Download (PDF:2.3MB)

9
CORPORATE PROFILE Leaping Forward

Transcript of Download (PDF:2.3MB)

Page 1: Download (PDF:2.3MB)

CORPORATE PROFILE

Leaping Forward

Page 2: Download (PDF:2.3MB)

21

The Kyowa Hakko Kirin Group has set a target of "leaping forward for Global Specialty Pharmaceutical Company (GSP)" as our Mid-term Business Plan for the period from 2016 to 2020. In order to continuously discover new drugs and develop, market, and distribute them on a global basis, we have established four strategic pillars:The first is "improvement of global competitiveness." Currently, development of the following two antibody drugs that are the key products for leaping forward in the European and the U.S. markets are in progress: KRN23 for the treatment of X-linked hypophosphatemia*1 and Benralizumab (KHK4563) for the treatment of asthma and chronic obstructive pulmonary disease. In 2016, to promote awareness of the brand around the world, we unified the corporate names of our pharmaceutical subsidiaries in Europe and the U.S. to "Kyowa Kirin."The second is "creating innovation." We foster an organizational culture enabling our scientists and employees to create innovation, and such culture is serving as our driving force of research and development. In addition, we promote joint researches with external organizations including universities and healthcare institutions as well as open innovation. We have also begun developing new technologies such as nucleic acid drugs*2 and regenerative therapeutics.The third is "continuous improvement for operational excellence." As part of the activities for this pillar, we have reinforced our organizations and functions according to the business environment changes in Japan. For example, we are working on

Utilizing our unique technological capability and human resources, we strive to introduce new drugs into the European and the U.S. markets to contribute to the world.

reorganizing the sales offices based on Secondary Medical Area in each region to address the super-aging society.The fourth is "contribution to health and well-being of people." From the perspective of CSV*3, it is important to recognize what society requires us to do in addition to creating drugs as a pharmaceutical company. We proceed with the CSV management, while remaining conscious of values that we may offer to society as well as patients.In order to proceed with these strategies and achieve the goals, the groups have to unite and share a common value. So, in October 2016, we designated "Commitment to Life" as our group-wide "Core Values" and determined three keywords to put our "Commitment to Life" into practice: Integrity, Innovation, and Teamwork/Wa. "Commitment to Life" is a phrase that expresses our mindset to perform work that is of value to human life, and daily living.We strive for realization of the management philosophy, pursuing activities to share our Core Values among employees and developing human resources.

*1 A rare disease that impairs growth and maintenance of bone, resulting from hypophosphatemia due to excessive phosphorous excretion caused by FGF23 existing in high concentrations in the blood.

*2 Nucleic acids such as DNA and RNA are bound to macromolecules within the body to treat and prevent associated diseases.

*3 CSV stands for "Creating Shared Value" and refers to realizing improved corporate value through both the creation of social value and the creation of economic value by addressing social issues.

Top message

STEP1

IntegrateStrength

2008-2009

STEP2

Select andConcentrate

2010-2012

STEP3

Strive towardGSP

2013-2015

STEP4

Being a "Japan-based world-leadingR&D type life science company"

2016 2020

Leaping forward for GSP

Improvement of Global Competitiveness

(Leaping Forward to US/EU Market)

Creating Innovation(Proactive Investment for R&D)

Continuous Improvement for Operational Excellence

(Group Management)

Contribution to Health and Well-being of People

(Creating Shared Value)

Management

PhilosophyThe Kyowa Hakko Kirin Group companies strive to contribute to thehealth and well-being of people around the world by creating new valuethrough the pursuit of advances in life sciences and technologies.

VisionKyowa Hakko Kirin will be a Japan-based Global Specialty PharmaceuticalCompany contributing to human health and well-being worldwide throughinnovative drug discovery and global commercialization, driven by state-of-the-art antibody technologies mainly in the core therapeutic areas ofoncology, nephrology and immunology.

Nobuo HanaiPresident and CEO

Road Map to Our Vision

Teamwork/Wa*

Core ValuesCommitment to LifeWork for the most precious presence on this planet.Create value for patients, caregivers, healthcare professionals, and customer.

IntegrityDo the right things. Be sincere and ethical consistently.Make a better world through good business practices.

InnovationTransform lives with passion and excitement.Challenge the status quoin all of our work.

One for all, all for one. Work in diverse teams and respect each other.Go beyond boundaries andcollaborate with stakeholders.

* harmony and loop among people

"Core Values" are a way of thinking and attitude that supports the activity of each officer and employee belonging to the Kyowa Hakko Kirin Group. It consists of core concept "Commitment to Life" and three key words.

Page 3: Download (PDF:2.3MB)

43

Global

We strengthen global partnerships and pursue sustainable growthKyowa Hakko Kirin has been accelerating our research and development activities on a global basis and strengthening the marketing system to leap forward for Global Specialty Pharmaceutical Company (GSP).In the area of research and development, the development of the global strategic products positioned as the key driver for growth (KRN23, KW-0761 and KW-6002) has progressed, and we are now preparing for the launch of these products in Europe and the U.S. earlier.For drug discovery, we have promoted open innovation including partnership between industry, government and academia.Furthermore, we have worked on putting in place a marketing system in Europe and the U.S. to accommodate the characteristics of the global strategic products and a logistic and distribution system to coincide with the expected timing of product approval in Europe and the U.S. so that we can provide the customers with high quality products in a timely manner.

We put in place a logistic and sales system to accommodate the marketing of global strategic products and enhance global competitiveness.The development of global strategic products is going well. We are steadily taking steps for early, successful market launches and for maximizing their value. We put in place a global logistic and sales system to coincide with approval of the products in Europe and the U.S. In addition, we strive for continuous growth also in Asia through the market penetration of our major products.

ATL: Adult T-cell Leukemia/Lymphoma

CTCL: Cutaneous T-cell Lymphoma

SHPT: SecondaryHyperparathyroidism

COPD: Chronic ObstructivePulmonary Disease

XLH:X-Linked Hypophosphatemia

KHK4563 Asthma

KW-0761 ATL (US/EU) KW-0761 CTCL (US/EU)

KW-6002 (US)Parkinson's Disease

KHK4827Psoriasis

KRN23

KHK4563

KHK7580

●Kyowa Kirin International plc (UK)

●Kyowa Kirin Pharma S.A.S. (France)

●Kyowa Kirin Farmacéutica, S.L.U. (Spain)

●Kyowa Kirin GmbH (Germany)

●Kyowa Kirin Holdings B.V. (Netherlands)

●Kyowa Kirin S.r.l. (Italy)

●Kyowa Kirin AB (Sweden)

Europe ●Kyowa Hakko Kirin Co., Ltd.

●Kyowa Hakko Kirin China Pharmaceuticals Co., Ltd.

●Kyowa Hakko Kirin Korea Co., Ltd.

●Kyowa Hakko Kirin (Taiwan) Co., Ltd.

●Kyowa Hakko Kirin (Hong Kong) Co., Ltd.

●Kyowa Hakko Kirin (Singapore) Pte. Ltd.

●Kyowa Hakko Kirin (Thailand) Co., Ltd.

Asia●Kyowa Kirin USA Holdings, Inc.

●Kyowa Kirin Pharmaceutical Development, Inc.

●Kyowa Kirin Pharmaceutical Research, Inc.

●BioWa, Inc.

●Kyowa Kirin, Inc.

North America

We increase the proportion of overseas sales to strengthen global competitivenessIn 2017, KRN23 will be ready for the launch in Europe and be applied for approval in the U.S. In addition, KW-0761 will be applied for approval in Europe and the U.S. We have already entered into an agreement with AstraZeneca for the commercialization of Benralizumab (KHK4563), from which we expect large licensing revenues in the future.As described above, we will constantly create excellent drugs, grow in the European and the U.S. markets, and expand our businesses to the overseas countries. By these efforts, we aim to achieve the proportion of overseas sales of 50% or higher across the groups and to strengthen global competitiveness.

Promoting Organizations

Drug discovery

Development

Production

Marketing

2020

2016

We bring innovative new drugs with a completely new mechanism into the world

*4 Human immune function, which allows an antibody to bind to an antigen of a target cell so that an effector cell binds to the antibody and releases a substance that attacks and lyses the target cell.

*5 A chemokine receptor associated with leukocyte migration. In normal tissues, CCR4 is known to be selectively expressed on (CD4-positive) type 2 helper T cells that produce cytokines such as IL-4 and IL-5. It is also known to be highly expressed in certain types of blood cancer.

It is a human monoclonal antibody utilizing our original activity-enhanced antibody technology "POTELLIGENT®." It quickly removes eosinophil that is considered to be highly involved in inflammatory respiratory diseases by the ADCC*4 activity.

KHK4563Asthma and chronic obstructive pulmonary disease

(Already launched in Japan)

It is an antibody that binds to CCR4*5 expressed on ATL (adult T-cell leukemia-lymphoma) cell surface, enhances ADCC activity to damage the ATL cells bound to this antibody, and exerts anti-tumor effect.

KW-0761Adult T-cell leukemia-lymphoma

(Already launched in Japan)

It has a new mode of action that blocks adenosine A2A receptor action. It has also shown efficacy in patients with the wearing-off phenomenon, which is one of the motor complications.

KW-6002Parkinson's disease

It binds to FGF23 overproduced in the blood due to a genetic abnormality and inhibits its action, and consequently, enhances renal tubular reabsorption of phosphorus and increases phosphorus blood levels.

KRN23X-linked hypophosphatemia (XLH), tumor-induced osteomalacia, or epidermal nevus syndrome

New Geographic Area New Drugs New Application

Major Pipeline Drugs Targeted for Approval

Improvement of Global Competitivenes

Page 4: Download (PDF:2.3MB)

65

Acceleration of research and development using open innovationKyowa Hakko Kirin has actively incorporated open innovation that utilizes external information and knowledge in our drug discovery research process. We are working together with universities, healthcare institutions and venture companies and proceeding with the collaborative development of new drugs at early stages. These collaborative works include challenges to new technologies such as nucleic acid drugs and regenerative therapeutics. The research for nucleic acid drugs has reached a stage where results are being produced. For regenerative therapeutics, we have conducted a collaborative research of cancer immunotherapy*6 with the Center for iPS Cell Research and Application, Kyoto University. We aspire to nurture these areas to make them one of the pillars of our future research and development.

*6 Therapies that attempt to destroy cancer cells by controlling the body’s autoimmune system.

Toward further technological evolution with the strength of our cultivated technological capabilitiesOne of the representative technologies of Kyowa Hakko Kirin is antibody technology. As the results of our long-term biopharmaceutical study, we have created POTELLIGENT® and COMPLEGENT® technologies that dramatically increase antibody activity as well as fully human antibody-producing technology.In addition to the development of new drugs with these antibody technologies, we are also working on driving our antibody business forward based on strategic alliances.

HumanResources

TechnicalCapabilities

Developing human resources who can exercise leadership and bringing innovationFor leaping forward for Global Specialty Pharmaceutical Company (GSP), the organizational climate creating innovation and human resources who build such a climate are important.To this end, Kyowa Hakko Kirin has a detailed human resource development program for each level of employees and each purpose. We are undertaking multilateral initiatives such as training according to rank, training to develop female managerial staff and executives, and global training to develop human resources who can participate actively in Japan and overseas. In addition, we have been establishing a framework for strategic human resource assignment and development that cuts across countries and regions.

We continuously create new values based on our outstanding technological capability and diverse human resources. Kyowa Hakko Kirin's diverse human resources and the organizational culture enabling innovation have created original antibody technologies including POTELLIGENT® which enhances the activity of therapeutic antibody. We further pursue evolution of the technologies actively utilizing open innovation.

Training by rank

Developingfemale staff

Self-development

Estab

lishment of N

ew Techno

log

y

Further Evo

lution of E

xisting Techno

log

y

Next GenerationTherapeutic Antibodies

Immuno activating antibodyCell/tissue homingantibody

Nucleic Acid DrugsNucleic acid function-enhancing technology DDS technology usinglipid nanoparticles

New Small Molecule DrugsIntegrated approach with science of biologicsPrecise drug design and synthesis basedon structural analysis of target molecule

Regenerative TherapeuticsiPS-T cell technology (collaborationwith Kyoto University)Skills in stem cell culture anddifferentiation control

Our Core StrengthsEstablished by R&D and Production

of BiopharmaceuticalsGenetic engineering technologyProtein/antibody engineering technologyExcellence in analysis and control of carbohydratesSkills in cell culture and control of cell differentiationTechnology for manufacturing of biologics

Training through

appointment/public

advertising

Human resource development program

InnovationCreating Innovation

Utilization of open innovation and development of four major modalities

Page 5: Download (PDF:2.3MB)

87

Investigationald

rug

Marketed

prod

uct

Development stage

CMC research*7

Drug discovery,non-clinical andclinical division, etc.

Regulatory, Quality Assurance,Sales Division, etc.

Application

Applicationdocument creation

Marketing

Life cyclemanagement

Technologyto see

Technologyto create

Technologyto purify

Technologyto preserve

•Physicochemical test•Bioassay•Characterization test

•Cell construction•Culturing process

•Purification process

•Physical property test•Formulation development

InnovationStable supply of high quality biopharmaceuticals through world-class production technology.As an R&D-type company, we are committed to the innovation of production and formulation technologies as well as research and development of new drugs.

We establish a consistent process from R&D and application for approval to launchThe Bio Process Research and Development Laboratories investigate the way to manufacture high-quality products efficiently, and work with the Takasaki Plant to establish a manufacturing processes and analysis methods for commercial production. Furthermore, the Bio Process Research and Development Laboratories support Kyowa Hakko Kirin in the production of biopharmaceuticals, combining the four technological factors required for the production of biopharmaceuticals: "to create," "to see," "to preserve," and "to purify" with the state-of-the-art technologies. The results of their study are transferred to the Manufacturing section and Quality Control section of Takasaki Plant and utilized for the production and quality control of investigational drugs and marketed products.

Cooperation between laboratories and plantAs Bio Process Research and Development Laboratories and Takasaki Plant are situated next to each other, we are using this to our mutual advantage by conducting the world’s best biologics research and production.We are working together to provide superior products to the people of the world.

We have accommodated the increasing demand for therapeutic antibodies by establishing a new drug substance manufacturing buildingThe Takasaki Plant has a large number of facilities for manufacturing drug substances and drug products. Besides the existing production facilities, we newly established a drug substance manufacturing building (Building HB6) for biopharmaceuticals in August 2016. It has enabled us to accommodate the increasing demand for therapeutic antibodies. At the drug product manufacturing building (Building HA5), various product lines, mainly injectable drugs, are efficiently manufactured. All of these facilities comply with the GMP regulations*8

of Japan, the U.S. and Europe and are capable of supplying products globally.

*8 GMP stands for Good Manufacturing Practice and refers to international criteria for the manufacturing and quality control management of pharmaceutical products, etc.

Factors in Biopharmaceuticals Production Technology

Creating Innovation

Manufacturing facilities for injection products (building HA5)

Drug substance manufacturing building for biopharmaceutical products (building HB6)

Culture tank

*7 CMC stands for chemistry, manufacturing, and controls, which is the research and development activities including the drug formulation, manufacturing of investigational drug, and development of analytical methods for drug substance and drug products.

Page 6: Download (PDF:2.3MB)

109

Centus Biotherapeutics*9 AstraZeneca

FUJIFILMKYOWA KIRIN BIOLOGICS

Technologies and expertisein biopharmaceutical R&D

and manufacturing

Production, quality controland analysis technologies,

and production processimprovement expertise

Development and sales of FKB238 Expertise concerning developmentand sales in the field of oncology

Provide products that offer outstandingreliability, quality and cost competitivenessDevelop innovative biopharmaceutical production technologies through both parents company synergies

A1c iGear KGlycohemoglobin analyzer

In the biochemicals field, we have the "Fine Chemicals" business dealing with amino acids for medical use, nucleic acid related substances, drug materials and intermediates, the "Healthcare" business providing a mail-order service of various types of functional ingredients including amino acids, vitamins and carotenoids and health foods and the "Phytech" business dealing with agricultural chemicals.

Kyowa Hakko BioKyowa Medex is developing, manufacturing and marketing diagnostic drugs (clinical reagents) used for blood and urine tests and diagnostic instruments (automatic analyzers) used for efficient diagnostic examination as an integrated strategic business.

Product lines that contribute to healthcare across the worldKyowa Hakko Kirin has discovered innovative and effective ethical drugs in four categories of nephrology, oncology, immunology/allergy, and the central nervous system.Our wide variety of high-value product lines contributes to the world's medical needs.

In this field, we are developing biosimilar drugs (bio-generic drugs) that are comparable to branded biological drugs. We will provide high-quality biosimilar products at low prices to meet medical needs.

●G-Lasta®

Long-acting G-CSF product

●Topina®

Antiepileptic drug

●NOURIAST®

Parkinson's disease drug●LUMICEF®

Human antibody for psoriasis treatment

●ASACOL®

Ulcerative colitis drug●Dovobet®

Plaque psoriasis drug●GRAN®

G-CSF product

●ALLELOCK®

Allergic disease drug

●REGPARA®

A treatment for secondary hyperparathyroidism

●ONGLYZA®

A treatment for type 2 diabetes

●DEPAKENE®

Antiepileptic drugDrug for manic disorder/manic state and migraine

●Apokyn®

Parkinson's disease drug

Nephrology Oncology Immunology / Allergy Central Nervous System

As a leading company in nephrology, we are committed to the treatment of complications of chronic kidney disease through our drugs such as a treatment for nephrogenic anemia NESP®

and a treatment for secondary hyperparathyroidism REGPARA®

for dialysis patients. We also have ONGLYZA®, a treatment for diabetes which is a cause of chronic kidney disease, in the product line to contribute to the total care of diabetes and chronic kidney disease.

We are contributing to helping patients who are battling cancer by providing drugs such as a long acting G-CSF product G-Lasta® used for the inhibition of the onset of febrile neutropenia due to cancer chemotherapy, a therapeutic antibody POTELIGEO® which applies our POTELLIGENT® technology and the cancer pain treatments.

We are contributing to improving patients' satisfaction with treatment and to making their daily life comfortable, primarily through products such as an allergic disease drug ALLELOCK® which is established in the market and has a strong reputation and an ulcerous colitis drug ASACOL®. Recently, we have launched Dovobet® and LUMICEF® for dermatology to provide new treatment options for psoriasis.

For Parkinson's disease, we propose new medications mainly including a non-dopaminergic agent NOURIAST® with a new mode of action and a rescue agent Apokyn®. We are also contributing to the treatment of central neurological diseases through products such as antiepileptic drugs DEPAKENE® and Topina®.

Kyowa Medex FUJIFILM KYOWA KIRIN BIOLOGICS

Health food product lines *9 A joint venture established in 2015 for development and sales of biosimilar FKB238

Group Management

●NESP®

A treatment for nephrogenic anemia

●Romiplate®

Thrombopoiesis stimulating agent

Group Showcase

Page 7: Download (PDF:2.3MB)

We will actively contribute to healthcare through consideration to provide our nephrogenic anemia treatment NESP® as an authorized version*11 and promotion of the production and supply of biosimilar drugs.

We will be aggressive also in the new business fields such as "preventive healthcare" to prevent diseases and "presymptomatic healthcare" before becoming a disease through expansion of the health food business and promotion of the self-care business utilizing the diagnostics business.

Amid the growing interest in health, we will proceed with the discovery of innovative drugs that meet unmet medical needs, the expansion of new indications and dosage forms of existing products, and provision of stable supply of products with excellent quality.

Contribution to Kirin Group’s CSV

CSV Managementbased on Our UniqueBusiness Structure

Provision of NewMedical Value to Customers

Contribution ofPreventive and

Presymptomatic Healthcare

Meet Social Demandsfor Medical Cost Containment

Creating Shared Value

1211

Our Commitment to StakeholdersCompanies are expected to create and offer value that is useful to society. When companies meet social expectations, society rewards them with recognition, trust and support. The Kyowa Hakko Kirin Group seeks to determine what role it should play from the society's perspective based on the idea that we are a member of society. The Group believes that this will help it meet the expectations of stakeholders including customers, business partners, employees, shareholders, investors and society/community and build relationships based on trust. We will place more importance on commitment to and dialogue with stakeholders to meet expectations toward the Kyowa Hakko Kirin Group.

Costomers

Business Partners

Employees

Shareholders and Investors

Society and Community

The EnvironmentWe energetically take the initiative in areas such as CO2 reduction to protect the environment, and promote activities to support the achievement of a sustainable society.

We want to be a company that earns the trust of society and the community, so we are dedicated to social contribution activities that make use of the assets we have acquired through our businesses.

Committed to transparency, fairness and consistency, we earn the trust of shareholders and investors through appropriate information disclosure.

We respect the human rights and individuality of employees, and seek to be a company that promotes diversity while growing along with employees.

We promote fair transactions and partnering and CSR procurement to become a global specialty pharmaceutical company.

We support the effective, safe use of our drugs by collecting and providing information that meets various needs.

We cope with social challenges through the CSV management to contribute to the health and well-being of people.Amid the aging society and growing interest in health, the role of pharmaceutical company is becoming more important.We will solve the social issues and meet the expectations of stakeholders through CSV management*10 based on our distinctive business foundation.

*10 Management that seeks the enhancement of corporate value with both the "creation of social value" and "creation of economic value" through providing solutions to challenging issues in society.

*11 Branded generic drugs that have been licensed by the patent holding company of the original drug for manufacturing and commercialization and are identical to the original drug in terms of active pharmaceutical ingredients, excipients and manufacturing method.

Contribution to Health and Well-being of People

Page 8: Download (PDF:2.3MB)

1413

Corporate DataCompany Name

Established

Capital

Number of Employees

President & CEO

Head Office

Consolidated Sales

Main Business

Parent Company

BranchesSapporo BranchImon Sapporo Park Front Building 5F, 7-1-1 Odorinishi, Chuo-ku, Sapporo-shi, Hokkaido 060-0042TEL: +81-11-261-3127 FAX: +81-11-261-2584

Tohoku BranchSendai Hashimoto Building 9F, 27-21 Tachi-machi, Aoba-ku, Sendai-shi, Miyagi 980-0822TEL: +81-22-262-7691 FAX: +81-22-223-6563

Tokyo Branch, Chiba-Saitama Branch,Kita-Kanto Branch, Koshinetsu Branch,Yokohama BranchDaiwa Rivergate 13F, 36-2 Nihonbashi-Hakozaki-cho, Chuo-ku, Tokyo 103-8503TEL: +81-3-5641-8600 FAX: +81-3-5641-8681

Nagoya BranchIchigo Marunouchi Building 10F, 3-17-13 Marunouchi,Naka-ku, Nagoya-shi, Aichi 460-0002TEL: +81-52-962-1091 FAX: +81-52-962-5243

Osaka Branch, Keiji-Hokuriku BranchDojima Avanza 14F, 1-6-20 Dojima, Kita-ku, Osaka-shi, Osaka 530-8280TEL: +81-6-6346-6900 FAX: +81-6-6346-6825

Chugoku BranchHiroshima Inarimachi Daiichi Seimei Building 7F, 2-16 Inari-machi, Minami-ku, Hiroshima-shi, Hiroshima 732-0827TEL: +81-82-262-6680 FAX: +81-82-262-5242

Shikoku BranchMatsuyama Daiichi Seimei Building 9F, 3-2-11 Ichiban-cho, Matsuyama-shi, Ehime 790-0001TEL: +81-89-945-1288 FAX: +81-89-932-1237

Kyushu BranchFukuoka Center Building 13F, 2-2-1 Hakataekimae, Hakata-ku, Fukuoka-shi, Fukuoka 812-0011TEL: +81-92-473-5631 FAX: +81-92-475-4573

Research LaboratoriesTokyo Research Park3-6-6 Asahi-machi, Machida-shi, Tokyo 194-8533TEL: +81-42-725-2555 FAX: +81-42-726-8330

Fuji Research Park1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731TEL: +81-55-989-2004 FAX: +81-55-986-7430

Bio Process Research and Development Laboratories100-1 Hagiwara-machi, Takasaki-shi, Gunma 370-0013TEL: +81-27-353-2011 FAX: +81-27-353-2123

CMC R&D Center1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731TEL: +81-55-989-2004 FAX: +81-55-986-7430

PlantsTakasaki Plant100-1 Hagiwara-machi, Taksaki-shi, Gunma 370-0013TEL: +81-27-353-2011 FAX: +81-27-353-2123

Fuji Plant1188 Shimotogari, Nagaizumi-cho, Sunto-gun,Shizuoka 411-8731TEL: +81-55-986-7600 FAX: +81-55-989-2091

Ube Plant2547-3 Fujimagari, Ube-shi, Yamaguchi 755-8501TEL: +81-836-22-5508 FAX: +81-836-22-5534

JapanKyowa Medex Co., Ltd.Harumi Island Triton Square Office Tower X 4F, 1-8-10 Harumi, Chuo-ku, Tokyo 104-6004TEL: +81-3-6219-7600 FAX: +81-3-6219-7614

Kyowa Medical Promotion Co., Ltd.Rivergate 13F, 36-2 Nihonbashi-Hakozaki-cho, Chuo-ku, Tokyo 103-0015TEL: +81-3-5641-8658 FAX: +81-3-5641-8697

Kyowa Kirin plus Co., Ltd.Nakano-Sakaue Sunbright Twin 12F, 2-46-1 Honcho, Nakano-ku, Tokyo 164-0012TEL: +81-3-6853-5880 FAX: +81-3-6853-5882

Overseas

U.S.A.Kyowa Kirin USA Holdings, Inc. / Princeton212 Carnegie Center, Suite 101, Princeton, NJ 08540, U.S.A.TEL: +1-609-580-7400 FAX: +1-609-919-1111

Kyowa Kirin Pharmaceutical Development, Inc. / Princeton212 Carnegie Center, Suite 101, Princeton, NJ 08540, U.S.A.TEL: +1-609-919-1100 FAX: +1-609-919-1111

Kyowa Kirin Pharmaceutical Research, Inc. / California9420 Athena Circle, La Jolla, CA 92037, U.S.A.TEL: +1-858-952-7000 FAX: +1-858-952-7001

BioWa. Inc. / Princeton212 Carnegie Center, Suite 101, Princeton, NJ 08540, U.S.A.TEL: +1-609-580-7340 FAX: +1-609-228-5247

EuropeKyowa Kirin International plc / ScotlandGalabank Business Park, Galashiels TD1 1QH, United KingdomTEL: 44-1896-664000 FAX: +44-1896-664001

AsiaKyowa Hakko Kirin China Pharmaceuticals Co., Ltd. / Shanghai970 Long Dong Road, Pudong New AreaShanghai, 201203, ChinaTEL: +86-21-5080-0909 FAX: +86-21-5080-0026

Kyowa Hakko Kirin Korea Co., Ltd. / Seoul11F, Asia Tower, 430, Nonhyeon-ro, Gangnam-gu, Seoul, 06223, KoreaTEL: +82-2-3471-4321 FAX: +82-2-3471-4322

Kyowa Hakko Kirin (Taiwan) Co., Ltd. / Taipei14F, No. 44, Sec 2, Chung Shan N. Road, Taipei 10448, TaiwanTEL: +886-2-2564-2800 FAX: +886-2-2560-1667

Kyowa Hakko Kirin (Hong Kong) Co., Ltd. / Hong KongUnit B, 13/F, @Convoy, 169 Electric Road, North Point, Hong KongTEL: +852-2956-0828 FAX: +852-2956-1627

Kyowa Hakko Kirin (Singapore) Pte. Ltd. / Singapore260, Orchard Road, #07-06 The Heeren, 238855, SingaporeTEL: +65-6836-3991 FAX: +65-6836-3928

Kyowa Hakko Kirin (Thailand) Co., Ltd. / Bangkok323 United Center Building, 20th Fl., Room 2003B Silom Road, Silom, BangrakBangkok 10500, ThailandTEL: +66-2631-2126 FAX: +66-2631-2125

Main Business OfficesOur headquarters in the heart of Tokyo oversees and coordinates the operation of 13 branches (107 domestic sales offices) as well as the four state-of-the-art research laboratories that drive our pharmaceuticals business and the three plants that are fully compliant with international standards of quality control. Kyowa Hakko Kirin Co., Ltd. is ready to provide total support in every stage from research & development to sales & marketing.

Main Group CompaniesOur business is global in vision and scale. We are working in close collaboration with our group companies to bring exciting new products to markets around the world.

Kyowa Hakko Kirin Co., Ltd.

July 1, 1949

¥26,745 million (As of December 31, 2016)

7,465 (Consolidated basis, as of December 31, 2016)

Nobuo Hanai

Otemachi Financial City Grand Cube 17F, 1-9-2

Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan

TEL: +81-3-5205-7200 FAX : +81-3-5205-7182

¥343,019 million (Fiscal Year ended December 31, 2016)

Kyowa Hakko Kirin is engaged in the manufacture and marketing of pharmaceuticals.

As the holding company of the Kyowa Hakko Kirin Group and with the pharmaceuticals

business as its core, it manages business activities such as biochemical business.

Kirin Holdings Company, Limited.

*Company name changed from Kyowa Hakko Kogyo Co., Ltd. following merger with Kirin Pharma Company, Limited on October 1, 2008.

FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd.Otemachi Building 9F, 1-6-1 Otemachi, Chiyoda-ku, Tokyo 100-8185TEL: +81-3-3282-0700 FAX: +81-3-3282-0611

Kyowa Hakko Bio Co., Ltd.Otemachi Financial City Grand Cube 17F, 1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004TEL: +81-3-5205-7300 FAX: +81-3-5205-7149

Diagnostics

Biosimilars

Ethical Pharmaceuticals

Bio-chemicals

Kyowa Hakko KirinFocusing on the four categories of nephrology, oncology, immunology/allergy, and the central nervous system, we are enhancing cooperation from research and development to production, sales and marketing to rapidly evolve into a global specialty pharmaceutical company. We will steadily launch products from our well-stocked pipeline of development candidates while creating an effective, highly specialized sales and marketing organization with the objective of earning the trust of healthcare providers.

Kyowa MedexIn cooperation with Kyowa Hakko Kirin’s R&D operations, Kyowa Medex seeks to generate synergies with the pharmaceuticals business and enhance added value through the development and launch of diagnostic reagents, analyzers, and companion diagnostics that contribute to personalized cares.

Kyowa Hakko BioKyowa Hakko Bio supplies a range of products in Japan and overseas, including amino acids, nucleotides, vitamins, peptides, and synthetic compounds. We will be a biochemical innovator which provide people in the world with products and services to fulfill their healthcare needs, using deep and wide knowledge of fermentation and synthesis.

FUJIFILM KYOWA KIRIN BIOLOGICSThe mission of Fujifilm Kyowa Kirin Biologics is to deliver reliable, high-quality and cost-competitive biosimilars by using new technologies that merge Kyowa Hakko Kirin’s strength in biopharmaceutical manufacturing technologies with engineering technologies for manufacturing, quality control, and analysis developed by FUJIFILM Corporation through its various businesses.

Corporate Data

Page 9: Download (PDF:2.3MB)

CORPORATE PROFILE

Leaping Forward

http://www.kyowa-kirin.com May, 2017