On the 19th, Yuhan Corporation's non-small cell lung cancer treatment "Leclaza" (ingredient name: Lazertinib) marks one year since it became the first domestically produced anticancer drug to receive approval from the U.S. Food and Drug Administration (FDA). Non-small cell lung cancer, which is characterized by large cancer cells, accounts for 70-80% of all lung cancers. The pharmaceutical industry evaluates this as "a successful case of creating a virtuous cycle by developing a new drug through the introduction of external technologies and reinvesting the technology transfer results back into research and development (R&D)."
Leclaza received approval from the domestic Ministry of Food and Drug Safety in January 2021. Following this, it gained FDA approval on August 19 last year as part of a combination therapy used with Johnson & Johnson's (J&J) anticancer drug "Rybrevant." Anticancer drugs must demonstrate superior efficacy over existing medications to receive approval, marking a significant achievement in domestic pharmaceutical history. The company transferred global exclusive rights to J&J's subsidiary Janssen for a maximum contract size of 1.4 trillion won in 2018.
Leclaza has not only obtained FDA approval but has also become a revenue-generating drug. It is now a popular treatment used by one in four patients in the United States. Yuhan Corporation has already received over 200 billion won in technology fees and expects to receive more than 1 trillion won in the future. Thanks to the success of Leclaza, Yuhan Corporation has become the first domestic pharmaceutical company to surpass annual sales of 2 trillion won.
◇Sales from combination therapy projected at 7 trillion won in 2027
Yuhan Corporation has been employing an "Open Innovation" strategy, accepting external technologies and ideas, for the past 10 years. Leclaza was the starting point. Yuhan Corporation developed the drug through direct clinical trials after introducing a new drug candidate co-developed by the domestic biotech company Oscotec and its subsidiary Genosco in 2015.
As Leclaza penetrated the U.S. market, Yuhan Corporation opened the "2 trillion won annual revenue era," becoming the first domestic pharmaceutical company to achieve this milestone. Last year's sales for Yuhan Corporation reached 2.0678 trillion won, an 11.2% increase from the previous year. For the first half of this year (January-June), sales amounted to 1.0256 trillion won, an 8.2% increase compared to the same period last year, and operating profit surged 149.1% to 54.3 billion won.
The fruits of successful technology exports and commercialization are growing. Yuhan Corporation is set to receive milestone payments of $900 million from the transfer of Leclaza technology, of which $175 million (240 billion won) has already been received, leaving $725 million (1 trillion won) remaining. Royalty fees from global sales will be generated separately.
J&J announced that the combined sales of Leclaza and Rybrevant for the first half of this year amounted to $320 million (443.9 billion won). The company noted that one in four non-small cell lung cancer patients in the U.S. is receiving treatment with the Leclaza and Rybrevant combination therapy. J&J has set a global sales target of $25 billion (approximately 7 trillion won) for Leclaza and Rybrevant in 2027.
After receiving approval in Europe last December, Leclaza and Rybrevant were also granted approval for launch in the U.K., Japan, and Canada in the first quarter of this year, and in the second quarter, they were approved for launch in China in July. Prescriptions in Japan are expected to start from May. Lung cancer is the most prevalent cancer in China and also has a high mortality rate.
Experts from the domestic and international pharmaceutical community participated in the development of Leclaza. A notable case is Professor Cho Byeong-cheol of Yonsei University College of Medicine, a specialist in oncology and director of the Yonsei New Il Han Institute for Integrative Cancer Research. Professor Cho conducted clinical trials for Leclaza and Rybrevant around the same time. He reflected, "At first, no one knew they would pair together; it was nothing short of a miracle," and mentioned that he thought of the combination therapy while conducting their respective clinical trials.
◇Increases patient survival by at least one year
Before the emergence of Leclaza, the only available non-small cell lung cancer treatment worldwide was AstraZeneca's anticancer drug Tagrisso. Leclaza has become a game changer that altered this landscape.
In clinical phase 3 trials, patients treated with Leclaza and Rybrevant together showed a 30% reduction in the risk of cancer progression and death compared to those receiving only Tagrisso. Experts expect that the Leclaza and Rybrevant combination therapy could extend overall survival (OS) by more than one year compared to competing drugs like Tagrisso.
OS refers to the period from when a patient begins treatment until death. Pharmaceutical companies announce the median OS once half of the trial patients have died. However, it has been one year since the clinical trial began, and the number of deaths among patients has not reached half. Oh Se-woong, director of Yuhan Corporation's central research institute, noted, "When the OS data comes out later, the value of Leclaza will rise once again."
J&J is currently developing Rybrevant as a subcutaneous (SC) formulation, transitioning from the intravenous (IV) form, aiming for launch. While intravenous administration takes about six hours, subcutaneous administration will only take about five minutes, significantly enhancing patient convenience. The subcutaneous formulation has been approved for prescription in Europe and is expected to receive approval in the U.S. as soon as next month.
Once the Rybrevant subcutaneous injection is available, it will be easier to combine it with the oral medication Leclaza. This will likely expand prescriptions and increase technology fee revenues for Yuhan Corporation. Jo Wook-je, CEO of Yuhan Corporation, stated, "Our goal is to reinvest Leclaza's revenue back into R&D and continue to contribute to society by succeeding in innovative new drug development."