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Company
Samsung Bioepis recruits Lina Choi as new global head
by
Nho, Byung Chul
Sep 19, 2024 05:48am
Lina Choi named as new global head for Samsung Bioepis. Samsung Bioepis garners attention as the company recruits specialists to strengthen its global entry capacity. Sources said that Samsung Bioepis has recruited Linda Choi, Vice President, as the Head of Global Commercial in August. Choi studied pharmacy at Ohio State University College of Pharmacy and has 28 years of experience in multinational pharmaceutical companies. She is recognized as a specialist with expertise in sales and marketing. Choi started a career at Eli Lily in the United States, where she served as Senior Director. At UCB Biopharma in Belgium, Choi was the chief operating officer for global marketing. Before joining Samsung Bioepis, Choi also served as the Chief Operating Officer (COO) at AVANIR, Japan's Otsuka Holdings subsidiary, and ADESIS, a U.S.-based CDMO. By recruiting Choi, who has years of experience in the global biopharmaceutical industry, Samsung Bioepis is expected to further strengthen biosimilar product sales in the global market. Samsung Bioepis has commercialized 9 biosimilar products in immunology, oncology, ophthalmology, and hematology. Partnering with Biogen, Organon, and Sandoz, Samsung Bioepis sells 8 products in Europe and 4 in the United States. In addition to partnership deals, Samsung Bioepis focuses on establishing an independent sales network overseas. For 'Episcli,' a rare disease drug launched in Europe in July 2023, Samsung Bioepis' local subsidiary was responsible for direct sales. Samsung Bioepis has become the company with the most FDA-approved biosimilar antibody products after obtaining eight marketing authorizations from the U.S. FDA. The company expects to launch Stelara biosimilar (U.S. product name, 'Pyzchiva') in the United States. Samsung Bioepis plans to expand its product portfolio for various diseases in the global market.
Company
Will Columvi be reviewed for reimb by CDDC in OCT?
by
Eo, Yun-Ho
Sep 19, 2024 05:48am
Demand is rising for the reimbursement of ‘Columvi,’ the first bispecific antibody treatment option for lymphoma, in Korea. The Korea Leukemia Patients Organization has requested the CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) be redeliberated at the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee meeting that will be held in October. In addition, the organization urged the manufacturer, Roche Korea, to come up with a financial sharing plan to accelerate the drug’s reimbursement listing. “Columvi is a third-line treatment that can be immediately used in situations where death can occur within a few months,” said KIPO, adding, “Patients with diffuse large B-cell lymphoma who have failed two or more lines of treatment strategies are sincerely awaiting Columvi’s prompt health insurance reimbursement listing.” The drug was presented for deliberation to the CDDC last July but failed to make the cut for reimbursement. However, Roche recently submitted an application again for its reimbursement. It remains to be seen if the hopes of the medical community and patient groups for Columvi’s reimbursement listing will be fulfilled this time. Columvi was approved in Korea last December for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. The drug is a third-line treatment option for DLBCL, like Novartis’s chimeric antigen receptor (CAR)-T-cell therapy Kymriah (tisagenlecleucel). The two drugs have different benefits; therefore the choice will likely be based on each patient's condition and circumstance. Columvi demonstrated efficacy in Phase I/II NP30179 trial in 155 patients with relapsed or refractory DLBCL after two or more prior systemic therapies. Results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate(ORR) of 52%. The efficacy was also consistent across all subgroups. The most common adverse event was cytokine release syndrome (CRS). Adding to the encouraging data, at the 2024 Congress of the European Hematology Association (EHA 2024), the company unveiled the results of the Phase III STARGLO study, which demonstrated an improvement in overall survival (OS) with Columvi. The STARGLO study enrolled patients with relapsed or refractory (R/R) diffuse DLBCL who were not eligible to receive an autologous stem cell transplant after one or more prior systemic therapies, or who had received two or more prior systemic therapies. In the primary analysis (median follow-up 11.3 months), Columvi and gemcitabine+oxaliplatin (GemOx) combination significantly improved the primary endpoint of OS with a 41% lower risk of death compared to rituximab+GemOx. Seok Jin Kim, Professor of Hematology and Oncology at Samsung Medical Center, said, "There had been much unmet need in DLBCL for more effective third-line treatment options for patients who fail first-line or experience repeated relapses. We expect the introduction of Columvi to significantly improve the outcomes for patients with relapsed or refractory lymphoma in Korea." Although the drug is non-reimbursed, the drug can be prescribed in various general hospitals in Korea. The drug has passed the drug committees (DCs) of Samsung Medical Center, Seoul Asan Medical Center, Sinchon Severance Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital, Ulsan University Hospital, Korea University Anam Hospital, Wonju Severance Christian Hospital, and Chonnam National University Hwasun Hospital.
Company
Reimb for orphan drug 'Welireg' for cancer has been denied
by
Eo, Yun-Ho
Sep 19, 2024 05:48am
An orphan drug, 'Welireg,' for cancer still faces challenges in entering insurance reimbursement coverage. Sources said that MSD Korea is preparing to reapply for reimbursement review of its oral hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), after failing to pass the Cancer Disease Review Committee (CDRC) review last month. MSD Korea filed a reimbursement application in April, and the issue was posted on a national petition platform in May. The petition had received over 50,000 signatures, but the drug did not pass the hurdle of the CDRC review. The analysis suggests that finance will be a determining factor for the outcome. Welireg received an orphan drug designation in South Korea last year for its rare indication to treat von Hippel-Lindau (VHL) disease. It won final approval in May last year. The drug is indicated to treat adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery. The drug has a mechanism of reducing cell proliferation, new blood vessel growth, and tumor growth-associated HIF-2α targeting gene transcription and expression. The efficacy of Welireg was demonstrated through an open-label Study-004 clinical trial, which involved 61 patients with VHL-associated RCC who had at least one measurable solid tumor localized to the kidney. Enrolled patients had other VHL-associated tumors, including CNS hemangioblastomas and/or pNET. The primary endpoint for the clinical trial was an objective response rate (ORR), evaluated radiologically by independent central review according to RECIST v1.1. Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). The results showed that the ORR for patients with VHL-associated RCC treated with Welireg was 49%. All other responses were partial responses. The treatment has yet to reach the median for DoR. The percentage of patients who continued responding after 12 months was 56%. The median TTR was 8 months. In 24 patients with VHL-associated CNS hemangioblastomas, the ORR was 63%. This group had a 4% complete response rate and a 58% partial response rate. Recently, Welireg also added an indication to treat RCC in the United States. The efficacy of the drug was demonstrated through the LITESPARK-005 clinical trial, which involved advanced RCC that has progressed following PD-1 and/or PD-L1 inhibitor or VEGF-TKI therapies. Based on the results, Welireg improved progression-free survival (PFS) compared to everolimus in patients with RCC that has progressed following PD-1 or PD-L1 immune checkpoint inhibitor or VEGF receptor targeting therapies. The drug also reduced the disease progression and death risk by 25%.
Company
JAK inhibitor 'Jyseleca' approved for use at 'Big 5'
by
Eo, Yun-Ho
Sep 13, 2024 05:50am
Product photo of Jyseleca. The JAK inhibitor 'Jyseleca' has been successfully introduced to general hospitals. Sources said Jyseleca, the fifth JAK inhibitor in South Korea, has passed the drug committees (DC) of 'Big 5' tertiary hospitals, including Samsung Medical Center, Seoul University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. The drug also passed DC of medical centers, including Kangbuk Samsung Hospital, Korea University Anam Hospital, Cha University Bundang Medical Center, Sejong Chungnam National University Hospital, Ulsan University Hospital, Konkuk University Hospital Chungju Hospital, and Hanyang University Medical Center, as well as national university hospitals in major cities. Considering that it is the fifth approved JAK inhibitor in South Korea, it has quickly become available for prescription at hospitals following reimbursement listing in November last year. Jyseleca’s initial indication for reimbursement was for the treatment of rheumatoid arthritis and moderately to severely active ulcerative colitis. Its reimbursement criteria are set for individuals who have had an inadequate response to conventional therapies or have no drug tolerance to each disease. For those who are over 65 years old, the criteria are set for individuals who have had an inadequate response to TNF-α inhibitors or have no drug tolerance. In South Korea, JAK inhibitors, such as 'Xeljanz (tofacitinib),' 'Olumiant (baricitinib),' and 'Rinvoq (upadacitinib),' are being prescribed. It is to be watched whether Jyseleca would have a competitive advantage over these drugs. Since their launch, these drugs have been expanding indications and reimbursement criteria. Xeljanz additionally secured indications for ulcerative colitis and psoriatic arthritis, and latecomers, such as Rinvoq, are also expanding prescription areas in autoimmune diseases, including atopic dermatitis, Chron’s disease, and ankylosing spondylitis. Since their launch, these drugs have been expanding indications and reimbursement criteria. Xeljanz additionally secured indications for ulcerative colitis and psoriatic arthritis, and latecomers, such as Rinvoq, are also expanding prescription areas in autoimmune diseases, including atopic dermatitis, Chron’s disease, and ankylosing spondylitis. Consequently, patients are expected to have improved treatment options for rheumatoid arthritis. Of course, the use of JAK inhibitors, including Jyseleca, will substantially increase. According to the market research firm UBIST, the JAK inhibitor outpatient prescription market size for the first half of 2023 was KRW 27.5 billion, up by 54% from KRW 17.8 billion year over year. Meanwhile, Jyseleca is a selective ATP-competitive and reversible JAK1 inhibitor. JAK1 transmits signals from a cytokine, and it is regarded as the key target for the treatment of rheumatoid arthritis. Recently launched treatments inhibit JAK2 or JAK3, depending on their mechanism. However, there are concerns that adverse reactions may occur, as two signaling pathways regulate immune cell proliferation and homeostasis. The FINCH1, FINCH2, and FINCH3 Phase 3 trials have demonstrated the effectiveness of Jyseleca. In the FINCH1 trial, Jyseleca 200 mg treatment in patients with moderately to severely active rheumatoid arthritis reached ACR20 at 20 weeks more quickly despite continued treatment with MTX.
Company
Global guidelines recommend Leclaza combination therapy
by
Son, Hyung-Min
Sep 13, 2024 05:49am
Leclaza plus Rybrevant combination therapy has been listed as a first-line therapy in global guidelines after demonstrating improvements in survival rates. Leclaza plus Rybrevant combination therapy, which is the new treatment for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), received U.S. Food and Drug Administration (FDA) approval as a first-line therapy last month. This combination therapy showed statistically improved progression-free survival (PFS) and overall survival (OS) than Tagrisso monotherapy. Leclaza plus Rybrevant combination therapy has been listed in the NCCN guideline…demonstrated clinical effectiveness Product photos of YuhanSources said on September 12th Leclaza plus Rybrevant combination therapy has been recommended by the National Comprehensive Cancer Network (NCCN) as a first-line therapy based on its recent clinical effectiveness. As a result, the combination therapy now has an expert assessment that it can be used as a first-line therapy for treating NSCLC harboring mutations of EGFR in exon 19 and exon 21. The NCCN provides guidelines recommending cancer diagnosis, treatment, and prognosis. It is an alliance of 33 centers, including the U.S. National Cancer Center and research centers. Physicians worldwide use the NCCN as the primary cancer diagnosis and treatment guideline. As the NCCN recommends Leclaza plus Rybrevant combination therapy, its presence as a first-line therapy is expected to be expanded. Until now, the NCCN and other guidelines have recommended Tagrisso monotherapy, a third-generation tyrosine kinase inhibitor (TKI) targeting exon 19 and exon 21, for the treatment of NSCLC harboring EGFR mutations. However, Leclaza, the third-generation TKI like Tagrisso, and Rybrevant, targeting mutation in EGFR exon 20, have shown more effective results than Tagrisso monotherapy. This indicates a potential change to the major cancer treatment guidelines. The OS results of Leclaza plus Rybrevant combination therapy are suggested to be the key to commercialization. Moreover, inclusion in the NCCN guidelines is a significant achievement. Leclaza plus Rybrevant combination therapy shows continual benefits…3-year OS follow-up data have been disclosed Leclaza plus Rybrevant combination therapy is listed in the NCCN due to its proven effectiveness results. In terms of interim OS analysis, Leclaza plus Rybrevant combination therapy showed superior benefits than Tagrisso. These clinical results were from the Phase 3 MARIPOSA study, which was disclosed during the European Society for Medical Oncology (ESMO) conference and the annual World Conference on Lung Cancer (WCLC) conference. The clinical trial compared the effectiveness and safety of Leclaza plus Rybrevant combination therapy to Tagrisso monotherapy. The patients were randomly assigned at a 1:1 ratio to either the Leclaza plus Rybrevant combination therapy group (429 individuals) or the Tagrisso group (429 individuals). The clinical trial showed that 61% of the Leclaza plus Rybrevant combination therapy group had a three-year OS rate, which was higher than 53% of the Tagrisso monotherapy group. 75% of the Leclaza plus Rybrevant combination therapy group had a two-year OS rate, whereas 70% for the Tagrisso group. Leclaza plus Rybrevant combination therapy shows continued benefits than Tagrisso monotherapy in terms of the overall survival (OS) rate. The median follow-up of 31.1 months showed that 155 patients of the Leclaza plus Rybrevant combination therapy group had a disease progression and discontinued further treatment, whereas 233 patients of the Tagrisso group discontinued further treatment due to disease progression. Then, the patients received follow-up therapies using chemotherapy, such as Alimta (pemetrexed) plus carboplatin. The second PFS (PFS2) measurement showed that the Leclaza plus Rybrevant combination therapy group had a significantly longer median time between treatment discontinuance and follow-up therapy than the Tagrisso group. Additionally, Leclaza plus Rybrevant combination therapy showed positive results for the intracranial PFS, which is an indicator for brain metastasis. The results showed that the median PFS, which was set as the primary endpoint, for Leclaza plus Rybrevant combination therapy was 23.7 months. The Leclaza monotherapy group had a median PFS of 18.5 months, longer than 16.6 months for the Tagrisso monotherapy group. Leclaza plus Rybrevant combination therapy also reduced the disease progression and death risk by 30% compared to the Tagrisso group. The PFS2 results showed that the Leclaza plus Rybrevant combination therapy group had a 25% lower disease progression and death risk than the Tagrisso monotherapy group. Researchers stated, "Leclaza plus Rybrevant combination therapy is showing improvements in the outcomes of disease progression as well as OS than Tagrisso monotherapy," adding, "We have confirmed Leclaza plus Rybrevant combination therapy is a first-line standard therapy for EGFR-mutated advanced NSCLC."
Company
Hugel offers guide to safe injection of dermal fillers
by
어윤호
Sep 12, 2024 04:16pm
Dr. Jung Jae Eun, the medical director of DICARATCLINIC in Seoul, performs a live demonstration of injection of dermal filler The ChaeumHugel Inc., a leading global medical aesthetics company, said on Thursday it hosted The Chaeum Safe-tech Session (TSS) seminar for injection of dermal fillers for some 20 medical experts in Seoul on September 11 to improve their understanding of safe treatment and Hugel’s hyaluronic acid filler brand The Chaeum. The lecture covered anatomical knowledge of filler administration in key facial areas and critical points that practitioners should be aware of. Following the lecture, Seoul-based DICARATCLINIC’s Medical Director Jung Jae Eun performed a live demonstration focusing on injecting techniques for nasolabial folds, forehead, cheeks and lips and explained the importance of safe filler injection. Dr. Jung, advisor on The Chaeum, has extensive experience in filler injection and uses more than 3,000 syringes of The Chaeum a year. She highlighted providing safe and professional medical services and strengths of The Chaeum fillers in the seminar. “We are very pleased to have successfully hosted the seminar with The Chaeum advisor Dr. Jung to meet medical aesthetics professionals and share knowledge and skills. Hugel will continue to host academic events for proper use of fillers,” a Hugel official said. “Diagnostic accuracy and delicate skills are essentials for effective filler injection. With Hugel, we will strive to promote knowledge and skills in the use of The Chaeum which has proven its safety for over the past 10 years in the market,” Dr. Jung said.
Company
Yuhan earns ₩80B milestone with Leclaza's FDA nod
by
Chon, Seung-Hyun
Sep 12, 2024 05:51am
On the 11th, Yuhan Corp announced that it will receive USD 60 million (approximately KRW 80 billion) as milestone payments from Janssen Biotech for Leclaza. View of Yuhan Corp headquarters The company explained, “This is a milestone payment (step-by-step technical fee) for the commercialization of Leclaza and Janssen Biotech's amivantamab combination therapy.” The US Food and Drug Administration (FDA) has approved Yuhan Corp’s Leclaza in combination with Rybrevant for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. With the approval, Leclaza became the first homegrown new anticancer drug to receive US approval. Leclaza is a non-small cell lung cancer treatment approved as the 31st domestically developed new drug in January 2021. Yuhan Corp succeeded in passing the US market gateway 6 years after licensing out Leclaza to Janssen Biotech in November 2018. In November 2018, the company received a USD 50 million upfront payment for Leclaza. In April 2020, the company received a USD 35 million milestone payment from Janssen. Johnson & Johnson paid the additional milestone to the company when it initiated the clinical trial for the Rybrevant and Lexarza combination. In November 2020, Johnson & Johnson paid an additional milestone of USD 65 million to Yuhan Corp as it began recruiting subjects for the trial. Additional milestone payments followed upon successful completion of the trial and FDA approval. In total, Yuhan Corp has earned a total of USD 210 million (KRW280 billion) in technology fees since licensing out Leclaza’s technology.
Company
HK inno.N signs supply deal with Pfizer for COVID-19 vaccine
by
Son, Hyung-Min
Sep 12, 2024 05:51am
(from left) Pfizer Korea CEO Oh Dong-wook and HK inno.N CEO Kwak Dal-won. HK inno.N announced on September 11th that it has signed an agreement with Pfizer Korea for the domestic distribution of the new COVID-19 vaccine. On September 10th, two companies held an agreement ceremony celebrating the strategic collaboration for the distribution of Pfizer Korea's COVID-19 vaccine, 'Comirnaty JN.1 Inj (bretovameran),' which is a SARS-CoV-2 Spike Protein encoded messenger Ribonucleic Acid. Attendees for the agreement ceremony included HK inno.N CEO Kwak Dal-won, Pfizer Korea CEO Oh Dong-wook, and employees who have contributed to the deal from both companies. Upon the agreement, HK inno.N will be responsible for the domestic distribution of Pfizer's new COVID-19 vaccine for the general public, excluding high-risk groups (people aged 65 and older and the immunocompromised individuals) eligible for the National Immunization Program. 'Comirnaty JN.1 Inj' is an mRNA vaccine designed to produce antigen against COVID-19's JN.1 variant. It is administered as a single intramuscular injection of 0.3 mL without dilution to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals over 12 and older. Comirnaty JN.1 Inj was approved in South Korea on August 30th. HK inno.N CEO Kwak Dal-won said, "With the recent rise in COVID-19 infection numbers, we plan to swiftly supply COVID-19 vaccines through our distribution partnership and contribute to public health." Pfizer Korea CEO Oh Dong-wook said, "We are pleased to have signed an agreement with HK inno.N, a company with broad-spectrum know-how of vaccine supply and years of experience," adding, "Through close collaboration among companies to supply COVID-19 vaccines to the market, we can help more patients receive immunization."
Company
Celltrion aims for KRW 5T sales with 'ADC‧CDMO'
by
Hwang, Byung-woo
Sep 12, 2024 05:51am
Celltrion aims to achieve KRW 5 trillion in sales by 2025 based on the growth of the biosimilar pipeline and new business operations. Celltrip Group President Seo Jung-jin (center) and Celltrion CEO Seo Jin-seok (right). Celltrip Group President Seo Jung-jin and Celltrion CEO Seo Jin-seok announced on September 9th that they have participated in the 'Morgan Stanley 22nd Annual Global Healthcare Conference' in the United States on September 6th and presented the group's strategic plan for the future. Morgan Stanley Global Healthcare Conference is an event hosted by the global investment bank (IB) Morgan Stanley. It invites promising biotechnology companies worldwide and provides an opportunity to meet with global institutional investors. This year marks the 22nd event. Celltrion Group participated in a presentation session titled 'From Pioneer to Innovator.' The group presented the group's new drug pipeline and disclosed the ongoing development and schedule of follow-up biosimilars. For its biosimilar business sector, Celltrion plans to receive 11 product approvals by 2025 and secure a 22-product portfolio by 20203 to expand market dominance. In addition to studying autoimmune diseases, the group will expand the treatment field to asthma·rash, ophthalmology, and metabolic bone disease. Celltrion also focuses on strengthening collaboration with prescription benefit managers (PBM) to increase sales efficiency. Celltrion has secured a sales expansion foundation by signing agreements with the top 3 PBM companies over prescription reimbursement within six months after the launch of Zymfentra in the United States in March. According to the company, target sales for Zymfentra will likely reach KRW 250 billion this year. Additionally, other biosimilar products have a continuously expanding market presence. As a result, the company is expecting to reach target sales of KRW 3.5 trillion. The analysis suggests that Celltrion can reach KRW 5 trillion in sales next year if Zymfentra continues expanding its market presence as planned. Furthermore, Celltrion has a high expectation for improving revenue as its merger with Celltrion Healthcare is nearing completion. Celltrion emphasized that the temporarily increased cost to sales rate upon merger is quickly being reduced, and the sales and margin rate will rise with time. Celltrion will start developing antibody-drug conjugates (ADC) and multispecific antibodies as a new drug pipeline this year. By next year, the company will announce new drug candidates that are 'best-in-class.' Celltrion has selected three ADCs and three multispecific antibodies and started development. The company aims to commercialize its first product by 2029. Celltrion will disclose two new ADCs nearing completion and plans to enter clinical stages by next year. President Seo stated, "We must build additional manufacturing plants to secure product manufacturing capacity for a sustainable future. The company will decide on securing new plants in South Korea or overseas within this year," adding, "New facilities will be incorporated as a wholly owned subsidiary, and the group will use those for CDMO businesses."
Company
Switching between JAKis reimbursed for rheumatoid arthritis
by
Eo, Yun-Ho
Sep 12, 2024 05:50am
JAK inhibitors being prescribed in Korea The issue of reimbursement being not allowed for switching between JAK inhibitors in rheumatoid arthritis, which has been a pet peeve on site, will be resolved soon. According to Dailypharm coverage, the health authorities decided to allow insurance reimbursement benefits for cross-dosing between JAK inhibitors in rheumatoid arthritis in October. Currently, 4 drugs are prescribed for rheumatoid arthritis in Korea, including Pfizer Korea’s Zelanz (tofacitinib), Lilly's Olumiant (baricitinib), AbbVie's Rinvoq (upadacitinib), and Eisai Korea’s Jyseleca (filgotinib). As such, the treatment landscape for rheumatoid arthritis is expected to improve significantly starting next month. The government has been adhering to the position that it is difficult to reimburse switching JAK inhibitors due to the lack of clinical evidence. However, after continuous statements submitted by the Korean College of Rheumatology and other organizations, as well as prescription experience on cross-dosing, the government reconsidered its position and came to a positive conclusion. Meanwhile, the reimbursement for switching is expected to further boost the market for JAK inhibitors. According to the market research institution UBIST, the outpatient prescription market for JAK inhibitors was worth KRW 27.5 billion in the first half of last year. This is a 54% increase in 1 year compared to KRW 17.8 billion in the first half of last year. The market for JAK inhibitors is expanding at a rapid pace. The market, which had been around KRW 12.5 billion in 2019, had expanded to KRW 18.7 billion in 2020, KRW 25.5 billion in 2021, KRW 33.5 billion in 2022, and KRW 40 billion last year. This year, the market reached KRW 27.5 billion in the first half of the year alone and is expected to exceed KRW 50 billion by the end of the year.
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