By Fineline Cube 
China-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced that the National Medical Products Administration (NMPA) has granted marketing authorization to its Minjuvi (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. The approval is for use in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This marks the first approval of its kind for this indication in China.
Global Approval and Development History
Tafasitamab is already approved in the US, EU, and other major markets. It is an Fc-enhanced, humanized, anti-CD19 monoclonal antibody used alongside lenalidomide for DLBCL in patients ineligible for stem-cell transplant. The drug was first developed by US firm Xencor, licensed to MorphoSys AG in 2010, and subsequently acquired by Incyte Therapeutics from MorphoSys in 2020. InnoCare signed a licensing agreement with Incyte for the Greater China rights to the molecule in 2021.
Clinical Application
The combination treatment regimen of tafasitamab plus lenalidomide was first prescribed in Boao, Hainan for the treatment of DLBCL in July 2022. This approval by the NMPA further validates the therapeutic potential of tafasitamab in addressing unmet needs in DLBCL treatment.-Fineline Info & Tech