collaboration and license agreement for the global development and commercialization of tafasitamab. On March 3, 2020, the agreement received antitrust clearance and thus became effective. In March 2020, MorphoSys announced that the FDA had accepted the Biologics License Application (BLA) for filing and granted priority review for tafasitamab, setting a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020. On July 31, 2020, Monjuvi (tafasitamab-cxix) was approved by the U.S. FDA in combination with lenalidomide for the medical treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Pipeline As of December 2020, MorphoSys had 116 drug candidates which are developed by MorphoSys and other pharmaceutical companies, 28 of which were in clinical development. Two antibodies developed by MorphoSys are already approved and marketed. Tafasitamab (MOR208) is a humanized monoclonal antibody directed against CD19 in clinical development for the treatment of B-cell malignancies. Tafasitamab is being evaluated in several clinical trials, alone and in combination with other anti-cancer drugs. Felzartamab (MOR202)is a humanized monoclonal antibody directed against CD38 for the treatment of anti-PLA2R-positive membranous nephropathy, an autoimmune disease affecting the kidneys. In 2017, MorphoSys entered into a regional licensing agreement with I-Mab Biopharma to develop and commercialize Felzartamab (called TJ202 by I-Mab) in Greater China. Felzartamab (MOR202/TJ202) is currently under investigation by I-Mab in three clinical trials. Otilimab (MOR103/GSK3196165) is a fully human monoclonal antibody directed against GM-CSF. The program is outlicensed to GlaxoSmithKline. Otilimab is currently under investigation in a Phase 3 trial in rheumatoid arthritis that started in July 2019. Technology MorphoSys has discovered a number of antibody technologies that are use for drug development. MorphoSys’ main technology is HuCAL (Human Combinatorial Antibody Library), which is a collection of more than ten billion fully human antibodies in the form of a phage display bank and a system for their optimization. Another technology recently developed is the OkapY bispecific antibody technology. MorphoSys’ OkapY technology is a new proprietary “2+1” bispecific antibody format with the hysicochemical properties to simplify the development and large-scale production of such molecules. References External links MorphoSys US Inc. Xencor Inc. I-Mab Biopharma Lanthio Pharma B.V. Biotechnology companies of Germany Biotechnology companies established in 1992 1992 establishments in Germany Companies in the TecDAX Companies in the MDAX