- Yuhan’s Leclaza (lazertinib) (Image provided by Yuhan Corporation)
SEOUL, Aug. 23 (Korea Bizwire) – In a significant breakthrough for South Korea’s pharmaceutical industry, Yuhan Corporation’s non-small cell lung cancer treatment has cleared a crucial hurdle with the U.S. Food and Drug Administration (FDA).
On August 20, the FDA approved the combination therapy of Yuhan’s Leclaza (lazertinib) and Johnson & Johnson’s targeted cancer drug Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations.
This approval comes approximately six months after the FDA granted priority review status to the therapy in February. The next steps will involve pricing negotiations and other procedures for the U.S. market launch.
Yuhan Corporation Central Research Institute (Image courtesy of Yuhan Corporation)
According to multiple media reports, J&J projects that this combination therapy could generate over $5 billion in peak annual sales. Industry analysts anticipate a U.S. launch within the year, as newly approved drugs typically reach the market within two to three months of authorization.
Upon the drug’s launch, Yuhan is expected to receive a milestone payment of $60 million from J&J. This marks a significant return on Yuhan’s investment, which began in 2015 when it acquired the Leclaza candidate from the domestic biotech firm Oscotec.
After conducting its own clinical trials, Yuhan out-licensed the global development and commercialization rights (excluding South Korea) to J&J’s subsidiary Janssen for $1.25 billion.
Dr. Ilhan New, the late founder of Yuhan Corporation, remains one of South Korea’s most esteemed business figures, celebrated for his ethical leadership and corporate integrity. In the 1960s, when tax evasion was widespread among corporations, Yuhan Corporation stood out for its exemplary conduct, earning recognition as a model taxpayer by not evading a single won during audits. In 1969, Dr. New set a precedent in corporate governance by retiring from management and passing the presidency to a company executive rather than his children, paving the way for the rise of professional managers in South Korea. (Image courtesy of Wikimedia)
To date, Yuhan has received an upfront payment of $50 million and $100 million in development milestone payments. The remaining $1.1 billion is contingent on drug approvals and commercialization in other countries, with additional royalties on sales to follow.
J&J has also submitted approval applications for the combination therapy in Europe, China, and Japan, with expectations of European approval within the year.
The approval of the Leclaza-Rybrevant combination therapy positions it as a potential competitor to AstraZeneca’s Tagrisso (osimertinib), the current standard treatment in this field, which recorded global sales of approximately 7.7 trillion won last year.
Yuhan plans to leverage the milestone payments from this FDA approval to accelerate the development of its pipeline products. A company representative indicated that the funds would likely be used for open innovation investments to maintain a virtuous cycle of R&D.
The Korea Pharmaceutical and Bio-Pharma Manufacturers Association hailed Leclaza as a prime example of successful open innovation collaboration between domestic and international companies.
The association expressed optimism that this FDA approval would elevate the status of South Korean pharmaceuticals and accelerate their entry into global markets like the U.S. and Europe.
Ashley Song (ashley@koreabizwire.com)
