ChemExpress Provide One-Stop CRO & CDMO Services

Who we are

ChemExpress is a global CRO & CDMO company with nearly 20 years of experience. We specialize in providing CDMO services for small molecules and new modalities to pharmaceutical and biotech clients worldwide. Our comprehensive, one-stop service platform supports our clients' projects from early drug discovery and process development to commercialization.

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We specialize in

• Drug Discovery: synthetic chemistry; medicine chemistry; FTE/FFS services.
• Process Development: APIs and intermediates development; formulation development.
• New Modalities Development: ADC; peptide; oligonucleotide and so on.
• Manufactory: support production from milligrams to kilograms, both with GMP and non-GMP capabilities.
• Analytical Development & Quality Control: R&D testing; stability study; genotoxic impurity research and so on.
• Regulatory CMC Support

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ChemExpress One-Stop CRO & CDMO Platform

Our Capacity

10+ R&D and Manufacturing Sites

ChemExpress operates 10+ R&D and manufacturing sites, significantly enhancing our capacity to support our clients.

For example:

Ma'anshan Anhui, China-ADC Payload-Linker HPAPI Manufacturing：

• Total area: ~118,403 square feet
• 4 GMP HPAPI production lines (OEB5, OEL 0.01μg/m3), total volume over 4,000L
• Multiple prep-HPLC and Lyophilizers
• Compliant with FDA/EMA/NMPA regulatory standard, passed 2 EU QP audits

Qidong, Jiangsu, China- Drug Product Manufacturing：

• Total area: ~139,930 square feet
• 7 Independent cleanrooms meet cGMP
• Oral solid dosages: 4 commercial-scale plants, ~1 billion units per year
• Semi-solid topical dosages: 2 commercial-scale plants, ~40 million tubes per year
• Solid dispersion: a large-scale topical preparation line
• Drug manufacturing license: tablets, hard capsules, granules, powder, cream, ointment, gel and anti-tumor drugs

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ChemExpress CRO & CDMO Global Footprint

8 Enabling Technologies Platforms

We have 8 Enabling Technologies Platforms, equipped with professional teams and advanced instrumentation that can effectively accelerate the progress of drug research and development.

For example:

• Our photochemistry platform embodies green and sustainable development principles, with over 16 years of experience. Equipped with multiple sets of LED light sources, we can assist our clients in synthesizing complex and difficult-to-scale compounds, supporting production from milligrams to kilograms.

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ChemExpress Enabling Technologies Platform

As one of the earliest CDMO companies engaged in ADC production, we possess unique advantages in ADC drug development.

ChemExpress provides a one-stop CRO & CDMO service for the small molecule aspect of ADC drugs, as well as customized ADC conjugation services. We have assisted with the launch of the ADC drug RC48, the first ADC drug developed and approved in China. With an existing inventory of 80 payloads and 400 linkers, along with over 1,000 experiences in linker compound synthesis, we have empowered over 780 customers in their ADC small molecule projects to date.

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ChemExpress New Modalities Enabling Platform

Quality Assurance Compliance

• 5+ successful EU 3rd party QP on site GMP audit
• 6+ successful China NMPA inspections
• > 160+ client audits (USA, EU, Canada, China, Israel, etc.)
• 2 joint State and Provincial NMPA on-site PAI and GMP inspections supporting NDA by MAH

Intellectual Property Management

We strictly implement IP management to ensure the confidentiality of customers intellectual property and information transmission, as well as the security of archival data storage.

ESG management

ChemExpress enhances ESG management to achieve sustainable development. We have two process safety laboratories, accredited by CNAS, ensuring process safety management throughout the production cycle.

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