Mabion S.A.

Mabion S.A. is a Polish biotechnology company focused on developing and manufacturing biosimilar and innovative biological medicines. The company's primary product is MabionCD20, a biosimilar version of rituximab, which is in advanced stages of development for the treatment of non-Hodgkin's lymphoma (NHL) and rheumatoid arthritis (RA). Mabion utilizes its own proprietary technology platforms for the development and production of monoclonal antibodies.

In March 2021, Mabion expanded its operations by entering into a manufacturing agreement with Novavax for the production of the Covid-19 vaccine antigen. This collaboration was extended in June 2024, demonstrating the company's growing capabilities in contract manufacturing. Mabion operates a state-of-the-art manufacturing facility in Konstantynów Łódzki, Poland, which received Good Manufacturing Practice (GMP) certification for both active substance and medicinal product manufacturing in July and August 2019, respectively.

The company has been actively pursuing regulatory approvals for MabionCD20. In June 2018, Mabion submitted a marketing authorization application for MabionCD20 to the European Medicines Agency (EMA). However, in March 2020, the company withdrew this application to implement a new regulatory strategy. As of January 2024, Mabion was continuing its efforts to obtain marketing authorization for MabionCD20 in both European and US markets.

In addition to its biosimilar development, Mabion is also engaged in innovative drug development. The company has filed patent applications for its MabionMS project, indicating ongoing research in the field of multiple sclerosis treatment.

Key customers and partnerships

Mabion's primary commercial partnership is with Novavax, Inc. In March 2021, Mabion entered into a framework agreement with Novavax for the contract manufacturing of the SARS-CoV-2 vaccine antigen. This collaboration was strengthened in October 2021 when Mabion signed a commercial manufacturing agreement with Novavax for the period 2022-2025. The partnership was further extended in June 2024, with Mabion concluding an annex to the quality agreement, demonstrating a continued strong relationship between the two companies.