Hanmi’s Rolontis post sales of KRW 4.8 bil in H1

FDA new drug prepares to settle in Korea

Started sales in Korea in late 2021... has continued to show growth every quarter since

Cumulative sales in Korea amount to KRW 8 billion... makes quarterly sales of KRW 20 billion in the U.S. market

Hanmi Pharm’s new drug ‘Rolontis’ has been slowly increasing its influence in the domestic market.

 

In the first half of the year, 2 years into its release, the drug has posted sales of nearly KRW 5 billion.

 

The drug has also been achieving fair results in the early stages of its release in the U.S.

 

According to the pharmaceutical research institution IQVIA, Hanmi Pharm’s Rolontis posted sales of KRW 4.8 billion in 1H and rose over 10 times from the previous year.

 

Rolontis is a new biodrug that Hanmi Pharmaceutical licensed out to Spectrum Pharmaceuticals in 2012.

 

The drug is indicated for the treatment or prevention of neutropenia in cancer patients who receive myelosuppressive chemotherapy.

 

As a granulocyte colony-stimulating factor (G-CSF) class that stimulates the granulocyte to increase neutrophil production, the drug has a similar mechanism of action with Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim).’ In Korea, Rolontis was approved in March as the 33rd homegrown novel drug and listed for reimbursement in November 2021.

 

Quarterly Sales of Rolontis(Unit: KRW !

 

million, Data: IQVIA)

Rolontis exceeded KRW 1 billion in sales in Q4 last year.

 

Sales continued to rise to KRW 2.3 billion and KRW 2.5 billion in Q1 and Q2 this year, respectively.

 

At this trend, sales are expected to exceed KRW 10 billion this year, in only the second year of its release.

 

Rolontis’s cumulative domestic sales have recorded KRW 8 billion.

 

Rolontis is receiving much attention after successfully entering the U.S.

 

market.

 

Rolontis was approved by the U.S.

 

FDA under the brand name Rolvedon in September 2021.

 

The drug was successfully commercialized and released into the U.S.

 

market 10 years after the licensing-out deal was made.

 

With the approval, Rolontis became the first new drug to receive FDA marketing authorization among those being developed by Hanmi Pharm.

 

It is the first new drug to be sold in the US market after being produced at a domestic plant (Pyeongtaek Bio Plant) that has received on-site inspections from the FDA.

 

Rolontis was released in the U.S.

 

market in earnest in October last year.

 

The U.S.

 

neutropenia treatment market is worth KRW 3 trillion a year.

 

Since its launch, Rolontis has been showing smooth performance in the U.S.

 

market.

 

Rolvedon recorded sales of USD 15.6 million (about KRW 20 billion) in the Q1.

 

In Q2, sales amounted to $21 million (about KRW 28 billion), up 34.6% from the previous quarter.

 

Rolvedon initially received FDA approval after the technology was licensed out to Spectrum Pharmaceuticals, and in April, Spectrum was acquired by Assertio Holdings, a pharmaceutical company specializing in central nervous system, pain, and inflammation.

 

In its Q2 performance earnings report, Assertio explained, “The acquisition of the Spectrum and Rolvedon asset has brought significant changes to the company.

 

We plan to maintain a highly effective sales and marketing organization to expand the success of the new asset.”