The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).
Tafasitamab, already approved in the US, EU, and other significant markets, is an Fc-enhanced humanized anti-CD19 monoclonal antibody. It is used in conjunction with lenalidomide for the treatment of DLBCL in patients who are not candidates for stem-cell transplants. Initially developed by the US firm Xencor, the rights to the drug were licensed to MorphoSys AG in 2010. Subsequently, Incyte Therapeutics acquired global development rights from MorphoSys in 2020. InnoCare secured an agreement with Incyte for the Greater China rights to the molecule in 2021. The combination treatment of tafasitamab and lenalidomide was first prescribed in Boao, Hainan for DLBCL in July 2022.- Flcube.com