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Approval for German Medical Device in China

Jul 17 2017 Read 700 Times

Gilupi CellCollector®, the first medical device for in vivo CTC isolation, manufactured by Gilupi, was approved by the Chinese registrations agency (China Food and Drug Administration – CFDA) in June. As a result, the Potsdam-based company gains access to one of the most significant geographical markets worldwide. This milestone was reached in close cooperation with Gilupi’s strategic partner, Hebei Viroad Biotechnology Co Ltd (Viroad). Besides its role as strategic partner, Viroad is also the largest investor and shareholder of Gilupi.

Alexander Herrmann, Managing Director of Gilupi GmbH commented: "Viroad is an excellent partner and we achieved this important approval based on their outstanding knowledge of the Chinese market and their regulatory expertise. Together with Viroad, we can realise a rapid market access in China and expect a significant sales growth within the next years.”

The importance of the strategic partnership with Viroad to GILUPI is also pointed out by Brandenburgs Economic State Secretary Hendrik Fischer and the CEO of Brandenburg Invest (WFBB), Sebastian Saule, during their current delegation visit to China. Yesterday, they visit Ms Baozhi Xu the CEO of Hebei Viroad in Shijiazhuang, the capital of Brandenburgs partner province Hebei. State Secretary Fischer explained: “The economic relations with China are very important for the German county Brandenburg. We are pleased that a Brandenburg company is generating attention on the Chinese healthcare market.” WFBB CEO Saule said: “This is a new quality on external economic relations with China and at the same time strengthens the healthcare location Brandenburg. This is of course a wonderful success of the joint efforts in China and Brandenburg, supporting the develop of Gilupi.“

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