GC Cell Obtains Advanced Biopharmaceutical Approval for Immuncell-LC

[Asia Economy, reporter Yoo Hyunseok] GC Cell, a company specializing in cell therapy, announced on the 30th that it has obtained approval for its advanced biopharmaceutical product, Immuncell-LC, under the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (hereinafter referred to as the Advanced Regenerative Bio Act).

According to the Advanced Regenerative Bio Act, which took effect in August 2020, advanced biopharmaceuticals that previously obtained product approval under the Pharmaceutical Affairs Act were required to resubmit for re-approval within one year by submitting documents in the Common Technical Document (CTD) format. Immuncell-LC successfully received re-approval on the 27th.

Immuncell-LC was first approved as an anti-cancer agent for liver cancer in 2007. In 2015, it became the first cell therapy in Korea to achieve annual sales of 10 billion KRW, and last year, it reached 35.6 billion KRW, continuing its steady growth.

Lee Deukjoo, CEO of GC Cell, stated, "GC Cell has stably produced Immuncell-LC for over 10 years, treating more than 6,000 patients to date. We have completed large-scale Phase 3 clinical trials and post-marketing surveillance, which were considered challenging for cell therapies, and with this advanced biopharmaceutical approval, Immuncell-LC has become the only immune cell therapy among domestic pharmaceutical and bio companies." He added, "Going forward, we will leverage our production technology and commercialization know-how for Immuncell-LC to drive research and development of CAR-T therapies and off-the-shelf CAR-CIK products, as well as achieve global growth through our specialized CDMO business in cell therapy."

GC Cell manufactures and sells the immune-oncology drug Immuncell-LC. Through its US subsidiary, Novacell, the company is advancing into US clinical trials for a CAR-T therapy targeting pancreatic cancer. Additionally, it is developing an off-the-shelf allogeneic CAR-CIK (cytokine-induced killer cell) therapy using its CAR platform technology.

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