COVID-19 RDT

One of the Largest Pharmaceutical Companies in the World

Mylan was founded nearly 60 years ago, and today it is one of the world’s largest manufacturers of API.1

>7500 165 countries2 ~59B doses

products2 sold2

12 R&D and 40+ Regulatory ~40% of HIV+

manufacturing approvals of BS in patients depend
facilities2 >65 countries2 on our products2

API: Active pharmaceutical ingredient; R&D: Research and development; BS: Biosimilar; HIV+: Human immunodeficiency virus-positive.

• 1. Mylan. Better health for a better world (2018). Available at: https://www.mylan.in/-/media/mylanin/documents/english/mylan_india-fact-sheet.pdf?la=en. Accessed
on: 11 July 2019. 2. Mylan. About Mylan. Available at: https://www.mylan.com/en/about-mylan. Accessed on: 13 June 2019.

2 2
This document contains confidential and proprietary information of Mylan N.V.
Unauthorized use, duplication,HIGHLY CONFIDENTIAL
dissemination – INTERNAL
or disclosure USEisONLY.
to third parties FOR DISCUSSION
strictly prohibited. © 2019 PURPOSES ONLY
 Mylan’s ARV Franchise and Contribution in HIV Space

Worldwide, 40% of HIV-positive individuals use Mylan’s

ARV on a daily basis.1

Mylan is a leading supplier of ARV API.1

Mylan produced 4 billion ARV capsules and tablets in 2017

alone.1 Mylan provides access to affordable ARVs in more than
100 countries around the world.1

Mylan’s ARV franchise Mylan uses approximately 50% of its API stock for
the production of ARVs.1

Mylan brought the global gold standard of HIV/AIDS

treatment to developing countries years ahead of others.2

ARV: Anti-retroviral; HIV: Human immunodeficiency virus; API: Active pharmaceutical ingredient.

1. Mylan. Antiretrovirals (2019). Available at: https://www.mylan.in/en/antiretrovirals. Accessed on: 11 July 2019. 2. Biospace. Mylan Expands Access to HIV/AIDS Medicines with
Launch of First Generic Sustiva Tablets (2018). Available at: https://www.biospace.com/article/releases/mylan-expands-access-to-hiv-aids-medicines-with-launch-of-first-generic-
sustiva-tablets/.
3 Accessed
This document contains on: 11 Julyand
confidential 2019.
proprietary information of Mylan N.V.
3 Unauthorized use, duplication,HIGHLY CONFIDENTIAL
dissemination – INTERNAL
or disclosure USEisONLY.
to third parties FOR DISCUSSION
strictly prohibited. © 2019 PURPOSES ONLY
Commercial Partnership

In partnership with

Largest manufacturer of ARV Drugs and Guangzhou Wondfo Biotech Co. Ltd
more than 40% of HIV Patients take Mylan - Pioneer of Point of Care Tests
Drugs Offers  ISO13485:2016, ISO9001:2015
 FDA-21 CFR820
 WHO PQ

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Key Information and Qualifications
• First approved COVID-19 rapid test by CFDA.
• Total Clinical Study includes 596 specimens, positive specimen 361 (includes 101 early
diagnosed patients) ; Sensitivity 86.43%, Specificity 99.57%; Overall Accuracy 92%
• CE Certificate received
• Working to get the product in FIND/WHO Emergency Use List program
• Product Listed at FIND-COVID-19 DIAGNOSTIC PIPELINE, await further validation.
(See link: https://www.finddx.org/covid-19/)
• Product widely used in China, daily supply 300,000 Test.

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SARS-CoV-2 Antibody Test Quick Reference Guide

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Guangzhou Wondfo Biotech Co., Ltd-Pioneer of POCT

Founded in 1992
Stock Code:300482

Company Vision
Dedicated to providing professional products and services of rapid diagnosis and chronic disease management,
we are always in the pursuit of friendly and convenient user experience. We strive to enhance people’s well
being and fulfill shared dream of our staff, customers and partners.

FocusFounded
on Globalization & Big
in 1992 , focusing on Diagnostic: The first public company in
POCT （point of care testing） POCT in China(300482)
Locally manufacture-Asia, Africa, CIS and Latin America. Layout in-Pathology, Imaging, Molecular, Eugenic

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Business Profile
In the stage of high-speed development with the total market value exceeding 1.5 billion USD.

USA·SAN DIEGO
JAPAN·TOKYO
CHINA·GZ/SZ

Production Capacity: QMS Guidelines:

 Annual HIV kit Capacity: 20 Million Test  ISO13485:2016, ISO9001:2015
 Annual RDT kit Capacity: 150 Million Test  FDA-21 CFR820
 NMPA-National Medical Products Administration
Certificate & Trademark & Patent  MDSAP-FDA,TGA ,ANVISA, HC, MHLW
 180 CFDA, 158 CE, 68 FDA, 1 WHO PQ-HIV  etc.
 288 Patent 25 times QMS Audit(FY2018-FY2019)
 117 Trademark(China), 113 Oversea( of 42 countries) 10
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