InnoCare's BLA for Tafasitamab with Lenalidomide to Treat Relapsed/Refractory DLBCL in China Accepted

InnoCare Pharma, a prominent biopharmaceutical company with listings on HKEX (09969) and SSE (688428), has made a significant announcement today. The China National Medical Products Administration (NMPA) has accepted and prioritized the review of a biologics license application (BLA) for the combination therapy of tafasitamab and lenalidomide. This treatment is intended for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not suitable candidates for autologous stem cell transplant (ASCT).

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, emphasized the importance of this milestone for the company. She pointed out that DLBCL is the most prevalent form of non-Hodgkin lymphoma worldwide, with a considerable unmet need for effective treatments in China. Dr. Cui expressed optimism that the tafasitamab regimen would offer a new therapeutic option for Chinese DLBCL patients.

Tafasitamab is a humanized Fc-modified cytolytic CD19-targeting immunotherapy. Combined with lenalidomide, it has already secured approval for treating eligible DLBCL patients in Hong Kong. Additionally, under the early access programs in the Bo’ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, the combination therapy has been prescribed at the Ruijin Hainan Hospital and Guangdong Clifford Hospital for qualifying DLBCL patients.

In the United States, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory DLBCL who are not candidates for ASCT. Similarly, the European Medicines Agency (EMA) has conditionally approved the same combination therapy for this patient group.

DLBCL accounts for 31% to 34% of all non-Hodgkin lymphomas (NHL) globally. The incidence is even higher in China, where it represents 45.8% of all NHL cases.

Tafasitamab is a monoclonal antibody engineered to target CD19. Developed by MorphoSys, who licensed the global rights from Xencor, Inc., tafasitamab features an XmAb® engineered Fc domain that facilitates B-cell lysis through apoptosis and immune effector mechanisms, including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

MorphoSys and Incyte entered into a global collaboration and licensing agreement in January 2020 to develop and commercialize tafasitamab. In February 2024, Incyte obtained exclusive global rights for the same. In August 2021, InnoCare and Incyte formed a collaboration and license agreement to advance and exclusively commercialize tafasitamab in hematology and oncology in Greater China.

In the U.S., tafasitamab (marketed as Monjuvi®) has received accelerated approval in combination with lenalidomide for adult patients with relapsed or refractory DLBCL not otherwise specified, including cases arising from low-grade lymphoma, who are not suitable for ASCT. In Europe, the therapy (marketed as Minjuvi®) received conditional Marketing Authorization from the EMA in combination with lenalidomide, followed by Minjuvi monotherapy, for the same patient population.

InnoCare Pharma is dedicated to discovering, developing, and commercializing first-in-class or best-in-class drugs for treating cancer and autoimmune diseases, catering to unmet medical needs in China and globally. The company has offices in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

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