On November 1, 2026, international hematologic oncology consensus panels highlighted Epkinly® (Epcoritamab-bysp 4 mg/0.8 mL and 48 mg/0.8 mL solution for subcutaneous injection) co-developed by Genmab and AbbVie as a benchmark subcutaneous bispecific antibody for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

As an off-the-shelf T-cell redirecting bispecific antibody delivered via convenient subcutaneous injection, Epkinly circumvents the substantial logistical barriers of autologous CAR-T cell manufacturing while eliciting profound, durable complete responses in heavily pretreated high-risk lymphoma populations.

Through Critical Kare Pharma, certified genuine manufacturer packs of Epkinly Epcoritamab Subcutaneous Injection are supplied directly to tertiary hematology centers, bone marrow transplant units, and named patients globally via GDP-certified 2°C–8°C thermal transit with full Certificate of Analysis (COA) batch release.

Mechanism of Action: Subcutaneous CD3xCD20 Dual Targeting

Epkinly utilizes full-length IgG1 bispecific antibody engineering (DuoBody technology):

• Dual Antigen Engagement: Binds selectively to CD20 on malignant B-cells and CD3 on endogenous T-cells, triggering targeted immune synapse formation.
• Subcutaneous Absorption Kinetics: Subcutaneous injection provides slow systemic release, blunting the peak plasma concentrations that drive severe intravenous Cytokine Release Syndrome (CRS).
• Cytolytic Eradication: Induces potent T-cell activation and targeted release of perforin and granzymes, destroying malignant B-cells irrespective of prior CAR-T failure.

EPCORE NHL-1 Trial Benchmarks

In the pivotal EPCORE NHL-1 trial, Epkinly demonstrated practice-changing outcomes:

• Overall Response Rate: Achieved an overall response rate of 63.1% with a 38.9% complete response rate in patients with relapsed/refractory DLBCL who failed median three prior lines.
• Post-CAR-T Activity: Among patients previously treated with CAR-T cell therapy, the complete response rate reached 34%, confirming its role as an indispensable salvage therapy.

Step-Up Dosing & Inpatient Surveillance

Treatment follows a 28-day cycle protocol with mandatory priming:

• Cycle 1 Step-Up: 0.16 mg on Day 1, 0.8 mg on Day 8, and full dose 48 mg on Day 15 and Day 22.
• Premedication: Dexamethasone 20 mg, diphenhydramine, and acetaminophen administered prior to each step-up dose.

Global Cold-Chain Sourcing via Critical Kare Pharma

Supplied under US FDA Personal Importation, UK MHRA Special Import, and ANVISA corridors with real-time temperature tracking.