To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with...
Transcript of To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with...
Livzon Diagnostics,Combat COVID-19
with Science
To become the best diagnostic company
M a y L i v z o n B r i n g T h e R e v i v i n g H o p e T o T h e W o r l d
CONTENTS1 Livzon Group
2 Livzon Diagnostics Inc.
3 Fighting COVID-19
Livzon GroupL i v z o n P h a r m a c e u t i c a l G r o u p
PART
01
Livzon-A Leading Pharmaceutical Group in China
Livzon Journey-towards a more precise and complete future
Nation-wide Robust Distribution Network in Commercialization
◆ 10 regions, over 31 provinces
◆ 65 Provincial GMs
◆ Over 9,000 Sales
Representatives
◆ 800 Distribution Agents
◆ 4,800 Major Hospitals
◆ 10,000+ Pharmacies
◆ Well-known Industry KOL Network
Diversified Product Portfolio in Multiple Therapeutic Areas
L i v z o nDiagnost i csZhuhai Livzon Diagnostics Co., Ltd.
PART
02
Overview of Livzon Diagnostics
30Since1989 · dedicated in IVD for years
Zhuhai Livzon Diagnostics Inc.As the medtech subsidiary under dual listed company Livzon Group,
dedicated in R&D, manufacturing and sales of professional in-vitro
diagnostic products and equipment.
● More than 750 employees working in Livzon Dx with over
50% holds bachelor degree or above, 60+ with master and
10+ doctorate degree.
● Full R&D and manufacturing capabilities on immunoassays,
molecular diagnostics, automation analyzers and other test
products.
● Sales revenue over USD 100MM in FY2019
Best-in-Class Products ● First advocator for the test of Mycoplasma
Pneumoniae (MP) lgM
● PIVKA-II as HCC (Hepatocellular carcinoma)
tumor marker be firstly introduced to China
● KL-6 as as ILD (Interstitial Lung Diseases)
serum marker be firstly introduced to China
● SYVA TDM (Therapeutic Drug Monitoring) system
holds 50% of the immunochemistry test market
NO.190
%
50%
● TPPA as the gold standard in reference lab for
syphilis test
● HIV confirmation test (HIV BLOT2.2) are widely
used in almost every HIV confirmation lab in
China
● MYCOII as the gold standard in reference lab for
Mycoplasma Pneumoniae
Dedicated and Experienced in Building BEST and/or FIRST in-Class Products
Market Dominant Products
First-in-Class Products
Partnering with
☆on-site service mainland coverage within 24 hours
☆in-house team with 400+ professional sales & support
☆3,000+ end-users: clinical labs, CDCs, blood banks, hospitals (50% top tier level)
☆partner with over 1,000 distributors and channels
Established Sales Network, Professional Practice in Commercialization
TEAM
CHANNEL
END-USER
SERVICE
MEDICAL DRIVEN
☆1,000+ seminars annually with national KOL relationship
Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval Portfolio
ISO 13485
Drug Approval
6 Items with
GMP License
Class II Medical Device
27 Items
Class III Medical Device
38 ItemsClass I Medical Device
4 Items
Few and only China IVD company
that has pharma product approvals
Heavy Input into R&D, Numerous Technology Platforms
ELISA Test Kits POCT Rapid Diagnostic Tests
Microbiology Detection Kits
Ultra Multiplex Automation
Immunofluorescence
Molecular Diagnositcs
Individual Kit CLIA System
R&D Platforms
Automated Equipment Development
10%
R&D inputs
of revenue
3
R&D centers
6000m2
R&D lab
space
20%
R&D
employees
of total
50%
master
degree and
above
Wide Range of Immunoassay Platforms for Any Tests in Needs
Ultra MultiplexImmunofluorescence System
Colloidal Gold Rapid Test Device & Reader
ELISA kitsImmunoblotting
System
Individual-KitChemiluminescence System
ImmunoAssays
Transfusion Safety
HIV, HBV, HCV…
Respiratory Infection
MP/CP/…
Autoimmune Disease
ANA Panels, autoimmune antibodies
Reproductive Health
TORCH, STI pathogens, Hormones
Allergy Tuberculosis
IGRA
Inflammation
IL-6, PCT
Therapeutic Drug
Monitoring
Innovations in Molecular Diagnostic Platform
Extraction Free One Step NAAT Kit
First in China① Superb resistance to reaction inhibitors
② Much ease to use
HBV/HIV Dual Target Amplification
First in ChinaEnrusing detection target with mutation
Quantification by Internal Control
First in ChinaNo need for standard curve and better control in whole process
Robust in Anti-contaminationFirst in ChinaMineral Oil Cover and UNG
enzyme system
Master Mix All-in-One LyophilizationFirst in Worldwide
Shipped and Stored at 2-8℃
Rapid Nucleic Acid ExtractionPioneer in China3 mins without heating
Livzon Dx Strategic Areas Layout
Blood Irradiation
Blood Bank Screening
Allergy
Mastocyte degranulation test
Panel Screening
Autoimmune Diseases
EMIT (ISD, antipsychotics, antiepileptic, Voriconazole)
Chromatography/MS (antibiotics, antituberculosis, antipsychotics)
Therapeutic Drug Monitoring
Syndromatic POC Screening
Drug Resistance Tests
Respiratory Diseases
Reproductive Health
Pre-Transfusion TestingQuantitative Measure
Transfusion Safety
Tuberculosis Diagnosis
Sexual-Transmitted Infection
Maternal Health
Panel Screening
Other Interested Areas
Chronic Diseases Management Neurodegenerative Disease and Mental Health
CardiovascularDiabetesDepression
Alzheimer's Disease
Autism
Parkinson's diseaseHepatopathyGastropathy
Complicated Diagnose
17
Key Highlights of Livzon Dx
First-in-Class,
Delivered
Medical Insights
Always target medical UNMET NEEDS, to
provide best fit solutions for diagnostic
scenarios and innovative tests/biomarkers.
30-year Livzon brand journey with high quality
reputation, trusted by customers with services
beyond expectations Experienced in brand new concepts establishment
in niche markets. Proven track records in fostering
first-in-class market from 0 to 1.
To integrate any methods/assays towards better
diagnosis for diseases, to automate process with less
manual steps to free our customers’ hands
Integration, Automation Platforms
High Quality,
Excellent Service
Fighting COVID-19W i t h L i v z o n D i a g n o s t i c s
PART
03
COVID-19 has become a real PANDEMIC of the century!!
Livzon Dx COVID-19 antibody IgM & IgG rapid test, Ideal Diagnostic Tool to Help
Dec 2019
End Dec 2019
Wuhan Institute
of Virology, CAS
quickly launch
research project
and collaborate
with Livzon Dx
for antibody test
development
Jan 282020
2019-nCoV
PCR test kit
and IgM/IgG
antibody ELISA
kit were
submitted to
NMPA (CFDA)
for emergency
approval
Unknown Viral
Pneumonia
started in
Wuhan, Hubei
province
Livzon took actions and developed the First COVID-19 antibody test in China
Jan 292020
The first antibodytest in China forCOVID-19 waslaunched by WuhanInstitute of Virologyand Livzon Dx
Feb 12020
The lateral flow
method antibody
test to COVID-19
IgM/IgG was
launched, rapid as
15 min to result
Feb 22020年
The official
submission to
NMPA of the
diagnostic kit to
coronavirus
antibody IgM &
IgG for emergent
approval
Emergent Approval and Rapid Response to Pandemic in China and Overseas
Feb 112020
Both ELISA and
lateral flow
antibody tests
from Livzon Dx
were officially
admitted in the
fast track review
of NMPA
Feb-Mar2020
One of the most
sufficient clinical
validation trial
completed in
Wuhan and 5
more cities to
prove excellent
performance of
Livzon test
Mar 142020
Diagnostic Kit for
COVID-19 antibody
IgM & IgG (lateral
flow method) from
Livzon Dx was
officially approved
by NMPA
Mar 152020
First gov order
received from
Czech Republic and
start the journey of
combating COVID-
19 along side
people in the world
Publications on Livzon pioneering antibody tests (Lateral Flow and ELISA methods)
Reputation Built by Customers Worldwide, Proven Quality
Czech Republic (MoH)
Denmark (Embassy)
Brazil (National Tender)
Spain (MoH)
Russian (Military)
Indonesia (National Tender)
……
WHO FIND Dx program
Karolinska Institute (Sweden)
Institut Pasteur (France)
Copenhagen University Hospital
(Denmark)
Texas Medical Center Houston (US)
……
Modern and Certified Workshops, World Class Production Capacity
GMP and ISO13485 certified, one of the largest In-vitro Diagnostic production line in China
Design Capacity of Daily Production over 1,000,000 cassettes of COVID-19 rapid test!
Our Vision
—— Keep learning, Strive for Excellence,
to become the Best Diagnostic Company in China
Thank You For Your Attention