Yuhan Corporation's Lung Cancer Drug 'Reclaza' FDA Approval: "A New Milestone for Korean Pharmaceutical Industry" [AK Radio]

New Drug Independently Developed by Yuhan Corporation
Expansion of Korean Pharmaceutical Industry in Global Market

Leclaza, a new lung cancer drug developed by Yuhan Corporation, has received final approval from the U.S. Food and Drug Administration (FDA). This approval is significant as it marks the first time in the history of Korean pharmaceutical companies that a novel anticancer drug has passed the FDA's rigorous review. It draws great attention from the pharmaceutical industry and investors because it is not a simple generic or biosimilar, but a new drug independently developed by Yuhan Corporation that has been recognized in the global market. Especially as Korea's pharmaceutical industry is gaining attention on the global stage, this approval is seen as an example demonstrating Korea's emergence as a hub for new drug development.

Leclaza is a lung cancer treatment developed by Yuhan Corporation, successfully commercialized based on a new drug candidate called Lazertinib. This compound was first synthesized by Genosco, a Korean biotech company’s subsidiary established in Boston, USA. Genosco, a small biotech firm, focused more on discovering promising drug candidates and licensing them out to large pharmaceutical companies rather than developing new drugs independently. In 2015, Yuhan Corporation recognized the potential of Lazertinib early on and acquired the license. Subsequently, Yuhan Corporation proceeded with new drug development based on Lazertinib and succeeded in commercializing Leclaza through domestic clinical trials in Korea.

Im Hyo-young, Vice President of Yuhan Corporation, is explaining about 'Reclaza,' a treatment for non-small cell lung cancer, at a press conference held on the afternoon of the 23rd at the Conrad Hotel in Yeongdeungpo-gu, Seoul, regarding the approval of 'Reclaza' by the U.S. Food and Drug Administration (FDA).
[Photo by Yonhap News]

During the development process of Leclaza, Yuhan Corporation pursued two strategies simultaneously. The first was clinical trials and commercialization within Korea. Yuhan Corporation collaborated with Severance Hospital in Korea to complete Phase 1 clinical trials and proceeded with Phase 2 trials until 2018. During this process, Leclaza received approval from the Korean Ministry of Food and Drug Safety (MFDS) and began to be sold in the domestic market. Leclaza is used as a monotherapy and has established itself as a first-line treatment option available for early-stage lung cancer patients.

The second strategy targeted the global market. To commercialize Lazertinib globally, Yuhan Corporation signed a technology export contract with the global pharmaceutical company Johnson & Johnson. Based on the results up to Phase 1 clinical trials, Yuhan Corporation licensed Lazertinib out to Johnson & Johnson. Consequently, Johnson & Johnson continued developing lung cancer treatments based on Lazertinib for global markets including the U.S. and Europe. In particular, Johnson & Johnson promoted the development of Leclaza in combination therapy with their existing lung cancer drug Rybrevant. Combination therapy is a strategy that uses multiple drugs together to maximize therapeutic effects, especially emphasized in cancer treatment.

This FDA approval is specifically for this combination therapy. The U.S. FDA confirmed that Leclaza, when used in combination with Rybrevant, showed significant efficacy compared to existing treatments. Accordingly, Leclaza is expected to be used alongside Rybrevant in the U.S. market. In contrast, in Korea, Leclaza was approved for use as a monotherapy. This has allowed Yuhan Corporation to implement differentiated strategies in the two markets, which is expected to enhance Leclaza’s potential for global expansion in the future.

Yuhan Corporation’s recent achievement can be seen not only as new drug development but also as a result of their investment insight and strategic decisions. Recognizing the potential of Lazertinib synthesized by Genosco early on, Yuhan Corporation introduced this compound and succeeded in commercialization. They have steadily prepared for Leclaza’s global launch through a 'two-track strategy' dividing development between the Korean and global markets. Notably, Yuhan Corporation reaffirmed the importance of Open Innovation during this new drug development process. Open Innovation is a method where multiple companies collaborate to achieve innovation and has become an essential strategy in the pharmaceutical industry for new drug development.

[Image source=Reuters Yonhap News]

With Leclaza’s FDA approval, Yuhan Corporation can expect considerable financial benefits. Through the technology export contract with Johnson & Johnson, Yuhan Corporation agreed to receive milestone payments at each development stage, including the FDA approval point. With this FDA approval, Yuhan Corporation will receive approximately 80 billion KRW in milestone payments. Additionally, if Leclaza is sold in the U.S. and other global markets in the future, Yuhan Corporation is expected to receive royalties of at least 10% of sales revenue. This is anticipated to significantly boost Yuhan Corporation’s financial performance.

Meanwhile, Genosco, which holds the original technology for Lazertinib, and its parent company Oscotec are also expected to gain substantial profits. Genosco will receive 20% of the milestone payments from this FDA approval, and Oscotec will receive another 20%. This compensation reflects their contributions to the initial technology development and is expected to greatly improve their financial outcomes. In particular, Oscotec, a KOSDAQ-listed company, is expected to see a positive impact on its stock price and corporate value from this achievement.

Leclaza’s FDA approval has provided Yuhan Corporation with an important foothold in the global pharmaceutical market. This achievement is not limited to the Korean market but also serves as proof of Yuhan Corporation’s competitiveness in the global market. Such success will contribute to raising the international status of Korea’s pharmaceutical industry, and expectations for Yuhan Corporation’s new drug development will continue to grow. Especially, there is keen interest in how this approval will affect Yuhan Corporation’s global expansion strategy and what strategic decisions will be made in future new drug development.

Furthermore, this FDA approval is expected to be a significant milestone for both Yuhan Corporation and the Korean pharmaceutical industry. It has laid the foundation for the Korean pharmaceutical industry to play a larger role in the global market, and expectations for Yuhan Corporation’s new drug development and global expansion strategies are increasing.

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