Yuhan Corporation announced on Sep 11., via a regulatory filing, that it will receive a $60 million (about 80.4 billion won) milestone payment from Janssen Biotech, a subsidiary of Johnson & Johnson, following the successful commercialization of its out-licensed anticancer drug, Lazertinib (marketed in Korea as Leclaza). This payment, which represents roughly 4.3% of Yuhan’s total sales of 1.859 trillion won last year, is expected within 60 days. The milestone is tied to the real-world use of a combination therapy involving Yuhan’s Lazertinib and Janssen’s bispecific cancer antibody, Amivantamab (Rybrevant), in the U.S.
In August, the FDA approved the Lazertinib-Amivantamab combination as a first-line treatment for non-small cell lung cancer (NSCLC) patients, marking a significant achievement. This is not only the first Korean-developed anticancer drug to gain FDA approval, but also the first case of technology transferred from a Korean company to a global pharmaceutical giant to pass FDA scrutiny.
Lazertinib inhibits the epidermal growth factor receptor (EGFR), crucial for cancer cell growth, slowing the proliferation of these cells. The combination with Amivantamab has proven particularly effective in patients resistant to standard treatments, including those with EGFR mutations and MET amplification. Lung cancer, which includes small cell lung cancer and non-small cell lung cancer, sees NSCLC accounting for 70-80% of all cases.
Yuhan emphasized the importance of this milestone, viewing it as a testament to their global R&D efforts and commitment to developing groundbreaking cancer therapies. The company reiterated its intention to continue collaborating with Janssen to accelerate the commercialization of the Lazertinib combination and push forward with further research and development.
In addition to the milestone payment, Yuhan will also receive royalties from product sales. J&J has previously estimated that Leclaza and Rybrevant could generate over $5 billion (around 6.6 trillion won) in annual sales.
Yuhan started developing Lazertinib in 2015 after acquiring its early-stage compound, and in 2018, out-licensed it to J&J in a deal worth $1.255 billion (1.7 trillion won). The drug was approved for marketing in Korea by the Ministry of Food and Drug Safety in 2021 and has been covered by national health insurance as a first-line treatment since January this year.
