WuXi is a dominant company, how does the local biopharmaceutical CDMO walk out of the differentiated route?

The biopharmaceutical market continues to rise, and biopharmaceutical CDMOs take advantage of the trend

Biopharmaceutical CDMOs take advantage of the momentum

In 2002, after the world's first fully human monoclonal antibody drug adalimumab (trade name: Humira, English trade name Humira) was launched, the global biopharmaceutical field started 20 years of rapid development and still has great growth potential

▲Source: Frost & Sullivan Report

In China, compared with chemical drugs and traditional Chinese medicine, the growth trend of biological drugs is more obvious

However, the development of new drugs is a life-and-death situation, and the industry has been circulating the saying "Double Ten Laws", that is, it takes an average of 10 years to develop a new drug and costs 1 billion US dollars.

China's biopharmaceutical CDMO market has grown from RMB 2.

WuXi Biologics: China's leading biopharmaceutical CDMO

WuXi Biologics: China's leading biopharmaceutical CDMO

At present, in the domestic pharmaceutical contract R&D outsourcing service industry, the WuXi Department occupies an absolute leading position

▲The pattern of China's biopharmaceutical CDMO market in 2020

WuXi Biologics' business covers a comprehensive range, covering the whole process service from the early research and development of biological drugs to commercial production, pioneering the CRDMO model, and promoting the development and changes of the biological drug service industry

As of December 31, 2021, the number of comprehensive projects of WuXi Biologics has increased by 156 to 480, including 72 bispecific antibodies, 60 ADCs, and more than 20 new crown-related projects, including 255 IND, 8 1 BLA/MAA approved, 8 BLA/MAA/NDA applications

▲The total number of comprehensive projects of WuXi Biologics from 2016 to 2021

Source: WuXi Biologics JPM Conference Display

In the past 8 years, WuXi Biologics' financial performance has maintained rapid growth, with a compound annual growth rate of 63.

▲ Revenue of WuXi Biologics from 2014 to 2021

Source: WuXi Biologics Financial Report

At present, WuXi Biologics has 15 stock solution factories, with a production capacity of 250,000 liters put into operation by the end of 2022

WuXi Biologics has a long and wide moat, greatly expanded production capacity, rich project experience and excellent technology platform; sufficient growth drivers, and it is expected to maintain a strong development momentum in the future.

How does the local biopharmaceutical CDMO walk out of the differentiated route?

01.

01.

Gene therapy CDMO "first strand"

At present, the global gene therapy CDMO industry is in a stage of rapid development

In China, the gene therapy CDMO industry will enter a stage of rapid development after steady growth in recent years

It is reported that Heyuan Biology is in a leading position in China in terms of vector development technology, quality inspection technology development, downstream purification process technology and other major indicators; in large-scale plasmid transfection and suspension cell culture scale indicators, it is on par with domestic companies in the same industry; The large-scale preparation of plasmids, the comprehensiveness of cell culture technology, the richness of cell types that can be cultured on a large scale, the types of gene therapy vectors that can be produced on a large scale, and the project execution capabilities have reached or are relatively close to the international leading gene therapy CDMO companies

02.
Kangri Baiao: Building an international standard CDMO, this upstart grows at an astonishing rate

02.
Kangri Baiao: Building an international standard CDMO, this upstart grows at an astonishing rate

As a rising star in the CDMO field, Bioworkshops, established in 2019, has grown at an astonishing rate
.
The company is a professional one-stop biopharmaceutical CDMO service provider .
The company's services include cell line development, stock solution and preparation process development, analytical method development, preparation formulation development, and cGMP production of stock solution and finished products
.
The company is located in the core area of ​​Suzhou Industrial Park.
It has a building with a construction area of ​​28,000 square meters.
It is the largest biopharmaceutical macromolecule CDMO plant in Suzhou with the largest area and single building area.
Helped multiple partners to obtain multiple clinical approvals including the United States, China, and Australia, and the delivery speed is also at the leading level in the industry
.

The professional one-stop biopharmaceutical CDMO service provider has helped multiple partners to obtain multiple clinical approvals including the United States, China, and Australia within less than 3 years of establishment, and the delivery speed is also at the leading level in the industry
.

▲2000L reactor production

During the research process of the Pharnex Cloud Data ( team, it was found that Kangri Bioall is one of the few macromolecular CDMOs that has both the production capacity of the original solution and the production capacity of various dosage forms.
, can provide multi-dimensional, one-stop service
.

The complexity of biological products increases the cost of drug development and puts forward higher requirements for production and manufacturing processes
.
As the last link of the whole biopharmaceutical GMP production, aseptic preparation filling requires professional knowledge, good design and strict regulations to ensure the quality of the final product
.
A high standard of sterility assurance system runs through this very complex continuous production process
.
The whole process involves multiple processes such as thawing and mixing of the stock solution (Drug Substance, DS), sterilization filtration, bottle washing, filling and stoppering, freeze-drying, capping, light inspection, packaging, etc.
Each process will directly affect the final product.
quality
.

It is reported that Kangri Bioall has already put into production a number of aseptic filling production lines that can be filled commercially, including vials, freeze-drying, pre-filled needles and cartridges
.
It only took 4 months from equipment installation to equipment verification and official production .
They showed us the great prospects of the company's development with their solid foundation
.
The company's professional preparation filling team has more than 10 years of experience in aseptic production, mainly dedicated to the filling and production of liquids, freeze-drying, pre-filled needles, and cartridges.
The products that can be filled include antibodies, fusion proteins, vaccines, etc.
It is a biological preparation with a filling capacity of 15 million bottles per year
.
Filling production lines with different capacities can fully flexibly meet the increasing demands of partners for filling volumes of different processes and different types of formulation production lines
.

Only 4 months from equipment installation to equipment validation and official production

▲Commercialized vial filling production line

In addition, the company's team members are all experienced biopharmaceutical industry veterans, who have a deep understanding of biopharmaceutical CMC technology and regulations, and are committed to building Kangri Bioo into an international standard CDMO
.
In November 2020, the company passed the audit of the quality system and production site by the European drug quality authorized person, and obtained the "Drug Production License", which not only interprets the high-quality "Kangri Baiao Speed" again, but also highlights the company A sound quality system can fully meet the requirements of EMA, NMPA, and FDA drug regulations.
While continuously optimizing the construction of the quality system, they are also accelerating the operation of document data and building "high-quality production capacity"
.
This makes the company one of the few domestic CDMO service providers whose finished product filling lines have been audited by the EU quality authorized person
.

Become one of the few domestic CDMO service providers whose finished product filling lines have passed the audit of the EU quality authorized person
.

In 2021, Kangri Bioall has delivered nearly 100 batches of GMP production, including the production of 2000L clinical samples,
with advanced facilities and equipment, a complete quality system and an experienced team.
That said, it was a very impressive achievement .
At the same time, Kangri Bioall has a complete clinical stage process characterization technology platform (PCPV), and team members have helped many well-known domestic and foreign companies to successfully transfer, scale up and produce 2000L clinical and commercial products, including many batches with relatively high quality.
High technical difficulty, directly enlarged from 3L to 2000L production project, the success rate is 100%
.
In the future, Kangri Bioall is expected to continue to grow in the process of rapid expansion of the biopharmaceutical CDMO industry
.

Nearly 100 batches of GMP production including 2000L clinical sample production have been delivered, which is a very impressive achievement for a new CDMO
.

03.
Opmax: Culture medium + CDMO to create a domestic alternative "leader"

03.
Opmax: Culture medium + CDMO to create a domestic alternative "leader"

Founded in 2013, Opmax is an integrated service platform for cell culture solutions and end-to-end CDMO, accelerating the process of innovative drugs from gene (DNA) to clinical application (IND) to clinical sample production.
The process reduces the cost of biopharmaceutical production
.
The company organically integrates cell culture medium and biopharmaceutical CDMO , and relies on its OPM® and Sureness® brands to provide customers with an overall solution of technology + services
.

Cell Culture Media and Biopharmaceutical CDMOs

▲Source: Oppermay

Cell culture medium products are one of the important raw materials for biopharmaceutical companies in the process of drug development and production, especially in the mass production of biological products such as antibodies and vaccines
.
In the process of R&D and production, there are high requirements and standards for cell process expression, cloning level, and batch-to-batch stability of cell culture media
.
According to the report of CITIC Construction Investment, culture medium will account for 35% of the biopharmaceutical consumables market in 2020
.
According to a research report by Industrial Securities, the total global cell culture medium market size in 2020 is US$4.
65 billion and is expected to reach US$8.
24 billion in 2028, with a compound annual growth rate of 7.
4% from 2020 to 2028
.

▲Source: Research and Markets, Markets and Markets, CITIC Construction Investment, etc.

The main market for culture medium at home and abroad has long been occupied by large international technology companies, such as Thermo Fisher, Danaher, Merck and other manufacturers
.
However, with the continuous improvement of the technology of domestic manufacturers, the control costs of upstream production caused by the sharp drop in the prices of medicines in the medical insurance catalogue, and the supply risk of imported products caused by factors such as the epidemic, the domestic substitution power has been increased
.
In recent years, the proportion of the import scale of China's culture medium market has gradually decreased, and the trend is obvious
.
According to statistics, in the Chinese culture medium market, the market share of domestic culture medium has increased from 18.
6% in 2016 to 22.
8% in 2020.
It is expected that the import dependence of China's cell culture medium products is expected to continue to decline
.
From 2016 to 2020, the domestic proportion of my country's culture medium market is as follows:

As a leader in domestic substitution of culture medium, the OPM® brand under Opmax focuses on the research and development and production of protein antibodies, vaccines and culture medium for cell therapy.
It has built a 1500 square meter culture medium research and development base in Shanghai Cell Industrial Park and a 2000 square meter GMP-compliant medium.
The required medium production base (Plant 1); its 6,000-square-meter GMP-compliant medium Phase II large-scale production base (Plant 2) will be put into operation in early 2021
.
According to Opmax's prospectus, in the domestic culture medium market in 2020, the company's market share ranks second among domestic manufacturers
.
Sureness® is a CDMO service platform under Opmax, dedicated to providing full-process services from antibody engineering humanization screening and transient expression, stable cell line construction, process development to pilot production and clinical phase I and II sample production.
Si Lun Bio has a 4,000-square-meter biopharmaceutical CDMO service platform, equipped with GMP production lines of 200L and 500L disposable reactors that meet international and domestic standards
.
The 6,000-square-meter Phase II CDMO production base is equipped with multiple 200L - 2000L production lines to meet the needs of commercial production of antibody drugs
.

04.
Maibury: ADC star CDMO

04.
Maibury: ADC star CDMO

In 2013, Maibari was jointly funded and established by Mabplex and its management team, Tongji University, and the Management Committee of Yantai Development Zone.
It is one of the few companies in the world that can fully provide one-stop CDMO services for ADC drugs.
A professional one-stop biomedical CDMO company that has obtained a bioengineering product drug production license
.

One-stop CDMO service for ADC drugs

In recent years, ADC drugs have set off a global research and development boom
.
Due to the dual advantages of high targeting of monoclonal antibodies and high activity of cytotoxins in tumor tissues, ADC drugs can effectively kill tumor cells, have lower side effects than chemotherapy drugs, and have better efficacy than traditional antibody tumor drugs.
It is called the "biological missile" in the field of tumor treatment
.
Rongchang Bio was established in 2008 and is a leader in ADC drugs in China.
The company's Aidexi (vedicetumab, RC48) is China's first self-developed ADC drug, and it has entered the National Medical Insurance Drug List in 2021.

.
It is estimated that the global ADC drug market size is expected to exceed US$40 billion in 2026.
According to the article "The Oncology Market for Antibody-Drug Conjugate" published in Nature Reviews, the market size of the first 10 ADC drugs is expected to exceed $40 billion by 2026.
$16.
4 billion
.

▲Schematic diagram of ADC drug structure

ADC drugs have high technical barriers and are not a simple combination of antibodies, linkers, and cytotoxins.
It is necessary to select an appropriate combination to optimize the overall efficacy and safety
.
The production process is also complex, including multiple production links such as monoclonal antibody, stock solution, preparation, etc.
, especially the biological conjugation technology, which has a high threshold and is difficult
.
These factors pose huge challenges to the R&D, production and commercialization capabilities of ADC drug origin companies, so many companies are looking for CDMO companies to empower new drug development
.
Most of the world's ADC drug development is outsourced, and CDMO companies are used to enter the clinic and the market faster.
In order to reduce R&D costs, overseas companies also choose domestic CDMO companies for cooperation
.
With the rapid development of the ADC drug field at home and abroad, especially the intensified competition for the same type of targets, efficient clinical promotion and differentiated indication selection have become the focus of many pharmaceutical companies to gain a competitive advantage.
Therefore, choosing a suitable CDMO partner is also a new drug development.
important strategy
.
In the past, ADC original research companies needed to find multiple CDMOs to cooperate with each other on monoclonal antibodies, cytotoxins, linkers, etc.
, which led to low R&D production efficiency and brought trouble to production and supply chain management
.
Today, building an end-to-end integrated service platform for ADC products has become an industry trend
.

Maibari's mature CHO cell large-scale culture and ADC technology platform can provide innovative biological drugs such as monoclonal antibodies, double antibodies, fusion proteins, ADCs, and biosimilars from cell line construction, process development, clinical sample production and commercial production.
One-stop, customized service
.
Microberry has more than 50,000 square meters of production facilities, including 12 cell culture production lines equipped with multi-brand 2000L disposable bioreactors; ADC coupling scale can reach 150L, ​​and it is the second biologic in the industry to have its own ADC preparation line.
Pharmaceutical CDMO company, its production facilities meet the GMP standards of China, the United States, the European Union and other countries and regions
.

Epilogue

Epilogue

With more and more players entering the game, the competition of biological drug CDMOs has become increasingly fierce.
In addition to local CDMO companies, a few overseas CDMO giants have also entered the Chinese market, in order to explore opportunities in the wave of innovative drug research and development in China
.
It is worth noting that in the Chinese market, the service demand of multinational pharmaceutical companies is relatively small, and the demand for CDMO services is mainly concentrated in local companies.
In this environment, local biopharmaceutical CDMOs can further tap the unmet needs of local pharmaceutical companies and create differentiation.
capacity, and strengthen technology accumulation through project cooperation, actively expand overseas markets, and respond to future changes in the industry.
.
.

refer to:

refer to:

NMPA/CDE;

NMPA/CDE;

Yaorong Cloud Data, Cloud Data, FDA/EMA;

FDA/EMA;

Public disclosure of relevant companies;

Public disclosure of relevant companies;

Industrial Securities, Southwest Securities, CITIC Securities, Frost & Sullivan;

Industrial Securities, Southwest Securities, CITIC Securities, Frost & Sullivan;

WuXi Biologics-2022 JPM-Slides, 2021 financial report;

WuXi Biologics-2022 JPM-Slides, 2021 financial report;

Prospectus of Heyuan Bio, Opmax, and Rongchang Bio;

Prospectus of Heyuan Bio, Opmax, and Rongchang Bio;

The surge in outsourcing demand for aseptic preparations of biological drugs under the epidemic, why this CDMO has attracted much attention, https://mp.
weixin.
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com/s/BcYFbgKU9qqIaus0kQ8L3g

The surge in outsourcing demand for aseptic preparations of biological drugs under the epidemic, why this CDMO has attracted much attention, https://mp.
weixin.
qq.
com/s/BcYFbgKU9qqIaus0kQ8L3g

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