April 20, 2024

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NeoImmuneTech, an immunotherapy drug development company, announced on April 16 that its drug candidate HyLeukin-7 has been designated an orphan drug by the US Food and Drug Administration.

HyLeukin-7, which is an immunotherapeutic treatment designed to induce T cell proliferation and that helps the body fight serious disease, was co-developed by Korean company Genexine and Maryland-based NeoImmuneTech. 

The FDA grants orphan status to drugs that are intended for the treatment of rare diseases, with limited profitability potential, affecting fewer than 200,000 people in the US. Drugs with orphan status receive benefits including tax breaks, approval fee reductions and a guarantee of seven-year market exclusivity.

“We are glad that the FDA saw the potential in Hyleukin-7 as a revolutionary treatment for the disease Idiopathic CD4+ Lymphocytopenia and we expect to proceed clinical trials,” NeoImmuneTech Chief Medical Officer NgocDiep Le said in a statement.

In May 2017, NeoImmuneTech’s drug candidate Hyleukin-7 was also designated for treating rare diseases by the European Medicines Agency.

Established in 2014, NeoImmuneTech is a spun-off entity of Korean new drug developer Genexine.

Since the company is preparing to be listed in Korea under the “Tesla standards” to allow the listing of promising companies that have not yet posted significant profits, industry sources expect the US FDA’s orphan drug designation to play a positive role. Industry insiders project the company’s value to be around 400 billion won ($352 million).

By Song Seung-hyun (ssh@heraldcorp.com)