Yuhan Corporation's 'Leclaza,' the first domestic anticancer drug to break through the U.S. Food and Drug Administration (FDA) barrier, has received sales approval in seven countries, including South Korea, the United States, Europe, the United Kingdom, Japan, Canada, and China, just one year after its launch. The industry anticipates the emergence of the first domestic 'blockbuster' anticancer drug with annual sales exceeding KRW 1 trillion.

The Korean lung cancer treatment 'Leclaza' marks its first anniversary of FDA approval on the 19th. Leclaza, which inhibits the epidermal growth factor receptor (EGFR) involved in the growth of lung cancer cells to prevent further cancer cell growth, received FDA approval on August 19 last year, becoming the first domestic anticancer drug to do so, garnering significant attention. EGFR is a genetic mutation present in about 40% of non-small cell lung cancer patients, and before Leclaza's advent, AstraZeneca's 'Tagrisso' catered to this demand.

However, the atmosphere shifted when Johnson & Johnson, which holds the global rights to Leclaza, announced the results of its Phase 3 clinical trial at the European Lung Cancer Conference (ELCC) in March this year. When used in combination with the oral drug Leclaza and the injectable antibody treatment 'Rybrevant,' patients' overall survival (OS) was extended by more than a year compared to Tagrisso. Consequently, Johnson & Johnson set a sales target of approximately USD 5 billion (about KRW 7 trillion) for Leclaza-Rybrevant by 2027. In the second quarter of this year (April to June), global sales reached USD 179 million (about KRW 247.9 billion), a 159% increase compared to the same period last year.

With the rise in Leclaza's sales, Yuhan Corporation's performance is also improving. Yuhan Corporation exported Leclaza's technology to Johnson & Johnson in 2018 for a total of USD 950 million (about KRW 1.3158 trillion). Of this, USD 175 million has been received based on commercialization in the U.S. and Japan, with USD 725 million in remaining royalties (milestone payments) yet to be received.

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