K-made anticancer drugs Leclaza, Rolontis show sales growth

Leclaza generated 22.6 billion won in sales last year, becoming the first Korea-made new anticancer drug to exceed 20 billion won in sales

Rolontis generated 11.4 billion won in sales in the second year after its launch and cumulative sales of 14.6 billion won

New anticancer drugs developed by Korean pharmaceutical companies are showing a steady growth path in the market.

 

Yuhan’s Leclaza, a lung cancer treatment, surpassed 20 billion won in annual sales, becoming the first domestically developed anticancer drug to achieve this.

 

Hanmi’s Rolontis, a treatment for neutropenia, reached 10 billion won in sales just two years after its launch.

 

Last year, Leclaza generated 22.6 billion won in sales, showing a 40.3% year-over-year (YoY) growth, according to a drug market research company IQVIA on the 21st.

 

Leclaza is the 31st domestically developed new drug approved in Korea for treating non-small cell lung cancer (NSCLC) in January 2021.

 

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

 

The following year after its launch, Leclaza’s sales surpassed 10 billion won, reaching 16.1 billion won.

 

Last year, Leclaza surpassed 20 billion won in sales.

 

Qauterly Leclaza sales trend (Unit: 1 million won, Source: IQVIA).

Leclaza was the first domestically developed anticancer drug to surpass annual sales of 10 billion won and later achieved sales of over 20 billion won.

 

Domestically developed new anticancer drugs receiving approval before Leclaza are Il-Yang Pharm's Supect, Dong-A Pharm's Milican, Chong Kun Dang's Camtobell, Samsung Pharm’s Riavax, and Hanmi Pharm's Olita.

 

None of these drugs have exceeded annual sales of 10 billion won.

 

The expanded reimbursement of Leclaza as a first-line treatment will likely drive rapid market growth.

 

Initially, Leclaza was approved as a second-line treatment for locally advanced or metastatic NSCLC that had developed acquired resistance due to a specific genetic mutation (T790M) following the administration of first or second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI).

 

Then, Leclaza has received approval for use as a first-line treatment.

 

Last June, the Ministry of Food and Drug Safety (MFDS) approved the application for approval of changes for expanding the use of Yuhan’s Leclaza to a ‘first-line treatment of NSCLC.’ Yuhan submitted an application to the Ministry of Health and Welfare (MOHW) for Leclaza’s reimbursement as a first-line treatment.

 

The MOHW approved Leclaza’s reimbursement expansion to include its use as a first-line treatment last month.

 

Starting this year, Leclaza became available for health insurance reimbursement as a ‘first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations.’ The MOHW has estimated that granting reimbursement of Leclaza as a first-line treatment option will require an additional budget of 88.1 billion won.

 

Numerically, there is potential for Leclaza’s sales to surpass 1 trillion won next year.

 

However, competition is expected to increase due to expanded reimbursement of Tagrisso, a similar drug in the same class.

 

Hanmi’s Rolontis generated 11.4 billion won in sales last year, expanding three times compared to its 2022 sales of 3.2 billion won.

 

Rolantis became the second domestically developed new anticancer drug, after Leclaza, to exceed annual sales of 10 billion won.

 

Quarterly Rolontis sales trend (Unit: 1 million won, Source: IQVIA).

Rolontis is administered to cancer patients who have undergone myelosuppressive chemotherapy as a treatment of neutropenia or as a preventative measure.

 

Rolontis belongs to a granulocyte colony-stimulating factor (G-CSF) class, which stimulates granulocytes to enhance neutrophil production.

 

It shows a mechanism of action similar to Amgen’s blockbuster drug, Neulasta.

 

After it generated its first sales in Q1 of 2022, Rolontis showed a steady growth in sales.

 

It surpassed 2 billion won in sales last Q1; later, it surpassed 3 billion won in the previous Q4.

 

After its launch, Rolontis generated a cumulative sales of 14.6 billion won.

 

Rolontis is a domestically developed new drug that also received approval from the U.S.

 

Food and Drug Administration (FDA).

 

In 2012, Hanmi Pharm made a technology transport of Rolontis to Spectrum.

 

In September 2021, it won FDA approval under the U.S.

 

product name of Rolvedon.

 

Initially, Rolvedon secured FDA approval after Spectrum Pharmaceutical acquired Rolvedon’s technology transport.

 

Following the approval, Assertio Holdings, a pharmaceutical company specializing in the central nervous system, pain, and inflammation, acquired Spectrum in April last year.