Diagnostics for Utopia. Company Introduction

Transcription

1 Diagnostics for Utopia Company Introduction

2 Contents SUMMARY Ⅰ. Current Status of the Company Ⅱ. IVD Market Trends & Future Forecast Ⅲ. Market Analysis and Marketing Strategy Ⅳ. Company Location 1

3 SUMMARY EuDiPia Co., Ltd. EuDiPia has established the headquarters and a research institute at the business center in Sogang University with a motto of Diagnostics for Utopia in September, We acquired certificate as a venture company from the KOTEC in April, 2013 and in January, 2014 moved into OSONG Medical Innovation Foundation. In June, 2014 EuDiPia has acquired KGMP(Korea Good Manufacturing Practice), In November, 2014 we also acquired certificate of ISO13485:2003. EuDiPia possesses technology named One-tube Nested Multiplex real-time PCR, and the first product using that technology is the EuDx TM -MTB(Mycobacterium tuberculosis). And that has 100 times higher sensitivity compare to threshold cycle value of conventional real-time PCR products. EuDx TM -MTB detection that was registered with trade mark in April, 2013, that a company in partnership, Solgent Co., Ltd. has been consigned for the production of it. After acquired approval from MFDS(Ministry of Food & Drug Safety), the first quarter of 2015 via proceeding of clinical trial in Seoul Asan Hospital, it is scheduled to provide products to large scaled institutions including general hospitals, central laboratories, and Korean Institute of Tuberculosis etc. Technologies and products to be developed in the future are in the field of respiratory infectious diseases first and then covering other infectious viruses like hepatitis and HPVs etc.. It is planned to make a fully automated POCT system that is with improved convenience for users and also accuracy. For entering to the market, local distributors are to be involved for Korean market. And in case of China, the joint corporation is planned to be established. In addition, it is scheduled to establish country-specific trade route for emerging markets in other foreign countries. Achieves sales amount of ten billion won within 5 years since the first product is launched. 2

4 Ⅰ. Current Status of the Company 1 Outline 2 History 3 Business Partnership 4 R&D and Business Direction 3

5 Outline Ⅰ. Current Status of the Company Company Laboratory Name Registration No. EuDiPia Co,. Ltd Address #506, Venture Research Center, , Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbukdo, Korea CEO Date of Foundation In Soo Kim Lab. Tel Location OSONG Medical Innovation Foundation Employee 9 (R&D, 4) Area 63 m2 Address Homepage #506, Venture Research Center, , Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea Technology Development R&D 4 One-tube Nested Multiplex Real-time PCR diagnosis tech. of respiratory infectious disease Tel./Fax / Cooperation of R&D Meta-Biomed Co., Ltd. 4

6 Major History Year of Acquired certificate of ISO13485: Concluded MOU with NanoBioSys Inc.. 6 Acquired approval of EuDx TM -MTB detection kit from MFDS(Ministry of Food & Drug Safety) and KGMP(Korea Good Manufacturing Practice). 5 Succeed in SMEs(The Promotion of Small And Medium Enterprises) R&D Program for Establishment and Growth. 4 Succeed in KOTRA(Korea Trade-Investment Promotion Agency) Export Gateway Project. 1 Moved into #506, Venture Research Center,OSONG Medical Innovation Foundation Year of 2013 Ⅰ. Current Status of the Company Acquired certificate of company affiliated research institute Concluded strategic business partnership(r&d, Marketing) with Meta Biomed Co., Ltd.. 9 Approved for clinical trial plans of medical devices, EuDx TM -MTB detection(mfds). 8 Concluded MOU with Yunnan Baiyao Group in China. 7 Approved Medical Device Manufacturing License (MFDS). 4 Acquired certificate of venture business (Korea Technology Finance Corporation). 4 Concluded partnership agreement with Rapigen inc.. 3 Concluded partnership agreement with Solgent Co., Ltd.. 2 Applied registration for domestic trademark of EuDx TM -MTB Year of Acquired patent implementation right for TB Real-time PCR. 9 Founded EuDiPia Co., Ltd.. 8 Moved into business center at Sogang University 5

7 Current Status of Business Partnership Ⅰ. Current Status of the Company Through cooperation with universities and companies in possess of core capability in each field, acquiring competitiveness in the molecular diagnostic field and rapidly creating achievement in the market. Academic-Industrial Cooperation (Sogang University, Yonsei University, M & D Co. Ltd.) EuDiPia Co., Ltd. Plan and Marketing products Acquire product portfolio Clinical trial, approval and certification Select the market and marketing strategy Quality control management R&D Develop technology and improve product s performance Solgent Co., Ltd. Consignment Production Acquire raw materials of good quality Utilize commercialized facilities Produce prototype and final products Molecular Diagnostics Market 6

8 R&D and Business Direction Ⅰ. Current Status of the Company Domestic Field Launch product of tuberculosis diagnosis MTB-Detection Drug resistance (MDR-TB) -Domestic sole distributor, expansion the scope of sales in large scaled hospital -Acquire KGMP System -Acquire ISO 13485, CE Mark Develop and launch respiratory and pneumonia molecular diagnosis product - Acquire Micro-Fluidics technology Develop and launch hepatitis and HPV diagnosis products -Mutually researching POCT device with the company specialized in medical device. -Start constructing the molecular diagnosis laboratory 2017 ~ - Develop and launch Fully Automated POCT products - Complete construction of the Molecular diagnosis laboratory ~ ~ Establish joint corporate with Pharmaceutical company in China Transfer the MTB diagnosis technology - Explore Southeast Asia Market(Vietnam) - Explore Russia/CIS Market 2015 ~ -Transfer the technology of follow-up MTB diagnosis products(mdr-tb) and launch those products -Enter the bidding market in foreign market (Tuberculosis) 2016~ - Expand the number of item via Joint corporation in China Respiratory virus and pneumonia - Acquire country-specific trade route in other foreign countries 2017~ - Expand the scope of sales network in emerging markets in Asia, Middle East, Africa, and South America, etc. (have own sale corporation and branch) Foreign Fields 7

9 Ⅱ. IVD Market Trends and Future Forecasts 1 Global IVD Market 2 Global Molecular Diagnostics Market 3 Global POCT Market 4 Korean Molecular Diagnostics Market *IVD: In Vitro Diagnostics POCT: Point of care testing 8

10 IVD - Molecular Diagnostics Ⅱ. IVD Market trends and Future Forecasts Culture Chemistry Immunology Molecular Biology Detection for target DNA or RNA IVD Trends * Real-time PCR Performing simultaneously amplification & analysis 9

11 Global IVD Market Ⅱ. IVD Market trends and Future Forecasts IVD Classification Molecular Diagnostics Immunochemistry Self monitoring blood glucose Hematology Use specimen collected from human including, sputum, urine, and blood to analyze whether they infect human and the cause of them Point Of Care Test Laboratory Hemostasis Clinical Microbiology In Vitro Diagnostics Classification: Depending on Diagnosis Methods Classification: Depending on Location of Diagnosis Market Size and Prospects IVD market is steadily being grown in a stable manner entailing with development of various diagnosis technology and expansion of demand. Global IVD market size is expected to be grown from billion US dollars in 2012 to billion US dollars by [Bio-Engineering Policies Research Center BioINdustry 2013 ] Source: Frost&Sullivan, Analysis of the Global In Vitro Diagnostics Market(2013) [Global IVD Market Size and Prospect] 10

12 Global Molecular Diagnostics Market Ⅱ. IVD Market trends and Future Forecasts Molecular diagnostics is to detect target DNA or RNA of the cause of a disease that is now in a market size of 5 billion US dollars as of 2012 taking the share of 11% of the entire IVD market. The market is expected to be grown to 9.07 billion US dollars by 2017 recording 12.6% of annual growth. The demand of current products is being increased as the demand of clinical test and analysis is being increased in China, India, and Korea that are in growing phase [Bio-Engineering Policies Research Center BioINdustry 2013] Average Growth Rate in the Market and Share of Each Company Source: Frost&Sullivan, Analysis of the Global In Vitro Diagnostics Market(2013) [Molecular Diagnostics Market Size and Market Share] 11

13 Global POCT Market Ⅱ. IVD Market trends and Future Forecasts POCT diagnosis made it feasible to immediately cope with diseases. The size of the market is 5.92 billion US dollars in 2012 taking up 13% of the entire IVD market and also expected to grow to 8.74 billion US dollars by 2017 recording 8.1% of the annual growth. It is currently in a limelight as a field that can solve expenses and regulatory issues that other diagnostic products suffer from in west Europe. [Bio-Engineering Policies Research Center BioINdustry 2013] Average Growth Rate in the Market and Share of Each Company Source: Frost&Sullivan, Analysis of the Global In Vitro Diagnostics Market(2013) [POCT Market Size and Market Share] 12

14 Korean Molecular Diagnostics Market Ⅱ. IVD Market trends and Future Forecasts Molecular diagnostics market has been growing 18% annually since 2011 expecting it to be grown to the size of 100 billion Won by The market of infectious disease(tuberculosis, respiratory problem, hepatitis, STD, and HPV, etc) diagnosis is mainly being established. Even though MNCs(Roche, Abbott, Siemens) are currently major player with automation system with reagents, many new entrants are positioned to penetrate the market in the next few years with new products in genetic, oncology, and critical care infectious disease, further increasing the competitive intensity. Roche is dominant player in the established molecular diagnostics market such as HBV/HCV, and LG Life Sciences is ranked on top in the field of tuberculosis. Other than them, Seegene, Bioneer, and Samsung Techwin are currently developing diagnostic technology and analysis devices. Market size and share of each company (Unit : Hundred million Won) % 8% 7% 3% % 17% Roche Abbott LG Seegene Siemens Others 13

15 Ⅲ. Market Analysis and Marketing Strategy 1 Changes in the Diagnostic Market 2 Molecular Diagnostic Products of Our Company (Tuberculosis) 3 Domestic Competitors Analysis 4 Strategy for Procuring Products 5 Marketing Strategy 14

16 Changes in the Diagnostic Market Ⅲ. Market Analysis and Marketing Strategy The scope of diagnostic market and application of use are rapidly increased by changes in the recognition of importance of Diagnosis and introduction of various molecular diagnostic products having high sensitivity and specificity. Changes of Demands of Molecular Diagnostics Developed Countries Developing Countries Changes in the awareness of the diagnosis and treatment due to aging Increase in the demand of treating epidemic/infectious diseases or any other diseases Personalized diagnostics for preventing the disease Improve accuracy of diagnostics Develop diagnosis method for new diseases Expansion the importance of the molecular diagnostics in field of the IVD Steadily release products improved with multiple-test, accurate and rapid test, and convenience of consumers Development Courses of POCT High Expand the scope of use including molecular diagnostics and BIT integrated with diagnostic technology Level of Technology Low Establish the original market with blood sugar diagnosing products Expand the market by development of diagnostic technology for pregnancy, heart disease, or infectious diseases Restricted Kind of Disease Diverse 15

17 Products Ⅲ. Market Analysis and Marketing Strategy World TB: Tuberculosis (TB) remains a major global health problem. In 2012, an estimated 8.6 million people developed TB and 1.3 million died from the disease (including 320,000 deaths among HIV-positive people). Among these numbers in China there were 859 thousand people developed TB and 44 thousand died from the disease. In 2012, there were an estimated 2.9 million cases and 410,000 TB deaths among women, as well as an estimated 530,000 cases and 74,000 deaths among children worldwide. (Source: WHO, TB Statistics) TB in Korea: The number of patients with new-infection of M.tuberculosis in Korea is reported about 35 thousand every year, and, among them, 2300 patients die. More than 50% of the middle-aged class are infected with tuberculosis. Hereupon, it is expected that more people are to be exposed to tuberculosis. Therefore, We launched tuberculosis molecular diagnostic reagent kit in order to keep up with increased demand of the market for accurate and immediate tuberculosis diagnosis. Launched Product: EuDx TM -MTB detection kit High Performance (Sensitivity & Specificity) Incorporate sensitive PCR technologies (Nested PCR + Real-time PCR) Detect 2 genes (Multiplex PCR) Using high quality enzyme Prevent Contamination EuDx TM -MTB detection kit Perform 2 steps of PCR reaction in one test tube UDG(Uracil-DNA glycosylase) system is applied Follow-up Product: EuDx TM -MDR-TB: Isoniazid and Rifampicin of MDR-TB detection kit. 16

18 Domestic Competitors Analysis Ⅲ. Market Analysis and Marketing Strategy Current Status of Companies Dealing with Tuberculosis Molecular Diagnosis Company 회사명name LG Life Sciences Roche Seegene EuDiPia Tuberculosis 설립일 products AdavanSure TM TB Cobas TaqMan Magicplex MTB EuDx TM -TB Characteristics 본사위치 Target Specimen Object Technology IS6110 sputum, urine, blood, body liquid, and tissue MTB/NTM Real-time PCR Target Specimen Object Technology 16s rrna gene Respiratory specimen(sp utum, bronchial tube cleansing liquid) MTB Real-time PCR Target Specimen Object Technology IS6110, MPB64 sputum, urine, blood, body liquid, and tissue MTB Real-time & Multiplex PCR Target Specimen Object Technology IS6110, rpob sputum, urine, blood, body liquid, and tissue MTB Real-time & Nested Multiplex PCR Domestic 매출액 market share Business 비고 structure 37.5% -Immune diagnosis/ Molecular diagnosis product -Focus on pharmaceutical business 37% -Basic PCR technology (patent expired) -Focus on analysis tools 5% -Various molecular diagnosis products -Possess exclusive technology(dpo,toce) - -Focus on respiratory infectious diseases Product Image 17

19 Strategy for Procuring Products Ⅲ. Market Analysis and Marketing Strategy Reagents for molecular diagnosis Micro -Fluidics Products Fully Automated POCT Products Detect targeted pathogen Upgrade accuracy Respiratory disease (tuberculosis, respiratory virus), Hepatitis, HPV, and etc. Automation of specimen pretreatment and DNA extraction Performing PCR and analyzing real-time based data Develop small device Upgrade rapidity of diagnosis Upgrade convenience of users Available in the small clinic 18

20 Marketing Strategy Ⅲ. Market Analysis and Marketing Strategy Rapidly Create Market Achievements Korea China Emerging Market Large general hospitals, Laboratories, Korean Institute of Tuberculosis Co-work with partner distribution network Local general hospitals, Laboratories, International institutions Product presentation and clinical test Produce and distribute in local area Exhibition, demonstration, and invitation of buyer Sole distributor in each region Joint corporate in China Best partner in each country (India, Russia, South-east Asia, Middle East, Africa) Academic-industry cooperation/ Production and technology partnership Develop in Korea/ commercialize the products Acquire CE mark and ISO

21 Ⅳ. Company Location 1 OSONG Medical Innovation Foundation 2 Launching Area 3 Contact Us 20

22 OSONG Medical Innovation Foundation Ⅳ. Company Location 五松尖端医疗产业振兴财团 2014 年 2013 年 The Government of Korea has chosen the Korea Medical Cluster to accelerate medical research and improve the research commercialization. The Cluster was launched in December 2010 pursuing to foster biotechnology as the next growth engine of the economy in Korea by providing structural and organizational support in establishing the Cluster as the center for growth and development. Vision: Establishment of the Global Biomedical Research and Development Hub Mission:Provide comprehensive world class research infrastructure to support anyone with an idea for research in developing high-tech medical technology. 21

23 Launching Area Ⅳ. Company Location 2014 年 Launching Area: Amenities Facility - Venture Research Center 2013 年五松尖端医疗产业振兴财 20 - In January, 2014 EuDiPia moved into OSONG Medical Innovation Foundation, and settled in Venture Research Center both headquarters and Laboratory. EuDiPia - By making full use of the Cluster s world class research infrastructure and various health and medical administrations such as KFDA, EuDiPia is more than ready to take every step necessary to become a leading international IVD expert. R&D Support Organizations: - New Drug Development Center - Medical Device Development Center - Laboratory Animal Center - Clinical Drug Manufacturing Center 22

24 Contact Us Ⅳ. Company Location 五松尖端医疗产业振兴财团 2014 年 2013 年 Address. #506 Venture Research Center, , Osongsaengmyeong 1ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea T e l F a x Homepage 23