GCCL said it contributed clinical bioanalysis and central laboratory integrated services to the regulatory approval process for CureCell’s CAR-T therapy Rimkato (anbal-cel) in South Korea.

Rimkato is the first domestically developed CAR-T therapy approved in South Korea. The orphan drug is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more lines of systemic therapy.

The approval is viewed as a milestone demonstrating that Korean-developed CAR-T therapies have entered the commercialization stage, highlighting the country’s growing capabilities in cell and gene therapy development.

The launch is also expected to improve treatment access for patients with refractory blood cancers by establishing a domestic production and supply base in a field previously dependent on imported CAR-T products.

GCCL participated in the pivotal clinical trial “CRC01-01,” providing integrated bioanalytical and central laboratory services.

The company said it handled the full process, including assay development and validation, clinical sample analysis, specimen operations and project management, helping generate and manage reliable clinical analysis data used to evaluate the therapy’s safety and efficacy.

Clinical trials for CAR-T therapies require comprehensive evaluation of immune responses, cellular immunity, pharmacodynamic responses, residual persistence at the genetic level and safety indicators, requiring high levels of analytical sensitivity, reproducibility and quality control.

Leveraging multiple analytical platforms and immunoassay experience, GCCL supported immune response and biomarker evaluations, demonstrating its clinical development capabilities for CAR-T therapies.

The company noted that clinical trials involving cell and gene therapies often involve complex coordination among specimen types, analytical items, processing conditions, transportation and storage requirements, making integrated specimen management expertise critical alongside analytical capabilities.

As a central laboratory, GCCL systematically managed the collection, transport, storage, preprocessing and analytical linkage of clinical samples collected from multiple domestic trial sites.

The company said the system helped ensure stable generation of reliable clinical analysis data even in complex multicenter clinical trial environments.

Following previous participation in pivotal clinical analyses supporting major domestic vaccine development projects, GCCL said the Rimkato program further demonstrated its capabilities as a clinical analysis partner supporting advanced biopharmaceutical development through integrated bioanalysis and central laboratory services.

The company is also continuing analytical support for follow-up clinical trials of the same therapy in adult B-cell acute lymphoblastic leukemia (ALL), further expanding its CAR-T clinical development experience.

GCCL CEO Cho Kwan-gu said, “It is meaningful to participate as a clinical trial analysis partner in the approval of Korea’s first CAR-T therapy,” adding, “We will continue supporting new drug development across cell and gene therapies, oncology and biopharmaceuticals through globally competitive analytical infrastructure and quality management systems.”

Rimkato receives approval without Phase 3 trial

Meanwhile, Rimkato has drawn attention as a next-generation CD19 CAR-T therapy developed by CureCell using its proprietary OVIS (Overcome Immune Suppression) technology.

The technology is designed to control immunosuppressive signals within the tumor microenvironment, helping address T-cell exhaustion and maintain anticancer activity over longer periods.

Rimkato was approved for adult patients with relapsed or refractory DLBCL and PMBCL following at least two prior systemic therapies.

In the Phase 2 trial supporting approval, Rimkato demonstrated an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%.

The therapy also showed manageable safety outcomes, with severe cytokine release syndrome (CRS) occurring in 10% of patients and severe immune effector cell-associated neurotoxicity syndrome (ICANS) occurring in 5%.

CureCell initially applied for conditional approval requiring a Phase 3 trial. However, South Korea’s Ministry of Food and Drug Safety waived the Phase 3 requirement during the review process, citing the therapy’s role as a third-line CAR-T treatment for lymphoma.

Instead, similar to other global CAR-T therapies, the regulator granted full approval on the condition that long-term follow-up studies and risk management plans continue to monitor safety and efficacy after commercialization.

GCCL said it contributed clinical bioanalysis and central laboratory integrated services t …

Korea’s First Domestic CAR-T Therapy Just Won Approval—and That’s a Bigger Deal Than It Sounds