Cha Biotech "Immune Cell Therapy Designated as Orphan Drug by US FDA"

[Asia Economy Reporter Seo So-jeong] Cha Biotech (CEO Oh Sang-hoon) announced on the 16th that it has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its immune cell therapy ‘CBT101’ targeting glioma.

CBT101 is an immune therapy developed by Cha Biotech by proliferating NK cells, which play a crucial role in innate immunity.

The scope of the FDA’s orphan drug designation includes not only the indication proposed by Cha Biotech, recurrent glioblastoma, but also all malignant gliomas such as astrocytoma, oligodendroglioma, oligoastrocytoma, and ependymoma. The FDA proactively expanded the indication range and designated it as an orphan drug.

The FDA’s orphan drug designation system supports the development and approval of treatments for rare and intractable diseases or life-threatening conditions. Treatments designated as orphan drugs receive benefits such as tax reductions, exemption from new drug approval review fees, and seven years of market exclusivity after approval. In particular, it is expected to significantly shorten the time required from clinical trials to commercialization.

According to GlobalData, a global market research firm, the market size for glioblastoma treatments is expected to grow from 734 billion KRW in 2014 to 3.6 trillion KRW in 2024. Cha Biotech plans to accelerate its entry into the global market, including the U.S., by rapidly advancing clinical trials and commercializing the product following this orphan drug designation.

A representative from Cha Biotech stated, "CBT101 applies Cha Biotech’s proprietary cell culture technology to increase NK cell proliferation by about 2,000 times and enhance NK cell activity from 5-10% to 90%, greatly strengthening its anticancer effects."