celltrion healthcare company brochure(2016)

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Celltrion Healthcare Co., Ltd. Contact information 19, Academy-ro 51 beon-gil, Yeonsugu, Incheon, 406-840, Republic of Korea T +82-32-850-6400 F +82-32-850-6498 E [email protected] For more information, please visit www.celltrionhealthcare.com © Celltrion Healthcare Co., Ltd. 2016 HCREM-00 PB-0916/03 Advanced Therapeutics within Everyone’s Reach

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Page 1: Celltrion Healthcare Company Brochure(2016)

Celltrion Healthcare Co., Ltd.

Contact information19, Academy-ro 51 beon-gil, Yeonsugu, Incheon, 406-840, Republic of KoreaT +82-32-850-6400 F +82-32-850-6498 E [email protected] more information, please visit www.celltrionhealthcare.com

© Celltrion Healthcare Co., Ltd. 2016 HCREM-00 PB-0916/03

Advanced Therapeutics within Everyone’s Reach

Page 2: Celltrion Healthcare Company Brochure(2016)

Advanced Therapeuticswithin Everyone’s Reach

Celltrion Healthcareis a biopharmaceuticalcompany committed

to delivering moreaffordable advanced

therapeutics for patients.

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Meeting the needs of the medical �eld

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A ccess to advanced yet costly therapeutics isoften a challenge to patients and healthcareproviders. In particular, biologics1) have become

an increasingly important but also expensive part of the global medicine cabinet.

We believe that every patient deserves access totreatments they need. Based on this belief, Celltrion Healthcare has been steadfast in our mission to meet the needs of patients who previously had limited access to advanced therapeutics since our inception in 1999 by developing biosimilar2) products. As a result, our biosimilar products have been approved in over 70 countries, being prescribed in more than 50 countries.

Ushering a new era of biologics in, we strive to o�erhigh-quality and cost-e�ective solutions in breakthroughtherapies and contribute to improving global healthcare.

1) biologics: a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

2) biosimilar: bio-equivalent versions of already-licensed biological medicines. A true biosimilar must be proven equivalent in terms of safety, e�cacy and quality to a previously-licensed biologic.

Page 3: Celltrion Healthcare Company Brochure(2016)

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Biosimilar development to distribution

Celltrion

Cell LineDevelopment &

Cell Banking

STAGE 1Manufacturing

Process

STAGE 2Celltrion Healthcare

North America

South America

Australia

North Africa

Asia

Europe

Korea

South Africa

Marketing,Sales, and

Distribution

STAGE 3

Celltrion Group

CelltrionCelltrion specializes in the research and development of highquality mAbs3) and innovative biopharmaceuticals utilizing itsaccumulated R&D technology and production capabilities.

Celltrion boasts one of the world’s largest state-of-the-artmammalian cell culture plants with a total production capacity of 140,000L.

Celltrion Healthcare Celltrion Healthcare conducts worldwide marketing, sales,and distribution of biological medicines developed byCelltrion through an extensive global network that spansmore than 120 di�erent countries, including bothdeveloped and emerging markets.

3) mAbs (monoclonal antibodies): antibodies that are made by identical immune cells that are all clones of a unique parent cell, in contrast to polyclonal antibodies, which are made from several di�erent immune cells.

Page 4: Celltrion Healthcare Company Brochure(2016)

Celltrion pipeline

New drugs

4) CDC: Centers for Disease Control & Prevention under the US Department of Health and Human Services5) Severance hospital: General hospital in the Republic of Korea6) SCW: Saitama College of Welfare* As of August 2016

CT-P19 CDC (US & China) Monoclonal antibody Infectious disease Preparation of non-clinical study

CT-P25 N/A Cell culture vaccine Infectious disease Preparation of non-clinical study

CT-P24 SCW6) (Japan),Severance Hospital Monoclonal antibody Infectious disease Preparation of non-clinical study

CT-P27 CDC4) (US) &Severance Hospital5) Monoclonal antibody Infectious disease Preparation of phase III clinical trial

CT-P26 Celltrion ChemicalResearch Institute Antibody-drug conjugation Oncology Preparation of non-clinical study

Project Collaborator Molecular type Therapeutic area Status

Monoclonal antibody biosimilars

1) INN: International Nonproprietary Name2) EMA: European Medicines Agency3) RSV: Respiratory Syncytial Virus

Project

CT-P10

CT-P16

CT-P06

CT-P15

CT-P05

CT-P17

CT-P14

Mechanism of action

CD20 inhibition

VEGF inhibition

HER2 inhibition

EGFR inhibition

TNF-α inhibition

TNF-α inhibition

Prevention ofRSV3) infection

INN1)

Rituximab

Bevacizumab

Trastuzumab

Cetuximab

Etanercept

Adalimumab

Palivizumab

Status

EMA2) review process

Preparation of clinical trial

Preparation of EMA submission

Preparation of non-clinical study

Preparation of non-clinical study

Preparation of non-clinical study

Under process development

Therapeutic area

Hematology,Autoimmune disease

Oncology

Oncology

Oncology

Autoimmune disease

Autoimmune disease

Infectious disease

For more information, please visit www.celltrionhealthcare.com© Celltrion Healthcare Co., Ltd. 2016 HCREM-00 PB-0916/05

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Biosimilars, a new horizon in the global pharmaceutical industry

Our devotion to the next generation of biologicsThanks to technological development, biologics have been used as a highly-e�ective and human-friendly treatment option for patients and healthcare providers since the late 1980s. They have opened up a whole new world of possibilities for treating a range of conditions, including autoimmune diseases, cancer, and chronic diseases.

Biologics, especially mAbs, are considered one of the fastest-growing sectors of the pharmaceutical industry. Although mAbs have treated many patients through their unique mechanism of action that targets speci�c antigens, these highly e�ective drugs have been beyond the reach far more patients due to their high price.

In an age where healthcare expenditures are a universal challenge, introducing biosimilar mAbs on the global market will help the patients to enjoy the bene�t for advanced treatments of life-changing diseases.

R emsima®4) is the world’s �rst biosimilar mAbapproved by the European MedicinesAgency (EMA) and the Food and

Drug Administration (FDA).

4) Remsima®: CT-P13, also known as In�ectra® and in�iximab-dyyb

Addressing a needby bringing a�ordable

and high-techbiosimilar mAbs to

medical �eld Increasingpatient access to

new biosimilar mAbsfor a wide range of

conditions

Putting patientsand healthcare providers �rst,

we are devoted to coming to theforefront of the biopharmaceutical

industry by providing novel therapeuticsas well as high-quality biosimilar mAbs

through our global leadership in themarketing, sales, and distribution

of breakthrough biologicalmedications.

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