[Featured Stock] Pharos iBio Designated as a Rare Drug by the MFDS

Pharos iBio is showing strong performance. The news that the treatment for relapsed and refractory acute myeloid leukemia (AML), ‘PHI-101,’ has been designated as an orphan drug in the development stage by the Ministry of Food and Drug Safety appears to be influencing the stock price.

As of 9:13 AM on the 4th, Pharos iBio is trading at 11,230 KRW, up 6.45% from the previous day.

PHI-101 is a compound derived using the artificial intelligence (AI) drug development platform ‘Chemiverse®’ and received orphan drug designation (ODD) approval from the U.S. Food and Drug Administration (FDA) in 2019. It is Pharos iBio’s core pipeline, having completed patient recruitment for Phase 1 clinical trials in July this year and is expected to conclude within the year. Pharos iBio is preparing for global Phase 2 clinical trials of PHI-101 in the U.S., Australia, and other countries.

Since 2013, the Ministry of Food and Drug Safety has introduced the ‘Development Stage Orphan Drug Designation System’ to designate drugs as orphan drugs early in the development stage, aiming to increase predictability of approval data requirements and improve development success rates. Drugs designated under this system receive benefits such as ▲extension of marketing authorization validity period (from 5 years to 10 years) ▲reexamination period granted within 10 years to encourage development motivation through data protection ▲relaxation of manufacturing and quality control standards (GMP) evaluation data requirements ▲removal of market size limitation criteria ▲exemption from pre-review fees, among other benefits.

PHI-101, for which Pharos iBio is conducting multinational Phase 1 clinical trials, is an FLT3 (FMS-like tyrosine kinase 3) targeted anticancer drug for patients with acute myeloid leukemia who are refractory to or have relapsed after existing treatments. Acute myeloid leukemia is a type of blood cancer characterized by bone marrow blasts (BM Blast) accounting for 20% or more in the bone marrow, and the FLT3 mutation, observed in 30-35% of leukemia patients, is considered a major factor.