To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with...

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Livzon Diagnostics, Combat COVID-19 with Science To become the best diagnostic company May Livzon Bring The Reviving Hope To The World

Transcript of To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with...

Page 1: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 2: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

CONTENTS1 Livzon Group

2 Livzon Diagnostics Inc.

3 Fighting COVID-19

Page 3: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 4: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

Livzon-A Leading Pharmaceutical Group in China

Page 5: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

Livzon Journey-towards a more precise and complete future

Page 6: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 7: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

Diversified Product Portfolio in Multiple Therapeutic Areas

Page 8: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

L i v z o nDiagnost i csZhuhai Livzon Diagnostics Co., Ltd.

PART

02

Page 9: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 10: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 11: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

☆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

Page 12: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 13: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 14: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 15: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 16: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 17: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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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

Page 18: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 19: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

COVID-19 has become a real PANDEMIC of the century!!

Page 20: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

Livzon Dx COVID-19 antibody IgM & IgG rapid test, Ideal Diagnostic Tool to Help

Page 21: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval
Page 22: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval
Page 23: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 24: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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

Page 25: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

Publications on Livzon pioneering antibody tests (Lateral Flow and ELISA methods)

Page 26: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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)

……

Page 27: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

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!

Page 28: To become the best diagnostic company Livzon Diagnostics ...☆1,000+ seminars annually with national KOL relationship. Recognized Quality System, Strong NMPA (CFDA) Regulatory Approval

Our Vision

—— Keep learning, Strive for Excellence,

to become the Best Diagnostic Company in China

Thank You For Your Attention