K-onocology drug Leclaza posts KRW 25.4B in sales in 3 mths

Leclaza records KRW 25.4 billion in Q1 sales, may likely surpass KRW 100 billion annually for the first time

Sales surge following reimbursement expansion for first-line treatment in 2024

Being an oral drug, nearly 80% of prescriptions are dispensed to outpatients… Last year’s outpatient prescriptions reached KRW 79.3 billion.

The domestically developed cancer drug Leclaza (lazertinib) continues to perform strongly in the prescription market. The drug generated over KRW 25 billion in sales during the first quarter alone, putting it on track to exceed KRW 100 billion in annual sales. Following reimbursement expansion as a first-line lung cancer treatment, Leclaza has maintained strong momentum and emerged as one of Korea's most successful homegrown oncology drugs. Being an oral medication, the unusual phenomenon of approximately 80% of total sales being generated through outpatient prescriptions has also emerged, as the patients may take the drug at home.

According to IQVIA data released on June 13, Yuhan Corp’s Leclaza recorded KRW 25.4 billion in Q1 sales, representing an 8.0% increase YoY.

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Leclaza was approved in January 2021 as Korea's 31st domestically developed new drug for the treatment of non-small cell lung cancer (NSCLC). It officially entered the prescription market in July 2021 following inclusion in the national reimbursement list.

The product's growth grew steeply after its reimbursement coverage was expanded to first-line treatment.

Leclaza was first approved as a second-line therapy for patients with locally advanced or metastatic NSCLC who developed the EGFR T790M resistance mutation after treatment with first- or second-generation EGFR tyrosine kinase inhibitors (TKIs). In June 2023, the Ministry of Food and Drug Safety allowed its indication expansion to include first-line treatment of NSCLC.

Beginning in January 2024, the Ministry of Health and Welfare extended reimbursement coverage to first-line use. As a result, patients with EGFR mutation-positive locally advanced or metastatic NSCLC became eligible for reimbursement when receiving Leclaza as initial therapy. At the time, the ministry estimated that the reimbursement expansion would require an additional KRW 88.1 billion in healthcare spending.

Leclaza generated KRW 6.2 billion in sales during Q4 2023, but sales surged to KRW 18.9 billion in the first quarter of 2024 following the expansion of reimbursement. This is almost a threefold increase in sales from the first-line reimbursement expansion. In effect, the reimbursement decision added more than KRW 10 billion in quarterly first-line treatment sales in just 3 months.

Sales exceeded KRW 20 billion in the second quarter of 2024 and have continued to grow thereafter. Leclaza generated KRW 99.6 billion in sales last year and will potentially surpass the KRW 100 billion annual sales milestone for the first time this year.

A defining feature of Leclaza is its overwhelming reliance on outpatient prescriptions.

During Q1, outpatient prescriptions accounted for KRW 20.3 billion, representing 79.8% of total sales. The drug’s outpatient share has never fallen below 70% ever since it exceeded the mark in Q4 2022. In the fourth quarter of last year, outpatient prescriptions totaled KRW 19.5 billion, representing 80.4% of total quarterly sales of KRW 24.2 billion.

Leclaza is setting a new sales record among domestically developed Korean anticancer drugs. Other domestically developed anticancer drugs approved in Korea before Leclaza include Il-Yang Pharm's Supect, Dong-wha Pharm's Milican, Chong Kun Dang's Camtobell, Samsung Pharm’s Riavax, and Hanmi Pharm's Olita. None of these products has achieved annual sales exceeding 100 billion won.