AbbVie's key CD20xCD3 bispecific antibody faces setbacks in China

According to a November 3 update on China's NMPA website, AbbVie's Epcoritamab Concentrated Solution for Injection and Epcoritamab Injection were listed in the list of dispatched notifications. This suggests the marketing authorization applications for these products may not have been approved, for undisclosed reasons.

In China's drug regulatory process, "Pharmaceutical Notification Dispatch" refers to official correspondence sent by the National Medical Products Administration (NMPA) to applicants, such as drug manufacturers. A successful application results in the issuance of a "Drug Approval Document." Conversely, if an application is rejected, the NMPA issues a "Notification Document," such as a "Notification of Review Opinions," which outlines the reasons for the rejection.

It is reported that a general notification will explain the reasons for non-approval, which may include failure to pass technical review, supplementary data not meeting requirements, or issues discovered during on-site inspections. Applicants can conduct additional research or adjust their application strategy based on the feedback. Therefore, receiving a "drug notification" does not necessarily mean the complete failure of drug marketing, and theoretically, there is a possibility of continuing the application process after improving and supplementing the data.

Previously, AbbVie had submitted four marketing applications for Epcoritamab to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), all of which were accepted. Two of these correspond to the items listed in the drug notification delivery information mentioned above, while the other two were accepted by the CDE on September 23, 2025, with the acceptance numbers JXSS2500127 and JXSS2500128. Thus, the number of indications it covers is now exactly equivalent to the number of indications already approved or currently under review globally.

Epcoritamab is a CD20×CD3 bispecific antibody that can simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of lymphoma B cells. The drug was initially developed by Genmab using the DuoBody technology platform. In June 2020, AbbVie and Genmab entered into a $3.9 billion collaboration agreement to co-develop three next-generation bispecific antibody products, including Epcoritamab. Both parties share commercialization responsibilities in Japan and the United States, while AbbVie is responsible for further global development.

In May 2023, the FDA approved Epcoritamab for marketing. Currently, the drug has been approved for marketing in the United States, the European Union, and Japan, with indications covering diffuse large B-cell lymphoma, follicular lymphoma, and primary mediastinal large B-cell lymphoma. In early May this year, Genmab submitted a new indication application to the FDA for use in combination with Lenalidomide plus Rituximab (trade name: Mabthera) to treat relapsed/refractory follicular lymphoma (R/R FL) that has undergone at least one systemic therapy. The application received priority review, with a PDUFA date of November 30, 2025.

On August 7, Genmab announced positive results from the Phase III EPCORE® FL-1 trial on its official website. The trial aimed to evaluate the efficacy of subcutaneous bispecific antibody Epcoritamab in combination with Rituximab and Lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The results showed that Epcoritamab in combination with Rituximab and Lenalidomide (R2) significantly improved both the overall response rate (ORR: 95.7%, p<0.0001) and progression-free survival (HR 0.21, p-value<0.0001) in patients with relapsed/refractory follicular lymphoma (FL) compared to R2 regimen alone.

Commercially, Epcoritamab generated global sales of $281 million in 2024, establishing itself as a core growth product in AbbVie's hematology portfolio. Revenue for the first half of this year reached $121 million, a year-on-year increase of 92.1%.