Yuhan’s Leclaza to receive ₩100B in milestone payment

Upon approvals in China and Europe

China approves Leclaza+Rybrevant combo... Milestones payments alone amount to USD 45 million

Company yet to receive milestone payments for the drug’s European approval at the end of last year...Expected to be received after the sales launch in major countries

Company secured USD 300 million in Leclaza technology fees... Sales royalties expected to increase further

With Yuhan Corp’s new anticancer drug Leclaza approved in China, the company announced that it will receive KRW 63 billion in technology fees.

 

Added to the technology fees secured at the end of last year for the drug’s approval in Europe, over KRW 100 billion in additional milestone payments are expected to be paid to the company.

 

As a result, Yuhan Corp has secured a total of over KRW 400 billion in technology fees and sales royalties for Leclaza.

 

1 According to industry sources, the Chinese National Medical Products Administration (NMPA) recently included Leclaza in its list of newly approved drugs.

 

Leclaza has been approved as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation in combination with Johnson & Johnson's Rybrevant.

 

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

 

Yuhan Corp exported the technology for Leclaza to Janssen Biotech in November 2018.

 

Yuhan Corp will receive an additional $45 million in milestone payments from Janssen when sales of Leclaza begin in China.

 

The combination therapy of Leclaza and Rybrevant was approved by the US Food and Drug Administration (FDA) in August last year and received approval from the European Commission (EC) at the end of last year.

 

Japan's Ministry of Health, Labour and Welfare approved the combination therapy in March.

 

Yuhan Corporation has not yet received the USD 30 million milestone payment for Leclaza's European approval.

 

The fee will be paid once Leclaza goes on sale in major European countries.

 

This means that Yuhan has secured a total of USD 75 million (approximately KRW 100 billion) in technology fees from China and Europe.

 

Yuhan Corp has received a total of USD 225 million from Janssen since signing the licensing out deal for Leclaza.

 

Yuhan Corp received USD 50 million in November 2018 as an upfront payment for Leclaza’s licensing out deal.

 

Yuhan Corporation then received a milestone payment of USD 35 million from Janssen in April 2020.

 

At that time, Johnson & Johnson paid Yuhan an additional milestone payment as it began clinical trials of Rybrevant in combination with Leclaza.

 

Johnson & Johnson paid Yuhan an additional milestone payment of USD 65 million in November 2020 as it began recruiting subjects for clinical trials.

 

Then, the company received an additional USD 60 million in milestone payments last year with the approval of Leclaza in the United States.

 

In May, it received an additional KRW 15 million with the launch of Leclaza in Japan.

 

Yuhan Corporation posted KRW 25.5 billion in milestone payments in the second quarter from the Japanese approval.

 

With the addition of payments to come from China and Europe, Leclaza's technology fees will total near USD 300 million (KRW 420 billion).

 

Yuhan Corporation receives a percentage of Leclaza's overseas sales as sales royalties.

 

In other words, the more Leclaza's global sales expand, the more its revenue expands.

 

According to Johnson & Johnson, the combination therapy of Leclaza and Rybrevant recorded sales of USD 320 million in the first half of this year.

 

Forty percent of the technology fee revenue secured by Yuhan Corp will be paid to Oscotec, the original developer.

 

Yuhan Corporation acquired the rights to develop Leclaza, which was in the preclinical stage, from Oscotec and its subsidiary Genosco in 2016.

 

The total contract value was worth KRW 1.5 billion.

 

Oscotec received KRW 1.289 billion in sales royalties from Leclaza in the first quarter of this year.