Company Overview

Technologies

Businesses

Social Values
 30+ Years Efforts in POCT
Focusing on the R&D, manufacturing, sales and services of rapid diagnostic reagent and equipment

Top 100 ＞ 200,000 ＞ 1,000,000,000

Medical device companies by sales 2024 Units of Finecare installation worldwide Rapid tests distributed annually

3000+ employees worldwide

20+ subsidiaries
Listed on SZ Stock Exchange in 2015
First public POCT company in China
(Stock Code: [Link])

Providing service for 150+ countries

and regions

Focus on POCT , Look Byond POCT

[Link]
 Milestone
We are dedicated to improving efficiency for labs, hospitals and the society

1992 2002 2009 2011 2015 2018 2022

Wondfo International Wondfo The first National- Listed on HIV rapid Recognized as a national
foundation business was USA Regional SZ Stock test was enterprise technology center
HQ in GZ started subsidiary Cooperative Exchange prequalified Recognized as a national
foundation Engineering Lab in by WHO post-doctoral research station
POCT in China

2004 2005 2009 2015 2019 2020

First CE First FDA First batch First overseas First overseas First batch got
passed US FDA on- R&D center (San local manufacturing approved by NMPA for
site audit in IVD in China Diego) project （ Mexico ） covid-19 antigen &
10,000 devices Launched CLIA antibody tests in China
installation products First overseas launch of
worldwide POCT Molecular
Diagnostic products
R&D Investment

R&D-to-revenue ratio(2018-2024)
Snibe IVD Average Wondfo Mindray

12.00%

Wondfo ; 10.24% Mindray,10.31%

10.00% IVD Average ;
9.05%

8.00% Snibe ; 7.78%

6.00%

4.00%

2.00%

0.00%
[Link]
 Wondfo Founders

Prof. Wang Prof. Li

Chairwoman Founder & Executive Director

Prof. in Ji’nan University Prof. in SCUT （ South China University of Technology ）

 Major: Medicine, Biochemistry  Major: Chemical Engineering

 237 authorized patents  Member of Chinese POCT industry
 59 authorized invention patents
 Top 100 Chinese Powerful Businesswomen in Forbes 2020  Member of Clinical Laboratory Testing

 Top 50 Chinese Women in Tech in Forbes 2022 and （IVD

Systems Test
SAC/TC136 ）
 48 authorized patents
[Link]
R&D Investment

Guangzhou HK, Dongguan, Hangzhou San Diego Tokyo

10%+ Annual R&D to revenue ratio

6 R&D centers, in China, the US and Japan
800+ R&D staffs, are professionals in biochemistry, clinical medicine, etc.
[Link]
 Facilitating standardization of industry
 Deeply involved in development of a variety of standards  Compilation of multiple textbook/monograph

National standard | GB/T

40999-2021

National standard |
GB/T 40999-2021
Quality National standard |
Standard GB/T 40999-2021
for 2019-nCoV
Antigen Test

Quality
Standard Serum
for 2019-nCoV Amyloid A
Antibody Test Test Kit
General
Industry standard | The Blue Book of
Technological POCT Technology & Application IVD Industry in China
GA/T 1456-2017
Requirements
for DOA Testing
Device with HIV Antibody
Influenza A Saliva Sample Oral Mucosal
Test Kit Transudate Test
(Immunochroma- (colloidal gold
tography) immunochromat-
ography)
Serum
Industry standard | Amyloid A Test
YY/T 1725-2020 Kit Industry standard | Chief Editor
YY/T 1727-2020
Prof. Li
Industry standard | [Link]
YY/T 1725-2020
 Intelligent Manufacturing
1. Lizhishan Road Campus 3. Songshan Lake Campus

4
117,000 m²
CORPORATE
CAMPUS

≈16 Football field

2. Shenzhou Road Campus 4. GZ Knowledge City Campus

Manufacturing factory 60,000+ m²
GMP factory 11,000+ m²

Daily capacity up to
3 million tests and keep improving

[Link] gold, FIA reagents, 2. Electrochemistry, CLIA, Molecular, Pathology reagents, 3. Production lines for all devices/ analyzers [Link]
 International Quality Management System
Our system is recognized by WHO, China, US, EU, Canada, Australia, Brazil etc.

01. Registered certificates 600+

300+ NMPA/ 240+ CE, 17 MDALL certificates
70+ FDA certificates , 3 WHO prequalification

All 13 items passed Recognized by CNAS lab certification

IFCC-RELA JCTLM in 2023 in 2020

First IVDR quality management system ISO13485:2016 MDSAP quality management WHO
certificate in Chinese POCT industry ISO9001:2015 system certification in 2019 Prequalification
[Link] patents 400+
480+ valid patents,130+ invention patents

[Link]
Company Overview

Technologies

Businesses

Social Values
Technologies
Focus on POCT but look beyond POCT

[Link]
 9 Technology Platforms
NO.1 extensive product lines in POCT

 Immune Colloidal Gold Platform

 Immunofluorescence Platform
 Electrochemistry Platform
 Chemiluminescence Platform
 Molecular Diagnostics Platform
 HPLC (HbA1c) Platform
 Pathological Diagnosis Platform
 Instrument Platform
 Biological Raw Material Platform

[Link]
Providing Scenario-Targeted solutions to global partners
Cardiovascular Respiratory Infectious
DOA Gynecology Oncology
disease disease disease

Emergency & Infection &inflammation Coagulation testing

Critical care solution testing solution solution

Chronic Disease Maternal & Child Health Pathology total

Management Solution Screening Solution solution

Prevention /Screening Diagnosis Treatment Monitoring / Rehabilitation

[Link]
Immune Colloidal Gold Platform

Fertility European Market & Export Volume

DOA Domestic & North America Market No.1

Infectious Disease & STD Global Public Health

[Link]
WHO pre-qualification

Wondfo One Step HIV 1/2 Test

PQDx 0357-004-00 (Nov 29, 2018)

Wondfo HIV Self-Test

PQDx 0357-004-01 (Jul 13, 2022)

Wondfo One Step Malaria Test

PQDx 0651-004-00 (Jul 30, 2024)

[Link]
Test Menu
Fertility Drugs of Abuse

HCG
AMP EDDP MET/mAMP TCA
Format: Strip, Cassette, Midstream (M, M2, M4, M6)
BAR EtG MDMA KRA
LH
BZO FTY MOP
* 6-MAM
Format: Strip, Cassette, Midstream (M, M2, M4, M6)
BUP KET OPI
* GAB
FSH
COC THC OXY
* HMO
Format: Strip, Cassette, Midstream (M)
COT MTD PCP * LSD
Sperm Concentration Test
PPX K2 TRA *
Format: Cassette
PDG
*

Urine Test Oral Test Hair Test

NMPA WHO Pre- * In [Link]

qualified development
Test Menu

Respiratory Hepatitis HIV Tropical Infectious Diseases

HBsAg
Flu A&B/ HIV 1/2 (Ab) HRP2 (P.f)
HBsAb
2019-nCoV/RSV/ADV/MP HIV 1/2 Oral HRP2/pLDH (P.f/Pan)
HBV
Flu A&B/
HCV * HIV 1/2 Ag/Ab Combo HRP2/pLDH (P.f/P.v)
2019-nCoV/RSV/ADV HIV-HCV-HBsAg-Syphilis Dengue NS1 Ag
HAV-IgM
Flu A&B/RSV/ADV/MP HIV-HCV-HBsAg Dengue Ab
HEV
RSV/ADV/MP Dengue Ag/Ab
ADV Ag
RSV Ag
MP Ag
STD Enteric Infection Others
Flu A&B
Strep A H. Pylori Ag / Ab FOB
MP Ab Syphilis Norovirus PSA
CP Ag Chlamydia CA16-EV71
Troponin I
Gonorrhea ADV
RV
ADV-RV
EV71

NMPA WHO Pre- * In [Link]

qualified development
Immunofluorescence Platform

 200,000+ units installed worldwide

 No. 1 market share in the global fluorescence

quantitative testing market
 Broad test menu 59 items –
Applicable to various medical scenarios

FS-113 FS-114 FS-205 FS-301

[Link]
 Test Menu
Immunofluorescence Platform

Diabetic &
Fertility&Thyroid Coagulation &
Renal Injury Cardiac Markers Tumor Markers & Others 2019-nCoV
Function Markers Inflammation
Markers

5 items 13 items 12 items 16 items 7 items 6 items

HbA1c β-HCG TSH cTnI H-FABP AFP Dengue NS1 Ag D-Dimer 2019-nCoV Ab
Cys C FSH T3 cTnT cTnl/NT-proBNP PSA iFOB D-Dimer 2019-nCoV Ag
β2-MG LH T4 CK-MB cTnl/CK-MB/Myo fPSA ASO (one 2019-nCoV IgM
MAU Prog fT4 Myo hsCRP CEA Total IgE step) 2019-nCoV IgG
NGAL PRL fT3 NT-proBNP Vitamin D RF PCT 2019-nCoV IgM/ IgG
AMH BNP Vitamin B12 Anti-CCP CRP 2019-nCoV RBD
Testo Lp-PLA2 Cortisol [Link] Ag CRP/PCT

E2 ST2 Ferritin SAA

S100β IL-6

CA125,CA199,CA153 will be ready this year.

[Link]
 New Immunofluorescence Platform
——Perfect choice for critical and acute care

Faster than ever

• 8-min to all cardiac testing results
• One step operation, no buffer needed for cardiac testing

Unprecedented stability
• All test items CV ＜ 10%
• Deliver stable results even
under high temperature
FS-2000 As accurate as CLIA
FS-1000 • Correlation rate with CLIA method≥90%

Immunofluorescence
methodology Available when no electricity
• Built-in battery design
Level-up! • Support 12 hours of use without external power suppl

[Link]
 Chemiluminescence Platform
Mono-test CLIA Analyzer
 Accurate: ALP/APS-5 chemiluminescence immunoassay (CLIA)
 Convenient: Space-saving, ready to use, maintenance-free
 Consistent: 24 hours standby, 18 months shelf life, 600 days MTBF
 Rapid: Short TAT, whole blood sample supported
 Economical: All-in-one reagent cartridge, no extra cost

ACCRE 8 ACCRE 90 ACCRE 120

[Link]
 Test Menu
 Broad : 60+ parameters available
 Exclusive: Thrombus and hypertention
 Innovative: 100+ parameters in 5 years

Cardiac Inflam- Torch Others

Fertility Thyroid Tumor infectious Anemia Thrombus
Markers mation

 CEA
 hs cTnI  AMH  TSH  Den NS1 Ag  VB12  D-DImer  PCT  Toxo IgG*  IgE
 AFP
 cTnI  Prog  TT3   Den IgG  Folate  TM  IL-6  Toxo IgM*  25 OH-VD
CA125
 CK-MB  Testo  TT4  CA19-9  Den IgM  Ferritin  TAT  CRP*  Rubella IgG*  Insulin
 MYO  Prolactin  FT3  CA15-3  HIV  FDP  SAA*  Rubella IgM*  C-peptide
 BNP  LH  FT4  tPSA  HBsAg  PIC  CMV IgG*  Cortisol
 NT-proBNP  E2  Tg  fPSA  Anti-HCV  t-PAIC  CMV IgM*  S100β
 H-FABP  FSH  Anti-Tg  CA72-4  Anti-TP  HSV-1 IgG*  PG I
 hs cTnT  β-HCG  Anti-TPO  HE4  [Link]*  HSV-1 IgM*  PG II
 ST2  Inhibin B*  CYFRA21-1  HSV-2 IgG*  G-17
 Lp-PLA2*  fTesto*  ProGRP*  HSV-2 IgM*  ACTH*
 CA50*  ANA*
 hs-CRP*  DHEA-S*
 CA242*  Anti-CCP*
 NSE*  PTH*
 SCCA*  INS-Ab*

 * In development [Link]
Chemiluminescence Platform
Fully-automatic CLIA Analyzer

 Flexiblility: Only 0.64 ㎡ footprint with 60

sample positions and 25 reagent positions

 Efficiency: <10 mins for the first result, with

high throughput of 200T per hour

 Precision: CV≤5%, featuring advanced

cleaning system to prevent carryover
FC-2100

[Link]
 Test Menu
 Broad : 50+ parameters available, complete cardiac and tumor markers.

 Featured panel: Thrombus, Pre-eclampsia, Hypertention.

Bone Gastric
Cardiac Tumor Markers Thyroid Fertility Thrombus Liver fibrosis Infectious disease TORCH
metabolism function

cTnT CA50 TSH AMH TM 25-OH VD G-17 HA* HBeAg* TOXO-IgG*

PTH PGI CIV* HBeAb*
BNP CA242 FT3 β-HCG TAT TOXO-IgM*
MYO CYFRA21-1 FT4 TESTO FDP PGII LN* HBcAb* Rubella IgG*
hs-cTnI SCCA TT3 PROG PIC HP-IgG* P III PN-P* HBsAg* Rubella IgM*
Lp-PLA2 HE4 TT4 E2 t-PAIC HBsAb* CMV-IgG*
CK-MB NSE Anti-TPO PRL D-Dimer Kidney Anti-TP* CMV-IgM*,
Hypertension
function
NT-proBNP CA72-4 Anti-TG LH HIV Ag/Ab* HSV-1-IgG*
ST2 CEA Tg FSH REN NGAL HCV* HSV-1-IgM*
CA15-3 CT* InhB Cortisol M. Pneumonia IgG* HSV-2-IgG*
CA125 T-Uptake* Anemia AI Pre- M. Pneumonia IgM* HSV-2-IgM*
Inflammation
CA19-9 TBG* A II eclampsia Chlamydia pn. IgG*
ProGRP TRAb* Ferritin ACTH Chlamydia pn. IgM*
PLGF IL-6
AFP TSAb* Folate ALD
sFlt-1 PCT
PIVKA-II* rT3* VB12 Craniocerebral injury
SAA
FPSA
TPSA S100β

 * In development Available by the end of 2024 [Link]

Blood Gas Platform
——For intensive care & respiratory support

 Flexible application in POCT or large labs

 Maintenance-free instrument no internal fluidic system.
 Easy-to-use with automatic calibration, simple test
procedures

BGA-102 Ucare-6000

[Link]
Test Menu
10 Measured parameters 24 Calculated parameters
pH cH+ sO2 (est)

Blood gas pCO2 cH+ (T) AnGap

pO2 pH (T) tHb (est ）

pCO2 (T) pO2 (A-a)

K+
pO2 (T) pO2 (A-a) (T)

Na+ HCO3-act pO2 (a/A)

Electrolytes
HCO3-std pO2 (a/A) (T)
Cl-
BB (B) RI
Ca++
BE (B) RI (T)

Glu BE (ecf) pO2 /FIO2

Metabolites
Lac ctCO2 pO2 (T) /FIO2

Hematocrit Hct Ca++ (7.4) POP

*Crea, BUN, COX, tBili ongoing !

[Link]
Coagulation Platform

 Portable  Overall analysis of the whole

 process of Coagulation and
Maintenance-free
Fibrinolysis
 First POCT blood
 Intelligent operation-automatic
coagulation analyzer
cup lifting and unloading
in China can test 5
items (PT, APTT, TT,  Multiple cup types supported-for
FIB, ACT) a variety of clinical applications

Coagulation Analyzer Thrombelastography Analyzer

OCG-102 TLT-101

[Link]
Test Menu

OCG-102
Item Sample volume Measuring Range

PT 20μL 7-90s

INR 20μL 0.5-9s

APTT 20μL 18-120s

TT 20μL 10-90s

FIB 20μL 1.5-6 g/L

ACT 20μL 50~500s

Non-anticoagulant
20μL 50~600s
ACT

[Link]
Test Menu

TLT-101
Test Items Reportable Parameters Standard Graph

Kaolin R, K, α, MA, LY30, EPL

Rapid-Kaolin ACT, K, α, MA, LY30, EPL

AA AA% inhibition

ADP ADP% inhibition

AA&ADP AA&ADP% inhibition

Heparinase R'=R(Kaolin Cup)-R(Heparinase Cup)

[Link]
 Pathology Platform

Instrument: PA-3600
( open system)
1 Pathology Staning System
6 Secondary Antibody + 179 Primary Antibody

 Support customization of incubation time and temperature for

each slide
 Staining cover plate & wave-like mixing technology, promote
uniform mixing of reagents, reduce reagent evaporation and loss
 RFID chip technology, automatically scan reagent information
 V-shape design bottom of bottle, enable small amount of reagent
Primary Antibody
( open system) residue
 Continuous and random slide processing, optimize laboratory
Scondary Antibody workflow
( closed system)

[Link]
HPLC Hemoglobin PLatform

High Efficiency
• Test speed: 60s/test
• Independent emergency position, can add sample at any time

Reliable Result
• Report IFCC and NGSP results simultaneously
• Accurately report HbA1c results if there are abnormal hemoglobin
samples
• Be able to identify the most common glycosylated hemoglobin
variants
Innovative Function
• Patented automatic exhaust system reduces instrument failure rate
• Side-hole needle ensures accurate sampling
• Chromatographic column can be replaced easily

Intelligent Design
• Automatic calibration and control process
Truth-H80E • Highly polished steel probes minimize carry-over
• Automatically identify sample types and support bidirectional LIS
system

[Link]
Application Scenarios

Lab Clinical Department Primary Care Others

In-hospital lab ER&OR&ICU Clinics Self-test

Third party lab Endocrinology Pharmacy Judiciary & Criminal

setting

Cardiology GP office Employment screening

Pediatrics Customs

[Link]
Company Overview

Technologies

Businesses

Social Values
Businesses
Subsidiaries, sub-brands and cooperation with partners

[Link]
 Wondfo Health company

20+
Individual & family health management platform

Subsidiaries Wondko company

Rapid diagnosis service for vets, water quality
Expanding Business and food security testing
Boundary

Guangzhou A&C company

Provide top-class third party testing service,
serves mostly the public and government
institutions （ judiciary, police, customs ）

[Link]
Improve Diagnosis
Efficiency through
Continuous Cooperation

[Link]
Wondfo Training Center in Kenya Localization Project in Uganda
Jul 2023, Joint training center with the University of Nairobi. 28th Nov 2023
As the first training center in Africa that is from Chinese IVD industry, we Based on the Belt and Road, we provides a full range of technical support
provide trainings for over 500 students and lab technologists each year. It and assistance. The landing of the project will make Africa less
aligns with the vision of deepening academia-industry linkages and will also dependent on diagnostic reagent imports. It will provide high-quality and
strengthen clinical services at Kenyatta National Hospital (the largest referral more affordable diagnostic tests for the local people, benefiting more
hospital in East and Central Africa) African people and enhancing public health services in Africa.
[Link]
Cooperation with AstraZeneca in Pilot Project in Thyroid
Prostate Cancer Screening Screening by Wondfo and Merck

Facilitate the efficient clinical management of prostate Together with Merck, we launch a pilot project to improve
cancer in Asia, Central America, Latin America, the Middle the access to diagnosis and treatment of thyroid diseases
East, and parts of Africa at the primary care level

[Link]
 Agreement with MedAccess and CHAI
( Clinton Health Access Initiative)
27 Jul 2022, together we make Wondfo’s HIV self-test
available for US$1, the most affordable WHO prequalified self-
test on the market, which make HIV Self-Test available and
affordable in low- and middle-income regions.

[Link]
Resource: [Link]
Company Overview

Technologies

Businesses

Social Values
 Actively Undertaking CSR
Racing for life
Thailand Royal TV station Indonesian Ministry for Maritime
and investment Affairs

Hospital reconstruction after Approved as AIDS Prevention

civil war in Ethiopia and Control Center

Donate Malaria tests to Kenya CDC [Link]

Actively Undertaking CSR
Make Biological Technology Benefit Everyone

Wondfo Funds
[Link]
Wondfo Team Customer Oriented

“Trinity Mode” Technical Engineer Sales Marketing

Technical
support

200+ Marketing
Middle
Europe Africa
Latin
CIS
Molecular
&
Public
International Deliver East America
Pathology
health
Sales& Marketing Team team

Customer
Service

2500+
Backend Support Team
R&D Team Supply Chain Team Quality management Team
Wondfo efforts for people’s health in
every corner of the world
 Environment Planet Healthy Life

Wondfo Mascot
Where there is a will (whale), there is a way.
To raise awareness of protecting
environment and blue whales
FOFO

[Link]
Racing for Life
[Link]
Shenzhou Campus

[Link]
Lizhishan Campus-Headquarters

[Link]