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Gentian Diagnostics ASA

Regulatory Filings Jan 31, 2017

3604_iss_2017-01-31_71c036b8-d632-45cb-b5d7-04a03d2b90b1.html

Regulatory Filings

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IMPORT RESTRICTIONS OF HUMAN BIOLOGICAL SUBSTANCES INTO CHINA

IMPORT RESTRICTIONS OF HUMAN BIOLOGICAL SUBSTANCES INTO CHINA

Chinese authorities have recently implemented restrictions

on the importation of human biological substances. This

creates a challenge for one of Gentian's most important

distributors, as this distributor purchases so-called

calibrators from Gentian for sale and distribution in China.

Due to the restriction, the distributor has put its order

due for delivery in March 2017 on hold. The value of the

order amounts to approximately MNOK 1.8.

Gentian and its distributor have, however, applied for an

exemption from the import restriction. This application is

currently being reviewed by the authorities. In addition,

Gentian and its distributor has discussed an alternative

solution, which is to manufacture the calibrators locally.

Gentian is confident that such a solution will be successful

in case it is not possible to get an exemption. Further

notifications will be provided in respect of the development

of the above.

Gentian has a long history of delivering diagnostic products

to the Chinese market, and has previously managed to solve

similar issues. Gentian is also working on developing a new

generation of calibrators that will not be based on the

substances that are currently impacted by the Chinese import

restrictions. This will be a more permanent solution.

The challenge in China will not have any impact on Gentian's

pipeline of new products. Gentian's first new product is

still expected to be launched in 2017. The company also

expects to deliver proof of concept on several new product

candidates in 2017.

For further information, please contact:

Bård Sundrehagen

CEO, Gentian Diagnostics

E-mail: [email protected]

Cell Phone: +47 924 14 117

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