Yuhan’s Leclaza enters US 6yrs after signing licensing deal

How much did Yuhan earn with Leclaza?

FDA approved Leclaza+Rybrevant combination therapy…first domestically developed anticancer drug to enter the US

Secures USD 50 million upfront payment for licensing deal in 2018…Cumulative technology fee amounts to USD 210 million

Cumulative domestic sales of Leclaza KRW 61.7 billion...totals to over KRW 300 billion

Yuhan Corp’s new anticancer drug Leclaza has successfully entered the U.S.

 

market.

 

The drug has reached the commercialization stage 6 years after licensing out its technology to Janssen.

 

As a result, the company will receive USD 60 million as a milestone payment with Leclaza’s approval in the U.S.

 

The company has earned nearly KRW 300 billion in technology fees since licensing out Leclaza’s technology.

 

Yuhan Corp headquarters

According to industry sources on the 21st, Yuhan Corp’s new anticancer drug Leclaza received marketing authorization from the U.S.

 

Food and Drug Administration (FDA) on the 20th.

 

The U.S.

 

Food and Drug Administration (FDA) has approved Yuhan Corporation’s Leclaza in combination with Johnson & Johnson’s Rybrevant for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

 

As a result, Leclaza became the first domestically developed cancer drug to receive U.S.

 

approval.

 

Leclaza, which was approved as the 31st domestically developed new drug in January 2021, is an NSCLC treatment.

 

The company succeeded in entering the U.S.

 

market 6 years after licensing out Leclaza to Janssen Biotech in November 2018.

 

With the FDA approval of Leclaza, Yuhan secured additional milestone payments.

 

The FDA approval milestone for Leclaza was set at USD 60 million (around KRW 80 billion).

 

This is more than the company's operating profit of KRW 56.8 billion last year.

 

In November 2018, the company received a USD 50 million upfront payment for Leclaza.

 

In April 2020, the company received a USD 35 million milestone payment from Janssen.

 

Johnson & Johnson paid the additional milestone to the company after initiating a clinical trial for the Rybrevant and Leclaza combination.

 

In November 2020, Johnson & Johnson paid an additional milestone of USD 65 million to Yuhan Corp as it began recruiting subjects for the trial.

 

Additional milestone payments followed upon successful completion of the trial and FDA approval.

 

In total, Yuhan Corp has earned a total of USD 210 million in technology fees since licensing out Leclaza’s technology.

 

Of the total technology fee revenue, 40% is to be paid to the original developer, Oscotec.

 

In 2016, the company acquired the rights to develop the preclinical drug Leclaza from Oscotec and its subsidiary Genosco.

 

The total value of the agreement had been KRW 1.5 billion.

 

Of the amount, KRW 1 billion was set to be paid within 30 days of the signing of the agreement and KRW 500 million was to be paid after the approval of Phase I clinical trials.

 

Since exporting Leclaza’s technology, the drug settled as Yuhan’s stable cash cow.

 

From 2020 to Q2 this year, the company has recognized a total of KRW 253.8 billion as technology fee revenue.

 

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

Leclaza has already successfully settled in the domestic market.

 

According to drug research institution IQVIA, sales of Leclaza reached KRW 22.6 billion last year, up 40.3% year-on-year.

 

The year after its launch, Leclaza’s sales surpassed the KRW 10 billion mark and recorded KRW 16.1 billion, then exceeded KRW 20 billion last year.

 

Demand in Korea has surged since the drug was granted first-line treatment status this year.

 

Initially, Leclaza was approved for the second-line treatment of locally advanced or metastatic NSCLC with a specific gene (T790M) resistance after receiving first- or second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs).

 

In June last year, the MFDS approved the marketing authorization expansion for Leclaza to ‘first-line treatment of NSCLC.’ The MOHW approved the drug’s reimbursement expansion to first-line this year.

 

In Q1, Leclaza reported sales of KRW 18.9 billion, up 269.9% year-on-year from the KRW 5.1 billion in Q1 the previous year.

 

Leclaza’s revenues more than tripled in the first quarter compared to the previous quarter.

 

Since its launch in South Korea, the company's cumulative sales of Leclaza through the first quarter totaled to KRW 61.7 billion.

 

Together with the technology fee revenue, the company earned more than KRW 300 billion with Leclaza alone.

 

According to MFDS, Leclaza's production performance was KRW 112.2 billion last year.

 

Leclaza generated its first production revenue of KRW 9.8 billion in 2021, which soared to KRW 39.3 billion in 2022.

 

Last year, the company's production scale exceeded KRW 100 billion for the first time.

 

The increase in domestic sales and the acceleration of global clinical trials led to a rise in production performance.

 

Leclaza, which is produced and supplied by Yuhan, is being used in global clinical trials.

 

Therefore, the faster the global clinical trials progresses, the more the production of Leclaza increases.

 

The MOHW analyzed that reimbursement of Lexarza as a first-line treatment will cost an additional KRW 88.1 billion.

 

Based on Q1 sales of Leclaza and the reimbursement expansion, Leclaza’s sales will likely exceed KRW 100 billion this year.