Yuhan’s new lung cancer drug set for global market with Johnson & Johnson deal

A new lung cancer drug from pharmaceutical firm Yuhan Corporation, led by CEO and President Wook Je Cho, has emerged as a treatment with big potential.

Yuhan Corporation Central Research Institute [YUHAN]

A new lung cancer drug from pharmaceutical firm Yuhan Corporation, led by CEO and President Wook Je Cho, has emerged as a treatment with big potential.

The 31st first-in-class Korean drug to be registered, “Leclaza” was approved as first-line treatment for patients with non-small lung cancer in January of 2024, with Yuhan setting a sales goal of 100 billion won ($78 million) for the year. Starting on a high note, sales reached around 20 billion won in the first quarter alone.

Yuhan inked a deal for the licensing rights of lazertinib, the main compound of Leclaza in the drug’s phase-one trial, with Johnson & Johnson worth 1.4 trillion won in 2018. This deal transferred global sales rights of the drug to the U.S. pharmaceutical giant, which submitted a Supplemental Biologics License Application and New Drug Application in December of 2023 to seek FDA approval for the concurrent application of Leclaza and their own lung cancer drug, Rybrevant.

Accelerated approval was granted on Feb. 23 of this year. Should the process proceed without delay, industry experts speculate final approval to be granted as early as August.

When the American Society of Clinical Oncology (ASCO) held their annual meeting in May, the primary clinical outcomes of the concurrent treatment were honored as the “Best of ASCO.” Notably, the issue of split-dosing and prolonged infusion times stemming from the intravenous formulation of Rybrevant was resolved by switching the delivery to a subcutaneous injection (SC). This solution effectively reduced injection time from four to five hours down to only five minutes.

Building on such positive clinical outcomes, industry specialists are optimistic that FDA approval will be granted by August. If all goes well, this will be the first Korean-made oncology drug to receive FDA approval.

Applications have been submitted to get the drug approved outside of the United States, such as in Europe, China and Japan, and the concurrent treatment method using SC has already been submitted to the European Medicines Agency.

“The pairing of Leclaza and Rybrevant will double expected sales,” said Joaquin Duato, chairman and CEO of Johnson & Johnson, expressing confidence in the revenue outlook for the concurrent application of the two drugs. Johnson & Johnson has set their annual sales goal at $5 billion, anticipating global commercial success.

Once Leclaza wins FDA approval, not only will it be a record for a Korean-made drug in terms of global reach, but will also set a new precedent in non-small cell lung cancer treatment. Under the collaboration between Yuhan and Johnson & Johnson, Leclaza is anticipated to make big returns in the global market.

By Kim Yeonsoo [kim.yeonsoo1@joongang.co.kr]