1. WuXi AppTec
Laboratory Testing Division (LTD)
— Fully Integrated Discovery & Development Testing Solutions
Presenter:
Title:

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Lab Testing Division (LTD) at WuXi AppTec
An Engine to Support Drug Discovery Initiatives
• Strong financial growth fuels continued investment in nurturing talents and developing service
capabilities
• Synergistic businesses in the discovery, preclinical and clinical stages delivering end-to-end services for
PCC nomination and IND/NDA filings
Well-resourced Infrastructure
• 8 Major business platforms
• ～2,000 employees with seasoned leaders, proven scientific credentials and operational expertise
• Established global operations in both China and the U.S. with continued momentum
Unmatched Operational Scale
• One of Wuxi AppTec’s largest divisions with significant contribution to top line and cash flow
• Strong YTY growth driven by several cutting edge businesses
Growth Engine

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Testing Solutions for Drug Development
We provide a world class, fully integrated testing
solution enabling scientists to transform their ideas into the best
healthcare products, moving science from research bench to
hospital bed, in order to better serve our community.
We serve as a healthcare “Silk Road”, which enables
advanced technologies to enter the Chinese market effectively,
by leveraging our deep regulatory expertise, wide reaching sales
and marketing network.
We endeavor to transform ideas into the best healthcare products by offering integrated testing
solutions

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Global Operations
LTD Site
Other WuXi Site
Tianjin
ASU
Suzhou
ONC, DMPK, BAS, TOX, MD
Shanghai (Division Headquarter)
ASU, BIO, ONC, IMMU, DMPK, BAS
Wuhan
ASU
Nanjing
DMPK, BAS
Plainsboro New Jersey
BIO, DMPK, BAS
ASU: Analytical Service Unit
BIO: Biology
ONC: Oncology
IMMU: Immunology Center
DMPK: Drug Metabolism &
Pharmacokinetics
BAS: Bioanalytical Services
TOX: Toxicology
MD: Medical Device

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Synergistic Portfolio
(TOX) Toxicology
(DMPK) Drug Metabolism & Pharmacokinetics
(BIO) Biology
(ASU) Analytical Chemistry & Separation; Analytical Development & Stability
Preclinical
Discovery
Screening
Candidate
Nomination
Lead
Optimization
Clinical Market
A complete value chain supporting all phases of drug discovery
2. IND/NDA Package(ONC) Oncology
1. Discovery Package
(IMMU) Immunology Center
(MD) Medical Device Testing
(BAS) Bioanalytical Services
3. Device Package

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Analytical Service Unit
Analytical Solution from FDA, MPA and CFDA Inspected Laboratories
 The ONLY China-based CRO passing all FDA, MPA and CFDA inspections
 One of the world largest stability storage and testing facilities
 (30,000+ ft3 chamber spaces available)
 Submission-ready CMC Dossiers prepared for global or China submission
 GMP and non-GMP chiral and achiral separations (mg to multi-kg)
 100+ client-initiated audits from the US, EU and Japan since 2006
 Successfully filed 6 INDs to the FDA and 6 CTAs to CFDA
 Stability programs completed for 700 batches of API & drug products
 500+ early phase & 19 NDA/MAA stability programs
 Dedicated teams can perform 10,000 separations per year

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Biology
Better Treatments Begin with Better Screening Platform and Better Disease Models
 Globally recognized platform for antiviral R&D services including HBV, HCV, and
respiratory viruses
 State-of-the-Art in vitro screening platform with Mosaic –controlled compound
management system and Abase-enabled data management system
 Leading CRO in China for PK/PD capabilities in NASH, diabetes, and CNS/Pain
 1st telemetry Electroencephalography (EEG), Electro-Oculogram (EOG),
Electromyography (EMG) monkey models in China .
 1st clinical virology lab with CLIA certification supporting global and domestic HBV and
HCV clinical studies
 1st GLP electrophysiology (e.g. hERG testing) lab in China
 In vitro assay development and transfer: High/medium Throughputs Screening ( HTS & MTS ) and structure
activity relationship (SAR) iteration
 In vivo model development and transfer; efficacy testing; PK/PD analysis; in vivo ephys capabilities
 Early in vitro tox profiling panel: 90+ kinases, 10+ ion channels, 20+ GPCRs
 Since 2008, 20+ preclinical candidates (PCC) delivered ; 10+ in IND stage, 5 moved into phase I clinical
trials, 2 entered phase II clinical trials, 1 in phase III clinical trials with FDA breakthrough therapy designation.

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Oncology
Benefiting Cancer Patients through an Innovative Platform
 End to end Solution & Service with innovative platforms.
CRISPR · Tumor model · Immuno – oncology · Transactional science.
 CRISPR/Cas9 Gene Editing Platform for target ID, validation, and
understanding of drug-resistance mechanism.
 An Industry Leading oncology service platform with PDX, CDX,
syngeneic animal models
 AAALAC accredited animal facilities in Shanghai and Suzhou
 World class Integrated tumor model online database (onco.wuxiapptec.com)
 ~950 PDX models, 150 CDX models, ~50 syngeneic mouse tumor models
 World’s largest collection of Asia-prevalent PDX models
 460+ PDX models characterized by whole exome sequence/RNAseq/ expression/SNP 6.0
arrays

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Immunology Center
Efficacy and MoA studies to facilitate immunotherapy drug discovery
 Numerous autoimmune diseases and inflammation animal models
 Histopathology core equipped with best-in-class automated
systems for high throughput tissue biomarker analysis
 Advanced Flow Cytometry core with 18-color cellular biomarker
analysis and cell sorting capability
 20+ validated tissue biomarkers in IHC, FISH or DISH platform with Ventana Discovery Ultra.
 Validated cellular biomarker analysis of all major hematopoietic cell subsets in lymphoid organs,
tumor microenvironment and peripheral blood etc.
 10+ well-established animal models in rheumatic arthritis, multiple sclerosis, psoriasis, colitis etc.
 CAP accreditation and GCP compliance
 AAALAC accredited SPF animal facility

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Drug Metabolism & Pharmacokinetics
Where Pharmacy and Physiology Intersect
 Services from discovery screening to NDA filing both in China and the US
 ADME assays validated against literature data to ensure accuracy and reliability
 Quantitative whole-body autoradiography (QWBA) studies offered in the US
 Radioanalysis for both clinical (hAME) and nonclinical trials and assays (3H and 14C)
 Early discovery assays are highly automated to support high throughput screening
 Large panel of complicated surgical models offered in rats, dogs and NHPs
 Passed FDA ,CFDA and AAALAC inspections
 Experienced laboratory staff with AALAS certificates
 30+ global partners in new drug discovery leading to 12 PCCs in 2014
 350+ global clients involved in ~100 novel drug IND/NDA studies since 2009 (FDA and CFDA)
 200+ canine and 200+ non-human primate (NHP) colonies dedicated for PK studies
 100+ NHP colonies for PD/PK studies in; diabetes, obesity, dyslipidemia, arthritis, stroke, fibrosis, Parkinson’s

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Bioanalytical Services
Help Define the Best Therapeutic Opportunities
 The largest GLP regulated Bioanalytical lab in Asia with satellite operations in the US
 Nonclinical and clinical support for generic, innovator, biosimilars and biomarkers
 Top of the line equipment including API-6500 LCMS, GYROS, Dual MSD
 Rigorous training program authorized by the CFDA
 Custom in-house antibody production through Abgent to support large molecule studies
 Samples managed by Watson LIMSTM
 Passed FDA, EMA, OECD and CFDA inspections
 1st CLIA certified Central Lab in China
 2,000+ clinical trials supported collectively, 600,000+ samples analyzed per year
 Over 100 active clients and preferred vendor for 6/20 top multinational pharmaceutical
companies
 Fully validating (PK, ADA, Nab) top biologics to provide off-the-shelf analysis for biosimilars.

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Toxicology (Drug)
Ensuring Safe and Reliable Pharmaceutical Products
 Passed FDA, OECD and CFDA GLP inspections
 850+ general toxicology/safety pharmacology studies since 2011
 140+ IND/NDA packages delivered since 2011
 Passed 75+ sponsors’ GLP QA and animal welfare audits
 “ [WuXi Toxicology] maintains an exemplary program of animal care.”
- AAALAC 2013 inspection report
 One of the largest animal testing facilities in Asia at 314,000 ft2
 Housing up to 1,800 NHPs at a given time in US- or EU-compliant caging
 Double-barrier housing for rodents (CFDA and PMDA requirement)
 All animal vendors audited by ACLAM- vet led staff and QA dept. to ensure quality
 Experienced study directors (4 DABT/ERT) and robust training program for technicians.
 Reports can be provided in SEND-format

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Medical Device
Ensuring Safe and Reliable Medical Device Products
 An extension of WuXiAppTec’s US medical device experience
 Biosafety Assessment & Biocompatibility Test (Annex A ISO-10993-1)
 Safety consideration associated with extractable and leachable
 Regulatory consulting
 CFDA fling for international and China customers
 Global filing for China customers
 Tests for Cytotoxicity
 Tests for Genotoxicity
 Tests for Hemocompatability
 Tests for Implantation
 Tests for Sensitization
 Tests for irritation or Intracutaneous reactivity
 Tests for Pyrogenicity
 Tests for Systemic toxicity (acute)
 Test for subacute and subchronic toxicity
 Extractable and Leachable testing
Annex A ISO-10993-1

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LTD’s Core Competitive Advantages
LTD
Resource
Capability
Qualification
 Most comprehensive and integrated CRO with an unmatched portfolio
 Best positioned to support domestic and global drug discovery customers
 Talent Resource
 Financial Strength
 Global Footprint
 Strong Connections with
Pharmaceutical and
Biotechnology Companies
 Gateway to China Market
 1st CMC platform in China
inspected by FDA
 1st GLP preclinical laboratory
in China that is double certified
with an OECD country and
CFDA, passed FDA inspection
 1st GLP/GCP bioanalytical lab
in China that passed FDA,
OECD, and CFDA inspections

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