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Withreference to previous communication of Mabion S.A. ("Company") inrelation to applying to the European Medicines Agency (EMA) forthe marketing authorisation for the drug under the working name ofMabionCD20 and to Current Report no. 15/2020 of 16 March 2020 onthe change of the regulatory strategy for the drug as part of theregistration procedure with the EMA, the Management Board of theCompany hereby informs that on 30 March 2020, the EMA’s websitepublished information confirming the withdrawal of the Company’sregistration applications submitted in June 2018 and May 2019. 

Theconfirmation of the Company’s withdrawal of the registrationapplication concludes the existing registration procedureinitially based on a two-step strategy (obtaining small-scalemarketing authorisation, followed by a subsequent submission of avariation application relating to a large-scale manufacturingprocess). The Company managed to resolve the vast majority of allrequests for additional information, however, in light of theCompany’s goal to register a product based on a commerciallyattractive large-scale quality process, the Company consideringthe pervious interactions with the Agency adjudged that such databe reviewed in a future application, and hence the application forthe small-scale process was withdrawn.

The Companyinformed about its intention to withdraw the applications in theabove-mentioned report no. 15/2020. Today the Agency published the"Questions and Answers" (“Q&A”) document with a short summary ofthe process, however detailed information on the completedregistration procedure (European public assessment report - EPAR),in accordance with EMA regulations will be published by theregulator in the months to come. The EPAR will be based on thelatest approved by CHMP version of assessment report (Day 195)where there were more unresolved issues than at the moment ofwithdrawal so it will not be reflecting the most current status.

While theCompany acknowledged all remaining questions as valid based on theavailable data at the time of the last approved version of theassessment report (Day 195), the Company has since madesignificant progress towards a new marketing authorizationapplication based on the commercial-scale quality process.

Currentlythe Company is preparing such a new marketing authorizationapplication aimed at obtaining marketing authorisation forMabionCD20 from EMA in due time. The scope and format of the newapplication will be reviewed with representatives of EMA as partof a scientific advice procedure, in order to verify that theymeet all of the Agency's expectations.