China-based InnoCare (HKG: 9969) announced that the first prescription for its pipeline candidate tafasitamab (trade name: Monjuvi) has been issued in the Bo’Ao Lecheng Medical Tourism Pilot Zone. The drug is intended for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) in patients not eligible for autologous stem cell transplantation (ASCT), administered in combination with lenalidomide.
Drug Profile
Tafasitamab is a humanized Fc-modified cytolytic CD19-targeted monoclonal antibody (mAb) originally discovered by Germany-based MorphoSys AG. It was licensed to US firm Incyte for global co-development and commercialization in January 2020. InnoCare signed an agreement with Incyte in August 2021 to obtain Greater China development and commercialization rights to the drug.
Mechanism of Action
The drug mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
Regulatory Approval
The US FDA granted the first accelerated approval for tafasitamab in combination with lenalidomide in August 2020 to treat relapsed or refractory DLBCL, including DLBCL arising from low-grade lymphoma, as well as in patients not eligible for ASCT.-Fineline Info & Tech
