[photo of test tubes, Photo Credit to Pixabay]

On August 20, 2024, “lazertinib”, an anti-lung cancer drug developed by Yuhan Corporation, a renowned Korean pharmaceutical company, under the brand name LECLAZA, received US FDA approval.

Ms. Choi, Senior Director in charge of Regulatory Affairs & Drug Development Solutions at IQVIA Korea, a health information technology and clinical research company, recently sat down to discuss the significance of the FDA’s approval.

The FDA approved lazertinib as first line chemotherapy for non-small cell lung cancers in combination with amivantamab, an anti-lung cancer drug produced by the Janssen group under the brand name RYBREVANT.

The Janssen group, a global pharmaceutical giant, co-developed lazertinib and is selling it in the US market under the brand name LASCLUZE.

Lazertinib, the 31st among the domestically developed new drugs, is the first Korean anti-cancer drug to be approved by the FDA. Previously, the FDA approved 8 Korean drugs in areas other than chemotherapy.

“It takes more than a decade to develop a new drug, involving multiple stages, namely, pre-clinical trial, clinical trial and post-approval stages. The clinical trials are responsible for most of the cost and time during the entire cycle of drug development,” said Ms. Choi.

“Therefore, domestic pharmaceutical companies strategically engage in pre-clinical trials. That is, they research for substances that could be potential candidates for new drugs,” continued Ms. Choi.

Ms. Choi elaborated, “This research process involves what is called optimization. Once the substances are optimized to reach the level of ‘new drug candidates,’ the researching companies sell their intellectual property rights over these substances or ‘license them out’ to global pharmaceutical companies in return for royalties.”

According to Ms. Choi, lazertinib as a substance was first researched by Genosco Inc., a Boston-based biotechnology company owned by Osotec Inc., a Korean venture company. Then, it was licensed out in 2015 to the Yuhan Corporation.

Ms. Choi noted, “Interestingly, the Yuhan Corporation successfully conducted the pre-clinical trials as well as the early phases of the clinical trials for the domestic market. Based on good results from these clinical trials, the Yuhan Corporation was able to license out lazertinib to Janssen Biotech Inc. in 2018 to complete the clinical trials for the global market.”

The FDA approval of lazertinib this August, which is a milestone achieved 6 years after it was licensed out to the Janssen group, signals its commercialization in the US market. With the US occupying almost half of the world’s market for medical drugs, lazertinib could potentially become the first Korean blockbuster drug.

Ms. Choi agreed that the FDA approval of lazertinib could mark the beginning of Korean blockbuster drugs. “Blockbuster drugs are characterized by a sales volume of over 1 trillion Korean won. Janssen group is known to have set the sales goal for lazertinib in the US market at 5 billion US dollars which easily exceeds 6 trillion Korean won.”

Ms. Choi, however, believes what is more significant is the fact that Yuhan Corporation achieved good results during early clinical trials for the domestic market which enabled lazertinib to be licensed out to the Janssen group.

Ms. Choi concluded, “It is about time that Korean pharmaceutical companies start to be more aggressive about clinical trials and think beyond licensing by taking risks and making uncertain investments.”