Yuhan’s anticancer drug Leclaza secures European approval

Will receive KRW 44.2 billion in milestone payments

First homegrown anticancer drug to receive approval in the US and Europe

As lung cancer has the highest mortality rate, the company expects sales royalties upon European launch

Additional milestones can be received upon Asian approval in Japan, China, etc.

Pic of Yuhan Corp

Yuhan Corp’s new anti-cancer drug Leclaza (Lazertinib) has crossed the European threshold.

 

The European Commission (EC) approved the drug a month after receiving a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

 

As a result, the company will receive a USD 30 million European launch milestone.

 

According to industry sources on the 31st, the EC granted final marketing authorization to the combination of Yuhan Corp’s non-small cell lung cancer drug Leclaza and Johnson & Johnson's Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation.

 

The CHMP had previously issued a positive opinion recommending approval of the combination on March 14th.

 

The final approval of the combination comes just 1 month after the CHMP's recommendation.

 

The approval is based on results from the Phase III MARIPOSA study.

 

In the study, the combination of Rybrevant-Leclaza reduced the risk of disease progression or death by 30% compared to Tagrisso (osimertinib) monotherapy.

 

In addition, progression-free survival (PFS) was 23.7 months, compared to 16.6 months with osimertinib, and duration of response (DOR) was 25.8 months, 9 months longer than Tagrisso's 16.8 months.

 

Even in high-risk patients with TP53 mutations, brain metastases, or liver metastases, the combination of Rybrevant and Leclaza demonstrated a consistent PFS benefit over Tagrisso, with a trend toward superior overall survival (OS).

 

This renders Leclaza the first homegrown anticancer drug to be marketed in Europe following approval in the U.S.

 

The Rybrevant-Leclaza combination was previously approved by the U.S.

 

Food and Drug Administration (FDA) in August.

 

In Korea, it was approved by the Ministry of Food and Drug Safety in January 2021 for the treatment of non-small cell lung cancer.

 

As the Rybrevant-Leclaza combination passed the European threshold, the company will receive the European launch milestone of USD 30 million (approximately KRW 44.2 billion).

 

This brings the total amount received from Janssen for the export of Leclaza technology to USD 240 million (approximately KRW 353.7 billion).

 

In November 2018, the company received USD 50 million in upfront payment for the export of Leclaza’s technology.

 

In April 2020, Yuhan Corp received a milestone payment of USD 35 million from Janssen.

 

At that time, Johnson & Johnson paid Yuhan Corp an additional milestone payment after initiating clinical trials 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 patients for the trial.

 

Subsequent successful completion of the trial and FDA approval resulted in an additional USD 60 million in additional milestone payments.

 

Sales royalties are also expected to be recognized once the Rybrevant-Leclaza combination is launched in Europe.

 

The royalty rate on sales of Leclaza is expected to be in the range of 10% to 12%.

 

Lung cancer is the leading cause of cancer-related death, which causes an estimated 1.8 million deaths worldwide each year.

 

Patients with non-small cell lung cancer, which is targeted by the Rybrevant-Leclaza combination, account for 80-85% of lung cancer patients.

 

In addition, Yuhan Corp may receive additional milestones upon regulatory approval in Japan, China, and other Asian countries.

 

The total amount of additional technology fees that Yuhan may receive for future development and sales of Leclaza amounts to USD 740 million.