(Pangyo Techno Valley) 21, 644 beon-gil, Daewangpangyo-ro, Bundang-gu, Seongnam … ·...

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Head Office | (Pangyo Techno Valley) 21, 644 beon-gil, Daewangpangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea SEOUL GMP | Daeryung Post Tower 2nd Bldg. Digital-ro, Guro-gu, Seoul, Korea TEL | 02)3465-6677(Head Office) / 02)866-7141(Seoul GMP) / 080-264-9380(Customer Center) FAX | 02)3465-6688(Head Office) / 02)866-7144(Seoul GMP)

Transcript of (Pangyo Techno Valley) 21, 644 beon-gil, Daewangpangyo-ro, Bundang-gu, Seongnam … ·...

Page 1: (Pangyo Techno Valley) 21, 644 beon-gil, Daewangpangyo-ro, Bundang-gu, Seongnam … · 2016-12-09 · Stem cell therapeutics are pharmaceutical products manufactured by physical,

Head Office | (Pangyo Techno Valley) 21, 644 beon-gil, Daewangpangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, KoreaSEOUL GMP | Daeryung Post Tower 2nd Bldg. Digital-ro, Guro-gu, Seoul, KoreaTEL | 02)3465-6677(Head Office) / 02)866-7141(Seoul GMP) / 080-264-9380(Customer Center)FAX | 02)3465-6688(Head Office) / 02)866-7144(Seoul GMP)

Page 2: (Pangyo Techno Valley) 21, 644 beon-gil, Daewangpangyo-ro, Bundang-gu, Seongnam … · 2016-12-09 · Stem cell therapeutics are pharmaceutical products manufactured by physical,

CONTEN

TS

CEO MESSAGE

VISION

HISTORY

BUSINESS DIV.

CSR

ABOUT US

We are committed to become a global biotechnology company

MEDIPOST has dedicated its focus on biotechnology from its foundation in year 2000 until today, in spite of numerous adversities, rises and falls within the stem cell area.

As a result, MEDIPOST has become a front-runner in the field of the biopharmaceuticals not only in Korea but also in the world. MEDIPOST with its state-of-the-art platform

technology has led to the development and approval of the world’s first allogeneic stem cell therapy product – CARTISTEM®.

Biotechnology is considered to be the new growth engine to lead the future economy of Korea. In particular, stem cell-based therapeutics is considered to be the most pivotal cutting-edge industry area.

MEDIPOST recognizes the national and public expectations in the field both from within Korea and abroad, and continue to drive our efforts to achieve breakthroughs for the treatment of intractable diseases through stem cells.

MEDIPOST continues its endeavors on clinical development and commercialization of stem cell therapeutics to improve quality of lives of many patients with intractable diseases not only in Korea, but also iaround the globe.

We sincerely thank you for your trust, encouragement and support and we will continue to devote ourselves to strengthen MEIDPOST’s position as the global leader in the field of biotechnology and regenerative medicine.

CEO

MES

SAGE

THE FUTURE OF BIOTECHNOLOGY, MEDIPOST

CEO MESSAGE

Yang, Yoon SunCEO and President MEDIPOST Co., Ltd

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VISION

MEDIPOST’s growth and endeavor continues …

MEDIPOST’s goal is to help patients to conquer intractable diseases through stem cell and regenerative medicine technology

· Received US-FDA clearance for the Phase 1/2 clinical study of PNEUMOSTEM® - a stem cell therapeutic for the pulmonary disease in premature infants

· Received clearance from the Ministry of Food and Drug Safety (MFDS) Korea, for the Phase 1/2a clinical study for NEUROSTEM® - a stem cell therapeutic for Alzheimer's disease

· Received the Grand Prize in ‘The 1st Korea New Drug Award (The Minister’s Award from the MFDS Korea)’

· Received product approval of CARTISTEM®, the world’s first allogeneic stem cell therapy drug, from the MFDS Korea and launched in Korean market for commercial use

· Obtained approval from the MFDS for the Phase 2 clinical study for PNEUMOSTEM® - a stem cell therapeutic for the pulmonary disease in premature infants

· CEO Dr. Yang, Yoon Sun - Invited to ‘the 7th World Stem Cell Summit’ as a keynote speaker

· Granted approval for the Phase 1/2a clinical study of CARTISTEM® by the US FDA - the first approval by the US FDA for any cord blood-derived stem cell product

· Conducted a ‘first-in-kind’ clinical study of cord blood treatment for cerebral palsy in Korea

· Selected as an innovative case representing the biotechnology field in the AIC (Asia Innovation Conference) in 2009

· Supplied foreign countries with cord blood for transplantation - the first as a cord blood bank in Korea

· Opened the Seoul GMP facility for the manufacturing of stem cell drugs

· Awarded the Bronze Tower Prize for the Order of Industrial Service Merit· Received approval for the Phase 1/2 clinical study for CARTISTEM® from the Korea Food and Drug Administration (KFDA) – for treatment of knee articular cartilage defects such as osteoarthritis

· Listed on KOSDAQ

· Voted ‘the Best Venture Enterprise’ by the Federation of Korean Industries

· MEDIPOST was incorporated and began its services of public cord blood banking

HISTORY

HIS

TORY

2014

2013

2012

2011

2010

2009

2008

2006

2005

2002

2000

Improve people’s quality of lives by providing a comprehensive solution to achieve healthy and extended Life Expectancy

The World’s No.1 Stem Cell & Regenerative Medicine Company

• Talent-oriented: Challenge / Innovation / Passion • Customer-oriented: Care for life / Value Creation / Credibility

THE FUTURE OF BIOTECHNOLOGY, MEDIPOST

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“ More than just the ‘possibility’, the dream of stem cell therapy has now been achieved”

MEDIPOST is proud to possess the world’s leading technology in the field of stem cells• Stem cells

Stem cells are the basic building blocks of the human body and have not yet been differentiated into particular types of cells. Once certain environmental conditions are met, stem cells have the ability to differentiate into various types of cells, and capacity to replenish themselves. They also have ability to secrete various growth factors promoting regeneration of damaged tissues.

- Adult stem cells: Undifferentiated stem cells found in various tissues throughout the body since birth and they can be collected from the cord blood, bone marrow or fat tissues

- Embryonic Stem(ES) cells: Pluripotent stem cells derived from zygotes (fertilized eggs) within 14-days post-conception. - Induced-Pluripotent Stem(iPS) cells: Differentiated adult cells that have been artificially induced to become pluripotent cells

that can differentiate into multiple types of cells

• Stem cell therapeuticsStem cell therapeutics are pharmaceutical products manufactured by physical, chemical and/or biological manipulation of stem cells, including isolation and/or ex vivo expansion of stem cells.

- Allogeneic therapeutics: Pharmaceutical products derived from another individual other than the recipients themselves and administered as a drug product

- Xenogeneic therapeutics: Pharmaceutical products derived from species other than human, manufactured as a drug product and administered to human patients

- Autologous therapeutics: Pharmaceutical products derived from an individual’s own tissue, manufactured as a drug product and returned to the same individual’s body

• Characteristics of the umbilical cord blood-derived stem cell therapeutics- The youngest, freshest and healthiest among adult stem cells - Stem cells with high proliferative capacity and differentiation ability for multiple cell-types- Enables mass manufacturing and commercialization of stem cell therapeutic as off-the-shelf products - Induces little or no immune reaction; no concomitant use of immunosuppressants is required- Requires advanced technical skills for cell culture compared to other types of stem cells

“The world’s most promising company in the field of stem cells ”

• An umbilical cord blood-derived stem cell company with flexible growth platform

• MEDIPOST holds 46 intellectual property rights, including 25 international patents granted by USA, EU and other countries.

• Performed 26 national research projects in the field of biotechnology• Invests 30-50% of the company’s annual revenue in R&D • Named as “the world’s most promising company in the field of stem

cells” (HSBC, 2013)

BUSINESS DIV.

STEM CELLS

BUSI

NES

S DI

V.

Stem Cell Bank Cord blood bank

Adipose stem cell bank

Stem Cell Drugs CARTISTEM®

NEUROSTEM® PNEUMOSTEM®

Dietary Supplements

MOVITA

Cosmetics CELONIAPEVONIA

THE FUTURE OF BIOTECHNOLOGY, MEDIPOST

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• Cord blood Cord blood is the blood remaining in the newborn's umbilical cord after birth. It can be collected at the time of birth, processed and stored (cryopreserved) upon collection. It is a valuable life resource that can be used for a treatment when a person or his/her family members is/are diagnosed with intractable diseases later on in life.

• Use of cord blood Cord blood contains high number of hematopoietic stem cells that can generate all types of blood cells such as white/red blood cells and platelets. For this reason, cord blood is mostly used for the treatment of intractable blood-related diseases such as leukemia and aplastic anemia. Cord blood also contains Mesenchymal Stem Cells (MSCs) that can generate tissues including bone, muscle and nervous system. Therefore, the use of cord blood is being expanded into other disease areas such as cerebral palsy and developmental/pediatric disorders.

• Global Status of Cord Blood Bank The therapeutic efficacy of cord blood is well established by medical communities around the world. In the U.S., more than 60 cord blood banks are in operation and many other countries around Asia, Europe, South America and Australia have cord blood banks in operation for families to store the cord blood units.

Family cord blood bank market-share in Korea

Cord Blood Supply Rate for Cord Blood Transplantation in Korea

• Supply rate of cord blood for transplantation: MEDIPOST had supplied cord blood for 512 units (approximately 58%) out of 890 units of cord blood transplantations in Korea with zero incidence of non-conformity case.

• Cryopreservation technology: MEDIPOST achieves close to 100% on total nucleated cell viability upon thawing and release. (Data from 2012 Korea Association of Medical Technologists Academic Division’s Autumn Symposium)

• Long-term storage stability: MEDIPOST executed ‘Transfer and Management of Cord Blood Agreement’ with the Seoul National University College of Medicine to prevent possible damages to stored cord blood units under unforeseen circumstances.

• Achievement of active research: MEDIPOST has published outcome from the study for treating subjects with cerebral palsy using his/her own (autologous) umbilical cord blood units in 2011. In 2012, MEIDPOST has achieved a successful market-approval of the world’s first off-the-shelf stem cell therapy drug CARTISTEM® which is made using stem cells from the cord blood of an unrelated (allogeneic) donors.

Leading cord blood bank in Korea

Celltree from

MEDIPOST

43%

Other cord blood

banks

57%

STEM CELL BANK : CORD BLOOD BANK

BUSINESS DIV. BU

SIN

ESS

DIV.

• MEDIPOST has been acknowledged for its stem cell technology and was invited to provide technical consultation for the establishment of The Seoul Municipal Public Cord Blood Bank (the first national public cord blood bank in Korea) in 2006.

(Data from the Ministry of Health and Welfare as of the end of 2013)

Celltree from

MEDIPOST

58%

Other cord blood

banks

42%

The hematopoietic stem cells and other types of stem cells in cord blood are stored in cord blood bank and then supplied back when transplantation is needed for the treatment of diseases.

Global Status of Cord Blood Bank

Source: Parent's guide

Atlantic

Pacific Ocean Indian Ocean

Asia

Australia

Africa

South America

North America

THE FUTURE OF BIOTECHNOLOGY, MEDIPOST

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THE FUTURE OF BIOTECHNOLOGY, MEDIPOST

STEM CELL THERAPY (Allogeneic human Umbilical Cord Blood-derived Mesenchymal Stem Cells, hUCB-MSCs)

Damaged Brain Day 10 post-administration

Pre- and post-administration of NEUROSTEM (animal study)

Damaged Lung Day 5 post-administration

Pre- and post-administration of PNEUMOSTEM (animal study)

Clinical Indication Treatment and prevention of Dementia of the Alzheimer’s Type

R&D Status - Completed a Phase 1 clinical trial in Korea (2011)- Received clearance from the Ministry of Food and Drug Safety (MFDS) Korea for Phase 1/2a clinical trial (Samsung Medical Center, 2013)

- Planned IND submission to the US FDA

Clinical Indications1) Bronchopulmonary Dysplasia (BPD)

- developmental chronic lung disease2) Acute Respiratory Distress Syndrome (ARDS)

R&D Status- Completed Phase 1 clinical trial in Korea (2011). - Received clearance from the Ministry of Food and Drug Safety (MFDS) Korea for Phase 2 clinical trial (Samsung Medical Center and Asan Medical Center, 2012)

- Designated as an orphan drug by US FDA (2013).- Designated as an orphan drug under development by the Ministry of Food and Drug Safety (MFDS) Korea (2014).

- Received clearance for Phase 1/2 clinical trial by the US FDA (2014). - Planned submission for expedited market-approval of PNEUMOSTEM(R) to the MFDS Korea upon completion of Phase 2 clinical trial

OsteoarthritisDementia of the Alzheimer’s Type

Pulmonary Diseases

BUSINESS DIV. BU

SIN

ESS

DIV.

The safety and efficacy of CARTISTEM® have been proven from the Phases 1 through 3 clinical trials「The Korea Times」 July, 2014

Indication : For the treatment of knee articular cartilage defects in patients with osteoarthritis (ICRS grade IV) as a result of degenerative disease or repeated trauma

Pre- and post-administration of CARTISTEM

Advantage of CARTISTEM - The world’s only stem cell therapy approved by a regulatory agency for the treatment of osteoarthritis

- Regeneration of cartilage from single administration with no age limitation on patients

- Excellent durability and weight-bearing capacity of the regenerated cartilage tissues

- Improvement was observed in 97.7% of the subjects in the Phase 3 randomized control trial.

- Simple operation procedures and short hospitalization period Overseas Development of CARTISTEM ·Investigational New Drug (IND) approved by the US Food and Drug Administration (FDA)- Phase 1/2a clinical trial is being conducted at Rush University Medical Center, Chicago, IL and Brigham and Women’s Hospital, Boston, MA. (February, 2011~)

- The first Korean company to receive the US FDA’s approval of the IND of a stem cell therapy

·Contract Agreements for Overseas Copyrights - CARTISTEM® license agreement executed for Hong Kong and Macau (November, 2012)

- CARTISTEM® license agreement executed for Australia and New Zealand with Cell Therapies Pty Ltd an affiliate of the Peter MacCallum Cancer Center in Australia (February, 2013)

- CARTISTEM® license agreement executed for India with Alkem Laboratories Ltd. in India (December, 2013)

Damaged cartilage 48 weeks post-administration

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• CELONIA ‘CELONIA’ brand was created with the meaning of “Stem Cells On Intelligent Action” referring to multiple rejuvenating actions from the factors secreted by the stem cells collected into the culture media. CELONIA is a product developed from the culture media of cord blood stem cells containing multiple growth factors prepared with MEDIPOST’s exclusive state-of-the-art technology to achieve and maintain revitalized and flourishing skin.

CELONIA, functional cosmetics using culture media of the cord blood-derived stem cells as part of its raw materials.

THE FUTURE OF BIOTECHNOLOGY, MEDIPOST

DIETARY SUPPLEMENTS COSMETICS

• MEDIPOST MOVITA MEDIPOST MOVITA was adopted as a customized dietary supplement. It is manufactured by mixing quality raw materials in ideal compositions in order to meet dietary recommendations, with its excellent quality being widely recognized for safety and functionality. MOVITA is most preferred by pregnant women and nursing mothers with no synthetic coloring agents, preservatives, or sweeteners used in the products.

Exclusive domestic distribution rights for an environmentally-friendly and prestigious cosmetics brand PEVONIA® from the USA

BUSINESS DIV. BU

SIN

ESS

DIV.

STEP 1Most trusted brand in the field of dietary supplements for pregnant women and nursing mothers

STEP 2Comprehensive premium dietary supplements brand for the families

STEP 3Strategic product development for the new stem cell drug pipeline

• PEVONIA® PEVONIA® is an eco-luxury cosmetics brand sold across 100 countries and is available in Korea brought exclusively by MEDIPOST. PEVONIA® is manufactured from natural plant and marine ingredients without using 10 of the well-

known harmful ingredients such as artificial colorings and fragrances. It is also famous as the brand loved by Hollywood celebrities.

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The corporate philosophy of ‘Respect for Life’ and ‘Social Contributions’ has led MEDIPOST to improve the quality of lives by supporting research in the field of biotechnology, infertility and families with children suffering from pediatric cancer and cerebral palsy.

Major activities - Supports Seoul National University College of Medicine with 3 billion KRW for basic research

- Supports multi-children families with 3.3 billion KRW for the storage of cord blood units

- Operates a Public Cord Blood Bank with the storage capacity for 10,000 units - Complementary storage of the cord blood units of the siblings for patients with childhood leukemia

- Supports patients suffering from childhood cancers and intractable diseases with treatment costs

- Supports cerebral palsy children with complementary operations for cord blood transplant

- Supports 1,600 couples with difficulty in fertilization - Supports various charities and public foundations - Voluntary activities for providing daycare services in single mothers’ facilities

- Voluntary activities for providing entertainment-days for children with leukemia

- Campaigns for blood donation program

MEDIPOST is committed to protecting valuable human lives as our social responsibility. “The most important task is to develop an innovative business model and in this

respect, MEDIPOST is a great example among Korean companies on par with Apple of the USA.” “A business with easy market access is always highly competitive. An innovative philosophy is the way to the successful business.” “MEDIPOST is a model case of enterprise management in regards to its prominent social influences by improving the quality of life and its success in pioneering a new area.”

‘A master of worldwide creative management’, Raffi Amit (Professor, Businessman Science at Wharton School)

「Weekly International Conference on Entrepreneurial Spirit」, October, 2010. Seoul

MEDIPOST, the company with most-well implemented entrepreneurship in Korea

CSR

THE FUTURE OF BIOTECHNOLOGY, MEDIPOST

ABOU

T USSOCIAL RESPONSIBILITY

메디포스트(주) 해외법인Medipost America : 9605 Medical Center Drive, Suite 109, Rockville, MD 20850, U.S.A.Medipost HK : Units 1603-05, Tower2, Admiralty Centre, 18 Harcourt Road, Hong Kong

특허취득 : 미국, 호주, 멕시코, 일본, 싱가포르, 중국, 영국, 프랑스, 독일, 이탈리아, 스페인, 스위스

수출계약 : 홍콩, 마카오, 태국, 말레이시아, 인도네시아

파트너십 : 중국, 일본, 프랑스, 영국, 이탈리아, 스페인, 독일, 인도, 호주, 뉴질랜드, 러시아, 체코, 슬로바키아, 헝가리, 크로아티아, 슬로베니아, 세르비아, 우크라이나, 아제르바이잔, 카자흐스탄, 벨라루스, 캐나다, 아랍에미리트

제대혈이식 : 미국, 캐나다, 스웨덴, 호주

임상시험 : 미국

Overseas Subsidiaries of MEDIPOST Co., Ltd MEDIPOST America Inc.: 9605 Medical Center Drive, Suite 109, Rockville, MD 20850, U.S.A. MEDIPOST HK: Unit 1603-05, Tower2, Admiralty Centre, 18 Harcourt Road, Hong Kong

Joint Venture Company: Wonsaeng Bio. 2957 Beitianmen Street, Taian, Sandung Province, China

Patent acquisition: USA, Australia, Mexico, Japan, Singapore, China, England, France, Germany, Italy, Spain, Switzerland

Export contract: Hong Kong, Macau, Thailand, Malaysia, Indonesia

Partnerships: Russia, Czech Republic, Slovakia, Hungary, Croatia, Slovenia, Serbia, Ukraine, Azerbaijan, Kazakhstan, Belarus, France, England, Italy, Spain, Germany, Canada, Australia, New Zealand, China, India, Japan, United Arab Emirates

Cord blood transplantation partnerships: USA, Canada, Sweden, Australia

Clinical Trials: USA

Head office of MEDIPOST

JVC

Hong Kong Corporation

USA Corporation