Leclaza’s sales soar with reimbursement expansion

K-anticancer drug Leclaza

Leclaza's Q1 sales KRW 18.9 billion...270% YoY increase

Received reimbursement listing as a first-line treatment this year…sales increased threefold from the previous quarter

First domestic anti-cancer drug to surpass KRW 10 billion in Q1 sales...US approval is also in sight

The sales of Yuhan Corp’s new anti-cancer drug 'Leclaza' have jumped significantly.

 

Sales have more than tripled in one year since the drug has been granted reimbursement as a first-line treatment for lung cancer this year.

 

Leclaza’s sales quickly reached the KRW 20 billion mark in quarterly sales, paving the way for the drug to achieve the KRW 100 billion mark in annual sales.

 

According to the drug research institution IQVIA on Wednesday, Leclaza reported sales of KRW 18.9 billion in Q1, up 269.9% from the KRW 5.1 billion in Q1 last year.

 

Leclaza’s first-quarter sales more than tripled from the previous quarter.

 

Quarterly Leclaza sales (Unit: KRW 100 million, Source: IQVIA)

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

 

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

 

Leclaza’s quarterly sales last year were in the KRW 5 billion to 6 billion range, but its sales have more than tripled this year.

 

The surge in prescriptions is likely due to Leclaza’s reimbursement expansion as a first-line treatment.

 

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.

 

In June last year, the Ministry of Food and Drug Safety approved Leclaza’s indication expansion to ‘first-line treatment of NSCLC.’ Yuhan Corp applied for the reimbursement of Leclaza as a first-line treatment to health authorities in Korea, and the Ministry of Health and Welfare approved its reimbursement expansion to first-line treatment last month.

 

Starting this year, Leclaza will be reimbursed by health insurance as a ‘first-line treatment of locally advanced or metastatic NSCLC with certain gene mutations.’ The Ministry of Health and Welfare analyzed that Leclaza’s first-line reimbursement will cost the country an additional KRW 88.1 billion.

 

Combined with Leclaza’s Q1 sales and the reimbursement expansion, this means that Leclaza’s sales could exceed 100 billion won this year.

 

Leclaza is the first homegrown drug to exceed KRW 10 billion in quarterly sales.

 

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.

 

Sales of Leclaza surged in Q1 this year, bringing its cumulative sales since its launch up to KRW 61.7 billion.

 

Leclaza is also on track to enter the U.S.

 

market.

 

Late last year, Johnson & Johnson (J&J) submitted an Investigational New Drug (IND) application and a supplemental biologics license application to the U.S.

 

Food and Drug Administration (FDA) for a combination of its EGFR-positive non-small cell lung cancer drug Rybrevant and Leclaza.

 

In November 2018, Yuhan Corp licensed out its technology for Leclaza to Janssen Biotech for a non-refundable upfront payment of USD 50 million.

 

Johnson & Johnson's application is based on the results of the Phase III MARIPOSA trial, which evaluated the efficacy of the combination of Rybrevant plus Leclaza.

 

The interim analysis data from the trial were presented at the European Society for Medical Oncology Annual Congress (ESMO Congress 2023) in October.

 

Trial results showed that the combination of Rybrevant plus Leclaza improved progression-free survival (PFS), the primary endpoint, compared to Tagrisso (osimertinib) alone.

 

Median PFS was 23.7 months for the Rybrevant plus Leclaza combination arm versus 16.6 months for Tagrisso alone.

 

The Rybrevant plus Leclaza combination was associated with a 30% lower risk of disease progression and death compared with Tagrisso alone.