GC Green Cross Cell Signs CMO Agreement for U.S. Clinical Trial Drug Production

CMO Agreement Worth 8.1 Billion KRW Signed After Cell Center GMP Approval
Production of Cord Blood-Derived NK Cell Therapy for Phase 1/2 Clinical Trials in the U.S.

[Asia Economy, Reporter Park Hyungsoo] GC Green Cross Cell, a developer of cell therapy products, announced on June 22 that it has signed a contract manufacturing organization (CMO) agreement worth 8.1 billion KRW at its Yongin Cell Center.

The client is Artiva Biotherapeutics, a cell therapy research company based in San Diego, United States. The contract is for the production of AB-101, a cord blood-derived natural killer (NK) cell therapy product, for use in Phase 1/2 clinical trials in the United States.

The contract period for the AB-101 CMO agreement runs until the end of December next year. The contract is valued at 5.2 billion KRW, though the amount may be adjusted depending on the production schedule and yield.

While previous CMO products were all aimed at the domestic market, this agreement with Artiva marks the start of producing clinical trial drugs for the U.S. market. This highlights the global-level stability and quality of GC Green Cross Cell's technology and manufacturing facilities.

The other client is GC Green Cross LabCell. The company will produce MG4101, an allogeneic peripheral blood-derived NK cell therapy, and CT3103, an allogeneic mesenchymal stem cell therapy.

Through these CMO agreements, GC Green Cross Cell expects to achieve CMO sales of 8.1 billion KRW by next year. Last year, the company recorded CMO sales of 370 million KRW.

This CMO agreement marks the first achievement since the Cell Center received GMP manufacturing approval last month. Established in 2016, the Cell Center is equipped with advanced cGMP-level facilities and manufacturing systems optimized for cell therapy production.

The biopharmaceutical CMO market is drawing global attention and is expected to grow to 25 billion USD by 2025. The recent surge in innovative therapies such as cell and gene therapies is driving increased demand for specialized CMO companies.

Lee Deukjoo, CEO of GC Green Cross Cell, stated, "GC Green Cross Cell aims to lead the global CMO business specializing in cell therapies, leveraging the know-how accumulated from the production of Immuncell-LC and successful CMO cases such as Cellid."

He added, "It is highly significant that we are producing clinical trial drugs for the U.S. market," and continued, "As the first achievement through the Cell Center, we have signed CMO agreements with both Artiva and GC Green Cross LabCell."

GC Green Cross Cell is developing next-generation cell therapies, including CAR-T therapies. In March, the company announced preclinical research results for its MSLN (mesothelin) CAR-T therapy targeting solid tumors.

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