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GC Cell’s anticancer drug gains orphan drug designation from the U.S. FDA
2018-09-03

GC Cell has announced that it has received an orphan drug designation (ODD) from the U.S. Food and Drug Administration for its immunotherapy Immuncell-LC to treat glioblastoma in the brain.

In 2007, the company won approval from the Ministry of Food and Drug Safety for Immuncell-LC to treat liver cancer.

In June this year, the immunotherapy was also designated in the U.S. as a rare drug for liver cancer treatment (hepatocellular carcinoma).

FDA grants ODD status to drug that work towards curing rare or life-threatening diseases by encouraging them to accelerate the development, and obtain U.S. product license.

The ODD status provides companies with a variety of benefits that include tax breaks, and exemption from fees related to new drug approval review. After gaining marketing authorization, they are also eligible for a seven-year exclusive monopoly.

Through the ODD designation, GC Cell is planning to create a successful marketing strategy towards the U.S. oncology market, and is awaiting the FDA’s rare drug approval for pancreatic cancer treatment.

In particular, since the potential therapeutic value of Immuncell-LC is already recognized through its ODD status, GC Cell is expected to conduct its clinical trials under favorable terms.

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