Coronavirus Test Kit from Joonghun Pharmaceutical

Phone : +82 2 6928 9114

Fax : +82 2 6928 9119

E-mail : thankyou@joonghun.com

HQ : 15, Gukhoe-daero 62-gil, Yeongdeungpo-gu, Seoul, 07236, Korea

Factory : 28 Oksansandan-ro, Chungjoo-si, Choongchungbook-do, 28101, Korea

Website : www.joonghun.com

My name is Jinsung Ku of Joonghun Pharmaceutical in Korea and it is my honor to introduce myself and my company to you. I appreciate the chairman and related gentlemen of Korea-Saudi Friendship Society who was introduced by Mr. Kyung Ho Kim to give me a chance to introduce my product, RT-PCR test kit for coronavirus to Saudi Arabia. I do hope to work with Saudi Arabia for coronavirus test kit as well as pharmaceutical products.

We have been experiencing a serious disaster that we’ve never imagined before. ‘Covid-19’ generally called Coronavirus makes human society changed a lot, not only in medical system, but also in everyday life style regardless region, religion or political direction. Every government reviews their quarantine system and tries to find the related products such as RT-PCR kit, mask, gloves, PPEs and equipments. But it is very difficult to find good products,  trustful suppliers and competitive price, so many companies already work in this supply chain, though.

Joonghun Pharmaceutical is the only pharmaceutical company to produce RT-PCR test kit for coronavirus approved by MFDS (Ministry of Food and Drug Safety) of Korea. Our RT-PCR test kit was developed by R&D people who have worked in vaccine and diagnosis field for over 20 years and manufactured at pharmaceutical GMP (Good Manufacturing Practice) facility which is quite different from other test kits which are manufactured at medical device GMP or GLP (Good Laboratory Practice) facilities. For those reasons our test kit was claimed 100% sensitivity in clinical trial, and has CE mark, also EUA (Emergency Use Authorization) of FDA in the process.

Joonghun Pharmaceutical has also exported one of our medicines, Ribavirin which is approved for medication for coronavirus by MFDS like the situation of MERS (Middle East Respiratory Syndrome) in 2015 to Luxemburg. We are the only pharmaceutical company among many pharmaceutical companies in Korea to export the medicine for coronavirus to Europe.

Many doctors and scientists warn the second impact after this situation, some countries seem to announce the complete overcome against coronavirus, though. I think it is too early to close up the door. We are learning many things from this disaster, one of the lessons is that each government should store the proper volume of quarantine materials in normal time for unexpected disaster. So, I strongly suggest that you should take a look at our RT-PCR test kit and consider my company as a long-term partner.

Saudi Arabia as the leading country in Middle East is regarded one of the most important market for us. We, Joonghun Pharmaceutical is quite interested in cooperation with your country for this situation. So, please take a look at the attached files for your reference and get back to me for any questions. Your feedback will be highly appreciated.

Once again, I am so glad to talk to you and believe that your country will overcome this disaster very soon.

Sincerely,

Jinsung Ku

Executive Director / CMO

Joonghun Pharmaceutical Co.,Ltd.

Office  +82-2-6928-9114 | Mobile +82-10-4056-7771 

(HQ) 15 Gukhoe-daero, 62-gil, Youngdeungpo-gu 07236, KOREA 

5/4/2020

Kyo San Ku

AKI Health LLC

651 N Broad St, Suite 205 #2405

Middletown, DE 19709

UNITED STATES

Dear Kyo San Ku:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration

(FDA) has received your submission. This submission has been assigned the unique document

control number below. All future correspondence regarding this submission should be identified

prominently with the number assigned and should be submitted to the Document Control

Center at the above letterhead address. Failure to do so may result in processing delays. If you

believe the information identified below is incorrect, please notify the Program Operations Staff

at (301) 796-5640.

Submission Number: EUA200652

Received: 5/4/2020

Applicant: Joonghun Pharmaceutical Co., Ltd.

Device: JD COVID-19 qRT-PCR Kit

We will notify you when the review of this document has been completed or if any additional

information is required. If you are submitting new information about a submission for which

we have already made a final decision, please note that your submission will not be re-opened.

For information about CDRH review regulations and policies, please refer to

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.