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Adalvo Announces Successful Pivotal BE Study For Afatinib Film-Coated Tablets

30 June 2023

Adalvo is pleased to announce that the successful Pivotal BE Study for Afatinib Film-Coated Tablets has been completed and we are now preparing our dossier submission which is scheduled for November 2023.

Our product is Afatinib 20mg, 30mg, 40mg & 50mg FCT and has been developed based on the reference brand Giotrif® (Boehringer Ingelheim). This product is fully developed by our sister company, forming part of the Aztiq group.

Afatinib is used in the treatment of non-small cell lung cancer and has been selling for $306 Mn across the globe in 2022, according to IQVIA.

Based on our positive results, we believe we will be in a first-to-file first-to-market position in all our major markets.

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At Adalvo, there are no half measures – we arealways on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. – Central & Eastern Europe, Russia & CIS North Europe, APAC, MENA & Israel – Brazil LATAM (exc. Brazil) & South Europe – Europe – UK/Ireland, North America & South Africa - Head of Global BD&L

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