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According to public industry data, the number of ADC drug clinical registrations has doubled in the past two years, and Chinese ADCs have almost dominated the list of popular targets. The outsourcing rate for the development of ADC and other bioconjugate drugs is as high as 70%, far exceeding the overall outsourcing rate of 34% for other biological drugs.

According to market reports and WuXi Helian's 2023 annual performance report, by the end of 2023, WuXi Helian has enabled 345 customers, 427 early research projects, and achieved milestones such as early development of 10,000 molecules. In 2023, the number of comprehensive clinical projects served reached 143 (including 21 mid- and late-stage projects). The company has been recognized by the global industry and customers in the "World ADC Awards", the most influential in the global ADC field, for two consecutive years, and won the "Best CDMO Champion" in 2023. The continuous development of WuXi Helian fully demonstrates the strength and scale of the company's world-leading integrated comprehensive services such as early development, clinical research and commercial production of ADCs and pan-conjugate drugs.

WuXi Partners CEO, Lee Chin-Cai, said:

“If innovative drug companies

Have a good ADC or XDC drug candidate,

By partnering with our end-to-end platform,

It can be advanced to the clinic as quickly as possible.”

From research to clinical, speed is often the lifeline of ADC innovative pharmaceutical companies. In the era of the ADC industry's rapid development, WuXi Helian has fully demonstrated its technical strength and scale in empowering the industry with its world-leading integrated services such as early discovery, clinical development and commercial production of ADC and pan-conjugated drugs. This is a two-way rush of CRDMOs and ADC innovative pharmaceutical companies that have been verified by the technology platform capabilities. So, how is the strength forged?

"Killer weapon"

unified platform

WuXi Biopharmaceuticals is one of the few CRDMOs in the world that focuses on end-to-end services for ADC and other bioconjugate drugs.

According to the 2023 financial report, as of the end of December 2023, WuXi Helian served 345 customers, and the integrated and comprehensive technology platform was the key to success.

In fact, the ADC and pan-drug conjugate markets are developing very rapidly, but the inherent complexity of ADC molecules has made each link such as R&D processes and production more complicated. In order to meet the end-to-end development needs of the industry, WuXi Partners has established an integrated platform to serve this market, which is a full-chain CRDMO.

R stands for cutting-edge drug discovery.

D stands for process development.

M stands for production,

Therefore, the integrated platform created by WuXi Helian

We provide full-chain services.

Li Jincai introduced: "The ADC track is very complex. This is the first time in the history of biopharmaceuticals that small molecules and large molecules are combined to make a drug. Various types of companies have to support the drug's entry into the clinic and finally commercial production from ADC drug discovery to process development. This requires a full-chain service layout, which is also the main reason why WuXi Helian is committed to building an integrated end-to-end capability and platform."

What is the biggest difficulty in developing such end-to-end integrated platform capabilities?

Since the ADC track is developing very rapidly and is an interdisciplinary and cross-field industry, the general industry practice at present is to outsource the different needs of these different disciplines and fields to multiple companies to provide partial services, but this service model is very inefficient and more costly. "It is equivalent to a customer who wants to make a drug and has to connect with many different service companies at the same time, because each service company only has a part of the capabilities. But we can bring together the needs of these different fields and different stages, which is the so-called 'end-to-end service'."

“Due to the end-to-end service capabilities,

In every step of ADC development,

For each component of ADC,

We have a world-class technical team to provide support.

Enabling from drug discovery to commercial production

The whole process."

Fast IND filing

From more than 2 years to 15 months

In fact, in the development process of ADC, due to the many process difficulties of ADC, the research and development and production of "different parts" of ADC have different preparation methods. In the development process of ADC, CMC is a huge challenge.

WuXi Helix's Process Platform

With world-leading standards,

From DNA to IND can be completed within 15 months.

This is half the normal time in the industry.

Li Jincai said: "Customers only need to find one company, WuXi Partners, to complete all the work required for phased or integrated IND and BLA projects, so that the speed of commercialization of drugs can be very fast."

The magic weapon for WuXi HeLian to build a technology platform is to maintain the iteration and leadership of the integrated technology platform through a dual-wheel drive model of independent research and development and external cooperation.

Based on customer needs, WuXi Partners has reached a number of strategic collaborations with many well-known biotechnology companies or biopharmaceutical companies, including Qide Pharmaceuticals, SyntaBio, Multitude Therapeutics/HySlink, IntoCell, etc., including enabling customers to accelerate the discovery of ADC candidate drugs, develop more new bioconjugate drugs, and improve development efficiency and success rate.

ADC Drug GMP Production

No longer a low threshold

The industry has always referred to the drug development process as a "dangerous road with a high risk of death." The complex structure of ADC makes research and development and production face many challenges.

“An ADC drug is equivalent to

The workload of producing three drugs.

The production of an ADC,

Often 7 different suppliers are needed.

At different production bases, around the world several times,"

"The clinical and commercial production of ADCs is a common challenge for the industry, and capacity building is a capability that WuXi Helian focuses on building. We hope that if our customers' products are successfully advanced to the final production stage, they will not have difficulty in finding capacity."

Li Jincai introduced that ADC involves highly active and highly toxic chemicals. The small molecule end is what we call toxins. The production of highly active molecules needs to be carried out in specially designed and strictly operated and managed plant facilities. Existing traditional plants cannot be used. The zoning management model and strict operating procedures ensure that customers can improve the success rate and compliance of drug production. Therefore, a large number of plants need to be specially designed before they can be produced. With the rapid development of the ADC industry, the current production capacity is seriously insufficient worldwide.

At the same time, the safety of ADC drugs has always been a focus of major pharmaceutical companies.

The clinical and commercial production of ADC has always been a common challenge faced by the industry. Solving these challenges requires a professional ADC CRDMO, which conducts one-stop R&D and production based on a deep understanding of each component of the ADC drug, as well as control of complex process development and production capabilities. For the production of highly active and highly toxic molecules, WuXi Biopharmaceuticals currently has three bases in China, of which the Shanghai base focuses on the discovery and development of bioconjugate drugs. The Wuxi base has achieved "one-stop" production in the same park, covering the four core production segments of ADC, including antibody intermediates, payload linkers, conjugated stock solutions, and conjugated preparations, realizing a one-stop production layout in the same park, greatly simplifying the conjugate drug supply chain and significantly shortening the production cycle.

According to Frost & Sullivan, the global ADC drug market is expected to reach US$64.7 billion by 2030, with a compound annual growth rate of 30%. At the same time, the global ADC outsourcing service market is expected to grow significantly to US$11 billion by 2030, with a compound annual growth rate of 28.4%. At present, as a market with less competition, the domestic ADC CDMO, based on a market size of 15%, has derived at least a nearly 10 billion outsourcing market, which can be regarded as a potential CXO segment track.

"This year, many of our customers' products have advanced to the late clinical stage after years of development. They need to undergo process validation and enter the production stage. These are critical milestones before the products can be launched on the market. We need to help our customers successfully complete these important milestones."

Li Jincai emphasized that the capacity layout needs to be forward-looking and synergistic. WuXi Helian has also laid out an operating base in Singapore, which will be put into use from 2026. "According to the three-step strategic plan to increase production capacity, we are accelerating the layout of global commercial production bases to ensure that the company can meet customers' comprehensive and integrated supply chain needs." Li Jincai said.

The views of companies and experts do not represent the official position

Edited by: zy