[Asia Exclusive] "Domestic Anticancer New Drug Rekraza, Turning Point for Global Yuhan's Leap"

Jo Uk-je, President of Yuhan Corporation
Reclaza, 31st MFDS Approval in Korea
Phase 3 Clinical Trial Underway After Technology Export to Janssen
Interim Results to Be Announced Next Month... Positive Outlook
Expected to Be First Global Blockbuster New Drug
Management-Led ESG Permanent Organization Planned

Cho Uk-je, President of Yuhan Corporation, is explaining this year's management strategy in an interview with Asia Economy in the reception room where a photo of the late Dr. Yu Il-han, the founder, is displayed. / Photo by Moon Ho-nam munonam@

[Interview = Cho Young-joo, Head of the 4th Industrial Department at Asia Economy; Organized by Seo So-jung, Reporter] "The anticancer new drug ‘Reclaza’ (generic name: Lazertinib) will be a remarkable leap for Korean pharmaceutical companies moving from the domestic to the global stage."

Recently, at the Yuhan Corporation headquarters on Noryangjin-ro, Dongjak-gu, Seoul, Cho Wook-je, CEO of Yuhan Corporation, expressed great expectations for Reclaza, a non-small cell lung cancer treatment, in an interview with Asia Economy. Reclaza was approved in January as the 31st new drug developed domestically by the Ministry of Food and Drug Safety. Yuhan Corporation introduced Reclaza from Oscotec and Genosco in 2015, just before the preclinical stage, through open innovation.

Afterward, in 2018, it was licensed out to Janssen for about 1.4 trillion KRW, and they are currently jointly conducting combination clinical Phase 3 trials. CEO Cho said, "The interim clinical results will be announced next month, and the atmosphere is positive," adding, "If the results are favorable, sales exceeding the trillion KRW mark are expected, making it the first global blockbuster domestic new drug."

CEO Cho attributed special significance to Reclaza. It is Yuhan Corporation’s second new drug in 16 years since the anticancer agent ‘Revanex’ in September 2005. While Revanex was limited to the domestic market and is now almost discontinued, Reclaza is expected to actively advance beyond Korea into the global market. Although Yuhan Corporation ranked first in the pharmaceutical industry last year with sales of 1.6199 trillion KRW, it had no representative new drug and was once criticized as a ‘wholesaler for foreign pharmaceutical companies.’ Reclaza offers an opportunity to cross the threshold of the global market.

With five years left until its 100th anniversary, this could be a turning point for ‘Global Yuhan’ by reflecting on the founder’s teachings. CEO Cho said, "Reclaza perfectly aligns with the late Dr. Yuil Han’s teaching to ‘make good medicine to help the country and its people and return the profits to society.’ If Reclaza generates significant profits, we plan to participate in projects that can be usefully applied to patients suffering from lung cancer and medical staff engaged in lung cancer treatment research."

Below is a Q&A with CEO Cho.

- The interim clinical results of Reclaza will be disclosed at the American Society of Clinical Oncology (ASCO) next month.

▲ The announcement will cover the combination treatment of Reclaza and Janssen’s bispecific antibody ‘Amivantamab’ for patients resistant to AstraZeneca’s anticancer drug ‘Tagrisso.’ Although specific data have not yet been released, positive feedback has been received from participating medical staff, and the company has high expectations. Tagrisso is a third-generation anticancer drug applied to non-small cell lung cancer patients resistant to first- and second-generation TKIs (tyrosine kinase inhibitors). Since Tagrisso is currently the only third-generation drug, options are limited. Reclaza shows no significant difference in effectiveness compared to Tagrisso and has reduced side effects in Asians. The combination of oral Reclaza and injectable Amivantamab is expected to be effective for patients resistant to Tagrisso.

- What preparations are underway ahead of Reclaza’s launch in the second half of this year?

▲ Since Reclaza is a domestic new drug, we are striving to provide it to Korean patients as soon as possible. After obtaining product approval from the Ministry of Food and Drug Safety in January, it passed the Cancer Disease Review Committee’s assessment of reimbursement appropriateness and criteria in February. In April, it also passed the Drug Reimbursement Evaluation Committee. If the reimbursement registration process proceeds smoothly, we expect to launch in the second half of this year. Internal preparations for the launch are also progressing well. We have formed a dedicated team for Reclaza’s successful launch. Through systematic pre-launch preparations, we plan to effectively communicate Reclaza’s scientific and medical data and ensure rapid supply to hospitals after launch, making Reclaza a good treatment option for doctors and patients.

- Recently, you have strengthened open innovation. Reclaza is a result of that, right?

▲ Since 2015, Yuhan Corporation has invested 350 billion KRW in over 30 institutions possessing pipelines (new drug candidates) or platform technologies with high development potential. About half of the 30 pipelines Yuhan currently holds were secured through such open innovation. Besides Reclaza, the degenerative disc treatment ‘YH14618’ licensed out in 2018 and the non-alcoholic steatohepatitis (NASH) treatment ‘YH25724’ licensed out in 2019 were also achieved through open innovation. However, compared to global pharmaceutical companies, the number of drugs in clinical stages is still insufficient. To overcome this, we will actively pursue the introduction of pipelines in or preparing for clinical stages and expand early-stage candidates by introducing new technology-focused assets to strategically expand our pipeline. We plan to introduce technology not only domestically but also internationally, working with overseas subsidiaries such as Yuhan USA and Yuhan ANZ in the United States and Australia.

Cho Wook-je, CEO of Yuhan Corporation, is being interviewed by Asia Economy on the 6th. / Photo by Moon Ho-nam munonam@

- R&D investment has increased over the past three years. What areas are you focusing on?

▲ R&D investment increased more than twofold from 110.5 billion KRW in 2018 to 222.7 billion KRW last year. The R&D-to-sales ratio also rose from 7% to 14.2% during the same period. This year, we plan to invest a similar amount as last year to ensure the successful clinical trials of Reclaza and to advance new drug candidates into clinical stages. We will particularly focus on next-generation immuno- and targeted anticancer drugs and fibrosis/NASH disease treatments, as well as developing central nervous system (CNS) disease treatments using the blood-brain barrier (BBB) penetration platform. Additionally, we have newly entered the animal pharmaceuticals business. The domestic animal pharmaceuticals market is monopolized by global big pharma companies. Although still in its infancy, we plan to gradually expand this sector.

- ESG (Environmental, Social, Governance) has become a key topic in corporate management. What are your plans?

▲ Since companies must grow sustainably with society, we plan to establish a permanent ESG organization led by the CEO and top management. Under this, task force teams (TFTs) comprising relevant departments from each business site will engage in practical ESG activities. We will build a network to integrate ESG data management, strengthening and supplementing the company’s internal ESG capabilities, and identify key ESG issues to discover ESG achievements and provide accurate and comprehensive information. Next year, we plan to publish a global-level integrated report (annual report + sustainability report) to transparently disclose performance and status. Also, for the first time since the company’s founding, we separated the roles of the board chairman and CEO. Former CEO Lee Jung-hee remains chairman of Yuhan’s board, sharing roles to strengthen ESG management.

- Performance improved due to a base effect in Q1. What is your sales outlook for this year?

▲ Consolidated sales in Q1 this year were 379 billion KRW, and operating profit was 13.9 billion KRW, up 21% and 1194% respectively from the same period last year. Last year, some product sales stagnated due to COVID-19, but we expect improvement this year. Prescription drug (ETC) sales, a core part of the pharmaceutical business, rose 14.6% year-on-year to 222.1 billion KRW in Q1, showing recovery. Along with core strategic products that form the foundation of company sales, the increasing proportion of improved new drugs will enhance the profit structure. If Reclaza proceeds as planned, reimbursement will be recognized from the second half of this year, generating stable sales.

- The COVID-19 pandemic presents both crisis and opportunity for the pharmaceutical industry. Any suggestions for the government?

▲ The global market size of the pharmaceutical and bio sector (about 1,400 trillion KRW) is larger than the combined automotive and semiconductor industries. The past pharmaceutical industry structure was focused on domestic and generic drugs, but now it is shifting to a structure where generics, improved new drugs, and new drugs coexist, requiring active efforts to strengthen international competitiveness. Individual company limitations must be overcome through cooperative models. With an open mind, it is necessary to maximize synergy by combining the capabilities of individual entities such as pharmaceutical companies, ventures, global partners, industry, academia, research institutes, and hospitals. Reclaza, with blockbuster potential, is a result of ‘speed’ and ‘passion.’ Early swift investment decisions were crucial, and through collaboration with external developers like venture companies, we did not give up even small possibilities and made achievements in a short time with company-wide efforts. To create new opportunities, continuous communication with external parties must be maintained. Openness and collaboration are more necessary than anything else.

This content was produced with the assistance of AI translation services.