Korean-made new drug Rolontis readies for FN drug market

Targeting FN drug market, competition directly against Neulasta

Healthcare providers “The domestic market is limited, better target overseas”

Hanmi Pharmaceutical is readying for the febrile neutropenia (FN) treatment market for its first bio new drug Rolontis (eflapegrastim), as it finally received the South Korean health authority’s market authorization.

 

This could be an opportunity for the South Korean company to take over the domestic drug market, currently led by global pharmaceutical companies.

 

# On Mar.

 

18, South Korea’s Ministry of Food and Drug Safety (MFDS) approved the marketing of Hanmi Pharmaceutical's 'Rolontis' as the 33rd new drug developed in the country.

 

At the same time, Hanmi Pharm entered the countdown of Rolontis' entry into the U.S.

 

market.

 

The U.S.

 

Food and Drug Administration’s (FDA) `pre-approval inspection (PAI),’ previously delayed due to COVID-19 pandemic, has been scheduled in May.

 

A ‘long-term use' new drug, is it a blockbuster drug material?

 

FN refers to an abnormal decrease in neutrophils, which must occupy 50 percent to 70 percent of white blood cells.

 

There are many factors that cause FN, but it is typical that most cancer patients develop FN due to several anticancer treatments.

 

For this reason, treatments are mostly prescribed for the prevention or treatment of FN caused by anticancer treatment.

 

It has been prescribed for all carcinomas in recent years, including leukemia and breast cancer.

 

Professor Park Inkeun of Oncology Department at Gachon University explained, “Neutrophils are a type of white blood cell and, in simple terms, are responsible for defending against bacterial infection.

 

When chemotherapy is performed, the number of neutrophils decreases, but it recovers over time.

 

However, a treatment is prescribed because there is a risk of infection occurring at the stage of decreasing neutrophils.” The professor added, “Just as people drink differently, the amount of neutrophil reduction is different for each patient.

 

In particular, it could be fatal for elderly patients.

 

For this reason, FN treatments are also administered for prevention purposes every chemotherapy cycle.

 

It's not a one-off shot.” Then, how about the competitiveness of Rolontis in the market?

 

#The FN treatment market in the past used to be dominated by granulocyte colony-stimulating factor (G-CSF) drugs, but recently next generation G-CSF drugs for preventive purpose are expanding in the market.

 

At the moment, the market is dominated by Amgen’s Neulasta (pegfilgrastim), which Kyowa Kirin Korea is supplying to the South Korean market.

 

Meanwhile, Hanmi Pharmaceutical disclosed the data collected from two global Phase II trials (ADVANCE and RECOVER) facilitated by the company’s partner Spectrum Pharmaceuticals.

 

The two trials conducted on 643 early-stage breast cancer patients with FN caused by anticancer treatment confirmed the safety and efficacy of Rolontis.

 

Within total four treatment cycles, Rolontis, compared against its competitor Neulasta, demonstrated non-inferior duration of severe neutropenia (DSN) and superior reduction of risk.

 

Healthcare providers reserve opinion on Rolontis dominating the market Hanmi Pharmaceutical is planning to go through an official domestic market release process as it obtains the world's first approval for Rolontis in South Korea, regardless of the approval by the U.S.

 

FDA.

 

The size of the domestic market for FN drug is estimated at 80 billion won.

 

The figure is the sum of the annual sales of the first and second generation G-CSF drugs, but Rolontis would compete directly against the second generation G-CSF drugs.

 

The top-selling drugs are Neulasta (Kyowa Kirin Korea), Neulapeg (GC Pharma), Lonquex (Teva Handok) and Dulastin (Dong-A ST).

 

A pharmaceutical market research firm IQVIA reported, the sales of these four second-generation G-CSF drugs have been steadily increasing since 2017, reaching about 46 billion won last year.

 

Meanwhile, in the healthcare providers mostly predict, even if Rolontis is released in South Korea, highly unlikely the drug would dominate the market easily.

 

The market size is relatively small, while already-commercialized products have stable presence in the medical field.

 

Ultimately, the company would have to target the overseas market.

 

Currently, the global market is estimated at 3 trillion won.