MEDICAL & BIOLOGICAL LABORATORIES CO.,LTD. | MBL Life ... · 3 Medical & Biological Laboratories...

http: / /www.mbl.co. jp/

KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008 Japan Phone: +81-52-238-1901, Facsimile: +81-52-238-1440 Issued: 2016.12

COMPANY PROFILE

1 Medical & Biological Laboratories Co., LTD. Medical & Biological Laboratories Co., LTD. 2

Since establishing itself as the first Japanese company specializing in the manufacture and supply of antibody products, MBL has developed valuable relationships in the life sciences field. MBL provides unique clinical diagnostics and basic research reagents to detect proteins and DNA molecules primarily in the areas of autoimmune diseases, cancer, gynecologic diseases, and infectious diseases.

MBL is engaged in an area of clinical laboratory testing in which is reaching a major turning point regarding medical significance and combined with laboratory tests. We are witnessing continued advancement of new therapeutic approaches and prevention of diseases in medicine. These advances are observed from the correlation of research into genetic information such as genome and epigenome, and environmental factors such as infection and lifestyle with health and illness.

MBL’s future business direction is in the research and development of cutting-edge diagnostic products, life science translational research (LSTR), and in commercialization of unique products and services. We aim to launch biomarker tests and companion diagnostics products as clinical laboratory tests, and launch LSTR products for use in disease investigation as well as etiological elucidation of the mechanisms of various diseases.

After MBL’s consolidation into JSR’s Life Science Business, I believe all our corporate activities will lead to the further contribution by MBL to society as a corporate entity with a strong presence in the life science industry.

※Life Science Translational Research (LSTR) Products: LSTR is business category in which we collaborate with academia and pharmaceutical companies to develop disease-related basic research reagents (LSTR products) with the aim of developing technologies for future clinical diagnostics.

November 2016

President and CEOKimimasa Yamada

Message from the President

MBL’s Vision for the Future

Corporate Mission

Creating novel diagnostic reagents to meet healthcare needs of patients, however many or few.

A global niche company with a strong presence, generating value at the cutting-edge diagnostics.


Since establishing itself as the first Japanese company specializing in the manufacture and supply of antibody products, MBL has developed valuable relationships in the life sciences field. MBL provides unique clinical diagnostics and basic research reagents to detect proteins and DNA molecules primarily in the areas of autoimmune diseases, cancer, gynecologic diseases, and infectious diseases.

MBL is engaged in an area of clinical laboratory testing in which is reaching a major turning point regarding medical significance and combined with laboratory tests. We are witnessing continued advancement of new therapeutic approaches and prevention of diseases in medicine. These advances are observed from the correlation of research into genetic information such as genome and epigenome, and environmental factors such as infection and lifestyle with health and illness.

MBL’s future business direction is in the research and development of cutting-edge diagnostic products, life science translational research (LSTR), and in commercialization of unique products and services. We aim to launch biomarker tests and companion diagnostics products as clinical laboratory tests, and launch LSTR products for use in disease investigation as well as etiological elucidation of the mechanisms of various diseases.

After MBL’s consolidation into JSR’s Life Science Business, I believe all our corporate activities will lead to the further contribution by MBL to society as a corporate entity with a strong presence in the life science industry.

※Life Science Translational Research (LSTR) Products: LSTR is business category in which we collaborate with academia and pharmaceutical companies to develop disease-related basic research reagents (LSTR products) with the aim of developing technologies for future clinical diagnostics.

November 2016

President and CEOKimimasa Yamada

Message from the President

MBL’s Vision for the Future

Corporate Mission

Creating novel diagnostic reagents to meet healthcare needs of patients, however many or few.

A global niche company with a strong presence, generating value at the cutting-edge diagnostics.


1969 1975 1977 1987 1993 1996 2005 2014

1975 First successful domestic production of “MBL Plate,” an immunodiffusion plate for plasma protein assay

2012 Launch of 6 clinical diagnostics (RNP, Sm, SS-A, SS-B, mitochondria M2, and GBM) in the “STACIA MEBLux™ Test” series, fully-automatic rapid assay reagents for detecting systemic lupus erythematosus (SLE) and other autoimmune diseases Business acquisition from Beckman Coulter, Inc., USA: Launch of worldwide development, manufacture, and sales of MHC tetramer reagents and antigen’s epitope-identification reagents for infectious diseases and cancers

2015 Launch of “MEBGEN™ RASKET Kit,” a genetic testing reagent useful in prescreening diagnostic of anti-EGFR antibody therapy in colorectal cancer Launch of “STACIA MEBLux™ Test BCA225,” a clinical diagnostic, fully-automatic rapid assay reagent for detecting a biomarker of breast cancer by the CLEIA method Launch of “GENOSEARCH™ BRAF,” a genetic testing reagent for detecting mutations in BRAF genes Launch of “MESACUP™ Anti-MDA5 Test” and “MESACUP™ Anti-Mi-2 Test,” a diagnostic reagent for polymyositis and dermatomyositis

2016 Launch of “MESACUP™ Anti-TIF1-γ Test,” a clinical diagnostic for polymyositis and dermatomyositis

2014 Launch of “MESACUP™ Anti-ARS Test,” a clinical diagnostic for detecting polymyositis and dermatomyositis Launch of “STACIA MEBLux™ Test ANA,” a clinical diagnostic, fully-automatic rapid assay reagent for detecting antinuclear antibodies by the CLEIA methodRegistration of CE marking in Europe for reagents used in the detection of RAS (KRAS and NRAS) genes mutations, useful in prescreening diagnostic of anti-EGFR antibody therapy in colorectal cancer

2013 Launch of “MEBGEN™ HPV Kit,” a genetic testing reagent for detecting and typing high-risk human papillomavirus (HPV) genes in gynecology Launch of “GENOSEARCH™ AZF Deletion,” a reagent for detecting the microdeletions in Y-chromosome azoospermia factor (AZF) region for use in the study of male infertility Launch of 8 clinical diagnostics (Dsg-1, Dsg-3, BP180, dsDNA, ssDNA, Scl-70, CENP-B, and Jo-1) in the “MEBLux™ Test” series, fully-automatic rapid assay reagents for detecting pemphigus and other autoimmune diseases Launch of “MESACUP™-2 Desmoglein-1 and -3 Tests” series for detecting pemphigusLaunch of “GENOSEARCH™ ABO,” a genetic test reagent for determining ABO genotype of red blood cells Launch of “Fluoppi,” a research tool for drug discovery to visualize intracellular protein-protein interactions by fluorescence imaging

1978 Launch of “EIA IgE Test,” the world’s first allergy diagnostic reagent using the enzyme immunoassay (EIA) method

1984 Launch of 3 products in the microplate-based “EIA MESACUP™” series Launch of “FLUORO HEPANA Test,” an antinuclear antibody diagnostic reagent using the immunofluorescence method

1991 Launch of 4 products (Sm, RNP, SS-A/Ro, and SS-B/La) in the “MESACUP™” series as clinical diagnostics for detecting autoantibodies* using ELISA with recombinant proteins

1992 Launch of “Anti-human Fas Monoclonal Antibody,” a basic research reagent for use in the research of programmed cell death

1998 Launch of human and murine “IL-18 ELISA Kit” following the acquisition of a worldwide exclusive-license agreement for IL-18 with Hayashibara Biochemical Labs., Inc.

2002 Formation of a strategic alliance with Beckman Coulter, Inc., USA: Launch of development, manufacture, and sales of reagents for T cell analysis using MHC tetramer technology as well as contracted and collaborative research in association with this study

2007 Launch of “MESACUP™ Anti-p53 Test,” novel diagnostic reagent for measuring autoantibodies to a tumor suppressor protein, p53

2008 Launch of “Fucci,” a novel probe for real-time monitoring of cell cycle progression by fluorescence imaging

2009 Launch of the “TACAS™” series products (slides, fixative solutions, and instruments), the first domestically produced system in Japan of liquid-based cytology for detecting cervical cancer

2010 Launch of “MESACUP™ Anti-RNA Polymerase III Test,” a clinical diagnostic for systemic sclerosis Launch of “MESACUP™-2 Test CCP,” a clinical diagnostic for rheumatoid arthritis (RA) Launch of “MEBLux™ CL-CCP Test,” the first domestically produced fully-automatic rapid assay, clinical diagnostic for detecting autoantibodies by the chemiluminescent immunoassay (CLEIA) method in Japan Launch of “MEBChrom™ CCP Test” a clinical diagnostic for detecting rheumatoid arthritis-specific autoantibodies against citrullinated antigens using the immunochromatographic method

2011 Launch of 3 clinical diagnostics (CCP, MPO-ANCA, and PR3-ANCA) in the “STACIA MEBLux™ Test” series, fully-automatic rapid assay for detecting autoantibodies by the CLEIA method Launch of 2 clinical diagnostics (MPO-ANCA and PR3-ANCA) in the “MESACUP™-2 Test” series for detecting vasculitis syndrome

History of MBL

Corporate history

History of Research and Product Development

* Autoantibody: An antibody reacting with antigenic constituents of the host’s tissue (or "self antigen") in autoimmune diseases

1969 Foundation of MBL as the first antibody manufacturer/supplier in Japan

1975 Entry into clinical diagnostics field

1977 Start of research & development on diagnostics for autoimmune diseases

1987 Entry into basic research reagents field

1993 Establishment of a subsidiary company, MBL International Corporation, in Boston, USA

1996 Initial public offering on the JASDAQ Securities Exchange

2005 Establishment of a joint venture company, Beijing B&M Biotech Co., Ltd., (as of now MBL Beijing Biotech Co., Ltd) in China

2014 Affiliation with the JSR Corporation Group

MBL Plate

MESACUP™ series

STACIA MEBLux™ series TACAS™

MEBGEN™ seriesFLUORO HEPANA Test


1969 1975 1977 1987 1993 1996 2005 2014

1975 First successful domestic production of “MBL Plate,” an immunodiffusion plate for plasma protein assay

2012 Launch of 6 clinical diagnostics (RNP, Sm, SS-A, SS-B, mitochondria M2, and GBM) in the “STACIA MEBLux™ Test” series, fully-automatic rapid assay reagents for detecting systemic lupus erythematosus (SLE) and other autoimmune diseases Business acquisition from Beckman Coulter, Inc., USA: Launch of worldwide development, manufacture, and sales of MHC tetramer reagents and antigen’s epitope-identification reagents for infectious diseases and cancers

2015 Launch of “MEBGEN™ RASKET Kit,” a genetic testing reagent useful in prescreening diagnostic of anti-EGFR antibody therapy in colorectal cancer Launch of “STACIA MEBLux™ Test BCA225,” a clinical diagnostic, fully-automatic rapid assay reagent for detecting a biomarker of breast cancer by the CLEIA method Launch of “GENOSEARCH™ BRAF,” a genetic testing reagent for detecting mutations in BRAF genes Launch of “MESACUP™ Anti-MDA5 Test” and “MESACUP™ Anti-Mi-2 Test,” a diagnostic reagent for polymyositis and dermatomyositis

2016 Launch of “MESACUP™ Anti-TIF1-γ Test,” a clinical diagnostic for polymyositis and dermatomyositis

2014 Launch of “MESACUP™ Anti-ARS Test,” a clinical diagnostic for detecting polymyositis and dermatomyositis Launch of “STACIA MEBLux™ Test ANA,” a clinical diagnostic, fully-automatic rapid assay reagent for detecting antinuclear antibodies by the CLEIA methodRegistration of CE marking in Europe for reagents used in the detection of RAS (KRAS and NRAS) genes mutations, useful in prescreening diagnostic of anti-EGFR antibody therapy in colorectal cancer

2013 Launch of “MEBGEN™ HPV Kit,” a genetic testing reagent for detecting and typing high-risk human papillomavirus (HPV) genes in gynecology Launch of “GENOSEARCH™ AZF Deletion,” a reagent for detecting the microdeletions in Y-chromosome azoospermia factor (AZF) region for use in the study of male infertility Launch of 8 clinical diagnostics (Dsg-1, Dsg-3, BP180, dsDNA, ssDNA, Scl-70, CENP-B, and Jo-1) in the “MEBLux™ Test” series, fully-automatic rapid assay reagents for detecting pemphigus and other autoimmune diseases Launch of “MESACUP™-2 Desmoglein-1 and -3 Tests” series for detecting pemphigusLaunch of “GENOSEARCH™ ABO,” a genetic test reagent for determining ABO genotype of red blood cells Launch of “Fluoppi,” a research tool for drug discovery to visualize intracellular protein-protein interactions by fluorescence imaging

1978 Launch of “EIA IgE Test,” the world’s first allergy diagnostic reagent using the enzyme immunoassay (EIA) method

1984 Launch of 3 products in the microplate-based “EIA MESACUP™” series Launch of “FLUORO HEPANA Test,” an antinuclear antibody diagnostic reagent using the immunofluorescence method

1991 Launch of 4 products (Sm, RNP, SS-A/Ro, and SS-B/La) in the “MESACUP™” series as clinical diagnostics for detecting autoantibodies* using ELISA with recombinant proteins

1992 Launch of “Anti-human Fas Monoclonal Antibody,” a basic research reagent for use in the research of programmed cell death

1998 Launch of human and murine “IL-18 ELISA Kit” following the acquisition of a worldwide exclusive-license agreement for IL-18 with Hayashibara Biochemical Labs., Inc.

2002 Formation of a strategic alliance with Beckman Coulter, Inc., USA: Launch of development, manufacture, and sales of reagents for T cell analysis using MHC tetramer technology as well as contracted and collaborative research in association with this study

2007 Launch of “MESACUP™ Anti-p53 Test,” novel diagnostic reagent for measuring autoantibodies to a tumor suppressor protein, p53

2008 Launch of “Fucci,” a novel probe for real-time monitoring of cell cycle progression by fluorescence imaging

2009 Launch of the “TACAS™” series products (slides, fixative solutions, and instruments), the first domestically produced system in Japan of liquid-based cytology for detecting cervical cancer

2010 Launch of “MESACUP™ Anti-RNA Polymerase III Test,” a clinical diagnostic for systemic sclerosis Launch of “MESACUP™-2 Test CCP,” a clinical diagnostic for rheumatoid arthritis (RA) Launch of “MEBLux™ CL-CCP Test,” the first domestically produced fully-automatic rapid assay, clinical diagnostic for detecting autoantibodies by the chemiluminescent immunoassay (CLEIA) method in Japan Launch of “MEBChrom™ CCP Test” a clinical diagnostic for detecting rheumatoid arthritis-specific autoantibodies against citrullinated antigens using the immunochromatographic method

2011 Launch of 3 clinical diagnostics (CCP, MPO-ANCA, and PR3-ANCA) in the “STACIA MEBLux™ Test” series, fully-automatic rapid assay for detecting autoantibodies by the CLEIA method Launch of 2 clinical diagnostics (MPO-ANCA and PR3-ANCA) in the “MESACUP™-2 Test” series for detecting vasculitis syndrome

History of MBL

Corporate history

History of Research and Product Development

* Autoantibody: An antibody reacting with antigenic constituents of the host’s tissue (or "self antigen") in autoimmune diseases

1969 Foundation of MBL as the first antibody manufacturer/supplier in Japan

1975 Entry into clinical diagnostics field

1977 Start of research & development on diagnostics for autoimmune diseases

1987 Entry into basic research reagents field

1993 Establishment of a subsidiary company, MBL International Corporation, in Boston, USA

1996 Initial public offering on the JASDAQ Securities Exchange

2005 Establishment of a joint venture company, Beijing B&M Biotech Co., Ltd., (as of now MBL Beijing Biotech Co., Ltd) in China

2014 Affiliation with the JSR Corporation Group

MBL Plate

MESACUP™ series

STACIA MEBLux™ series TACAS™

MEBGEN™ seriesFLUORO HEPANA Test


● Since its establishment, MBL has developed and launched a substantial number of unique high-quality in vitro diagnostic products utilizing proprietary antigen/antibody engineering technologies that MBL possesses.

● MBL owns a broad range of antigen/antibody qualitative screening and quantitation technologies such as indirect immunofluorescence, double immunodiffusion, and ELISA assays, which have primarily been applied to the development of autoantibody test reagents. In 2010, MBL realized the first in Japan to achieve fully automated measurement of autoantibodies by chemiluminescent immunoassay (CLEIA). The assay is highly sensitive and effective in quantitating autoantibodies, resulting in a substantial reduction of assay time from several hours to less than an hour. Consequently, assay results can be obtained in a very short time after blood sampling, and prompt diagnosis can be established on the same day of hospital visit.

Immunological Assay Technologies

On October 31, 2015, a new manufacturing facility of MBL, the “manufacturing facility No.2” (3 stories high with a total floor area of 3,880 m2), was constructed adjacent to the current main manufacturing facility after receiving capital injection from JSR Corporation to expand the company’s manufacturing capacity, in response to growing demand for MBL products. MBL is distributing clinical diagnostic products not only in Japan but also overseas. The manufacturing facility No.2 is equipped with manufacturing facilities and systems, all compliant with the requirements of overseas regulatory authorities such as the US FDA. Regulatory control over the manufacture of clinical diagnostic products is certain to become even more stringent, and the management of regulatory requirements more sophisticated and more demanding. MBL will continue to exert its utmost efforts to provide customers with high-quality products that will ensure a high level of satisfaction.

MBL is a manufacturer and marketer of diagnostic products, speci�cally based on immunological and genetic assay technologies.

● MBL has developed genetic diagnosis reagents using a unique analysis technology that combination of the multiplex PCR and specific-oligo probe method (PCR-rSSO : Luminex® xMAP® technology), and has commercialized. These techniques distinguish single base change, it is possible to develop diagnostic reagents capable of detecting multiple mutations or polymorphisms simultaneously. These reagents, simple and quick to detect the genetic information for the diagnosis of cancer, will help to personalized medicine*.

● MBL has developed optimized reagents to various clinical samples (Formalin-fixed paraffin-embedded tissue, blood, sputum, urine, oral mucosa, etc.). * Personalized medicine: An approach to provide optimal treatment customized to each

patient’s needs.

Genetic Assay Technologies

Ina, Nagano

Manufacturing facility No.2

CoreTechnologies

ProductionFacilities


● Since its establishment, MBL has developed and launched a substantial number of unique high-quality in vitro diagnostic products utilizing proprietary antigen/antibody engineering technologies that MBL possesses.

● MBL owns a broad range of antigen/antibody qualitative screening and quantitation technologies such as indirect immunofluorescence, double immunodiffusion, and ELISA assays, which have primarily been applied to the development of autoantibody test reagents. In 2010, MBL realized the first in Japan to achieve fully automated measurement of autoantibodies by chemiluminescent immunoassay (CLEIA). The assay is highly sensitive and effective in quantitating autoantibodies, resulting in a substantial reduction of assay time from several hours to less than an hour. Consequently, assay results can be obtained in a very short time after blood sampling, and prompt diagnosis can be established on the same day of hospital visit.

Immunological Assay Technologies

On October 31, 2015, a new manufacturing facility of MBL, the “manufacturing facility No.2” (3 stories high with a total floor area of 3,880 m2), was constructed adjacent to the current main manufacturing facility after receiving capital injection from JSR Corporation to expand the company’s manufacturing capacity, in response to growing demand for MBL products. MBL is distributing clinical diagnostic products not only in Japan but also overseas. The manufacturing facility No.2 is equipped with manufacturing facilities and systems, all compliant with the requirements of overseas regulatory authorities such as the US FDA. Regulatory control over the manufacture of clinical diagnostic products is certain to become even more stringent, and the management of regulatory requirements more sophisticated and more demanding. MBL will continue to exert its utmost efforts to provide customers with high-quality products that will ensure a high level of satisfaction.

MBL is a manufacturer and marketer of diagnostic products, speci�cally based on immunological and genetic assay technologies.

● MBL has developed genetic diagnosis reagents using a unique analysis technology that combination of the multiplex PCR and specific-oligo probe method (PCR-rSSO : Luminex® xMAP® technology), and has commercialized. These techniques distinguish single base change, it is possible to develop diagnostic reagents capable of detecting multiple mutations or polymorphisms simultaneously. These reagents, simple and quick to detect the genetic information for the diagnosis of cancer, will help to personalized medicine*.

● MBL has developed optimized reagents to various clinical samples (Formalin-fixed paraffin-embedded tissue, blood, sputum, urine, oral mucosa, etc.). * Personalized medicine: An approach to provide optimal treatment customized to each

patient’s needs.

Genetic Assay Technologies

Ina, Nagano

Manufacturing facility No.2

CoreTechnologies

ProductionFacilities


Lines of Business

Lines of Business

MBL is working in collaboration with academia and pharmaceutical companies to develop disease-related basic research reagents (LSTR products) with the aim of sowing the seeds for future clinical diagnostics.

Life Science Translational Research (LSTR) Business

Market research and survey

Research and development

Clinical development

Commercialization of products

and technologies

Manufacturing and sales

Regulatory approval

What Are Clinical Diagnostic Products?Clinical diagnostics (in vitro diagnostics) are medical products used in assays of biological samples such as blood and urine at hospitals and clinical laboratories. Generally, most people do not personally come across clinical diagnostics; however, the diagnostics are absolutely necessary and indispensable for physicians in establishing diagnosis, deciding treatment method, and predicting the course of illness and treatment outcome. MBL performs research and development, manufacturing and distribution of clinical diagnostics.

MBL has been actively engaged in the development of clinical diagnostics for not only prevalent diseases but also orphan and intractable diseases. MBL holds top place in terms of the number of products registered in the national health insurance drug list in Japan as new clinical diagnostics to date. MBL is also researching and developing products based on novel diagnostic concepts and assay approaches and is promoting faster and more accurate automated assay of biological specimens at clinical laboratories. Further, MBL is developing products for personalized medicine such as genetic test reagents for the diagnosis of cancer and infectious diseases as well as companion diagnostics.

Clinical (In Vitro) Diagnostic Products Business

Segments of Business

Universities

Public research institutes

Pharmaceuticalcompanies

Hospitals

Clinical laboratories


and technologies


Lines of Business

Lines of Business

MBL is working in collaboration with academia and pharmaceutical companies to develop disease-related basic research reagents (LSTR products) with the aim of sowing the seeds for future clinical diagnostics.


Market research and survey

Research and development

Clinical development


and technologies

Manufacturing and sales

Regulatory approval

What Are Clinical Diagnostic Products?Clinical diagnostics (in vitro diagnostics) are medical products used in assays of biological samples such as blood and urine at hospitals and clinical laboratories. Generally, most people do not personally come across clinical diagnostics; however, the diagnostics are absolutely necessary and indispensable for physicians in establishing diagnosis, deciding treatment method, and predicting the course of illness and treatment outcome. MBL performs research and development, manufacturing and distribution of clinical diagnostics.

MBL has been actively engaged in the development of clinical diagnostics for not only prevalent diseases but also orphan and intractable diseases. MBL holds top place in terms of the number of products registered in the national health insurance drug list in Japan as new clinical diagnostics to date. MBL is also researching and developing products based on novel diagnostic concepts and assay approaches and is promoting faster and more accurate automated assay of biological specimens at clinical laboratories. Further, MBL is developing products for personalized medicine such as genetic test reagents for the diagnosis of cancer and infectious diseases as well as companion diagnostics.

Clinical (In Vitro) Diagnostic Products Business

Segments of Business

Universities

Public research institutes

Pharmaceuticalcompanies

Hospitals

Clinical laboratories


and technologies


Lines of Business

MBL has over 30 years of experience as a leading company of diagnostic reagents in the �eld of autoimmune diseases.

Autoimmune Diseases

MBL provides genetic test products that assist the selection of optimal treatment regimens for cancer and other diseases

Genetic Testing

An autoimmune disease is a pathological state in which an abnormality in the immune system causes it to recognize and attack the body’s own tissues and cells as foreign objects. Autoimmune diseases are broadly categorized into systemic autoimmune diseases that can affect throughout the body and organ-specific autoimmune diseases that cause damage to specific organs. Many autoimmune diseases are designated as intractable diseases by Japan’s Ministry of Health Labour and Welfare (MHLW).

Diagnosis of autoimmune diseases requires accurate measurement of parameters and indicators which are specific to individual immune disorders. Clinical diagnostic test results also serve to predict subsequent disease progression and evaluate therapeutic options. MBL offers a variety of diagnostic reagents for autoimmune diseases to be able to meet a broad range of clinical needs from screening to follow-up of patients.

Recently, personalized medicine has become recognized as particularly important in selecting and designing optimal treatment regimens for individual patients. In the occurrence and progression of cancer are somatic mutation is deeply involved, it has been important as a biomarker for the therapeutic effect prediction. In molecular targeted therapy,* potentially responsive patients are identified based on biomarkers of efficacy and/or adverse reactions prior to treatment initiation, and the efficacy is maximized and adverse reactions are minimized. We need to get not only the information of specific mutation as these biomarkers, the information of more than one gene mutation. MBL products meet these requirements with their simple, convenient, and cost-effective genetic diagnostic systems.* Molecular targeted therapy: A therapeutic approach to target key

molecules of cancer cells and inhibit the biological function of those molecules

Baseline screening

tests

De�nitive diagnostic

tests

�erapeutic decision-making

tests

Patient treatment

Follow-up tests

SystemicSymptoms

FeverMalaise

Weight loss Pain,

swelling, etc. in the joints

Muscle pain and weakness

Skin symptoms Organ damage

● Rheumatoid arthritis (RA)

● Systemic lupus erythematosus (SLE)

● Antiphospholipid syndrome (APS)

● Systemic sclerosis, scleroderma (SSc)

● Polymyositis/dermatomyositis (PM/DM)

● Mixed connective tissue disease (MCTD)

● Sjögren's syndrome (SS)

● Polyarteritis nodosa (PAN)

● Microscopic polyangiitis (MPA)

● Granulomatosis with polyangitis (GPA) (Wegener’ s granulomatosis [WG])

● Eosinophilic granulomastosis with polyangiitis (EGPA) (Allergic granulomatous angitis: [AGA] and Churg-Strauss syndrome [CSS])

● Chronic thyroiditis (CT) (Hashimoto thyroiditis)● Basedow’s disease (BD)

Systemic Autoimmune Diseases Organ-Speci�c Autoimmune Diseases

Thyroid

● Autoimmune hepatitis (AIH)● Primary biliary cirrhosis (PBC)

Liver

● Myasthenia gravis (MG) and multiple sclerosis (MS)

Nerve and muscle

● Ulcerative colitis (UC)● Crohn’s disease (CD)

● Autoimmune pancreatitis (AIP)Pancreas

● Pemphigus● Pemphigoid (including epidermolysis bullosa aquisita [EBA])

Skin

● Goodpasture’s syndrome (GPS)● Crescentic glomerulonephritis (CGN)

Kidney

Clinical Diagnostics Business

Gastrointestinaltract


Lines of Business

MBL has over 30 years of experience as a leading company of diagnostic reagents in the �eld of autoimmune diseases.

Autoimmune Diseases

MBL provides genetic test products that assist the selection of optimal treatment regimens for cancer and other diseases

Genetic Testing

An autoimmune disease is a pathological state in which an abnormality in the immune system causes it to recognize and attack the body’s own tissues and cells as foreign objects. Autoimmune diseases are broadly categorized into systemic autoimmune diseases that can affect throughout the body and organ-specific autoimmune diseases that cause damage to specific organs. Many autoimmune diseases are designated as intractable diseases by Japan’s Ministry of Health Labour and Welfare (MHLW).

Diagnosis of autoimmune diseases requires accurate measurement of parameters and indicators which are specific to individual immune disorders. Clinical diagnostic test results also serve to predict subsequent disease progression and evaluate therapeutic options. MBL offers a variety of diagnostic reagents for autoimmune diseases to be able to meet a broad range of clinical needs from screening to follow-up of patients.

Recently, personalized medicine has become recognized as particularly important in selecting and designing optimal treatment regimens for individual patients. In the occurrence and progression of cancer are somatic mutation is deeply involved, it has been important as a biomarker for the therapeutic effect prediction. In molecular targeted therapy,* potentially responsive patients are identified based on biomarkers of efficacy and/or adverse reactions prior to treatment initiation, and the efficacy is maximized and adverse reactions are minimized. We need to get not only the information of specific mutation as these biomarkers, the information of more than one gene mutation. MBL products meet these requirements with their simple, convenient, and cost-effective genetic diagnostic systems.* Molecular targeted therapy: A therapeutic approach to target key

molecules of cancer cells and inhibit the biological function of those molecules

Baseline screening

tests

De�nitive diagnostic

tests

�erapeutic decision-making

tests

Patient treatment

Follow-up tests

SystemicSymptoms

FeverMalaise

Weight loss Pain,

swelling, etc. in the joints

Muscle pain and weakness

Skin symptoms Organ damage

● Rheumatoid arthritis (RA)

● Systemic lupus erythematosus (SLE)

● Antiphospholipid syndrome (APS)

● Systemic sclerosis, scleroderma (SSc)

● Polymyositis/dermatomyositis (PM/DM)

● Mixed connective tissue disease (MCTD)

● Sjögren's syndrome (SS)

● Polyarteritis nodosa (PAN)

● Microscopic polyangiitis (MPA)

● Granulomatosis with polyangitis (GPA) (Wegener’ s granulomatosis [WG])

● Eosinophilic granulomastosis with polyangiitis (EGPA) (Allergic granulomatous angitis: [AGA] and Churg-Strauss syndrome [CSS])

● Chronic thyroiditis (CT) (Hashimoto thyroiditis)● Basedow’s disease (BD)

Systemic Autoimmune Diseases Organ-Speci�c Autoimmune Diseases

Thyroid

● Autoimmune hepatitis (AIH)● Primary biliary cirrhosis (PBC)

Liver

● Myasthenia gravis (MG) and multiple sclerosis (MS)

Nerve and muscle

● Ulcerative colitis (UC)● Crohn’s disease (CD)

● Autoimmune pancreatitis (AIP)Pancreas

● Pemphigus● Pemphigoid (including epidermolysis bullosa aquisita [EBA])

Skin

● Goodpasture’s syndrome (GPS)● Crescentic glomerulonephritis (CGN)

Kidney

Clinical Diagnostics Business

Gastrointestinaltract


Basic research reagents (for the Development and Commercialization of Clinical Diagnostics)

Lines of Business

Tumor Markers

Antibodies

MHC Tetramers

Pathology Research

Cytology


Tumor markers are proteins and DNA that are specifically associated with cancers and are released into the biological fluids including bloodstream or urine. MBL provides diagnostic reagents detecting for tumor markers and reagents detecting for autoantibodies against tumor markers and supports physicians in their diagnosis of cancers.

MBL has developed antibodies and assay kits by utilizing its core technologies and broadly supported academia and the pharmaceutical industry from basic research to clinical applications. MBL’s high-quality antibodies and kit products have long been highly appraised by researchers in molecular (cellular) biology.

Fluorescent Proteins

MBL provides an extensive lineup of unique fluorescent proteins and related products. Sophisticated measurement technologies and fluorescent proteins and fluorescent protein products are essential technologies and tools for the discovery of molecular target drugs and hence are widely used in research and development by pharmaceutical companies.

MBL is the only company in Japan, developing and marketing reagents, “major histocompatibility complex (MHC) tetramers,” used to detect antigen-specific T cells that play important roles in immune-cell therapy such as for cancer. MBL is also undertaking collaborative research with academic institutes and is out-licensing seeds for future cancer treatments.

MBL provides antibody products for pathological staining of cell and tissue sections (for use in research). Through a diverse product line-up, including US BioGenex’s antibodies and kits for pathological staining, MBL is contributing to advances in the field of pathology and pathological examination.

Cytology is a test to collect cells from the target area of the body and pathologically examine them under microscopy after staining. It is particularly useful for the cervical cancer screening. MBL is pursuing higher accuracy of cytology through standardization of testing procedures and assessment criteria of the test and supply of a liquid-based cytology system, “TACAS™,” which can also be used for other types of test (e.g. genetic tests and immunocytochemical staining). NB: Available only in Japan.

Normal cells

Antibodies to tumor markers

Tumor markers

Cancer cells

Antigen-specific T cellT-cell receptors

Fluorescence-labeled substance

MHC molecule

β-2m

Peptide

MBL is out-licensing of fluorescent protein-related technologies and seeds of therapeutic antibodies.


Basic research reagents (for the Development and Commercialization of Clinical Diagnostics)

Lines of Business

Tumor Markers

Antibodies

MHC Tetramers

Pathology Research

Cytology


Tumor markers are proteins and DNA that are specifically associated with cancers and are released into the biological fluids including bloodstream or urine. MBL provides diagnostic reagents detecting for tumor markers and reagents detecting for autoantibodies against tumor markers and supports physicians in their diagnosis of cancers.

MBL has developed antibodies and assay kits by utilizing its core technologies and broadly supported academia and the pharmaceutical industry from basic research to clinical applications. MBL’s high-quality antibodies and kit products have long been highly appraised by researchers in molecular (cellular) biology.

Fluorescent Proteins

MBL provides an extensive lineup of unique fluorescent proteins and related products. Sophisticated measurement technologies and fluorescent proteins and fluorescent protein products are essential technologies and tools for the discovery of molecular target drugs and hence are widely used in research and development by pharmaceutical companies.

MBL is the only company in Japan, developing and marketing reagents, “major histocompatibility complex (MHC) tetramers,” used to detect antigen-specific T cells that play important roles in immune-cell therapy such as for cancer. MBL is also undertaking collaborative research with academic institutes and is out-licensing seeds for future cancer treatments.

MBL provides antibody products for pathological staining of cell and tissue sections (for use in research). Through a diverse product line-up, including US BioGenex’s antibodies and kits for pathological staining, MBL is contributing to advances in the field of pathology and pathological examination.

Cytology is a test to collect cells from the target area of the body and pathologically examine them under microscopy after staining. It is particularly useful for the cervical cancer screening. MBL is pursuing higher accuracy of cytology through standardization of testing procedures and assessment criteria of the test and supply of a liquid-based cytology system, “TACAS™,” which can also be used for other types of test (e.g. genetic tests and immunocytochemical staining). NB: Available only in Japan.

Normal cells

Antibodies to tumor markers

Tumor markers

Cancer cells

Antigen-specific T cellT-cell receptors

Fluorescence-labeled substance

MHC molecule

β-2m

Peptide

MBL is out-licensing of fluorescent protein-related technologies and seeds of therapeutic antibodies.


MBL Network Companies

and O�ces of Business

Research, development, production, and domestic and overseas sales and marketing of clinical diagnostics and genetic testing reagents focusing autoimmune diseases and cancers, and laboratory reagents for use in basic research on immunology and molecular cell biology Headquarters: KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008, Japan Phone: +81-52-238-1901, Facsimile: +81-52-238-1440

JSR Corporation is deploying its business globally: petrochemical products business (including synthetic rubbers and resins), fine chemicals business (including semiconductor materials, display materials, and optical coating materials), and life sciences business.Headquarters: Shiodome-Sumitomo Bldg., 1-9-2 Higashi-Shimbashi, Minato-ku, Tokyo 105-0021, Japan Phone: +81-3-6218-3500, Facsimile: +81-3-6218-3682

ATLANTIC OCEAN

PACIFICOCEAN

PACIFICOCEAN

JAPAN

AMERICA

CHINA

INDIANOCEAN

Parentcompany

http://www.jsr.co.jphttp://www.mbl.co.jp/

Group companies MBL’s O�ces

● Headquarters: Nagoya, Aichi ● Research and manufacturing facilities: Ina, Nagano

● Sales offices Sapporo, Tokyo, Nagoya, Osaka, and Fukuoka

●①

●②

●⑤

●⑥

●③

●④

●

●

●

●

●

① G&G Science Co., Ltd., Fukushima, Fukushima

② New Histo. Science Laboratory Co., Ltd., Ome, Tokyo

③ MBL Venture Capital Co., Ltd., Chiyoda-ku, Tokyo

④ MBL Beijing Biotech Co., Ltd, Beijing, China

⑤ MBL International Corporation, Woburn, MA, USA

⑥ BION Enterprises, Ltd., Des Plaines, IL, USA


MBL Network Companies

and O�ces of Business

Research, development, production, and domestic and overseas sales and marketing of clinical diagnostics and genetic testing reagents focusing autoimmune diseases and cancers, and laboratory reagents for use in basic research on immunology and molecular cell biology Headquarters: KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008, Japan Phone: +81-52-238-1901, Facsimile: +81-52-238-1440

JSR Corporation is deploying its business globally: petrochemical products business (including synthetic rubbers and resins), fine chemicals business (including semiconductor materials, display materials, and optical coating materials), and life sciences business.Headquarters: Shiodome-Sumitomo Bldg., 1-9-2 Higashi-Shimbashi, Minato-ku, Tokyo 105-0021, Japan Phone: +81-3-6218-3500, Facsimile: +81-3-6218-3682

ATLANTIC OCEAN

PACIFICOCEAN

PACIFICOCEAN

JAPAN

AMERICA

CHINA

INDIANOCEAN

Parentcompany

http://www.jsr.co.jphttp://www.mbl.co.jp/

Group companies MBL’s O�ces

● Headquarters: Nagoya, Aichi ● Research and manufacturing facilities: Ina, Nagano

● Sales offices Sapporo, Tokyo, Nagoya, Osaka, and Fukuoka

●①

●②

●⑤

●⑥

●③

●④

●

●

●

●

●

① G&G Science Co., Ltd., Fukushima, Fukushima

② New Histo. Science Laboratory Co., Ltd., Ome, Tokyo

③ MBL Venture Capital Co., Ltd., Chiyoda-ku, Tokyo

④ MBL Beijing Biotech Co., Ltd, Beijing, China

⑤ MBL International Corporation, Woburn, MA, USA

⑥ BION Enterprises, Ltd., Des Plaines, IL, USA


The symposium has been held since 1993 with participants from around Japan and overseas. The 24th symposium was held in 2016.

Sponsorship of Symposia

Publications (Lecture Transcripts and Lea�ets)

ScholarlyActivities

Autoantibodies and Autoimmunity Symposium

The forum on medical care of patients with collagen disease has been held 14 times in Sapporo, Hokkaido, since 1997.

Sapporo Collagen Disease Forum

The symposium on molecular cell biology has been held every August since 1989. The 28th symposium was held in 2016.

Takato Molecular Cell Biology Symposium

The forums on diagnosis and medical care and treatment have been held in the Kansai and Kyushu areas since 2014 and 2016, respectively.

Kansai Forum on Diagnosis and Medical Care Kyushu Forum on Diagnosis and Treatment

Autoimmunity experts contribute their specialized knowledge on the subject of autoimmune diseases to be issued as academic publications.

MBL Autoimmune Reports

The latest information on diagnostic criteria and treatment guidelines for autoimmune diseases are published in leaflets to help medical professionals in carrying out treatments and tests. The information is summarized and presented as useful references for the physicians in determining optimal treatment options in a comprehensive manner that is easy to understand even for the physicians other than collagen disease experts, with diagnostic test flowcharts, lists of major clinical symptoms, and lists of autoantibody test items.

Diagnostic Criteria and Treatment Guidelines for Autoimmune Diseases

Lecturers in the symposium contribute their papers for publication.

Autoantibodies and Autoimmunity

Lecturers in the forum contribute their papers for publication.

Kansai Forum on Diagnosis and Medical Care

*Japanese only, there is some English

* Only in Japan

ISO ISO13485 certi�cation was acquired in 2006.

MBL has obtained ISO 13485 certification and is dedicating further efforts to improving product quality under the following quality assurance principles. 1. We will exert our best efforts to maintain the effectiveness of our quality management system and continually implement improvements to

provide customer-oriented high quality products and services. 2. We will give careful attention to information from customer and quickly and sincerely respond to their needs by implementing appropriate

measures. 3. We will prioritize compliance with applicable legal and regulatory requirements and provide safe and reliable products and services.

Quality Control Survey of the AutoantibodiesA law regarding medical treatment, etc., for patients with intractable diseases took effect on January 1, 2015. Autoimmune diseases, which are designated as “Specified Diseases” in Japanese law, are assessed by criteria and clinical severity scales established for individual disorders, and the presentation of diagnostic evidence of those disorders is a prerequisite for medical expense coverage under the public health insurance system. Thus, the accurate diagnosis of autoimmune diseases is of increasingly great importance for individual patients as well as physicians. MBL has practiced quality control survey for autoantibody assays since 1983. MBL is the only company in Japan providing the survey of autoantibodies continuously every year. Not only domestic hospitals and clinical laboratories in Japan but also in overseas locations such as Portugal, Italy, Korea, and Taiwan participate our quality control survey.Our quality control survey is implemented not only for detection of inter-laboratory discrepancies in measurement results but also for the unification and standardization of testing parameters based on primary aggregate data and secondary surveys.

ISO 13485:2003MBL’s Ina laboratory and Manufacturing facilities, Tokyo office, headquarters, and delivery center obtained ISO13458:2003 certificate for in vitro diagnostic products and devices.


The symposium has been held since 1993 with participants from around Japan and overseas. The 24th symposium was held in 2016.

Sponsorship of Symposia

Publications (Lecture Transcripts and Lea�ets)

ScholarlyActivities

Autoantibodies and Autoimmunity Symposium

The forum on medical care of patients with collagen disease has been held 14 times in Sapporo, Hokkaido, since 1997.

Sapporo Collagen Disease Forum

The symposium on molecular cell biology has been held every August since 1989. The 28th symposium was held in 2016.

Takato Molecular Cell Biology Symposium

The forums on diagnosis and medical care and treatment have been held in the Kansai and Kyushu areas since 2014 and 2016, respectively.

Kansai Forum on Diagnosis and Medical Care Kyushu Forum on Diagnosis and Treatment

Autoimmunity experts contribute their specialized knowledge on the subject of autoimmune diseases to be issued as academic publications.

MBL Autoimmune Reports

The latest information on diagnostic criteria and treatment guidelines for autoimmune diseases are published in leaflets to help medical professionals in carrying out treatments and tests. The information is summarized and presented as useful references for the physicians in determining optimal treatment options in a comprehensive manner that is easy to understand even for the physicians other than collagen disease experts, with diagnostic test flowcharts, lists of major clinical symptoms, and lists of autoantibody test items.

Diagnostic Criteria and Treatment Guidelines for Autoimmune Diseases

Lecturers in the symposium contribute their papers for publication.

Autoantibodies and Autoimmunity

Lecturers in the forum contribute their papers for publication.

Kansai Forum on Diagnosis and Medical Care

*Japanese only, there is some English

* Only in Japan

ISO ISO13485 certi�cation was acquired in 2006.

MBL has obtained ISO 13485 certification and is dedicating further efforts to improving product quality under the following quality assurance principles. 1. We will exert our best efforts to maintain the effectiveness of our quality management system and continually implement improvements to

provide customer-oriented high quality products and services. 2. We will give careful attention to information from customer and quickly and sincerely respond to their needs by implementing appropriate

measures. 3. We will prioritize compliance with applicable legal and regulatory requirements and provide safe and reliable products and services.

Quality Control Survey of the AutoantibodiesA law regarding medical treatment, etc., for patients with intractable diseases took effect on January 1, 2015. Autoimmune diseases, which are designated as “Specified Diseases” in Japanese law, are assessed by criteria and clinical severity scales established for individual disorders, and the presentation of diagnostic evidence of those disorders is a prerequisite for medical expense coverage under the public health insurance system. Thus, the accurate diagnosis of autoimmune diseases is of increasingly great importance for individual patients as well as physicians. MBL has practiced quality control survey for autoantibody assays since 1983. MBL is the only company in Japan providing the survey of autoantibodies continuously every year. Not only domestic hospitals and clinical laboratories in Japan but also in overseas locations such as Portugal, Italy, Korea, and Taiwan participate our quality control survey.Our quality control survey is implemented not only for detection of inter-laboratory discrepancies in measurement results but also for the unification and standardization of testing parameters based on primary aggregate data and secondary surveys.

ISO 13485:2003MBL’s Ina laboratory and Manufacturing facilities, Tokyo office, headquarters, and delivery center obtained ISO13458:2003 certificate for in vitro diagnostic products and devices.


Corporate Pro�leSales, Ordinary Income, and R&D Expenses

Consolidated Sales (47th Fiscal Year)

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae 4-chome, Naka-ku, Nagoya, Aichi 460-0008, Japan+81‒52‒238‒1901+81‒52‒238‒1440http://www.mbl.co.jp/MBL and its group companies are engaged in business activities encompassing pharmaceutical and biological sectors. 1. Research, development, manufacture, and sales of clinical diagnostics (mainly for autoimmune diseases), genetic testing

reagents, and pathological/cytological testing systems, targeted for hospitals and clinical laboratories 2. Research, development, manufacture, and sales of laboratory reagents for use in basic research, targeted for biological

research laboratories at universities, pharmaceutical companies, etc. 3. Research and development of cutting-edge biotechnologies in the areas of immunology, regenerative medicine, genome

biology, etc. 4. Research and development of new cancer biomarkers and those of antibody drugs developed by fully utilizing

cutting-edge antibody technologies 5. Contract services ranging from manufacture and sales to management and control operations, business development, and

consulting 6. Participation, assistance, and investment in the establishment and operation of biotech venturesAugust 23, 19694,482.93 million yenMarchPresident and CEO: Kimimasa Yamada Executive Vice President: Kenji Yasuda Board Director: Takashi Moritsu Board Director: Hozumi SatoBoard Director: Kiichiro Kamiya Board Director: Masayuki Ushida Full-time Auditor: Kazuo Kojima Auditor: Yuichi Komine Auditor: Hiroaki RokugawaKunihiko NakaiYuichi ItoMotoki KuharaTatsuhiko Kodama, M.D.,Ph.D. Professor, Research Center for Advanced Science and Technology, The University of TokyoJack D. Keene, Ph.D. James B. Duke Professor, Duke University Medical CenterZhu Xuejun, M.D. Professor, Peking University First Hospital291

Ina Laboratory and Manufacturing facility No. 1: 1063-103 Terasawaoka, Ina, Nagano 396-0002, Japan Manufacturing facility No. 2: 1018-1 Terasawaoka, Ina, Nagano 396-0002, Japan Ina Laboratory Komagane Branch: 15-502 Akaho, Komagane, Nagano 399-4117, JapanTokyo Office: MS Bldg. 6F, 2-65-8 Itabashi, Itabashi-ku, Tokyo 173-0004, Japan Sapporo OfficeNagoya OfficeOsaka OfficeFukuoka OfficeDistribution Office: Nagoya, Aichi, Japan

Corporate name:Headquarters:Phone:Facsimile:URL:Description of business:

Date of establishment: Capital:Account closing month:Board members:

Executive officers:

Adviser:

Employees:Research and manufacturing facilities:

Sales offices:

Delivery Center:

(end: 03/2016)

(¥ Mil)

Sale

s

Ord

inar

y in

com

e / R

&D e

xpen

ses

(¥ Mil)

0

1,000

1,500

-500

500

2,000

2,500

3,000

Ordinary income

R&D expenses

Ordinary income

R&D expenses

Sales Sales

Non-consolidated statement Consolidated statement

Reagents for cancer diagnosis

12.3%

Basic research reagents

30.0%

Contract manufacturing

4.8%

Other

4.5%

Investment-related business

0.8%

Reagents and medical devices for cytological testing

4.6%Reagents for plasma protein assay

3.5%Reagents for viral or other infectious diseases

1.8%Reagents for hematological testing

0.7%Medical devices, instruments, etc.

3.0%

Reagents for autoimmune diseases

34.0%

Clinical diagnostics

59.9%

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

1 5 10 15 20 25 30 40 47 FY35

Twelve Months Ended March 2016


Corporate Pro�leSales, Ordinary Income, and R&D Expenses

Consolidated Sales (47th Fiscal Year)

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae 4-chome, Naka-ku, Nagoya, Aichi 460-0008, Japan+81‒52‒238‒1901+81‒52‒238‒1440http://www.mbl.co.jp/MBL and its group companies are engaged in business activities encompassing pharmaceutical and biological sectors. 1. Research, development, manufacture, and sales of clinical diagnostics (mainly for autoimmune diseases), genetic testing

reagents, and pathological/cytological testing systems, targeted for hospitals and clinical laboratories 2. Research, development, manufacture, and sales of laboratory reagents for use in basic research, targeted for biological

research laboratories at universities, pharmaceutical companies, etc. 3. Research and development of cutting-edge biotechnologies in the areas of immunology, regenerative medicine, genome

biology, etc. 4. Research and development of new cancer biomarkers and those of antibody drugs developed by fully utilizing

cutting-edge antibody technologies 5. Contract services ranging from manufacture and sales to management and control operations, business development, and

consulting 6. Participation, assistance, and investment in the establishment and operation of biotech venturesAugust 23, 19694,482.93 million yenMarchPresident and CEO: Kimimasa Yamada Executive Vice President: Kenji Yasuda Board Director: Takashi Moritsu Board Director: Hozumi SatoBoard Director: Kiichiro Kamiya Board Director: Masayuki Ushida Full-time Auditor: Kazuo Kojima Auditor: Yuichi Komine Auditor: Hiroaki RokugawaKunihiko NakaiYuichi ItoMotoki KuharaTatsuhiko Kodama, M.D.,Ph.D. Professor, Research Center for Advanced Science and Technology, The University of TokyoJack D. Keene, Ph.D. James B. Duke Professor, Duke University Medical CenterZhu Xuejun, M.D. Professor, Peking University First Hospital291

Ina Laboratory and Manufacturing facility No. 1: 1063-103 Terasawaoka, Ina, Nagano 396-0002, Japan Manufacturing facility No. 2: 1018-1 Terasawaoka, Ina, Nagano 396-0002, Japan Ina Laboratory Komagane Branch: 15-502 Akaho, Komagane, Nagano 399-4117, JapanTokyo Office: MS Bldg. 6F, 2-65-8 Itabashi, Itabashi-ku, Tokyo 173-0004, Japan Sapporo OfficeNagoya OfficeOsaka OfficeFukuoka OfficeDistribution Office: Nagoya, Aichi, Japan

Corporate name:Headquarters:Phone:Facsimile:URL:Description of business:

Date of establishment: Capital:Account closing month:Board members:

Executive officers:

Adviser:

Employees:Research and manufacturing facilities:

Sales offices:

Delivery Center:

(end: 03/2016)

(¥ Mil)

Sale

s

Ord

inar

y in

com

e / R

&D e

xpen

ses

(¥ Mil)

0

1,000

1,500

-500

500

2,000

2,500

3,000

Ordinary income

R&D expenses

Ordinary income

R&D expenses

Sales Sales

Non-consolidated statement Consolidated statement

Reagents for cancer diagnosis

12.3%

Basic research reagents

30.0%

Contract manufacturing

4.8%

Other

4.5%

Investment-related business

0.8%

Reagents and medical devices for cytological testing

4.6%Reagents for plasma protein assay

3.5%Reagents for viral or other infectious diseases

1.8%Reagents for hematological testing

0.7%Medical devices, instruments, etc.

3.0%

Reagents for autoimmune diseases

34.0%

Clinical diagnostics

59.9%

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

1 5 10 15 20 25 30 40 47 FY35

Twelve Months Ended March 2016

http: / /www.mbl.co. jp/

KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008 Japan Phone: +81-52-238-1901, Facsimile: +81-52-238-1440 Issued: 2016.12

COMPANY PROFILE

MEDICAL & BIOLOGICAL LABORATORIES CO.,LTD. | MBL Life ... · 3 Medical & Biological Laboratories...

Documents

Transcript of MEDICAL & BIOLOGICAL LABORATORIES CO.,LTD. | MBL Life ... · 3 Medical & Biological Laboratories...