Wuxi PharmaTech (Cayman), Inc.

The manufacturing and regulatory process of biopharmaceuticals is highly complex and costly to implement, which can be challenging for big pharma companies and startups to take on themselves. Outsourcing the task to CDMOs allows these companies to spend less of their own time and resources at the cost of surrendering full control of the process. A growing number of clinical trials involving advanced therapies is increasing demand for CDMOs, with many technologies gaining traction such as CAR-T cell therapies and gene therapies. As a result, the global CDMO market for advanced therapies was valued ​ at $5.6 billion last year and is projected to soar to $18.8 billion by 2030. However, there are also challenges with the use of CDMOs. One example is evolving industry regulations that make it vital to stay up to date with the latest requirements. Another is the shifting political landscape, such as the U.S.’s movements toward passing the BIOSECURE act ​, which is aimed to clamp down ​ on the use of CDMOs based in China. Here are five of the key CDMOs leading the market, with sprawling facilities around the world and a wide array of services to offer for clients developing advanced therapies. Catalent (Novo Holdings) Headquarters: Somerset, New Jersey, US ​ Founded: 2007 ​ Catalent was set up ​ when Blackstone acquired the pharmaceutical and services assets from Cardinal Health and rebranded them under their current name. Catalent handles the production and supply of therapeutic products across the range of small molecules and biologics. In terms of advanced therapies, the firm has expertise in the production of induced pluripotent stem cells (iPSCs) and viral vectors for gene therapies. googletag.cmd.push(function () { googletag.display('text-ad1'); }); The company went public in 2014, raising around $822 million in an initial public offering on the New York Stock Exchange. In 2023, Catalent raked in ​ almost $4.3 billion in revenue, of which biologics accounted for $1.9 billion. Catalent was acquired by the investment company Novo Holdings, the investment arm of the Novo Nordisk Foundation, earlier this year ​. Novo Holdings forked out $16.5 billion for the CDMO, a 16.5% premium on Catalent’s closing price in February 2024. The move was prompted by a need to boost the production of Wegovy, Novo Nordisk’s lucrative drug for weight loss. Catalent also expanded its clinical supply facility in Germany as part of a $25 million project earlier this year. Lonza ​ Headquarters: Basel, Switzerland ​ Founded: 1897 ​ Nestled in the Swiss Alps, Lonza was set up by a group of Swiss financiers as a company that produced electrochemical products from hydroelectric power on the river Lonza. After World War 1, the firm began to produce more complex chemicals for use in industry and agriculture, and in the 1990s, the company branched into biotechnology with the acquisition of Celltech Biologics. Lonza helps its clients to take advanced therapies from late phase drug discovery and drug substance to commercial supply and drug product. For example, it offers services based on the microbial production of vaccines and recombinant proteins and the manufacturing of antibody-drug conjugates (ADCs) and different types of antibodies. It also helps users to navigate the complexities of cell and gene therapies including T-cell therapies and iPSCs. Lonza’s sales hit CHF 6.7 billion ​ ($7.6 billion) last year, of which its biologics division accounted for CHF 3.7 billion ($4.2 billion). In the same year, Lonza showed the drive to reinforce its expertise in the development of ADCs with the acquisition of the Dutch player Synaffix ​ for up to $175 million. In an expansion effort of its manufacturing capacity, Lonza acquired ​ a large-scale biologics manufacturing facility from Roche for $1.2 billion earlier this year. Thermo Fisher Scientific Headquarters: Waltham, Massachusetts, US ​ Founded: 1956 ​ Thermo Fisher Scientific is a heavyweight supplier ​ of lab equipment such as analytical instruments in addition to consumables. The company launched an initial public offering all the way back in 1967 and listed on the New York Stock Exchange in 1980, with a current market capitalization of $212 billion. In an effort to push into the CDMO space, Thermo Fisher Scientific acquired Patheon for $7.2 billion in 2017, nabbing the latter’s network of manufacturing facilities, which are largely in the US and Europe. At the time, Patheon had earned a neat $1.9 billion in revenue and was shuffled into the larger firm’s Laboratory Products and Services segment. Patheon has experience in the development of a wide range of advanced therapies, with services available for the production of viral vectors as well as cell therapies based on T cells, IPSCs, natural killer cells and more. The firm also offers help with the development of therapies based on messenger RNA (mRNA). Thermo Fisher Scientific’s revenue from 2023 ​ was $42.9 billion, with its Laboratory Products and Services segment accounting for roughly half of the total. Thermo Fisher Scientific also acquired the Swedish proteomics company Olink for $3.1 billion last year to help biopharmaceutical clients to examine diseases at the protein level. Rentschler Biopharma ​ Headquarters: Laupheim, Germany ​ Founded: 1927 ​ Rentschler Biopharma is a family-owned business that has its roots in a pharmacy that was opened in Laupheim in 1872. The company occupies a niche in rare orphan diseases ​ and focuses on offering services for the development and manufacturing of biopharmaceuticals for these conditions. For example, the firm is currently manufacturing eight approved products including bispecific antibodies and recombinant enzymes. Last year, Rentschler provided support with the manufacturing and regulatory development of four newly approved biopharmaceuticals in the US – roughly a quarter of the 17 biopharmaceuticals approved that year. Being family owned gives the CDMO strategic flexibility at the same time as a long-term outlook, among other advantages, said the CEO in 2020 ​. The company is also working with the UK organizations the Cell and Gene Therapy Catapult and Refeyn to deploy automated analytical technology and make the manufacturing of viral vectors more efficient than traditional methods. The CDMO recently completed ​ an expansion of its production site in Milford, Massachusetts, U.S., with a new production line opening operations, representing the biggest investment in the 150-year history of the company. WuXi Advanced Therapies (WuXi AppTec) ​ Headquarters: Shanghai, China ​ Founded: 2000 ​ WuXi Advanced Therapies is a CDMO arm of WuXi AppTec. The larger company originated as the drug development service provider and gradually expanded its offerings over the years, with the acquisition of AppTec Laboratory Services leading to the new name of WuXi Apptec. WuXi Advanced Therapies, also known as WuXi ATU, focuses on the development of advanced therapies such as cell and gene therapies with clients, with expertise in testing and manufacturing to speed up the path of new medicines to the market. For example, the team has cell banking tools to ensure that a client’s cells will pass regulatory standards, and analytical experts that deploy molecular biology, microscopy, flow cytometry-based tests and more to speed up the product development process. In 2021, WuXi AppTec acquired the UK CDMO Oxgene to absorb its gene therapy services into those of WuXi Advanced Therapies. In particular, WuXi was attracted by Oxgene’s viral vector technology which is designed to manufacture cell and gene therapies more simply and cheaply than current methods. Last year, WuXi AppTec reported ​ an overall revenue of RMB 40.3 billion ($5.5 billion) – a 2.5% increase from 2022. Revenue from its CDMO grew to RMB 1.31 billion ($180 million), though its profit margin declined due to the under-utilization of capacity, according to the company.

State-of-the-art facility expands WuXi STA’s capacity and capability for this novel modality, providing a one-stop shop from preclinical to commercial State-of-the-art facility expands WuXi STA’s capacity and capability for this novel modality, providing a one-stop shop from preclinical to commercial Shanghai, January 3, 2020: STA Pharmaceutical Co., Ltd. , (WuXi STA) – a subsidiary of WuXi AppTec – today announced the opening of its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. This significant milestone marks WuXi STA’s establishment of a comprehensive one-stop platform to support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. It enables customers around the world to advance promising new oligonucleotide therapies more rapidly to market for the benefit of patients. Nucleic acid drugs have gradually become a hot area in the global innovative drug industry and many nucleic acid drugs have been approved by the U.S. FDA in recent years. To help customers accelerate new drugs to market, WuXi STA is continuously strengthening its oligonucleotide platform. The new facility, with over 30,000 square feet, is located at WuXi STA’s Changzhou site. With its operation, the Changzhou site can manufacture oligonucleotide APIs up to 1 mol/synthesis run, to better meet the increasing demand of our customers. WuXi STA’s comprehensive platform covers the development and manufacturing of a variety of oligonucleotide modalities including DNA, RNA, Morpholino oligonucleotide (PMO) and peptide conjugates (PPMO). In addition, the company’s industry-leading small molecule process chemistry organization adds further value in handling complex conjugation chemistry that involves oligonucleotide and other molecular modalities, as well as a combination of solid and solution phase chemistry to support next-generation oligonucleotide manufacturing technology development. “By leveraging our small-molecule CMC (Chemical, Manufacturing, and Control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large scale manufacturing facility will empower more global partners to expedite the development and commercialization of oligonucleotide drugs to benefit patients worldwide,” commented Dr. Minzhang Chen, CEO of WuXi STA. WuXi STA’s Changzhou site can now provide services involving small molecule, oligonucleotide and peptide process R&D and manufacturing from laboratory to commercial scales. During the past years, it has successfully passed multiple inspections from the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA), adhering to the highest regulatory standards. About WuXi STA STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: About WuXi AppTec WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,700 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.” Please visit: .

STA Pharmaceutical Co., Ltd., – a subsidiary of WuXi AppTec – and Impact Therapeutics, a biotech focused on innovative drug discovery and development in anti-cancer therapeutics, announce the signing of a strategic partnership agreement. 11/18/19: STA Pharmaceutical Co., Ltd. , (WuXi STA) – a subsidiary of WuXi AppTec – and Impact Therapeutics , a biotech focused on innovative drug discovery and development in anti-cancer therapeutics, announce the signing of a strategic partnership agreement. Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of Impact Therapeutics, providing services covering the entire product development process of Impact’s pipeline new drug candidates for both drug substance and drug product. The new partnership will accelerate Impact Therapeutics’ new pipeline drug development towards commercialization both in China and in the US. Impact Therapeutics holds independent intellectual property rights for a diverse anti cancer therapeutics drug pipeline that includes PARP Inhibitors (IMP4297), Wee1 Inhibitors (IMP7068), DDR target Inhibitors and Hedgehog Pathway Inhibitors (IMP5471). Currently, IMP4297 is in Phase III clinical trials in China, with early clinical data targeting better safety and a wider treatment window. On August 26, 2019, the government of China passed amendments to the Drug Administration Law, which will take effect on December 1, 2019. The revised Drug Administration Law adds a new chapter to better establish the Drug Marketing Authorization Holder (MAH) System including new evaluation and approval systems. The collaboration between innovative pharmaceutical companies and their CDMO partners in this context is vital to optimize the resource allocation and accelerate the new drug development process. Furthermore, the MAH system will strengthen drug regulation and improve drug quality and safety. “We have formed an excellent partnership with WuXi STA over the last few years, and almost all of our pipeline molecules are developed in partnership using their comprehensive service platform. We chose WuXi STA to be our preferred CDMO partner because of their dedication as well as their world-leading integrated CMC (Chemistry, Manufacturing and Control) platform. This means they are able to expedite our products from clinical trial to commercial launch much faster.” said Dr. Jun Bao, President & CEO of Impact Therapeutics. Dr. Minzhang Chen, CEO of WuXi STA, commented: “We are delighted to see the breakthroughs being made by Impact Therapeutics’ diverse pipeline. We are looking forward to further leveraging the scale and innovation capabilities at WuXi STA, along with our global standard quality systems to help our partners accelerate the process of launching new drugs to benefit global patients.” About WuXi STA STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: About Impact Therapeutics Impact Therapeutics is a privately held clinical-stage biopharmaceutical company incorporated in Nanjing, China, dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. The lead program PARP inhibitor IMP4297 is ready for Phase 3 study in China. Impact has assembled most comprehensive global DNA damage response (DDR) pipeline of novel drug candidates generated by in-house discovery platform, and now is expanding to other novel synthetic lethality targets to broaden pipeline coverage. Impact has raised $46 million USD up to date invested by recognized venture capital firms including Lilly Asia Ventures. Currently series D fundraising is ongoing. For more information, please visit: