Copyright 2019. Bioneer Corporation. All rights reserved.
Making a Healthier Future for Humanity
with Genomic Technology
Making a Healthier Future with BIONEER
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Disclaimer
Innovation•Value•Discovery l BIONEER 5
Translating Genomics Technology into Healthcare Solution!!
Healthcare Innovator
Recombinant DNA
DNA / RNA / Gene
Synthesis
Chemical Synthesis
DNA Synthesizer
/ Gene Analyzer
Instruments
Separation & Purification
of Biomaterials
Nano-Bio
Research Grade
Enzymes & Reagents
Diagnostics
Molecular Diagnostics
Therapeutics
RNAi-Based New Drug
Development
Prevention
Probiotics & Microbiome
01 Key Technology Road Map
Corporate Identity
Innovation•Value•Discovery l BIONEER 6
Synergy in Business
• The key technology of each division is organically integrated.
• Create and maximize synergy by Bioneer strategy.
Location Daejeon, South Korea
KOSDAQ Listed
/Established 1992.08/2005.12
Key Products
MDx Instruments and Kits,
Oligos and Research Products,
siRNA Drug Development
Employees 380 (as of 2019.04)
Webpage www.bioneer.com
Han-Oh Park, President & CEO
• B.S. Chemistry, Seoul National
University (84’)
• Ph.D. Biochemistry, KAIST (92’)
• Vice President, Korea Biotechnology
Industry Organization
• Adjunct Professor, KAIST
• Committee Member,
Presidential Advisory Council on
Science & Technology
02 Company Overview
Corporate Identity
Genomic Healthcare Company
DNA/RNA oligonucleotide
Synthesis Technology
SAMiRNA (RNAi
therapeutics)
BNR17 Probiotics & Microbiome
Gene Analysis Kits &
Instrument
Molecular Diagnostics Kits & Instrument
Innovation•Value•Discovery l BIONEER 7
Bioneer continues to challenge itself to become a global healthcare company.
1992
• Est. Korea Biotech Inc. (1st KRIBB spin-off)
• First in Korea to develop and supply enzymes and primers for PCR
1996
• Renamed BIONEER Corporation
2001
• Completion of Daejeon DNA synthesis center
2002
• Development and deployment of Bio-terror agent detection real-time PCR instrument
(first in Asia)
2014
• Certification, Functional Indredient for KFDA of Lb.gasseri BNR17
2012
• Certification, Innovative Pharmaceutical Company (2012-2018)
2009
• Certification of Korean GMP for Korean IVDD manufacturing and quality management standard conformity
2005
• IPO (KOSDAQ)
2015
• Licensing-Out 3 drug candidates to Yuhan Corp.
• Selected as the K-BrainPower
2016
• 1st multiplex kit on Zika WHO EUAL
2018
• CE-IVD List A approval for HIV-1 Quantitative RT-PCR kit (First in Asia)
Corporate Identity
03 Company History
Innovation•Value•Discovery l BIONEER 8
Corporate Identity
04 Business Portfolio
DNA/RNA
Synthesis
AccuPower®
PCR technology DNA Synthesizer/
Gene Analyzer
BIONEER COMPETITOR
Life Science Research
Sustained and stabilized revenue growth 2018, CE-IVD List A approval for HIV-1 Quantitative
RT-PCR kit (First in Asia) 2019, CE-IVD List A approval is expected (HBV, HCV MDx kits).
Molecular Diagnostics
MDx Kits MDx Instrument
(qPCR/Prep) Package closed system
• Isolation of Lb. gasseri BNR17 from human breast milk (2006.08)
• Approved as functional ingredients with body fat reduction for functional foods by KFDA
• Establish subsidiary: AceBiome Inc. (2017.04)
• Global licensing agreement and supply contract
Lb. gasseri BNR17
2018, Preclinical tox study for IPF and keloid
• Two-track approach for new drug and healthcare products development
• Strong intellectual property position of siRNA and SAMiRNA
• Powerful siRNA delivery platform technology for various diseases
• Joint research partnership with Yuhan Corp. and global pharmaceutical companies
RNAi New Drug(SAMiRNA™)
2018, Global licensing agreement
• Life Science Research
• Molecular Diagnostics
• Lb. gasseri BNR17
• RNAi New Drug(SAMiRNA™)
Making a Healthier Future with BIONEER
Chapter
02 Market Products
Innovation•Value•Discovery l BIONEER 10
Sustained and stabilized revenue growth
Market Products
01-1 Life Science Research
ExiProgen™: Nucleic Acid Extraction & Protein Synthesis System
• The world’s first instrument for protein expression and purification, as well as nucleic acid extraction.
• Express and purify up to 16 proteins simultaneously for mutant screening, functional analysis, vaccine R&D, assay development and antibody development.
• Key Customers: Genentech, Stanford University, NPL, etc.
AccuPower ® PCR technology
• Lyophilized room-temp-stable PCR premix, longer shelf life – more than one year.
• Pyro-HotStart™ PCR: Enzyme -based HotStart PCR for the specific DNA amplification
• Dual-HotStart™ RT/PCR : One-tube RT/PCR for more specific & sensitive RNA amplification
MagListo™ Nucleic acid extraction
• Next Generation nucleic acid purification kits with magnetic silica Nanoparticle
BIONEER Competitor
Innovation•Value•Discovery l BIONEER 11
Sustained and stabilized revenue growth
Market Products
01-2 Life Science Research
DNA/RNA Synthesis
• Ensure High-quality & capacity Competitiveness with unique vertically-integrated DNA/RNA production
• The first developer of 384 parallel oligonucleotide synthesizer
• Raw material synthesis facility: Ton-scale phosphoramite capacity, >100 kinds of raw materials production
• Fully automated proprietary synthesis systems can produce over 30,000 oligonucleotides per day
• The state-of-art QC system: MALDI-TOF(7 systems), Capillary Electrophoresis system, LC-MASS
Gene Synthesis
• Fully automated and integrated Gene Synthesis technology
• With our oligo and molecular biology reagents, Bioneer offers the gene2protein™ service: codon optimization, gene synthesis, cloning and sequencing and protein synthesis.
Manufacturing Infrastructure
Innovation•Value•Discovery l BIONEER 11
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MDx Instruments
• First developer in Asia
• Patented Light-Tunnel-technology for more sensitive and uniform quantification
• Certified CE-IVD, sFDA(China), FSZ(Russia)
• Viral pathogens: Hepatitis B, C, HIV, Influenza, FMDV, CMV
• Tuberculosis, respiratory diseases, STIs
• GMO screening • Veterinary disease screening including bird flu,
foot-and-mouth disease etc.
• Food poisoning, water screening for Norovirus, enterovirus etc.
Real-time qPCR (Exicycler™ 96)
• Patented three protection devices against aerosol contamination enable high sensitive detection without noise signal.
• AccuNanobead™ silica magnetic nanoparticles enables pure and high yield extraction of nucleic acid
• Compact and economical design
Gene Extraction (ExiPrep™ 16 Dx)
MDx Kits
• Ultra sensitive molecular diagnostics technology from Pyro-HotStart™ and Dual-HotStart™
• Outstanding stability through patented lyophilized PreMix
• Superior sensitivity, specificity and convenience
• Detection of various pathogens and genetic mutations
• CE-IVD certified
Diagnosis
Plant /Animal
Screening
Food Screening
Market Products
02-1 Molecular Diagnostics
Competitive Edge • Bioneer has developed and commercialized total solution of MDx including instruments and kits.
• Secured cost advantage through the in-house production of expensive raw-materials
• MDx Key technologies invention such as Dual-HotStart™, the most sensitive RNA detection technology
MDx Kits (AccuPower® PreMix Technology)
Innovation•Value•Discovery l BIONEER 12
Innovation•Value•Discovery l BIONEER 13
* Only apply to ExiStation™ 48A
• Automated MDx system consists of ExiPrep™ 16 Dx and Exicycler™ 96
• Completion of diagnosis from sample preparation to Real-Time PCR in only 3.5 hrs
• Simultaneous diagnosis allows earlier detection of superinfection, such as HIV and TB.
• Optimized for ExiPrep™ Dx Extraction Kits and AccuPower® MDx Kits
• Consists of ExiPrep™ 48 Dx, Exicycler™ 96 and/or ExiLT*
• Advantageous when using same type of specimen.
• Nucleic acid extraction from 48 samples within an hour.
• Use primary tube directly : decapping/capping of sample tube and sample transfer motions are all automated.*
• Sample information is inputted automatically using built-in barcoding system*
Market Products
ExiStation™
02-2 Molecular Diagnostics System
ExiStation™48/48A System
Innovation•Value•Discovery l BIONEER 14
Sexually Transmitted Disease
Hepatitis & HIV • HBV Kit
• HCV Kit
• HIV-1 Kit
Transplantation -related Disease
• CMV Kit
• EBV Kit
• BKV Kit
Gastro-intestinal Disease
• Norovirus Kit
• Enterovirus Kit
Mosquito-borne Disease
• ZIKV multiplex Kit
(ZIKV, DENV, CHIKV) Respiratory Disease
• InfA Kit
• New InfA Kit
• CP Kit
• MP Kit
• MERS-CoV Kit
Human Papillomavirus
• HPV 16 & 18 Kit
• HPV Genotyping Kit
Tuberculosis • MTB Kit
• MTB & NTM Kit
• TB & MDR Kit
• TB & XDR Kit
• MTHFR Kit
• JAK2 V617F Kit Genotyping • ApoE Kit
• Warfarin Kit
• HLA-B27 Kit
• TPMT Kit
• Factor V Leiden Kit
Market Products
02-3 Applications
• STI 8A Kit (CT, NG, UU, MG)
• STI 8B Kit
(TV, MH, HSV1, HSV2)
• STI 4C Kit (TP, UP, CA, GV)
Innovation•Value•Discovery l BIONEER 15
Market Products
02-4 History of BIONEER’s MDx Product
* This history is based on the year of achievement of CE mark.
•Exicycler ™ 96
(2008)
~2008 2009 2010 2011 2013 2014 2015 2016 2018
•14 types of Real-Time PCR Kit
(including MTB&NTM, EBV,
InfA and etc.)
•BKV Quantitative PCR Kit
•MTB Real-Time PCR Kit
•6 types of ExiPrep™ Dx Kit
•TB & MDR Real-Time PCR Kit
•TV Real-Time PCR Kit
•UU Real-Time PCR Kit
•Exicycler ™ 96 V4
•5 types of Real-Time PCR Kit
•ExiStation ™ V4
•ExiStation ™ 48 / 48A
•ExiPrep ™ 48 Dx
•ExiPrep ™ 48 Viral DNA/RNA Kit
•ExiPrep ™ 48 Viral RNA Kit
•TB & XDR Real-Time PCR Kit
•CE-IVD List A approval for HIV-1
Quantitative RT-PCR kit (First in Asia)
•ExiStation ™
•ExiPrep ™ 16 Dx
•15 types of Real-Time PCR Kit
(including HPV 16 & 18 kit, STI
multiplex kit and etc.)
•STI8A-Plex Real-Time PCR Kit
•CT&NG Real-Time PCR Kit
•Listing of HIV(CE) on the
Global Fund
•ExiPrep ™ 96 Lite
•(Plan)CE-IVD List A
approval for HBV, HCV
Viral Load Test Kit
2003
SARS Diagnostic
Solution :
ABADIS
Mobile PCR Lab
in China 2009
Swine Flu (H1N1)
Diagnostic Kit :
about 2 million
cases were
tested 2014
Ebola Virus
Diagnostic Kit :
development
with Nigeria
Government 2016
Zika Multiplex
Diagnostic Kit
: 1st multiplex kit
on WHO EUAL
2019~
HIV-1 viral load
test kit : CE-IVD,
List A approval
& listing on “the
Global Fund” 2019
AIDS
Innovation•Value•Discovery l BIONEER 16
Functional recognition and commercialization
Screening of probiotic lactic acid bacteria from various sources and selection of Lb. gasseri BNR17 from human breast milk (August 2006)
2nd clinical trial to study anti-obesity activity supported by Korean government fund in progress
3rd clinical trial to study bowel function improvement in Irritable Bowel Syndrome and anti-diabetic activity supported by Korean government fund in progress
Approved as functional ingredients for Functional Foods by KFDA
Global licensing agreement and supply contract
Discovery of Lactobacillus strain for body weight control
• Project initiated on anti-obesity microorganisms
• Isolation of 1st anti-obesity microorganisms
1999 2003 2008 2013 2016
2000 2006 2012 2014 2018
• 1st patent application for anti-obesity microorganisms
• 2nd clinical trial: anti-obesity
• 3rd clinical trial: IBS
• KR patent registration for anti-obesity microorganisms
• Patent 10-1108428
• Isolation/characterization of Lb. gasseri BNR17 from human breast milk
• US Patent application for BNR17
• 1st clinical trial: anti-obesity
• US Patent registration for Lb. gasseri BNR17
• Approved as functional ingredients by KFDA
• Product launch
• Licensing-out
• Awarded Weight Management Ingredient of the Year, NutraIngredients-USA Awards 2018
Market Products
03 Anti-obesity probiotic, isolated from human breast milk
Innovation•Value•Discovery l BIONEER 16
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Central Dogma
DNA
RNA
PROTEIN
Blocking “production” of disease-causing proteins
siRNA (small interfering RNA)
Blocking “function” of disease-causing proteins
Antibody, conventional
chemical drugs
121 103 106
125 142
172
213 231
201
235 245 248
264 274
355
Source : Gary Carter, The Oligo Therapeutics Market Landscape, TIDES 2016 presentation
Number of total therapeutic oligo programs has almost tripled since early 2000.
Oligo Therapeutics Programs
New drug modalities are mainly based on sequence.
Market Products
04-1 RNAi New Drug
Innovation•Value•Discovery l BIONEER 18
• SAMiRNA™(Self-Assembled-Micelle-inhibitory-RNA) is a novel class of RNAi molecule developed by Bioneer, which provides the solution for virtually all major difficulties in the development of RNAi-based therapeutics including siRNA delivery.
• Using this novel RNAi prodrug technology, Bioneer is currently advancing clinical development of pipeline programs for previously non-druggable diseases through our own pipeline efforts as well as through partnerships with major global pharmaceutical companies.
SAMiRNA™ solves the unmet needs in RNAi drug development.
SAMiRNA Description Summary
• The world’s first siRNA prodrug technology: highly stable in circulation and siRNA is released and active only within the target cells
• in vivo efficacy validated in animal disease models via low dose I.V. injection
• Superb serum stability (PK/PD validated)
• Powerful siRNA delivery platform technology: Flexibility to incorporate siRNA sequences against any disease target
• Strong intellectual property position around SAMiRNA’s unique structure and manufacturing processes
• Extremely low toxicity and cytokine induction
• Fully automated solid phase chemical synthesis of siRNA conjugates; advantage of manufacturing & QC processes for large scale production of siRNA drug
Market Products
04-2 Competitive Edges
RNAi (drug)
Structure of SAMiRNA™
Innovation•Value•Discovery l BIONEER 19
Bioneer has vertically integrated siRNA drug development processes
from high throughput siRNA synthesis to screening of SAMiRNA™.
• Large scale RNA
synthesis
• In-house developed
automated
synthesizer
• In-house developed
raw material
• Next generation
siRNA nanoparticle
SAMiRNA™
• Target gene
knock-down
quantification by
MIQE qPCR
analysis
• in vitro siRNA
delivery/efficacy
validation
• in vivo efficacy
validation
• Patented
siRNA design
algorithm
Market Products
RNAi Core
Technologies
Design
Efficacy
Validation
siRNA
Delivery
Synthesis
Drug Development Roadmap
04-3 RNAi New Drug
Innovation•Value•Discovery l BIONEER 19
in vitro screening and validation of siRNAs
Design and Synthesize siRNAs
MIQE qPCR analysis Deep sequencing
Preclinical in vivo test using SAMiRNA
in mouse tumor model
Large scale manufacturing
Non human primate test, toxicity screen
IND filing
Innovation•Value•Discovery l BIONEER 20
Market Products
04-4 SAMiRNA™ Programs and Pipeline
Discovery Preclinical Clinical Trials
Phase Ⅰ Phase Ⅱ Phase Ⅲ
Consumer Testing (2019.2Q) Healthcare Programs
Androgen receptor
Preclinical Study (2018. 03)
Preclinical Planned (2019.4Q)
Bioneer Programs
IPF
CKD
Diabetes
Lung cancer
Autoimmune
NASH
Keloid
L/O to Yuhan Corp.
Keloids
Solid cancer 1
Psoriasis
Preclinical Planned (2019.2Q)
Innovation•Value•Discovery l BIONEER 20
Major fields of development
• New Drug : Fibrosis drug for lung, Skin, Kidney, Liver, Lung cancer, Autoimmune disease, Diabetes
• Healthcare : Hair loss prevention product
www.bioneer.com
Address | 8-11, Munpyeongseo-ro, Daedeok-gu, Daejeon 34302, Republic of Korea
Tel | +82.42.930.8513
Fax | +82.42.930.8600
E-mail | [email protected]