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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 gmkt@celltrion.com
For more information, please visit www.celltrionhealthcare.com
© Celltrion Healthcare Co., Ltd. 2016 HCREM-00 PB-0916/03
AdvancedTherapeutics
withinEveryone’sReach
AdvancedTherapeutics
withinEveryone’sReach
CelltrionHealthcare
isabiopharmaceutical
companycommitted
todeliveringmore
affordableadvanced
therapeuticsforpatients.
2
Meetingtheneedsofthemedicalfield
3
A
ccess to advanced yet costly therapeutics is
often a challenge to patients and healthcare
providers. In particular, biologics1)
have become
an increasingly important but also expensive part
of the global medicine cabinet.
We believe that every patient deserves access to
treatments 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 offer
high-quality and cost-effective solutions in breakthrough
therapies 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, efficacy
and quality to a previously-licensed biologic.
54
Biosimilardevelopmenttodistribution
Celltrion
CellLine
Development&
CellBanking
STAGE1
Manufacturing
Process
STAGE2
Celltrion Healthcare
North America
South America
Australia
North Africa
Asia
Europe
Korea
South Africa
Marketing,
Sales,and
Distribution
STAGE3
CelltrionGroup
Celltrion
Celltrion specializes in the research and development of high
quality mAbs3)
and innovative biopharmaceuticals utilizing its
accumulated R&D technology and production capabilities.
Celltrion boasts one of the world’s largest state-of-the-art
mammalian cell culture plants with a total production
capacity of 140,000L.
CelltrionHealthcare
Celltrion Healthcare conducts worldwide marketing, sales,
and distribution of biological medicines developed by
Celltrion through an extensive global network that spans
more than 120 different countries, including both
developed 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 different immune cells.
Celltrionpipeline
New drugs
4)
CDC: Centers for Disease Control & Prevention under the US Department of Health and Human Services
5)
Severance hospital: General hospital in the Republic of Korea
6)
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 Chemical
Research Institute
Antibody-drug conjugation Oncology Preparation of non-clinical study
Project Collaborator Molecular type Therapeutic area Status
Monoclonal antibody biosimilars
1)
INN: International Nonproprietary Name
2)
EMA: European Medicines Agency
3)
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 of
RSV3)
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
6
Biosimilars,
anewhorizonintheglobalpharmaceuticalindustry
Ourdevotiontothenext
generationofbiologics
Thanks to technological development,
biologics have been used as a highly-effective
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 specific antigens,
these highly effective 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 benefit for advanced treatments of life-changing
diseases.
R
emsima®4)
is the world’s first biosimilar mAb
approved by the European Medicines
Agency (EMA) and the Food and
Drug Administration (FDA).
4)
Remsima®: CT-P13, also known as Inflectra® and infliximab-dyyb
Addressinganeed
bybringingaffordable
andhigh-tech
biosimilarmAbsto
medicalfield Increasing
patientaccessto
newbiosimilarmAbs
forawiderangeof
conditions
Puttingpatients
andhealthcareprovidersfirst,
wearedevotedtocomingtothe
forefrontofthebiopharmaceutical
industrybyprovidingnoveltherapeutics
aswellashigh-qualitybiosimilarmAbs
throughourgloballeadershipinthe
marketing,sales,anddistribution
ofbreakthroughbiological
medications.
7

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Celltrion Healthcare Company Brochure(2016)

  • 1. 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 gmkt@celltrion.com For more information, please visit www.celltrionhealthcare.com © Celltrion Healthcare Co., Ltd. 2016 HCREM-00 PB-0916/03 AdvancedTherapeutics withinEveryone’sReach
  • 2. AdvancedTherapeutics withinEveryone’sReach CelltrionHealthcare isabiopharmaceutical companycommitted todeliveringmore affordableadvanced therapeuticsforpatients. 2 Meetingtheneedsofthemedicalfield 3 A ccess to advanced yet costly therapeutics is often a challenge to patients and healthcare providers. In particular, biologics1) have become an increasingly important but also expensive part of the global medicine cabinet. We believe that every patient deserves access to treatments 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 offer high-quality and cost-effective solutions in breakthrough therapies 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, efficacy and quality to a previously-licensed biologic.
  • 3. 54 Biosimilardevelopmenttodistribution Celltrion CellLine Development& CellBanking STAGE1 Manufacturing Process STAGE2 Celltrion Healthcare North America South America Australia North Africa Asia Europe Korea South Africa Marketing, Sales,and Distribution STAGE3 CelltrionGroup Celltrion Celltrion specializes in the research and development of high quality mAbs3) and innovative biopharmaceuticals utilizing its accumulated R&D technology and production capabilities. Celltrion boasts one of the world’s largest state-of-the-art mammalian cell culture plants with a total production capacity of 140,000L. CelltrionHealthcare Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion through an extensive global network that spans more than 120 different countries, including both developed 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 different immune cells.
  • 4. Celltrionpipeline New drugs 4) CDC: Centers for Disease Control & Prevention under the US Department of Health and Human Services 5) Severance hospital: General hospital in the Republic of Korea 6) 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 Chemical Research Institute Antibody-drug conjugation Oncology Preparation of non-clinical study Project Collaborator Molecular type Therapeutic area Status Monoclonal antibody biosimilars 1) INN: International Nonproprietary Name 2) EMA: European Medicines Agency 3) 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 of RSV3) 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 6 Biosimilars, anewhorizonintheglobalpharmaceuticalindustry Ourdevotiontothenext generationofbiologics Thanks to technological development, biologics have been used as a highly-effective 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 specific antigens, these highly effective 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 benefit for advanced treatments of life-changing diseases. R emsima®4) is the world’s first biosimilar mAb approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). 4) Remsima®: CT-P13, also known as Inflectra® and infliximab-dyyb Addressinganeed bybringingaffordable andhigh-tech biosimilarmAbsto medicalfield Increasing patientaccessto newbiosimilarmAbs forawiderangeof conditions Puttingpatients andhealthcareprovidersfirst, wearedevotedtocomingtothe forefrontofthebiopharmaceutical industrybyprovidingnoveltherapeutics aswellashigh-qualitybiosimilarmAbs throughourgloballeadershipinthe marketing,sales,anddistribution ofbreakthroughbiological medications. 7