Positive results of the clinical trial regarding
MabionCD20 in RA

Mabion S.A. is finalising the clinical development of its flagship product, and thus confirms its status and capacity to continue the race for the global market of biosimilar rutiximab.

  • Initial reports regarding both efficacy of treatment and pharmacokineticsindicate bioequivalence between MabionCD20 and MabThera.[1],[2]
  • The company has finalised enrolment and treatment of patients with non-Hodgkin's lymphoma (NHL) and is awaiting the trial results.
  • The Marketing Authorisation Application to be submitted to the EMA will be created on the basis of i.a. that data.

The first biotech company in Poland to successfully conduct a clinical trial

The report was issued on the basis of demasked results of the comparative analysis with the reference product, MabThera®. The analyses were carried out by two external entities and their results will be used for the Marketing Authorisation Application, which the company plans to submit in 1Q of 2018.

Sławomir Jaros, PhD, Head of Operations and Science at Mabion S.A. and Member of the Board: The reports drafted by external entities provide initial confirmation that we have received a product which is bioequivalent to the reference drug in terms of efficacy and pharmacokinetics. And this means that we have met one of the most important regulation guidelines. What we are happy about the most is that results for all endpoints, including all indirect results, e.g. the distribution of therapeutic response, which we find very important, were positive. Furthermore, adverse effects were similar in type, frequency and severity in both groups and were in line with the safety data published for MabThera. This is the data which will be analysed by the EMA in the Marketing Authorisation Application. We are very close to finalising the clinical process which took several years and we are the only Polish company who has managed to independently reach such an advanced development stage for a biotech drug.

Concluded drug administration in the NHL MabionCD20 NHL trial.

The treatment of the last patient with a non-Hodkin's lymphoma in the MabionCD20 clinical trial has been concluded. Enrolment to the MabionCD20 NHL trial was ceased in February this year. Currently, all patients enrolled in the MabionCD20 NHL trial have undergone a 26-week treatment and follow-up period. Now they will undergo a further 20-week long-term follow-up. Regardless of that, the Company may commence preparing data for analysis, after which the trial will be demasked and data will be analysed.

Artur Chabowski, President of the Board, Mabion S.A.: We are currently focusing on preparing data from both clinical trials, on analysing them and then preparing them for the marketing authorisation documentation. At the end of June we had another meeting with the EMA, the so-called pre-submission meeting, the aim of which was to discuss final aspects of the application submission which will take place soon and aspects associated with the company's marketing authorisation strategy. We find these meetings to be a very significant element of risk reduction in terms of receiving marketing authorisation for MabionCD20. We will receive a full review of the data at the beginning of 2018 the latest.On that basis, and on the basis of the data we have already received, the Marketing Authorisation Application will be prepared and submitted to the EMA.

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Mabion SA is a leading biotechnology company in Poland, created for the purpose of marketing cutting-edge biotechnological drugs based on humanised monoclonal antibodies.This technology, developed independently in Mabion, meets highest international standards. The process of humanising monoclonal antibodies, which is the pinnacle of modern biotechnology, allows for creation of targeted drugs which act selectively on tumour cells, thus ensuring greater effectiveness and lower toxicity of the therapy. Mabion is one of the few biopharmaceutoical companies with the capacity for comprehensive development and implementation of all kinds of biotechnology drugs – starting with the design stage, through the selection of the platform and manufacturing technology, and ending with the manufacture and obtaining marketing authorisation of the finished drug. Currently, the company conducts research and development works on several biotech drugs used in the treatment of cancers and inflammatory diseases. More information on

Małgorzata Siewierska
Communication and Investor Relations Division, Mabion S.A.

Telephone: 519066531

[1] The initial report covers results of the clinical trial verifying the similarity of MabionCD20 and MabThera in patients with active RA based on primary and secondary pharmacokinetic parameters in the 24th week of the trial. The reports were created by independent entities.

[2] Positive initial results of the comparative analysis do not guarantee that results of the trial presented in the final version of the report will be positive. Furthermore, positive results of the trial do not guarantee that the Product will be approved by the European Medicines Agency (EMA).