AbbVie’s CD20×CD3 bispecific antibody has been approved for marketing in China
On May 15, 2026, the official website of the National Medical Products Administration (NMPA) announced that Epcoritamab, a drug application submitted by AbbVie, was approved for marketing. The drug, when combined with Rituximab and Lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). (Acceptance number: JXSS2500127/8). This application had previously been included in the priority review process, indicating the speed of approval.
Epcoritamab was originally developed by Genmab. In 2020, AbbVie reached a collaboration agreement with Genmab worth a total of $3.9 billion to jointly develop and commercialize three next-generation bispecific antibodies from Genmab, including Epcoritamab.
As an IgG1 bispecific antibody, Epcoritamab can simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of lymphoma B cells. CD20 is a clinically validated therapeutic target and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.
In May 2023, Epcoritamab received its first global approval in the United States, and has since been approved for the treatment of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in multiple countries and regions including the United States, the European Union, and Japan. By 2025, Epcoritamab’s global sales had reached $468 million. This marks the first approval of Epcoritamab in China. However, no patents linked to Epcoritamab injection have been found in either the US FDA drug database or the Chinese registered platform for listed drug patent information, making it uncertain at present what the scope and strength of its patent protection are.
The study enrolled a total of 488 patients with R/R FL, who were randomly assigned in a 1:1 ratio to receive either the R2 regimen (Rituximab + Lenalidomide) or the combination of Epcoritamab and R2 regimen. At a median follow-up of 14.8 months, the objective response rate (ORR) in the combination group was as high as 95% (compared to 79% in the control group), and the complete response (CR) rate was 83% (compared to 50% in the control group). The differences between groups were highly statistically significant (P<0.0001).
More importantly, combination therapy significantly reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI 0.14-0.31, P<0.0001). The median progression-free survival (PFS) in the combination therapy group has not been reached, compared to 11.7 months in the R² monotherapy group. The estimated 16-month PFS rate in the combination therapy group was 85.5%, which was much higher than the 40.2% in the monotherapy group. In various high-risk subgroups (including patients with dual refractoriness and POD24), the trend of response benefit was consistent.
In terms of safety, the incidence of ≥ Grade 3 adverse events (AEs) in the combination group was 90%, with serious adverse events (SAEs) accounting for 56%. The incidence of CRS was 26% (Grade 1: 21%, Grade 2: 5%), all of which were low-grade and manageable. ICANS occurred in 0.8% of patients. The overall safety profile was consistent with the known safety profile of each drug, and no new safety signals were identified.
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