Epcoritamab Approved in China for Follicular Lymphoma, Bringing a New CD20×CD3 Bispecific Therapy Option
On May 15, 2026, AbbVie announced that its CD20×CD3 bispecific antibody — Epkinly (Epcoritamab) — has been approved by China’s National Medical Products Administration (NMPA).
This marks a significant milestone in lymphoma treatment, as epcoritamab approved in China for follicular lymphoma expands new therapeutic options for patients with relapsed or refractory B-cell malignancies. 🎯
The approved indication is in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
As the first CD20×CD3 bispecific antibody approved in China for second-line and beyond R/R FL, and also a subcutaneous administration therapy, epcoritamab represents a major breakthrough in lymphoma treatment in China.
China pharmaceutical wholesaler DengYueMed continues to track emerging therapies including bispecific antibodies, CAR-T, and immunotherapy.
What is Epcoritamab?
Epcoritamab was originally developed by Genmab and later partnered with AbbVie in 2020 under a collaboration worth up to $3.9 billion to jointly develop and commercialize multiple next-generation bispecific antibodies, including Epcoritamab.
Epcoritamab is an IgG1 bispecific antibody that simultaneously binds:
By bridging tumor B cells and T cells, it activates the immune system to precisely eliminate malignant B cells.
Compared with traditional monoclonal antibodies, epcoritamab has several advantages: 👇
- Dual-target immune activation
- Fc-silent engineered design
- Potential reduction of excessive immune activation risk
- Subcutaneous administration
- Improved convenience and patient compliance
The mechanism behind epcoritamab approved in china for follicular lymphoma highlights the growing shift toward precision immunotherapy in hematologic malignancies.
Why Do Follicular Lymphoma Patients Need New Treatment Options?
Follicular lymphoma (FL) is a common indolent B-cell non-Hodgkin lymphoma.
Although many patients respond well to initial therapy, relapse and drug resistance remain major long-term challenges, especially for:
- Patients failing second-line or later therapies
- Multiple relapsed cases
- Patients resistant to prior immunotherapy
There is still a significant unmet clinical need.
In recent years, CD20×CD3 bispecific antibodies have rapidly become one of the most promising modalities in hematologic oncology due to their “off-the-shelf immunotherapy” advantages.
The approval of epcoritamab approved in china for follicular lymphoma further strengthens this treatment paradigm.
EPCORE FL-1 Study: ORR Reaches 95%
The approval of epcoritamab approved in china for follicular lymphoma is primarily based on the global Phase III EPCORE FL-1 clinical trial.
Study design:
- Epcoritamab + rituximab + lenalidomide (R²)
vs - Standard R² regimen
The study enrolled a broad population of R/R FL patients.
Key results showed a 79% reduction in the risk of disease progression or death: HR = 0.21
The combination regimen significantly reduced the risk of disease progression or death by 79% (HR=0.21, P<0.0001).
Overall Response Rate (ORR)
95% vs 79%
- Combination: 95%
- Control: 79%
Complete Response (CR)
83% vs 50%
- Combination: 83%
- Control: 50%
Progression-Free Survival (PFS)
Median PFS was not reached in the combination group, compared with 11.7 months in the control group.
Overall Survival (OS)
At 16 months:
- Combination: 95.8%
- Control: 88.8%
Delay to Next-Line Therapy
At 16 months:
- 92.8% of patients did not require next-line treatment
- Control: 64.9%
These results further support epcoritamab approved in china for follicular lymphoma as a potential new standard treatment option for R/R FL.
Global Approval of Epcoritamab
Epkinly was first approved globally in 2023.
It is currently approved in:
- United States
- European Union
- Japan
- China
The main indications include:
- Diffuse large B-cell lymphoma (DLBCL)
- Follicular lymphoma (FL)
According to public data, global sales of Epcoritamab reached $468 million in 2025.
The expansion of epcoritamab approved in china for follicular lymphoma reflects its increasing global clinical value.
Accelerating CD20×CD3 Bispecific Competition in China
Currently, four CD20×CD3 bispecific antibodies have been approved globally:
- Mosunetuzumab
- Glofitamab
- Epcoritamab
- Odronextamab
Except for Odronextamab, which is still in clinical development in China, the other agents have already been approved.
At the same time, Chinese biotech companies are rapidly advancing in this field, including:
- Chia Tai Tianqing Pharmaceutical Group
- Sinocelltech
- Junshi Biosciences
- Keymed Biosciences
👉 More than 10 CD20×CD3 bispecific antibodies are currently in clinical development in China.
AbbVie Ongoing Phase III Programs in China
In addition to EPCORE FL-1, AbbVie is conducting multiple Phase III trials in China, including:
- Epcoritamab vs chemotherapy in R/R DLBCL
- Epcoritamab + R-CHOP in frontline DLBCL
- Epcoritamab + R² in untreated FL
- Epcoritamab + lenalidomide in R/R DLBCL
With expanding indications, epcoritamab may eventually cover a broader range of B-cell malignancies.
Conclusion
With epcoritamab approved in china for follicular lymphoma, patients with relapsed or refractory FL now have access to a new immunotherapy option.
Compared with conventional regimens, CD20×CD3 bispecific antibodies demonstrate higher response rates and deeper remissions, marking a shift from the chemotherapy era toward precision immunotherapy in hematologic oncology.
🐱🏍 From CAR-T to CD20×CD3 bispecific antibodies, China is rapidly becoming one of the most important global markets for innovative hematologic cancer therapies.
For international patients and overseas healthcare institutions, China pharmaceutical wholesaler DengYueMed is helping more global users understand newly approved drugs, supply channels, and advanced treatment options in China.
FAQ about Epcoritamab Approved in China for Follicular Lymphoma
What is epcoritamab approved for in China?
Epcoritamab has been approved in China for use in combination with rituximab and lenalidomide for adult patients with relapsed or refractory (R/R) follicular lymphoma. It is a CD20×CD3 bispecific antibody that helps the immune system target and destroy malignant B cells.
What are the clinical benefits of epcoritamab in R/R follicular lymphoma?
In the Phase III EPCORE FL-1 study, epcoritamab-based combination therapy showed an overall response rate (ORR) of 95% compared to 79% with standard R² therapy. It also significantly reduced the risk of disease progression or death by 79%.
How does epcoritamab work in relapsed or refractory follicular lymphoma?
Epcoritamab binds simultaneously to CD20 on lymphoma cells and CD3 on T cells. This mechanism activates T cells to selectively kill malignant B cells in follicular lymphoma.
Why is epcoritamab considered an important treatment option?
Epcoritamab represents a new class of CD20×CD3 bispecific antibodies and provides a subcutaneous treatment option for patients with limited alternatives. Its strong efficacy and durable responses make it a promising therapy for relapsed or refractory follicular lymphoma.
