Mar 2016

Integrated Solutions for

Drug Development，Clinical Diagnostics

and Medical Device Testing Laboratory Testing Division, WuXi AppTec

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Lab Testing Division (LTD) at WuXi AppTec An Engine to Support Drug Development Initiatives

Growth Engine Unmatched Operational

Scale

• One of Wuxi AppTec’s largest

divisions with significant

contribution to top line and cash

flow

• Strong YTY growth driven by

cutting edge businesses

• 7 Major business platforms

• ~1,600 employees with seasoned

leaders, proven scientific credentials

and operational expertise

• Established global operations in

both China and the U.S. with

continued momentum

• Strong financial growth fuels

continued investment in human

capital and developing our service

capabilities

• Synergistic businesses in the

preclinical and clinical stages

delivering services for PCC

nomination and IND/NDA filings

• Expansion into clinical diagnostic

and medical device testing

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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.

Our drug discovery and development service, clinical diagnostic

products and medical device testing experience will enable doctors to

better treat the patients and patients beneficial from precious

medicare.

We endeavor to transform ideas into the best healthcare products by offering integrated testing solutions

A Global Platform Operation in US and China

Wuhan

ASU

Nanjing

DMPK, BAS

Tianjin

ASU

Suzhou

DMPK, BAS, TOX,

MD, Antibody Services

Shanghai (Division Headquarter)

ASU, DMPK, BAS, CDx

Plainsboro New Jersey

DMPK, BAS

LTD Site

Other WuXi Site

ASU: Analytical Service Unit

DMPK: Drug Metabolism &

Pharmacokinetics

BAS: Bioanalytical Services

TOX: Toxicology

MD: Medical Device

CDx: Clinical Diagnostics

Antibody Services

San Diego

Antibody Services

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Integrated Testing Platform Drug Development ,Clinical Diagnostics & Medical Device Testing

• Preclinical Services

• Clinical Services

• Biosafety Assessment & Biocompatibility Test (ISO-10993-1)

• Safety consideration chemical and microbiology testing

• Regulatory consulting

• R&D on innovative clinical diagnostic instruments

• GMP IVD reagent manufacturing

Drug Development

Platform

Medical Device

Platform

In vitro Diagnostic

Platform

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Drug Development Platform

Synergistic Portfolio

(TOX) Toxicology

(DMPK) Drug Metabolism & Pharmacokinetics; PD Models

(ASU) Analytical Chemistry; Separation, Development & Stability

Preclinical Candidate

Nomination

Lead

Optimization Clinical Market

(BAS) Bioanalytical Services; Biomarker Testing

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Preclinical Services

Clinical Services

From preclinical to clinical service

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Preclinical Services IND Enabling Service Overview

Synthesis and Formulation

• Process development

• API manufacturing

• Preformulation

• Formulation development

• Clinical trial material

manufacturing

Quality Control

• Method development & validation

• Compound characterization & batch release

• Stability studies

Regulatory CMC

Analytical Chemistry

• Clinical pathology

• Immunogenicity

• Small/Large molecule bioanalysis

Toxicology

• General toxicology

• Safety pharmacology

• Developmental and reproductive toxicology (CFDA)

• hERG safety assessment

• Genetic toxicology

In Vitro ADME

• Plasma protein binding

• DDI and transporter phenotyping

• Metabolic stability studies

• Metabolite (radio)profiling and ID

In Vivo ADME

• Single and repeat dose PK

• Mass balance (hot or cold)

• Tissue distribution (cold, QTD, QWBA)

• Metabolite (radio)profiling and ID

Bioanalysis

• Biomarker analysis (soluble, cell,

tissue, genetic)

• Small/Large molecule bioanalysis

(GLP-like/GLP)

Metabolic Disease Models and PK/PD Correlation

• Rodent disease models for obesity, diabetes CNS and dyslipidemia

• Rodent NASH models

• Nonhuman primate models for obesity, diabetes and dyslipidemia

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Preclinical Services Track Record

CMC • FDA, MPA, CFDA inspected

• 6 INDs to the FDA, 6 CTAs to CFDA

• 500+ early phase, 19 NDA/MAA stability programs

Safety • AAALAC, FDA, OECD, CFDA inspected

• 125 IND/NDAs to the FDA, 114 CTA/MAAs to the CFDA

• 41 CTA/MAA packages to the EU, 2 IND/NDA packages to other agencies

ADME • AAALAC, FDA, CFDA inspected

• 44 INDs to the FDA, 43 CTAs to the CFDA, 4 IND/CTAs to other agencies

Pharmacology • AAALAC, FDA, CFDA inspected

• 20+ preclinical candidates (PCC), 10+ in IND stage (5 moved into phase I clinical trials, 2

entered phase II clinical trials, 1 in phase III clinical trials)

Clinical Services Overview

Bioanalytical Services Supporting Clinical Studies

• Small Molecule and Biologic Quantitation

• Generic and Innovator Study Support

• Clinical PK Sample Analysis

• Radiolabeled hAME Sample Analysis

• Clinical Metabolite ID and (Radio)Profiling: 3H and 14C

• MIST Cross-species Metabolite Comparison

• 14C-Labeled & 19F-NMR Mass Balance

• Soluble, Genetic, Cellular and Tissue Biomarker Analysis

Bioanalytical Services

Safety Testing

• Chemistry

• Urinalysis

• Hematology

• Coagulation

• Immunology

• Specific Protein

• HbA1C

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Other Services

ADME Services

• CYP, Phase II enzyme and

transporter substrate phenotyping

CMC Services

• Stability Studies and Dossier Preparation

Toxicology Services

• Chronic, Subchronic Tox

• Seg I-III DART Studies

• Carcinogenicity Studies

• Juvenile Tox

• 4-week batch impurity testing

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In Vitro Diagnostic Platform

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Clinical Diagnostics Services Your Partner for Clinical Diagnostics Testing in China

• Certified clinical reference laboratory by Chinese health authority;

• End-to-end tailored solutions from genetic biomarker discovery , development to precision

medicine;

• Advanced platforms and technologies covering immunological , genetic and genomic assays.

Discipline Methodology Biomarker Tests

Molecular

Pathology

• Tissue processing (FFPE, cryo,TMAs)

• H&E

• Assay development

• IHC, ISH, FISH

• Mutation and expression analysis(PCR, RT-qPCR)

• PI3K/EGFR/RTK pathway

• Companion diagnostic (CDx) assays

Genomics

• PCR ,ddPCR and variants

• SNP Analysis

• Digital array

• FISH

• Next generation sequencing

• Viral loads and genotyping

• ADME/PGx

• Gene fusion

• Targeted exome sequencing panels

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GMP Facility Project Plan

Total 3,000 m2 GMP facility for IVD product manufacture

2016 Q1 GMP facility location selection

2016 Q2-Q4 GMP facility installation and

commissioning

2017 Q1 GMP facility to pass validation

2017 Q2 GMP facility operational ready

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Medical Device Platform

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Medical Device

Ensuring Safe and Reliable Medical Device Products

• An extension of WuXi AppTec’s U.S. medical device experience (FDA consulting arm)

• Biosafety Assessment & Biocompatibility Test (ISO-10993-1)

• Tests for Cytotoxicity

• Tests for Genotoxicity

• Tests for Hemocompatability

• Tests for Implantation

• Tests for Sensitization

• Safety consideration associated with extractable and leachable

• Regulatory consulting

• CFDA filing for international and China customers

• Global filing for China customers

• Tests for irritation or Intracutaneous reactivity

• Tests for Pyrogenicity

• Tests for Systemic toxicity (acute)

• Test for subacute and subchronic toxicity

• Extractable and Leachable testing

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Antibody Services Customized Antibody Preparation and Services for Research and Drug Discovery

• Leading research antibody provider in the U.S. and China with a mature distribution and logistics network

• Custom antibody and antigen development to support both diagnostic and research applications

• Access to WuXi AppTec’s clinical trial infrastructure for companion diagnostics development

• Over 57,000 cataloged RUO Antibodies

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LTD’s Core Competitive Advantages

Transactional science, from preclinical to clinical , from laboratory to ward beds.

Platform of drug development ,clinical diagnostic and medical device testing.

Resource

• Talent Resource

• Financial Strength

• Global Footprint

Qualification

• 1st CMC platform in China inspected by FDA

• 1st GLP preclinical lab in China double certified

with an OECD member country with CFDA and

FDA inspections

• 1st GLP/GCP bioanalytical lab in China to pass

FDA, OECD and CFDA inspections

Capability

• Well established base

with pharmaceutical and

biotechnology companies

• Bridging pharmaceutists,

doctors and patients

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ltd.wuxiapptec.com

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Transforming ideas into the best healthcare products through

integrated testing solutions