simcere company presentation 2011.9

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1 Simcere Pharmaceutical Group Emerging Leader in Developing, Manufacturing and Marketing of pharmaceutical products in China September 2011

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Page 1: Simcere Company Presentation 2011.9

1

Simcere Pharmaceutical Group Emerging Leader in Developing, Manufacturing and

Marketing of pharmaceutical products in China

September 2011

Page 2: Simcere Company Presentation 2011.9

Disclaimer

The information contained in this presentation does not constitute or form part of any offer for sale or subscription of or solicitation or invitation of any offer

to buy or subscribe for any securities nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment

whatsoever. Any public offering of the securities to be made in the United States will be made solely by means of the prospectus in the registration

statement. The prospectus contains detailed information about the Company and its management as well as the financial statements of the Company.

Any decision to purchase securities in the offering for sale in the United States or anywhere else should be made solely on the basis of the information

contained in the prospectus. This presentation does not contain all relevant information relating to the Company or its securities, particularly with respect

to the risks and special considerations involved with an investment in the securities of the Company, and is qualified in its entirety by reference to the

detailed information appearing in the prospectus.

This presentation contains forward-looking statements, including statements about the Company’s business outlook, our strategy and market opportunity,

and statements about the Company’s historical results that may suggest trends for its business. These statements are individually and collectively

forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

These forward-looking statements are made only as of the date of this presentation and the Company undertakes no obligation to update or revise.

These statements are based on estimates and information available to the Company at the time of this presentation and are not guarantees of future

performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Therefore, prospective investors are cautioned

that actual results may differ materially from those set forth in any forward-looking statements herein.

The information contained in these slides has not been independently verified. No representation or warranty, express or implied, is made as to, and no

reliance should be placed on, the fairness, accuracy, completeness or correctness of any information or opinion contained herein. The information

contained in these slides should be considered in the context of the circumstances prevailing at the time and has not been, and will not be, updated to

reflect material developments which may occur after the date of the presentation. None of the Company, any underwriter of securities of the Company, or

any of their respective directors, officers, employees, agents or advisers shall be in any way responsible for the contents hereof, or shall be liable for any

loss arising from use of the information contained in this presentation or otherwise arising in connection therewith.

Before you invest, you should read the prospectus in the registration statement the Company filed with SEC and other documents the Company has filed

with the SEC for more complete information about the Company and this offering. You may get these documents for free by visiting EDGAR on the SEC

Web site at www.sec.gov. Alternatively, you may request the prospectus by sending us a request via our website at www.simcere.com.

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Page 3: Simcere Company Presentation 2011.9

Company Snapshot

Publicly listed on NYSE, with highest standard of corporate compliance and transparency

~3000 sales reps and 1,500 distributors, covering over 3,000 hospitals and 70,000 retail

pharmacies

Leading R&D capabilities in China ranging from early stage discovery to clinical operations

8 GMP facilities supporting small molecule, biologics, and vaccine manufacturing 3

Page 4: Simcere Company Presentation 2011.9

A Leader in China’s Pharmaceutical

Industry

304

466 564

737

951

1369

1741

1850

2141

0

500

1,000

1,500

2,000

2,500

2002 2003 2004 2005 2006 2007 2008 2009 2010

Ranking:

#21 in Net Profit in

China

healthcare

industry*

#7 among the Top

20 most

competitive

public listed

healthcare

companies in

China

* 2009 Chinese Medical Statistical Yearbook by Ministry of Industry and Information Technology of PRC

4

Revenue (M, RMB)

Page 5: Simcere Company Presentation 2011.9

Key Strategy

Focus on five therapeutic areas in the mid to high-end markets

Oncology, Neuroscience, Cardiovascular, Inflammation, and Infectious

Disease

Leveraged on deep channel penetration and branding advantage to

expand generic market

Strengthening in-house R&D capabilities and cross boarder

collaboration to develop products quickly and effectively

Executing Our Product-Oriented M&A Strategy

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Page 6: Simcere Company Presentation 2011.9

Differentiated Products with Market Leadership in

Oncology and CNS

6

Therapeutic Area Brand Name Product

Oncology

Endu Proprietary recombinant human endostatin injection, NSCLC

Jiebaishu Nedaplatin injection

Sinofuan 5FU sustained release implant

Jiebaili Pemetrexed

Lowvo Palonosetron

Neuroscience Bicun/Yidasheng Edaravone injection, ischemic stroke

Cardiovascular

Xinta Levamlodipine besylate tablets, hypertension

Shufutan Rotuvastain generics, hyperlipidemia

Infectious Disease Anxin Biapenem injection, bacterial infection

I

nflammation Yingtaiqing Diclofenac sodium delayed release capsules , arthritis pain

Page 7: Simcere Company Presentation 2011.9

Strong Commercial Muscle and Deep Channel

Penetration

7

Over 3,000 hospitals Over 70,000 retail

pharmacies

Large field force with broad geographical reach

Proven Ability To Quickly

- Select and Position Product - Generate Strong Sales - Build Up Brand and Loyalty

• Collaborating with distributors who have direct selling to the end customers

• Continuing to build up our well trained professional sales team

• Cooperating with nation wide top drug store chains

• Seeking opportunities to leverage on the healthcare reform

Page 8: Simcere Company Presentation 2011.9

Diversified R&D Strategy to Deliver

Sustainable Pipeline

8

Approaches

• Branded generics

• First-to-market generics

• Biosimilar

• Novel: best-in-class

Therapeutic Areas

• Oncology

• Neuroscience

• Cardiovascular

• Infectious disease

• Inflammation

Treatment Modalities

• Small molecules

• Biologics

• Peptides

• Vaccines

Page 9: Simcere Company Presentation 2011.9

With Increasing Focus on Novel Products

Category Contribution to Revenue

2005 2006 2007 2008

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Page 10: Simcere Company Presentation 2011.9

Endu: Proprietary Molecular Targeted

Therapy for NSCLC

rh-Endostatin with nine

additional AAs at the N-

terminus (Endostar)

Stable at low pH (2.5) and at

high temperature (100 ℃)

Solubility: >15 mg/ml

Shelf life: 18 months at 4 ℃

Manufactured in E. coli

Large-scale inclusion body

refolding

0.5 mg/ml, with >50%

recovery Endostatin Endu(Endostar)

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Page 11: Simcere Company Presentation 2011.9

Pipeline Overview

Inflammation Iguratimod tablets

Oncology Oxaliplatin

Oncology Endu combined with NP Therapy

Cardiovascular rh-RGD-Hirudin for injection

Oncology Bendamustine for injection

Cardiovascular Oral fixed dose combination of

amlodipine & irbesartan

Oncology SIM-0930 (protein tyrosine kinase

inhibitor)

Oncology SIM6802 (protein tyrosine kinase

inhibitor)

Oncology SIM010603 (protein tyrosine

kinase inhibitor)

Oncology SIMBD0801 (MAb)

Cerebrovascular SIM071201

Oncology SIM0710 (PEG-Endostar injection)

Onclogy SIM-817378

Key Product

Candidate

Therapeutic

Areas

Status

Pre-

clinical

Phase

I

Phase

II

Phase

III

New Drug

Application

Lead

Optimization

Lead

Discovery IND

IND approved

Approved

Page 12: Simcere Company Presentation 2011.9

A staff of ~300, located in Nanjing, Shanghai, Beijing and Yantai

PhD: ~20%; MS: ~60%; 25 staff members with Western training/working experience

Ongoing aggressive recruitment of industrial veterans from US in all R&D areas

Nanjing R&D Center: 200,000 sf

7% of total revenues as R&D budget

Institute of Discovery Chemistry

Nanjing Prof. Xiaojin Yin, SVP

Dr. Peng Wang, CSO

Institute of Discovery Biology

Nanjing

Institute of Chem., Pharm.

& Anal. Development

Nanjing

Institute of Biologics Research

Nanjing

Institute of Vaccine

Research

Nanjing

Shanghai R&D Center

Shanghai

Recombinant Proteins R&D

Center

Yantai

Beijing

Dept. of Market Res. and Business

Development

Nanjing

Institute of Clinical

Research

Nanjing

Office of Intellectual Properties

Nanjing

Dept. of Project

Management

Nanjing

Dept. of Regulatory

Affairs

Nanjing

Beijing

Dept. of Operation &

HR

Nanjing

Simcere R&D Organization

Page 13: Simcere Company Presentation 2011.9

Strong Track Record

Clinical development:

Over 30 successfully completed clinical trials

Endu Ph IV trial completed in Dec. 2009, with >3,000 patients recruited, the largest clinical

study in China history

Regulatory affairs:

Approximately 100 NDAs/ANDAs obtained

Five (5) INDs filed in 2010 alone

A FIH trial in Australia completed

Endu has been re-registered for marketing authorization in 2010: the first in China

New head of Regulatory Affairs, Mr. Bo Xu (a former SFDA reviewer), has been on board

since 2010

~120 patents and patent applications

Over 100 scientific publications

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Page 14: Simcere Company Presentation 2011.9

M&A Licensing and

Collaboration

Internal

Programs

Externalization Critical to Overall

R&D Strategy

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Page 15: Simcere Company Presentation 2011.9

Selected Key Partnerships

Innovative Strategic Partnership

Joint Venture partnership with Merck (2011):

A transformational deal that cements Simcere’s

leadership in branded generics market in China

A strategic partnership with development,

registration, manufacturing and sales capabilities

Initial focus on cardiovascular and metabolic

diseases

R&D strategic partnership with BMS (2010):

Co-development partnership

A small molecule oncology compound in preclinical

development

Simcere responsible for development and

commercialization in China

BMS has option to resume global development (ex-

China) after Simcere achieves PoC in man

Traditional In-Licensing

OSI Pharmaceutical (2009):

A small molecule protein kinase inhibitor in Phase I

development

Simcere responsible for development and commercialization

in China

OSI responsible for ex-China global development

Epitomics (2009):

A humanized rabbit monoclonal antibody in preclinical

development

Simcere responsible for development and commercialization

in China

Simcere and Epitomics to share cost of development

outside of China

GSK (2006):

Simcere licensed the rights to develop an authorized generic

version of Relenza in China

Product approved in China in 2010

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Page 16: Simcere Company Presentation 2011.9

Key Areas of Partnering Interests

Oncology

Molecular targeted therapies of both small molecules and biologics

based on validated or novel mechanism of action

Cytotoxics differentiated on efficacy and/or tolerability with proof-of-

concept in man

Early stage opportunities and novel technology platforms that lead to

step change in cancer therapy

Neuroscience

Cerebrovascular disease treatment and neuroprotectant

Alzheimer’s Disease – disease-modifying therapies with proof-of-

concept in man

Cardiovascular and Metabolic Disease

Atherosclerosis, thrombosis, anti-coagulation, anti-platelet, atrial

fibrillation agents and diabetes

Infectious Diseases

Antibacterias that address bacterial resistance and serious infections

Antifungals

Antivirals – HBV and HCV only

Inflammation

Rheumatoid Arthritis – disease modifying agents with potential to

differentiate based on efficacy and/or cost of treatment

Flexible deal

structures

Aim to create win-

win partnership

Structure deals to

fit partner’s

strategy

Committed to

fostering growth

and sharing

success

Efficient process

Identify and

evaluate

opportunity

Conduct due

diligence and

negotiate

agreement

Implement and

manage project,

moving toward

success

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Page 17: Simcere Company Presentation 2011.9

Value Proposition to Partners

Leverage Simcere’s internal R&D capability to develop partner’s asset in

China under the FDA and SFDA requirements

Accelerate clinical trials indications through faster patient enrollment

Generate critical data package to support global development

Leverage Simcere’s powerful commercial platform to achieve rapid and

broad market access

Utilize Simcere’s experience, resources, leadership and homeland

advantage to penetrate the market

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Page 18: Simcere Company Presentation 2011.9

Simcere’s Commitment

Clear corporate mandate of externalization

Bring products to address significant unmet medical needs in China

through sourcing global innovations

Commitment to fostering partnership and sharing success

Flexible deal structures

Highest standard of corporate compliance and transparency

Experienced management team with proven track record

World-class R&D leadership team with U.S. industry veterans

Clinical Advisory Board with leading thought leaders in the U.S.

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