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The 7Th Technological Presentation The 7th Technological presentation th March, 19 2010 0 Table of Contents 1. Opening remarks Hisashi Ietsugu President and CEO 2. Direction & Strategy of R&D Mitsuru Watanabe Member of the Managing Board and Executive Officer Head of R&D 3. Progress of R&D project Mitsuru Watanabe Member of the Managing Board and Executive Officer Head of R&D 1）Progress status in launching stage (1) Rapid diagnosis of lymph node metastasis technology (OSNA) (2) Bird flu diagnosis technology (3) Digital blood smear preparation technology (4) Reagent preparation technology 2） Progress status in practical stage (5) Blood testing technology (6) Cervical cancer screening technology (7) Postprandial hyperglycemia monitoring technology Kaoru Asano Executive Officer, Central Research Laboratories 3） Progress status in research stage （8） CTC Detection Technology （9） CNS disease diagnosis Technology with DNA chip 1 1. Introduction Hisashi Ietsugu, President and CEO 2 R&D Investment Policy More companies boosting healthcare offerings Companies entering from other fields of business M&A activities accelerating growth ReinforceReinforce R&D,R&D, thethe wellspringwellspring ofof corporatecorporate growthgrowth Sysmex’s研究開発投資に対する基本的な考え方 Basic Policy on R&D Investment As a technology-oriented company, our R&D investment benchmark is 10% of net sales. 3 R&D Investment Trends (Billions of yen) (%) 12 30 Aggressive ongoing investment in R&D 10.7 9.0 9.2 9 8.1 6.5 5.5 4.9 6 3.5 4.1 15 3 9.3 8.9 9.6 9.1 8.7 8.7 8.4 8.5 8.3 0 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 (Years ended March 31) R&D expenditure R&D expenditure per net sales ■ 2002 International Reagents ■ 2004 BMA Laboratory ■ 2008 Technopark Corporation becomes subsidiary ■ 2000 Central Research Laboratories ■ 2006 R&D Center Europe 4 Expansion of Overseas Development Bases －Recent Developments－ 欧州R&DR&D Centerセンター Europe（ドイツ） (Germany) July 2006 Opening October 2009 Lab relocation and expansion Reasons for Establishment Clinical evaluation in hematology and life sciences Develop products tailored to European needs 中国診断薬開発センターDiagnostic Reagent Development Center in China December 2009 Establishment within Sysmex Wuxi Co., Ltd. Reasons for Establishment Development of reagents (mainly immunochemistry) Joint research with local university hospitals Clinical evaluation 5 Moving into the 2nd Decade of the Central Research Laboratories ReasonReason forfor establishingestablishing CentralCentral ResearchResearch LaboratoriesLaboratories (2000)(2000) ContributeContribute toto developmentdevelopment ofof preventivepreventive andand regenerativeregenerative medicinemedicine Lymph node metastasis testing November 2008 technology (expand applicable cancer System for rapid detection of breast types) cancer lymph node metastasis Cervical cancer screening technology based on OSNA method covered by Cancer recurrent prediction technology Japanese health insurance Cancer treatment effectiveness prediction technology Minimally invasive glucose monitoring technology Clinical condition simulation technology ・ Designated ・ The gene amplification reagent ・ Technopark (Kobe) detector RD-100i Realizing新規技術の獲得 the “Disease Management” Concept Commercializing high-value-added analysis parameters Promoting R&D in life sciences (cancer, lifestyle diseases) 6 2. Direction & strategy of R&D Mitsuru Watanabe Member of the Managing Board and Executive Officer Head of R&D 7 Vision of R&D activity A Unique & Global Healthcare Testing Company ProvidingProviding highlyhighly valuablevaluable diagnosticsdiagnostics testingtesting toto optimizeoptimize andand standardizestandardize medicalmedical carecare ・ Improvement of ＱＯＬ / extension of healthy life expectancy ・ Improvement of Medical economy value Shaping the advancement of health care 8 Direction of R&D activity Selection of medical treatment Early detection Clinical value improvement Efficiency Quality Usability improvement Environmental friendliness Operability 9 Outline of technology strategy (1) Improvement of clinical value Selection of Early detection medical treatment Medical treatment and diagnosis in Combination (towards personalized medicine) To select an effective or a free side-effect drug for individuals 10 Outline of technology strategy (2) Improvement of usability Quality Efficiency Environmental friendliness Operability Advanced countries： Providing high-value-added system that improves productivity of clinical test to reach the limit Rising countries： Providing low cost prevalent instruments 11 Hematology and Infectious diseases Cancer Immune diseases Early Chronic diseases Screening Treatment monitoring detection Selection of therapeuticEarly drug detection e d v o i d t y Selection of h i e t s g c e o n l u e o e m d s s therapeutic drug n t f o v e y h i r h n o c t c l Early s p g e i g t i r e n a n t f g n l s e Technology platform c o H o i te l a e i e c n t e e s detection m o S r m a on e e e m r e c r n ti n i r h a s o f o o a l e r i s c h i u l d i c t i u o a s s l o n h c p p fi c i c p o i a F a l e b e i g e n e t m t i p t i R g l e a u G M S i m d H d A M id Treatment Test paper Test ap sis g SimplificationR no monitoring n g i ia n d i a t S Optimization of number of items Preparation of Measurement of biomathematical model biochemical parameters Sensing 12 gel reservoir 3. Progress of R&D project Mitsuru Watanabe Member of the Managing Board and Executive Officer Head of R&D 1）Progress status in launching stage （1） Rapid diagnosis of lymph node metastasis technology (OSNA） （2） Bird flu diagnosis technology （3） Digital blood smear preparation technology （4） Reagent preparation technology 2）Progress status in practical stage （5） Blood testing technology （6） Cervical cancer screening technology （7） Postprandial hyperglycemia monitoring technology Kaoru Asano Executive Officer, Central Research Laboratories 3）Progress status in research stage （8） CTC detection technology （9） CNS disease diagnosis technology based on DNA chip 13 Reporting subjects and policy of technological presentation 1．Reporting subjects ・Technical features of Sysmex technology and product ・Technical themes that Sysmex conducts R&D and their clinical benefits ・Outline of Sysmex Technology Strategy 2．Policy regarding report of technological themes To explain R&D themes in below 3 steps ＜Research stage＞Start of research and basic consideration ・Magnitude of value in practical use ・Explanation of future plan of R&D ＜Practical stage＞ Elemental research, practical and product commercialization stage ・Technological impact on characteristics of products ＜Launching stage＞ Accomplishment of development & introduction to market ・Details of technological features and superiority 14 Definition of R&D stage ResearchResearch stagestage PracticalPractical stagestage LaunchingLaunching stagestage Start of research or basic consideration Completion of Start of full-scale Objective means an product R&D activity establishment of 10～50% 50～80% commercialization towards measurement and determination principle and a commercialization verification of clinical of launching value. 15 1）Progress status in launching stage （1） Rapid diagnosis of lymph node metastasis technology (OSNA） 16 OSNA －Lymph node metastasis of colon cancer－ Evaluation protocol a, c b, d 3 Perpetual samples CK19 mRNA （after operation） a b c d (as same as breast cancer) Clinical research result Pathological test Marker gene ： CK19 ＋－ Concordance rate ：97.6% ＋ 33 1 OSNA － 292 The 38th Association of Cancer and Lymph node 2006 17 OSNA － Lymph node metastasis of stomach cancer－ Evaluation protocol a b Perpetual sample (after operation) CK19 mRNA a b (as same as breast cancer) Clinical research result Marker gene ： CK19 Pathological test ＋－ Concordance rate ：94.4% ＋ 40 4 OSNA － 5 113 The 62nd Annual Meeting of the Japanese Society of Gastroenterological Surgery(2007) 18 1) Progress status in launching stage (2) Bird flu Diagnostic technology 19 Threat of bird (avian) influenza A summary of tracking avian influenza A specimens and viruses shred with WHO from 2003-2009 鳥インフルエンザ感染症例 Samples 例 200 確定症例Isolated case 数 死亡例Dead case 150 100 50 0 2003 2004 2005 2006 2007 2008 2009 年 Infection risk still remains due to circulation of bird influenza virus 20 Key technology of detection for corresponding with bird influenza Nucleic protein of human influenza virus Val Asp 1aa 498aa Specific antibody that can ヒトインフルエンザ recognize an amino acid Humanウイルス influenza（A型） virus (type A) difference Arg Asp 100a 1aa 498aa 鳥インフルエンザ a101aa Bird influenzaウイルス virus Nucleic protein of bird influenza virus Successful development of a specific antibody that recognizes an amino acid difference in between human and bird influenza virus 21 Advantages of nucleic protein detection Surface antigen Nucleic protein Human influenza virus Bird influenza virus H1N1 H2N2 H3N2 H5N1 H7N7 H9N2 Surface antigen Nucleic protein Discrimination of nucleic protein difference Covering all bird influenza viruses except H5N1 by targeting nuclear protein 22 Features of bird influenza corresponding kit Bird influenza Human influenza corresponding kit rapid diagnosis kit Bird influenza virus Detection Detection Human influenza virus Not detected Detection Specific detection of bird influenza and elimination of seasonal influenza/swine influenza 23 1)Progress status in launching stage (3) Digital blood smear preparation technology 24 Medical needs in blood smear preparation Utilizing part time doctor or external body is Blood film the only way to perform bone marrow diagnostic
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