The CDMO with the KNOW HOW
To help you get things done
Company Overview
Bryan Splawn PhD, MBA
Director, Business Development – Large Molecules, Small Molecules, and Advanced Therapies
bryansplawn@asymchem.com
Stock Code: 002821.SZ / 6821.HK
1
Company Overview
State-of-the-Art Facilities
•
Founded 1999, North Carolina, USA
•
Manufacturing Site, Tianjin (TJ1) established 2001
•
Listed Shenzhen Stock Market 2016 and Hong Kong Exchange 2021
•
Total of 8 manufacturing sites
•
Built to US / European standards
•
Single Quality Management system across all manufacturing sites
•
Over 9800 employees (43% = R&D and Analytical employees)
•
Reactors ranging in size from 5L to 20,000L
•
Pilot scale up to commercial production
800+
Global Clients
20+
8
Years in
Business
R&D
Manufacturing
Sites
2
2
Company Overview
Confidential | 保密文件
Full Scope of Capabilities
Ingredients to match your project needs
ORAL SOLIDS
STERILES
BIOLOGICS
Tablets
Liquid-Filled Injectables
Monoclonal Antibodies (mAb)
Capsules
Lyophilized Powders
Bispecific Monoclonal Antibodies (bsAb)
Granules
Inhalation
Antibody Drug Conjugates (ADC)
Pellets
Nasal
Antibody Oligo Conjugates (AOC)
Suspensions
Ophthalmic
Radionuclide Drug Conjugates (RDC)
Peptide Drug Conjugates (PDC)
TOPICALS
Recombinant & Fusion Proteins
mRNA, siRNA, rDNA, Plasmids
Gels
Peptides, Oligonucleotides, Enzymes
Ointments
Lipids, Polysaccharides, Polymers
Creams
3
3
Company Overview
Confidential | 保密文件
Chemistry R&D
Innovative Chemistry for Improved Efficiency
R&D Capabilities
• Process Chemistry R&D
•
•
•
•
Safety Assessment
Full DoE Design
Flow Chemistry research
High Potency compounds synthesis research
4200+
R&D Capacity
Scientists
> 50% hold
MSc or above
• > 4200 research scientists
• > 50% hold an MSc or above
• > 600 hoods for chemical development
4
4
Company Overview
Confidential | 保密文件
Analytical Testing
Small Molecule Comprehensive Service Support
Capabilities
Equipment
• Analytical Method Development and Validation
• HPLC, GC, ICS-1500/5000, UPLC,SFC
• Stability Testing
• LC-MS, LC-MS/MS, LC-TOF, ICP-MS
• Spectroscopic Structure Confirmation
• GC-MS, HS GC-MS
• Release Testing
• NMR(300, 400,500MHz), ICP-OES, XRD,
FTIR, UV-vis, OR
• Identification Product and Pathway
• Cleaning Validation
• Physical Property Characterization
• Microbiology Testing
- Endotoxin/aseptic/potency/positive
bacteria testing
• pKa logP/D test, HS KF-V20, KF-C20, TOC,
Melting Point Detector
• TGA, DSC, DVS, PSA, Potentiometric Titrator
• Stability Chambers
• Full in-house release of DS and DP
5
5
Company Overview
Confidential | 保密文件
Bio-Analytical Testing
Biomolecule Comprehensive Service Support
6
6
Company Overview
Confidential | 保密文件
A single source for everything you need
Analytics, compliance, IP protection, supply chain assurance – we’re a one-stop shop for everything you need.
Asymchem full lifecycle support services*
Fully
Integrated
Service
Ecosystem
7
7
Company Overview
Confidential | 保密文件
Quality & Compliance
We play by the rules – and the results speak for themselves
50+
•
Received and passed quality audits from various regulatory agencies
from around the world
•
USFDA – 11 inspections since 2011; most recent 2022 (desktop
assessment)
•
Australian TGA (2015, 2019 onsite | 2022 Remote)
•
Korean MFDS (2017)
•
China NMPA – 26, most recent in 2019
•
Japan PMDA (2017, 2018, 2019)
•
Live virtual audits upon request
Successful
Product
Validations
< 3 Years
300+
Successful
Customer
Audits
30+
Successful
USFDA,
NMPA, TGA
Inspections
8
8
Company Overview
Confidential | 保密文件
Our Partners Agree
Asymchem has been regularly recognized as a “Most Valuable Strategic
Partner” by some of the world’s leading pharma companies.
“Great work in manufacturing more than
enough RSMs to meet our API demands
for our CTM/Validation campaign. You
did a great job controlling the purity of
these materials. Thank you.”
– Director of Synthetic Chemistry, at a Biopharma Company
“Asymchem’s ability to identify and provide
solutions to difficult challenges, while maintaining
outstanding quality under aggressive timelines,
has distinguished Asymchem as a top-notch
Contract Manufacturing Organization.”
– Tom Wagler, Ph.D., VP, CMC Drug Substance Development at Mersana
“We are impressed with the high competency
of all the Asymchem teams, in every aspect of
the business, and this gives us lots of
confidence in Asymchem.”
“Thank you! The Asymchem Team did a fantastic
job from start to finish in developing, characterizing
and validating a scalable, commercially viable
HPAPI manufacturing process”
– Director Global Procurement, at Major US Pharma company
– VP Drug Development, Mid-sized Biotech
9
9
Company Overview
Confidential | 保密文件
We Are a Partner Who’s Ready for What’s Next
Asymchem offers a superior mix of CDMO solutions today while continually
driving new innovations to give you a greater advantage tomorrow.
Thank You, we look forward
to working with you!
10