We are a leading contract research, development and manufacturing organization (“CRDMO”) focused on the global antibody-drug conjugate (“ADC”) and broader bioconjugate market and dedicated to providing integrated and comprehensive services. Leveraging expertise in both biologics and small molecules, we offer interdisciplinary and comprehensive services, covering bioconjugate discovery, research, development and manufacturing. We provide these services from proximately located and dedicated laboratories and manufacturing facilities, leading to significant reduction of development timeline and costs. We are the second largest CRDMO for ADCs and other bioconjugates globally in terms of revenue in 2022, according to Frost & Sullivan. Our global market share by revenue increased from 1.8% in 2020 to 4.6% in 2021 and 9.8% in 2022.
Our Services
Our fully integrated, one-stop bioconjugate platform offers comprehensive CRDMO services, including discovery, process development and Good Manufacturing Practice (“GMP”) manufacturing for bioconjugates, monoclonal antibody intermediates and payload-linkers associated with bioconjugates. Our discovery services involve discovery chemistry, conjugation discovery, in vitro and in vivo characterization and developability for preclinical candidate selection. We also enable preclinical and clinical studies through bioconjugate drug substance process development, bioconjugate formulation development, analytical method development and late-stage development and process validation. In addition, we have capability of GMP-compliant manufacturing of drug substance and drug product through our dedicated and specialized facilities. We also expect to launch the commercial GMP manufacturing of ADC products in the near future.
Our Capabilities
We are committed to continuously enhancing our platform, propelling and transforming the development of the bioconjugate industry, enabling global biopharmaceutical partners and benefiting patients worldwide. Our fully integrated, one-stop bioconjugate platform boasts a rich portfolio of conjugation technologies, extensive expertise in payload-linker synthesis and process development, industry-leading process development know-how, comprehensive analytical methods, as well as dedicated and specialized facilities. In particular, we seamlessly integrate the multidisciplinary expertise in both biologics and small molecules critical to comprehensive discovery, development and manufacturing of ADCs and other bioconjugates.
We have accumulated vast hands-on experience in bioconjugates, generating over 7,000 bioconjugate molecules for our customers incorporating over 500 protein carriers and over 600 payload-linkers. We have completed chemistry, manufacturing and control (“CMC”) development and initiated GMP manufacturing using over 10 conjugation technologies for both ADC and other bioconjugates, making our portfolio of conjugation technologies one of the richest among bioconjugate outsourcing service providers, according to Frost & Sullivan. Our conjugation expertise goes beyond ADC and encompasses radionuclide drug conjugates (“RDC”), peptide-drug conjugate (“PDC”), antibody-chelator conjugate (“ACC”), PEGylated protein or peptide (i.e., protein or peptide conjugated with polyethylene glycol (“PEG”)), antibody PROTAC conjugate (i.e., antibody conjugated with proteolysis targeting chimera (“PROTAC”), which is a type of targeted protein degradation agent), antibody-oligonucleotide conjugate (“AOC”) and fatty-acid conjugate, among others. We have also built extensive expertise in payload-linkers, which are critical components of bioconjugates. We not only have developed a rich library of off-the-shelf payload-linkers, but also enable our customers to develop and manufacture a wide variety of tailor-made or proprietary payload-linkers by offering synthesis, process development and GMP manufacturing services. Through expanding collaborations with our partners, we also provide customers with access to a large variety of proprietary payload-linkers and conjugation technologies.
Moreover, we have developed industry-leading process development know-how for various types of bioconjugates. Our process development expertise ensures optimization of critical quality attributes, including drug load ratio (DAR), free drug removal, process efficiency and consistency. As a demonstration of our capabilities, we have initiated GMP manufacturing of bioconjugates involving several conjugation technologies, including our patented WuXiDAR4 technologies, non-natural amino acid (“NNAA”) site-specific conjugation, tyrosine tubulin ligase-assisted conjugation, sortase-assisted conjugation, farnesyltransferase-assisted conjugation, and traceless affinity peptide labeling conjugation. WuXiDAR4 technologies enable customers to achieve tight control of product homogeneity and lot-to-lot consistency, which in turn improve the pharmacokinetics profile and stability of bioconjugate products and potentially result in better clinical outcomes.
Our integrated capabilities are also reflected in the one-stop GMP manufacturing of bioconjugates. We strategically offer our services from proximately located operation sites in Wuxi, Shanghai and Changzhou in China, where we have established dedicated and specialized facilities for bioconjugates. As such, we can better manage the supply chain and coordinate development and manufacturing operations, leading to expedited development timelines and improved quality and cost efficiencies for customers. For example, in general, we are able to process from the antibody DNA sequence to bioconjugate IND filing in approximately 13 to 15 months. Our fully integrated capabilities lay a solid foundation for our comprehensive service offerings that enable our customers to bring innovative bioconjugate therapeutic solutions to patients worldwide with high quality and speed. At the forefront of the global bioconjugate development, we believe our platform will also enable us to address the industry challenges and lead the global development trends of ADCs and other bioconjugates. As an industry recognition of our capabilities, we won the runner-up prize in the “Best Contract Manufacturing (CMO) Provider” category of the 2022 World ADC Awards and the “Best Contract Development Manufacturing Organization (CDMO)” prize at the 2023 World ADC Awards.
Our Achievements
We ranked No. 2 globally and No. 1 in China among CRDMO for ADCs and other bioconjugates in terms of revenue in 2022, according to Frost & Sullivan. Our global market share by revenue increased from 1.8% in 2020 to 4.6% in 2021 and 9.8% in 2022. By the end of 2022, we had 94 ongoing integrated projects, representing over 35% of the total number of outsourced integrated projects for bioconjugates globally in the same year, according to Frost & Sullivan. With our extensive technical capabilities and impeccable track record, we have become a trusted partner leading the bioconjugate development globally with a broad, loyal and fast-growing customer base. We employ an “enable, follow and win the molecule” strategy to not only grow with our existing customers by providing services from an early stage of their product development cycle, but also win new customers as their bioconjugates progress. As of the end of 2020, 2021, 2022 and June 30, 2023, as the result of our “enable” strategy, we had cumulatively progressed 9, 12, 24 and 30 ADC candidates, respectively, from discovery to CMC development. As the result of our “win the molecule” strategy, among the 110 ongoing integrated projects we had as of June 30, 2023, 36 were transferred to us from our customers or their outsourcing service providers. Our diverse and growing customer base includes both innovative biotechnology companies and global pharmaceutical companies, many of which are leading players in the ADC and bioconjugate space with potentially first-in-class or best-in-class pipeline programs. The number of our customers grew significantly from 49 in 2020 to 115 in 2021, 167 in 2022 and 169 in the six months ended June 30, 2023. As of June 30, 2023, we had served 304 customers cumulatively, including most of the major players in the global ADC and bioconjugate market. As of the same date, we had won ADC development contracts for all ADC candidates in China with dual filing of IND and/or BLA in China and the United States, and eight out of the 10 China-based companies that out-licensed their ADC pipelines overseas since 2022 are our customers.
We have a large number of integrated projects for ADCs and other bioconjugates. As of June 30, 2023, we had 110 ongoing integrated projects and helped customers to submit IND applications for 47 ADC candidates globally, and in 2022 alone, we helped customers submit IND applications for 18 ADC candidates globally. We have executed 350 discovery projects since our inception and as of June 30, 2023.
We attribute our success to our visionary team of seasoned senior management supported by a pool of talented scientists. We are led by Dr. Jincai Li, our chief executive officer, who is supported by members of our senior management team, all of whom have extensive experience and diverse expertise in the pharmaceutical industry both domestically and internationally. We also benefit from a strong shareholder support from the WXB Group and the WXAT Group. Our heritage brings us with strong trust from industry participants in our field-tested capabilities and world-class quality.
Source: WuXi XDC (02268) Prospectus (IPO Date : 2023/11/07) |