WuXi AppTec Laboratory Testing Division (LTD)— Fully Integrated Discovery & Development Testing Solutions

Presenter:

Title:

2

Lab Testing Division (LTD) at WuXi AppTecAn 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

3

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

4

Global Operations

LTD Site

Other WuXi Site

TianjinASU

SuzhouONC, DMPK, BAS, TOX, MD

Shanghai (Division Headquarter)ASU, BIO, ONC, IMMU, DMPK, BAS

WuhanASU

Nanjing DMPK, BAS

Plainsboro New JerseyBIO, 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

5

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

6

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

7

BiologyBetter 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.

8

OncologyBenefiting 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

9

Immunology CenterEfficacy 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

10

Drug Metabolism & PharmacokineticsWhere 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

11

Bioanalytical ServicesHelp 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.

12

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

13

Medical DeviceEnsuring 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

14

LTD’s Core Competitive Advantages

LTDResource

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

`

ltd.wuxiapptec.com

15

Endeavor to transform ideas into best healthcare

products by offering integrated testing solutions