dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “Today’s BLA acceptance marks another step forward after we received approval to conduct a registration trial for tafasitab and lenalidomide from China’s National Medical Products Administration (NMPA) – reinforcing our commitment to bringing an innovative therapy like tafasitamab in combination with lenalidomide to potentially address the unmet need of eligible DLBCL patients in greater China.”
Tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, is not approved by the NMPA for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone.
Tafasitamab is conditionally approved by both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for ASCT.
Tafasitab is a humanized Fc-modified CD19 targeting immunotherapy.
In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.
Tafasitab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvic® (tafasitamab-cxix) is approved by the US Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
In Europe, Minjuvic® (tafasitamab) received conditional approval, 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).
Tafasitab is being clinically investigated as a therapeutic option in B-cell malignancies in several combination trials.
Monjuvic® and Minjuvic® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI® in the US, and marketed by Incyte under the brand name Minjuvic® in Europe, the UK and Canada.As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitab in hematology and oncology in Greater China.
XmAb® is a registered trademark of Xencor, Inc.
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.
InnoCare Forward-looking Statements
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