to meet the needs of future commercial production; Traditional CDMO companies can develop and upgrade the entire process on the basis of the original two-dimensional cell culture, and input new technologies into the customer projects
they host.
Do not compete with traditional CDMO companies, export new technologies, traditional CDMO is also their customer
.
All in all, not only in the field of life science tools, but also in the CDMO track, domestic substitution in the upstream ecological chain is also a systematic entrepreneurial and investment opportunity
.
Lu Xianan, founder of Xiji Biotechnology, pointed out, "When we do gene cell drug research and development, we always have to consider the development of
the ecological chain.
A company has developed, or a certain research and development link has done well, but the upstream and downstream of the ecological chain are loopholes, or stuck in the neck, which will be subject to many restrictions
.
”
At present, most of the production processes, production tools and raw and auxiliary reagents of new drugs that have been marketed in China can only rely on imports
.
What are the new tools, new products, new technologies and new processes of China's original biomedicine? is a question
that the entire industry needs to answer.
