GC Cell Announces Approval of Immuno-Oncology Drug Immuncell-LC Injection as Advanced Biopharmaceutical

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[Asia Economy, reporter Seo Sojeong] GC Cell announced on August 30 that its immuno-oncology drug "Immuncell-LC Injection" received approval as an advanced biopharmaceutical on August 27 under the "Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals."

The Advanced Regenerative Biopharmaceuticals Act, which took effect in August 2020, requires advanced biopharmaceuticals that previously obtained product approval under the Pharmaceutical Affairs Act to submit an international common technical document (CTD) and other necessary materials within one year to receive re-approval.

Immuncell-LC Injection received product approval as an anti-cancer drug for liver cancer in 2007. In 2015, it became the first cell therapy product in Korea to achieve annual sales of KRW 10 billion, and last year, it recorded sales of KRW 35.6 billion.

GC Cell is producing and marketing Immuncell-LC Injection, and through its U.S. subsidiary Novacell, is pursuing entry into U.S. clinical trials for a CAR-T (Chimeric Antigen Receptor T-cell) therapy targeting pancreatic cancer. The company is also developing an off-the-shelf, allogeneic CAR-CIK (cytokine-induced killer cell) therapy.

Lee Deukjoo, CEO of GC Cell, stated, "We have completed large-scale Phase 3 clinical trials and post-marketing surveillance, which were considered difficult for cell therapies, and have now obtained approval as an advanced biopharmaceutical. Leveraging our production technology and commercialization know-how for Immuncell-LC Injection, we will grow into a global company through R&D in CAR-T therapies, off-the-shelf CAR-CIK products, and achievements in cell therapy-focused contract development and manufacturing (CDMO) services."

This content was produced with the assistance of AI translation services.