making a healthier future with bioneer · 2020-03-26 · pcr lab in china 2014 ebola virus...

Copyright 2020. 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

CONTENTS

Chapter

01

Corporate Identity Market Products

Chapter

02

Chapter

01


Corporate Identity

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

Key Technology Road Map

Corporate Identity


Synergy in Business

• The key technology of each division is organically integrated.

Location Daejeon, South Korea

KOSDAQ Listed

/Established 1992.08/2005.12

Key Products

MDx Instruments and Kits,

Oligos and Research Products,

Subsidiaries of RNAi drug

development and Probiotics

Employees 396 (as of 2019.09)

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

Company Overview

Corporate Identity

DNA/RNA

oligonucleotide

Synthesis

Technology

Life Science & Molecular Diagnostics RNAi New Drug Microbiome

• Create and maximize synergy by Bioneer strategy.

Gene

Analysis Kits

& Instrument

Molecular

Diagnostics Kits

& Instrument

SAMiRNA™

(RNAi

therapeutics)

BNR17

Probiotics &

Microbiome


Bioneer continues to challenge itself to become a global healthcare company.

Corporate Identity

Company History

1992 1996 2001 2002

2014 2012 2009

2005

2015

2016

2017 2018 2019 2020

• Est. Korea Biotech Inc. (1st KRIBB spin-off)

• First in Korea to develop and supply enzymes and primers for PCR

• Renamed BIONEER Corporation

• Completion of Daejeon DNA synthesis center

• Development and deployment of Bio-terror agent detection real-time PCR instrument

(first in Asia)

• IPO (KOSDAQ)

• Certification, Functional Ingredient for KFDA of Lb.gasseri BNR17

• Certification, Innovative Pharmaceutical Company (2012-2018)

• Certification of Korean GMP for Korean IVDD manufacturing and quality management standard conformity

• Licensing-Out 3 drug candidates to Yuhan Corp.

• Selected as the K-BrainPower

• 1st multiplex kit on Zika WHO EUAL

• CE-IVD List A approval for HIV-1 Quantitative RT-PCR kit (First in Asia)

• Est. AceBione Inc. • CE-IVD List A approval for HCV Quantitative RT-PCR kit

• CE-IVD List A approval for HBV Quantitative PCR kit


Corporate Identity

Business Portfolio

DNA/RNA

Synthesis

AccuPower®

PCR technology DNA Synthesizer/

Gene Analyzer

BIONEER COMPETITOR

Life Science Research

Sustained and stabilized revenue growth CE-IVD List A approval for Viral Load Test Kit (HIV, HBV, HCV) (First in Asia)


MDx Kits MDx Instrument

(qPCR/Prep) Package closed system

GLP toxicology studies of IPF was completed.

• Two-track approach for new drug and healthcare products development

• Strong intellectual property position of siRNA and SAMiRNA and Powerful siRNA delivery platform technology for various diseases

• Joint research partnership with Yuhan Corp. and global pharmaceutical companies

• Establish subsidiary: siRNAgen Therapeutics Corp. (2019.08)

RNAi New Drug(SAMiRNA™)

• 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, Global licensing agreement

• Life Science Research

• Molecular Diagnostics

• RNAi New Drug(SAMiRNA™)

• Lb. gasseri BNR17


Chapter

02 Market Products


Sustained and stabilized revenue growth

Market Products


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


Sustained and stabilized revenue growth

Market Products


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



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


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)



* 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™

Molecular Diagnostics System

ExiStation™48/48A System


Market Products

Applications

Sexually Transmitted Disease

• STI 8A Kit

(CT, NG, UU, MG)

• STI 8B Kit

(TV, MH, HSV1, HSV2)

• STI 4C Kit

(TP, UP, CA, GV)

Hepatitis & HIV

• HIV-1 Kit

• HBV Kit

• HCV 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

Tuberculosis • MTB Kit

• MTB & NTM Kit

• TB & MDR Kit

• TB & XDR Kit

Genotyping • ApoE Kit

• Warfarin Kit

• HLA-B27 Kit

• TPMT Kit

• MTHFR Kit

• JAK2 V617F Kit

• Factor V Leiden Kit

Human Papillomavirus

• HPV 16&18 Kit

• HPV Genotyping Kit

• hrHPV Kit

COVID-19 • COVID-19 Kit

• SARS-CoV-2 Kit

0197

0197

0197

0197


Market Products

History of BIONEER’s MDx

2003

SARS Diagnostic

Solution :

ABADIS Mobile

PCR Lab in China

2014

Ebola Virus Diagnostic Kit:

development with Nigeria

Government

2009 Swine Flu (H1N1) Diagnostic Kit :

about 2 million cases were tested

2016

Zika Multiplex Diagnostic Kit

: 1st multiplex kit on WHO EUAL

2018 CE List A approval of HIV-1

VL test Kit

2020 HIV-1 VL test kit was Listed

in Global Fund

FIND – Tuberculosis

(with RIGHT FUND)

CE List A approval of

HCV VL test Kit

2019 CE List A approval of HBV

VL test Kit

2015

Ebola Virus

Diagnostic Kit

CE approval of COVID-19

Virus Diagnostic Kit


Market Products

Why BIONEER’s Viral Load Test?

BIONEER provides the lowest LOD with the less sample volume

(CE-IVD List A approval for Viral Load Test Kit (HIV, HBV, HCV), First in Asia)

BIONEER Roche Abbott

System ExiStation™ CAP/CTM M200sp/m2000rt

Analytical sensitivity

HIV-1 33.1 IU/ml

*sample vol; 400 μL 33.4 IU/ml

*sample vol; 1000 μL 68 IU/ml

*sample vol; 600 μL

HBV 6.02 IU/ml




HCV 10.7 IU/ml

*sample vol; 400 μL 9.3 IU/ml



BIONEER’s viral load tests allow sensitive analysis using only 400ul sample,

but Roche’s kit using 1000ul sample.

• Sensitive test for infant blood

• Re-test and/or other tests can be possible


Market Products

Comparison of System

BIONEER Roche Abbott

Targets

HIV O O O

HBV O O O

HCV O O O

MDR-TB O X X

MTB&NTM O O O

STI Multiplex O (Total 12 targets) X △ (Total 2 targets)

CMV O O O

EBV O X X

BKV O X X

HPV 16 & 18 O X X

Influenza A, New influenza A O X X

C. pneumonia O X X

M. pneumonia O X X

Norovirus O X X

Enterovirus O X X

Zika, Dengue, Chikungunya O X △ (Only Zika)


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

RNAi New Drug


• 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

Competitive Edges

Hydrophilic polymer /

hydrocarbon bi-

conjugated natural RNA


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

RNAi New Drug


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


Market Products

SAMiRNA™ New Drug Programs and Pipeline

Major fields of development

• Anti-fibrotics: lung, Kidney, liver, skin, eye, autoimmune disease…

• Cancer: enhancing anti-proliferative effect/ favourable TME/ preventing acquired resist

Discovery Preclinical Clinical Trials

Phase Ⅰ Phase Ⅱ Phase Ⅲ

Phase I (2020)

Preclinical study

SAMiRNA-

AREG:

Anti-fibrotic

Programs

IPF

Radiation-induced fibrosis

Erectile Dysf (Vas Fib)

NASH (Fibrotic Hepatoma)

Reactive HF

Prevent CKD (DNP)

Hypertrophied/Keloid/Acne Scar

ARDS

Systemic sclerosis

IIT* planned in Late 2020 Cancer

Programs NSCLC/Pancreatic/Colorectal/

Breast/Ovarian

* IIT : Investigator Initiated Trial



Market Products

Other SAMiRNA™ Development Pipelines

• New Drug: Alopecia Areata, Ankylosing Spondylitis, Rheumatoid Arthritis, Sepsis, Diabetes

• Healthcare: Androgenetic Alopecia, Hair color

Major fields of development

Discovery Preclinical Clinical Trials

Phase Ⅰ Phase Ⅱ Phase Ⅲ

SAMiRNA™ Other

Programs

Alopecia Areata

Rheumatoid Arthritis

Diabetes

Sepsis

Ankylosing Spondylitis

Healthcare Programs

Androgenetic Alopecia (AGA)

Discovery Functional and

Safety Testing Clinical Study Consumer Testing

Hair color



Market Products

Anti-obesity probiotic, isolated from human breast milk


• Project initiated on anti-obesity microorganisms

• Isolation of 1st anti-obesity microorganisms

• 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

1999

2000

2003

2006

2008

2012

2013

2014

2016

2018

• TV Home Shopping Product launch with own-brand

• Various lineup products launch

2019

2020

⃝ 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

⃝ 2018, Own brand products launch for online & TV home shopping

⃝ 2020, Business diversification by launching various lineup products

Discovery of Lactobacillus strain for body weight control Commercialization


Market Products

Global Business

NA, EU, China, Aus

• Global Licensing • Supply Agreement

• Obtained ANVISA approval

Brazil

• Obtained Vietnam Food Association (VFA) approval

Vietnam

• TV Home Shopping

• on-line, off-line

Korea

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]

making a healthier future with bioneer · 2020-03-26 · pcr lab in china 2014 ebola virus...

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