Dr. Jasmine Cui, Co-Founder, President and CEO of InnoCare, said: “Today’s BLA acceptance marks another milestone after we received approval to conduct a registrational trial for the tafasitamab and lenalidomide from the China National Medical Products Administration (NMPA) – reinforcing our commitment to bring breakthrough therapy like tafasitamab in combination with lenalidomide to potentially address the unmet need of DLBCL-eligible patients in the greater China.
Tafasitamab, an Fc-modified humanized cytolytic monoclonal antibody targeting CD19, 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 the Administration medical products from Hainan Province for the treatment of eligible DLBCL patients, under the Early Access Program in the Boao Lecheng International Medical Tourism Pilot Area.
Tafasitamab is conditionally approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of patients with relapsed or refractory DLBCL who are not eligible at ASTC.
Tafasitamab is a modified humanized CD19 targeting immunotherapy.
In 2010, MorphoSys obtained exclusive worldwide development and commercialization rights to tafasitamab from Xencor, Inc.
Tafasitamab incorporates an XmAb® modified Fc domain, which mediates B cell lysis through apoptosis and the immune effector mechanism, including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP).
In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL resulting from basal lymphoma grade, 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 depend on verification of clinical benefit in one or more confirmatory trials.
In Europe, Minjuvi® (tafasitamab) has 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 an autologous stem cell transplant (ASCT).
Tafasitamab is being studied clinically as a treatment option in malignant B-cell tumors in several ongoing combined trials.
Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI® in the United States, and marketed by Incyte under the Minjuvi brand® in Europe, the United Kingdom and Canada. As part of its agreement with MorphoSys, Incyte received exclusive rights to commercialize tafasitamab outside of the United States, and in August 2021, Incyte entered into a collaboration and licensing agreement with InnoCare for the exclusive development and commercialization of tafasitamab in hematology and oncology in Greater China.
XmAb® is a registered trademark of Xencor, Inc.
InnoCare is a commercial-stage biopharmaceutical company engaged in the discovery, development and commercialization of first-in-class and/or first-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphomas, solid tumors and autoimmune diseases with significant unmet medical needs in China and globally. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.
InnoCare Forward-Looking Statements
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