Cinfa Biotech S.L.

Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. The Company develops, manufactures and commercializes high-quality biosimilars to treat oncology and inflammatory diseases to address the growing need for affordable therapies. An expert team specialized in biosimilars is conducting product development, clinical studies, manufacturing and quality control in Europe, according to the highest quality standards. Cinfa Biotech’s lead product candidate is B12019, a biosimilar version of Neulasta® (pegfilgrastim) used to treat chemotherapy-induced neutropenia. Pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF) receptor agonist, is used to stimulate bone marrow to produce more neutrophils in order to decrease the incidence of infection in patients undergoing chemotherapy.  The clinical development program was based on scientific advice from EMA and included two studies, which confirmed the analytical and biofunctional similarity of B12019 and Neulasta® in highly sensitive clinical study settings. A GMP manufacturing process for B12019 has been established at commercial scale. The Marketing Authorisation Application (MAA) for B12019 in the European Union is currently under review by EMA.  Interactions with the FDA are being prepared to agree on the data package required for FDA licensing of B12019.  We are looking for commercialization and marketing partnerships for our high quality biosimilar medicines. In particular, we are interested in out-licensing and co-development opportunities for the US and Canada. We have the structure, flexibility and entrepreneurial know-how to develop solutions tailored to the needs of our partners and customized for their markets.