Leclaza posts sales of KRW 25 bil in 2 years in Korea

Confirms efficacy and attempts use in the first-line

Q1 sales KRW 5.1 billion... 57% increase YoY

Applied for approval as a first-line treatment in March...If approved, sales will expand

First RWD presented...confirmed an efficacy higher than that identified in the P3 trial in the real-world study

Yuhan Corp’s anticancer drug ‘Leclaza’ is making good sales in the Korean market, and raised sales of KRW 5.1 billion in Q1 alone.

 

Its efficacy and safety were confirmed in the real world in actual patients at the time of treatment, and the drug is gradually expanding its market influence ahead of its approval as a first-line treatment.

 

According to the market research institution IQVIA on the 23rd, Leclaza’s sales were KRW 5.1 billion in Q1, up 57.4% YoY.

 

It is also a 12.9% increase from the KRW 4.5 billion made in the previous quarter.

 

Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year.

 

It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells.

 

It is currently approved as a treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs.

 

The drug entered the market in earnest after being listed for reimbursement in the National Health Insurance Service in July 2021.

 

The drug recorded sales of KRW 1.5 billion and KRW 2.6 billion in Q3 and Q4, respectively.

 

Last year, its quarterly sales had risen to the KRW 4 billion range, and continued growing this year.

 

Cumulative sales made during the 2 years since the release of Leclaza totaled KRW 25.2 billion.

 

Leclaza

Leclaza posted sales of KRW 16.1 billion last year, breaking the sales record made by homegrown new anticancer drugs in Korea.

 

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 have exceeded annual sales of KRW 10 billion.

 

At the current rate, Leclaza may likely exceed annual sales of KRW 20 billion this year.

 

Leclaza is considered to have made a smooth start in the market.

 

Anticancer drugs that are usually used in large medical institutions, can only be prescribed after the drug passes each institution’s drug committee, therefore, it takes a considerable amount of time before sales are generated after the initial stage of release.

 

With the added pressure of having to directly compete with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anticancer drugs developed in Korea to achieve commercial results.

 

Leclaza passed the drug committee of major large medical intuitions in Korea and is accelerating its market penetration efforts.

 

The drug is expected to expand further into the market if it receives approval in the first line.

 

In March, Yuhan Corp applied for approval of Leclaza as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation to the Ministry of Food and Drug Safety.

 

Leclaza demonstrated its efficacy over existing treatments in a global Phase III trial (LASER 301) that was conducted on 393 locally advanced or metastatic NSCLC patients with EGFR mutations.

 

The trial results had been presented at the European Society for Medical Oncology Congress that was held last year in Singapore.

 

The company has also been accumulating evidence of its efficacy and effect in the real world.

 

Lim Sun Min, Professor of Oncology at Yonsei Cancer Center, and Beung-Chul Ahn, Professor of Oncology at the National Cancer Center, recently published real-world data (RWD) on how Leclaza confirmed its safety and efficacy in practice in the journal, Lung Cancer.

 

This was the first-ever real-world study results announced since Leclaza’s approval, The research team conducted a retrospective study on 103 patients with EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza from January 2021 to August 2022 at Yonsei Cancer Center and the National Cancer Center.

 

90 of the 103 patients received Leclaza as a second or third-line treatment.

 

The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months.

 

This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval.

 

The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study.

 

In terms of safety, the drug was also well-tolerated, similar to previous studies.

 

The research team explained, “ The real-world study reaffirmed the consistent effect and efficacy of Leanza as a second-line treatment for EGFR T790M mutation-positive NSCLC patients in practice.” Yuhan Corp has invested a total of KRW 93 billion in the Phase III trial for Leclaza.

 

According to the Financial Supervisory Service, as of the end of the first quarter, Yuhan Corp reflected KRW 93 billion of Leclaza’s development cost as intangible assets.

 

In 2019, the Financial Supervisory Service set a standard that only R&D projects that have technical feasibility, including those for new drugs, shall be accepted as accounting assets.

 

The FSS suggested that R&D costs can be turned into assets after initiating Phase III trials for new drugs and receiving approval for its Phase I trial for biosimilars.

 

As for generic drugs, they can be capitalized after their bioequivalence test plan is approved.

 

Under such standards, Leclaza’s development costs of KRW 32.6 billion were first recognized as intangible assets in Q4 2020.

 

Its development costs were reflected as intangible assets after its Phase III trial began in earnest.

 

Leclaza’s development cost intangible asset increased to KRW 61.4 billion by the end of 2021, and then rose to KRW 88 billion last year, with the added KRW 26.6 billion last year.

 

In Q1 this year, an additional KRW 5 billion was invested as clinical expense.