Yuhan Yanghang's 'Reclaza', "Unlimited Free Supply... The Only Spiritual Successor"

Approval for First-Line Treatment of Non-Small Cell Lung Cancer
Introduction of Expanded Access Program (EAP)

Requires Patient Consent, Primary Physician Evaluation, and IRB Approval
Benefits Applied to Foreign Patients Prescribed Domestically

Yuhan Corporation's third-generation non-small cell lung cancer (NSCLC) treatment 'Reclaza' (active ingredient: Lazertinib) will be supplied free of charge to patients in South Korea.

Jo Wook-je, CEO of Yuhan Corporation, is speaking at the 'Yuhan Corporation R&D and Social Contribution Press Conference' held on the afternoon of the 10th at the Plaza Hotel in Jung-gu, Seoul.
[Photo by Lee Chun-hee]

On the afternoon of the 10th, at the 'Yuhan Corporation R&D and Social Contribution Press Conference' held at the Plaza Hotel in Jung-gu, Seoul, Yuhan Corporation announced its plan to implement an 'Early Access Program (EAP)' to provide Reclaza free of charge to domestic patients following its approval as a first-line treatment for NSCLC. Currently, discussions are underway with various medical institutions wishing to participate in the EAP, and the first beneficiaries are expected to emerge within this month. Patients eligible for the EAP will receive Reclaza, which costs approximately 75.5 million KRW annually based on the insurance price for second-line treatment, free of charge.

Reclaza has expanded its indication from second- and third-line treatment for NSCLC with epidermal growth factor receptor (EGFR) mutations to include first-line treatment as of the 30th of last month. Since anticancer drugs approved only for second- and third-line treatments cannot be used if a patient is cured or dies during the initial first-line treatment, the demand for first-line treatment is naturally higher.

However, among third-generation EGFR inhibitors like Reclaza, no drug currently has health insurance coverage for first-line treatment in South Korea. AstraZeneca's 'Tagrisso' (Osimertinib) was approved by the Ministry of Food and Drug Safety in 2018 but repeatedly failed to pass the Cancer Disease Review Committee, the first hurdle for reimbursement, until it finally succeeded after five attempts in March this year. Since price negotiations and other procedures remain, reimbursement is expected to be possible at the earliest by the end of this year.

Joo Wook-je, President of Yuhan Corporation, explained the background of the EAP initiative: "There was a strong internal consensus within the company that it would be better to allow those suffering from lung cancer who wish to take the third-generation EGFR tyrosine kinase inhibitor (TKI) drug Reclaza as soon as possible." He added, "With the approval of the first-line treatment indication, we have implemented a program to supply the drug free of charge after hospital review."

He also emphasized that this aligns with Yuhan Corporation's founding spirit. President Joo stated, "Yuhan Corporation has upheld the founding spirit of Dr. Yu Il-han, who aimed to 'create the best products to help the nation and compatriots.' Reclaza is a product born from the company's efforts and investments as well as the trust of many people, so we will not hesitate to contribute a portion of the profits to support lung cancer treatment."

EAP Conducted Under the Banner of 'Unlimited Free Supply'... Potential Expansion Overseas and to Other Drugs

The EAP will be conducted 'without limit' on the number of patients and institutions, provided that patients who meet the first-line indication for Reclaza voluntarily consent, and receive evaluation by their attending physician and approval from each medical institution's Institutional Review Board (IRB). Considering that approximately 30,000 new lung cancer patients are diagnosed annually in South Korea, with 30-40% having EGFR mutations, up to about 10,000 patients per year could be eligible. Yuhan Corporation also explained that even foreign patients receiving treatment and prescriptions in South Korea can benefit from the EAP.

Im Hyo-young, Vice President and Head of Clinical Medicine at Yuhan Corporation, is explaining the compassionate use program (EAP) for Reklaza at the 'Yuhan Corporation R&D and Social Contribution Press Conference' held on the afternoon of the 10th at the Plaza Hotel in Jung-gu, Seoul.
[Photo by Lee Chun-hee]

With the first patient support expected this month, the EAP will continue until the point when national health insurance coverage for Reclaza's first-line treatment is implemented. Hyoyoung Lim, Vice President and Head of Clinical Medicine at Yuhan Corporation, explained, "In countries like South Korea where a national health insurance system is in place, access to drugs is only practical after both approval and reimbursement notification. The EAP provides the drug free of charge on a compassionate basis until innovative drugs like Reclaza can be prescribed in clinical practice." He also noted, "Even if the competing drug Tagrisso is reimbursed first, the EAP will continue."

Yuhan Corporation also indicated plans to expand the EAP program overseas or to other pharmaceuticals. President Joo mentioned that since the global rights for Reclaza have been licensed to Janssen (a Johnson & Johnson subsidiary), "Although this is Yuhan Corporation's own idea, we are considering negotiating with Janssen to allow Reclaza to be used independently in countries where prescriptions are difficult due to lack of funds." Regarding other anticancer drugs, he added, "Since Yuhan Corporation's founding purpose is to create good drugs to help the nation and return profits to society, if another opportunity arises, we can fully implement the EAP."

"We Will Create the Second and Third Reclaza"... Follow-up Anticancer Pipeline Also Revealed

Meanwhile, at the press conference, Se-woong Oh, Vice President and Head of the Central Research Institute at Yuhan Corporation, presented on the anticancer pipeline. Currently, Yuhan operates about 11 anticancer pipelines, including Reclaza. The two fastest-developing candidates are 'YH32367' and 'YH42946.'

YH32367, which was introduced in 2018 from ABL Bio's bispecific antibody anticancer drug 'ABL105,' is a candidate drug that specifically binds to cancers expressing human epidermal growth factor receptor 2 (HER2) and activates immune cells by stimulating 4-1BB, enhancing the anticancer effect of immune cells. Oh explained, "In studies, even when the cancer was transplanted again, the same cancer did not develop, indicating that our immune cells remembered and attacked only that cancer." He also noted that no liver toxicity issues were observed. YH32367 is currently undergoing Phase 1 and 2 clinical trials in South Korea and also in Australia.

Oh Se-woong, Head of Central Research Institute (Vice President) at Yuhan Corporation, is explaining Yuhan Corporation's anticancer pipeline at the 'Yuhan Corporation R&D and Social Contribution Press Conference' held on the afternoon of the 10th at the Plaza Hotel in Jung-gu, Seoul.
[Photo by Lee Chun-hee]

Similarly, YH42946, which was licensed in May from J-Int Bio's 'JIN-A04,' targets the HER2 gene in NSCLC. Oh stated, "HER2 exon 20 mutations in lung cancer remain an unexplored area. Since no successful drugs have been developed so far, we aim to discover suitable drugs for this target and proceed with clinical trials." The goal is to enter clinical trials early next year.

Oh also introduced other pipelines, including the bispecific antibody 'YH32364' targeting 4-1BB and EGFR, and 'YH41723,' a bispecific antibody targeting TIGIT and PD-(L)1. He concluded, "We aim to create the second and third Reclaza by developing ▲precision medicine-based patient-tailored targeted anticancer drugs, ▲next-generation dual-target immuno-oncology drugs, and ▲innovative anticancer drugs based on fusion platform technology, thereby contributing to society through patient-centered future anticancer drug development."