Sales of K-anticancer drugs Leclaz and Rolontis rise in KOR

Preparing to settle in the Korean market

Sales of Yuhan’s Leclaza reached KRW 16.4 billion between Q1-Q3 this year… expected to exceed KRW 20 bil in annual sales

Cumulative sales of Hanmi’s Rolontis exceeded KRW 10 billion since its release…sales also smooth in the US

New anticancer drugs developed by domestic companies are gradually increasing their influence in their home market.

 

Sales of Yuhan Corp’s lung cancer treatment Leclaza are expected to exceed KRW 20 billion this year.

 

Also, cumulative sales of Hanmi Pharmaceutical's neutropenia treatment Rolontis have exceeded KRW 10 billion just 2 two into its launch.

 

According to the pharmaceutical research institution IQVIA on the 22nd, sales of Leclaza increased by 30.2% YoY to reach KRW 6 billion in Q3 this year.

 

Leclaza is a treatment for non-small cell lung cancer that was approved as the 31st novel homegrown drug in January 2021.

 

Leclaza entered the prescription market in earnest with its reimbursement listing in July 2021.

 

Leclaza generated sales of KRW 1.5 billion and KRW 2.6 billion in Q3 and Q4 2021, respectively.

 

Last year, sales reached KRW 16.1 billion, exceeding the KRW 10 billion mark just in the second year of its release.

 

Leclaza posted sales of around KRW 5 billion each in Q1 and Q2 of this year, and the sales increase was greater in Q3 this year.

 

Leclaza’s cumulative sales by Q3 this year became KRW 16.4 billion.

 

If this trend continues, sales are likely to exceed KRW 20 billion in its third year of release.

 

Quarterly Leclaza sales (Unit: KRW 1 mil, Data: IQVIA)

In the early stages of its release, Leclaza had made a smooth start.

 

As new anticancer drugs need to directly compete with promising new drugs from multinational pharmaceutical companies, it is not easy for local homegrown new anticancer drugs to achieve commercial results.

 

Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita.

 

None of the products posted annual sales that exceeded KRW 10 billion.

 

If the drug is reimbursed as a first-line treatment, its rate of market expansion may accelerate further in the future.

 

Leclaza was first approved as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) who developed a resistance to a specific gene (T790M) after being previously treated with 1st generation or 2nd generation EGFR-TKIs.

 

Recently, it also received approval as a first-line treatment.

 

The Ministry of Food and Drug Safety approved the change to extend Leclaza’s indications to ‘first-line treatment of non-small cell lung cancer’.

 

Fueled by the approval, Yuhan Corp applied for the reimbursement of Leclaza as a first-line treatment to health authorities in Korea.

 

Also, the company announced plans to provide Leclaza as a first-line treatment free of charge until reimbursement approval.

 

The company plans to provide the clinical trial formulation of Leclaza as a first-line treatment to patients free of charge using an Early Access Program (EAP).

 

Without reimbursement, the drug costs KRW 6 million per month.

 

Sales of Hanmi Pharmaceutical Rolontis in Q3 were KRW 2.9 billion, which is twice what it had made in the same period last year.

 

Rolontis is administered 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 novel homegrown drug and started to be sold in Korea after being listed for reimbursement in November 2021.

 

Sales of Rolontis continued on an upward trend since generating its first sales in Q1 last year.

 

Last year, it posted sales of KRW 3.2 billion.

 

This year, it made KRW 7.7 billion in just three quarters and exceeded KRW 10 billion in cumulative sales for the first time since its launch.

 

Quarterly Rolontis sales (Unit: KRW 1 mil, Data: IQVIA)

Rolontis is a homegrown novel drug that was approved by the U.S.

 

FDA.

 

Hanmi had licensed-out Rolontis’s technology to Spectrum Pharmaceuticals in 2012 and received FDA approval for the drug under the brand name, Rolvedon.

 

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 the US market, Rolvedon recorded sales of USD 15.6 million (about KRW 20 billion) in Q1 and USD 21 million (about KRW 28 billion) in Q2, continuing growth in the US market as well.