GC Cell’s Immuncell-LC gains orphan drug status from FDA

GC Cell Corp., a South Korean manufacturer of immune cell therapy drugs, said Friday the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation to one of its treatments for glioblastoma, the most common and malignant primary brain tumor in adults.

The drug - Immuncell-LC - is a personalized cancer immunotherapy medicine made from the patient’s blood. A sample of the patient’s T-cells, a type of white blood cell involved in fighting infection, is extracted from the blood and genetically modified to target and kill certain cancer cells before they are infused back into the patient.

Immuncell-LC has been marketed as a treatment for liver cancer in Korea after gaining approval from the Ministry of Food and Drug Safety in 2007. It also gained orphan status as a liver cancer drug from the FDA in June.

The orphan drug designation is a special status granted by the FDA to a drug that treats a rare medical condition. An orphan drug receives a host of financial incentives, such as tax cuts, waiver of application fees, and eligibility for seven-year exclusivity upon marketing approval.

Shares of GC Cell jumped on the news on Friday, surging 29.97 percent to close the day at 45,570 won ($40.5). Shares of its parent company Green Cross Corp. also rose 5.59 percent to finish at 189,000 won.

GC Cell in its latest regulatory filing reported that its operating profit for the first six months of the year jumped 62.1 percent year-on-year to 2.36 billion won, extending its profitability streak for 15 straight quarters. Sales were up 50.7 percent at 12.4 billion won. Net profit nearly quadrupled to 1.5 billion won.

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