On November 6, the CDE website showed that AbbVie's CD3/CD20 bispecific antibody Epcoritamab (US trade name: Epkinly) has been submitted for marketing authorization in China.Epcoritamab is an IgG1 bispecific antibody developed by Genmab using its proprietary DuoBody technology. It can simultaneously target CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of CD20+ cells. In June 2020, AbbVie and Genmab reached an agreement to jointly develop and commercialize three bispecific antibodies, including this product.
EculizumabMechanism of Action (Source: AbbVie Official Website)In May 2023, Epcoritamab based on the DLBCL cohort data from the Phase I/II EPCORE NHL-1 studyReceived FDA Accelerated Approval for Market Launch, Indication for third-line treatment after receiving two or more systemic therapies (systemic therapie）Patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). This product is the first bispecific antibody approved by the FDA for the field of DLBCL and also the second CD3/CD20 bispecific antibody approved by the FDA.In the EPCORE NHL-1 study,Patients with DLBCL(n=148) After receiving Epcoritamab treatment, the overall response rate (ORR) was61%, with a complete response rate (CR) of 38% and a median duration of response (mDOR) of 15.6 months;FL Patients(n=128) After receiving Epcoritamab treatment, the ORR was82%, mDOR has not been reached, and the proportion of patients with DOR reaching 12 months is 68.4%.DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for approximately 31% of all NHL cases. According to GLOBOCAN 2020, there were approximately 544,000 new cases and 260,000 deaths from NHL globally. FL is also a common type of NHL, accounting for approximately 20%-30% of all NHL patients. FL generally progresses slowly, with patients having a longer survival period, but it is prone to transform into DLBCL, and the recurrence rate after remission is extremely high.Currently, four CD3/CD20 bispecific antibodies have been approved for marketing globally, includingEculizumab,Motorezumab (Roche/Biogen),Gefitumab (Roche) andOdronextamab (Regeneron). Among them,Mozotuximab was approved for marketing in June 2022, onlyGefitumab has been launched in China.。Copyright © 2024 PHARMCUBE. All Rights Reserved.
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