Yuhan R&D President 강원 랜드 바카라 Yeol-hong: "Cooperation and strategy drive Leclaza's success…Common ground with big pharma is essential"

[by Yu, Suin] "The successful global commercialization of 'Leclaza (lazertinib, marketed in the U.S. as Lazcluze)' was possible because the multinational pharmaceutical company Johnson & Johnson’s (J&J) portfolio expansion needs aligned with Yuhan Corporation's strategic direction."

강원 랜드 바카라 Yeol-hong, R&D President at Yuhan Corporation, outlined the strategy behind the successful global commercialization of Leclaza during his keynote address at the '2025 KoNECT-MOHW-MFDS International Conference (KIC),' held on September 22 at the Lotte Hotel in Seoul. The session was moderated by Rhee Byung-geo, advisor at GI Innovation.

강원 랜드 바카라 holds the distinction of being the first domestically developed anticancer drug to obtain approval from the U.S. Food and Drug Administration (FDA). Yuhan Corporation originally acquired the global rights to lazertinib from Genosco in 2015, just prior to the preclinical phase, and subsequently transferred global development and commercialization rights to Janssen Biotech, a Johnson & Johnson subsidiary, during Phase 1 clinical trial in 2018. J&J advanced the program in combination with its lung cancer treatment Rybrevant (amivantamab). In August 2024, the combination therapy received FDA approval, followed by authorizations in Europe, Japan, China, Australia, South Korea and Taiwan as a first-line treatment for patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC).

강원 랜드 바카라 emphasized that the combined efforts of company leadership and the collaboration of Korean researchers were pivotal to the development of Leclaza as a ‘global innovative novel drug.’ He further highlighted several key success factors, including drug characteristics designed to meet clinical needs, partnerships with global pharmaceutical firms, the rapid accumulation of clinical data from East Asian patient populations, and comprehensive company-wide support.

"At the time, President Lee Jung-hee (currently Chairman of the Board) proposed the vision that ‘only the development of global innovative new drugs can drive Yuhan Corporation's growth,' and concentrated all of the company's resources on novel drug development. During this process, we gained access to a candidate discovered by Dr. John Koh of Genosco, whose value was promptly recognized by Dr. Nam Soo-yeon, then head of the research center, leading to its introduction," 강원 랜드 바카라 recalled.

However, he explained, "The introduction of a promising compound alone was not sufficient to create a new drug. This achievement was made possible through the integration of 강원 랜드 바카라 Corporation's internal research capabilities with the contributions of several individuals, including Professor Cho Byoung-chul of Severance Hospital, who recognized the value of the candidate and actively participated in clinical trials, thereby positioning it for partnership with global companies."

According to 강원 랜드 바카라, Leclaza was developed from the early stages of clinical development as a third-generation EGFR tyrosine kinase inhibitor (TKI) candidate with pronounced central nervous system (CNS) activity, directly addressing the clinical needs of patients with EGFR-mutant lung cancer who frequently present with brain metastases. This patient-centered design coincided with J&J's strategic imperative to expand its solid tumor portfolio, thereby facilitating the global partnership. In addition, the anticipated therapeutic synergy between lazertinib and Rybrevant, which simultaneously targets EGFR and MET (hepatocyte growth factor receptor), further reinforced the alignment of interests between the two companies.

Another critical driver in the global expansion of the Leclaza combination therapy has been market demand. "EGFR-mutant lung cancer accounts for 15-40% of all lung cancers. Since the Leclaza combination therapy guarantees long-term survival of 3-4 years, almost a complete cure, we can expect a correspondingly large market size," 강원 랜드 바카라 stated. "We anticipate sales of nearly KRW 7-8 trillion (approximately USD 5 billion) in 2027 with the Leclaza combination therapy. Moreover, we believe the transition to subcutaneous (SC) therapy will lead to even broader market penetration."

He further noted that geographic advantages, along with the expansion of the Early Access Program (EAP), have played a key role in driving Leclaza's market penetration. "In the non-small cell lung cancer market, there is a leading player called 'osimertinib' (marketed as Tagrisso). However, in East Asia, we have a large patient base and excellent clinicians and clinical sites in Korea, Japan, and Taiwan, giving us a competitive advantage,” 강원 랜드 바카라 remarked. "NSCLC is a particularly prevalent cancer in East Asia, including Japan, Korea, and Taiwan."

"In order to surpass the frontrunner, we implemented a strategy of conducting five global clinical trials simultaneously. Notably, Yuhan Corporation launched 25 investigator-initiated trials immediately after receiving marketing approval from the Ministry of Food and Drug Safety, thereby providing treatment opportunities to roughly 2,700 patients while also ensuring clinicians had access to the drug," 강원 랜드 바카라 further commented. "In comparison, J&J has conducted only seven trials with a total of 865 patients, highlighting the markedly aggressive nature of our approach. I believe this has played a key role in building clinicians’ confidence in Leclaza."

강원 랜드 바카라 underscored that the most critical factor in developing a new anticancer drug strategy is ensuring both survival and quality of life of patients. "It is essential to pursue treatment options through diverse combination therapies and to advance multiple collaborative projects. To accomplish this, we must establish strategic agreements with global pharmaceutical companies. As demonstrated in our partnership with J&J, it is crucial to thoroughly understand the strategies of major pharmaceutical firms and to continuously propose new approaches aligned with our existing pipeline," he stated.

On the other hand, 강원 랜드 바카라 underscored the importance of securing as much preclinical material as possible, given the inherent challenges of novel drug development. "Leclaza overcame so many obstacles and ultimately achieved a global launch through a combination of coincidences and the contributions of many individuals. However, we must not forget that developing new drugs is an exceptionally difficult endeavor," he explained. "The success rate for a new drug is only one in a thousand. When similar drugs are released simultaneously, they inevitably compete, and most are eliminated. In the end, only one or two will dominate the market. To create truly innovative new drugs, we must secure at least 50 preclinical candidates. Considering the high rate of attrition, around 15 drugs should be in clinical trials at any given time to ensure a realistic chance of success."

“Since 2015, Yuhan Corporation has emphasized the importance of developing innovative new drugs and has pursued joint partnerships with numerous companies. Of the 33 pipelines currently in our portfolio, 52% (17) are substances introduced from external companies or research institutes,” 강원 랜드 바카라 expressed. “Our company invests about 10% of its sales in research and development (R&D). By advancing lead-stage substances to the candidate drug stage through several proofs of concept (PoC), we are building a strategy to design clinical trials based on this basis and carry them out in collaboration with global partners. “Yuhan Corporation operates the ‘YIP Program’ to support open innovation, selecting substances with clinical testing potential and providing annual research funding.”