J&J seeks US, European approval for drug developed with Yuhan

Global healthcare giant Johnson & Johnson is seeking approval for a lung cancer drug developed with Yuhan Corp., bringing the South Korean pharmaceutical company a step closer to securing a new blockbuster medicine with expected global sales of $1 billion a year.

Johnson & Johnson on Thursday announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of Rybrevant in combination with Lazertinib for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The Janssen Pharmaceutical Companies of Johnson & Johnson separately said it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of Lazertinib, in combination with Rybrevant, for first-line treatment of adult patients who have advanced NSCLC with common epidermal growth factor receptor (EGFR) mutations.

Lazertinib, sold by Yuhan under the brand name Leclaza in South Korea, is an oral, third-generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Yuhan and Janssen Biotech for the treatment of NSCLC. Rybrevant, a fully human bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) with immune cell-directing activity, received accelerated approval from the FDA in May 2021.

"The combination of Rybrevant and Lazertinib demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to Osimertinib in patients with previously untreated EGFR-mutated NSCLC,” said Kiran Patel, M.D., vice president of Johnson & Johnson Innovative Medicine in a statement. Osimertinib, sold by AstraZeneca under the brand name Tagrisso, is a medication used to treat NSCLC with specific mutations.

“This remains an area of high unmet need as patients often experience treatment resistance and disease progression on currently available therapies."

Yuhan, which signed a licensing deal of up to $1.25 billion for Lazertinib with Janssen in 2018, has received $150 million so far. Once Johnson & Johnson secures approvals from the US and Europe, the South Korean company is likely to collect the rest.

COMPETITION WITH TAGRISSO

The first-line NSCLC treatment market has been dominated by Tagrisso, which reported sales of $5.4 billion last year. Johnson & Johnson expected the combination of Rybrevant and Lazertinib to generate annual revenue of more than $5 billion. Sales of Leclaza are forecast to top $1 billion a year, industry sources in Seoul said.

Yuhan aims to increase sales of Leclaza in South Korea as the drug, along with Tagrisso, will be covered by the country’s national health insurance from next year.

Once they are covered by the insurance, the domestic first-line NSCLC treatment market is forecast to surge up to 600 billion won ($460.8 million) from the current 50 billion won, according to industry sources.

Leclaza’s annual sales in South Korea are also expected to exceed 100 billion won from 16.1 billion won in 2022.

Write to Ji-Hyun Lee at bluesky@hankyung.com
 
Jongwoo Cheon edited this article.