Regulatory Filings • Jan 31, 2017
Regulatory Filings
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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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