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- 2026-04-28 05:52:11
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- Will Imfinzi finally be reimbursed for biliary tract cancer?
- by Eo, Yun-Ho May 27, 2025 06:18am
- With the advent of an era in which a single drug is used for multiple indications, awareness is growing on the need to address the issue of non-reimbursed indications. In particular, in order to improve Korea’s rigid reimbursement evaluation system, which is regarded as the main cause of reimbursement delays, not only using the flexible application of ICER but also the weighted average price (blended pricing) method for each indication is being specifically discussed. The recent “Policy Debate on Addressing Inequality in Access to Innovative Drugs and Improving Regulatory Frameworks” also focused on the need for system reforms to enhance patient access and discussed the necessity of introducing the blended pricing method in depth. The blended pricing method calculates the average drug price by reflecting the value of each indication for multi-indication drugs and is considered an effective way to enhance patient access while efficiently managing health insurance finances. Italy, France, and Australia are already using this method to secure flexibility in reimbursing innovative drugs. In particular, IBP applies to risk-sharing agreements (RSAs) and is emerging as a realistic alternative due to its high feasibility and lower administrative costs. One example is the PD-L1 inhibitor Imfinzi (durvalumab). This drug was first listed in 2020 for the treatment of non-small cell lung cancer and is currently undergoing the reimbursement process for biliary tract cancer, a disease with limited treatment options. In the poor prognosis setting of biliary tract cancer, where the average survival period was just over 7 months, the emergence of the innovative new drug Imfinzi has brought about a shift in the treatment landscape. Compared to the standard chemotherapy regimen, Imfinzi improved overall survival by more than twofold at the 3-year mark, and in a subgroup analysis of Korean patients, the drug demonstrated superior survival benefits over the overall patient population. However, in Korea, patients' access to treatment is still limited due to the high reimbursement barrier. It has been almost three years since Imfinzi was approved by the Ministry of Food and Drug Safety as a first-line treatment for metastatic biliary tract cancer, but there has been no concrete progress on reimbursement since it was approved by the Cancer Disease Review Committee in November 2024. Jung Yong Hong, Professor of Hematology and Oncology at Samsung Medical Center, said, “The ultimate goal of the government, pharmaceutical companies, and healthcare professionals is to provide the verified treatment benefits of Imfinzi as standard therapy to patients with biliary tract cancer as quickly as possible. We must explore ways to strengthen institutional flexibility to enhance treatment access for patients with bile duct cancer.” Korea applies a relatively strict ICER criteria in the pharmacoeconomic evaluation process for innovative new drugs. The lower the cost of existing treatments and the longer the extended survival period, the more unfavorably the ICER value is set. In other words, when compared to chemotherapy approved 20 years ago, the cost-effectiveness of Imfinzi is difficult to fully reflect under the current evaluation system. It is encouraging that there is a growing movement in Korea to flexibly apply ICER thresholds. In February, the Health Insurance Review and Assessment Service applied more flexible ICER standards than before in the process of evaluating the appropriateness of reimbursement for Trodelvy (sacituzumab), a targeted therapy for triple-negative breast cancer. The government is also gradually promoting institutional improvements to increase patient access to new drugs. At a recent policy debate, Jung-kyu Lee, Director of the Bureau of Health Insurance Policy at MOHW, said, “We agree on the need to introduce blended pricing and will comprehensively review the matter to ensure that innovative new drugs are supplied at the right time,” raising expectations for future system improvements. Given that the government has directly mentioned the possibility of institutional improvements, attention is focused on whether discussions regarding the flexible application of ICER and the introduction of blended pricing will lead to actual cases, enabling prompter access to innovative drugs such as Imfinzi to patients with biliary tract cancer. Meanwhile, countries such as Canada, the United Kingdom, Australia, Japan, and Taiwan have acknowledged the clinical innovativeness of Imfinzi and moved quickly to provide reimbursement. In the case of the UK, considering the dire treatment landscape for biliary tract cancer and the fact that Imfinzi is the first first-line treatment for this indication, an exception was made during pharmacoeconomic evaluations by applying a weighted adjustment to Quality-Adjusted Life Years (QALY), thereby allowing for a more flexible application of the ICER threshold.
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- K-Bios head to ASCO…anticancer drugs to AI predictions
- by Kim, Jin-Gu May 27, 2025 06:18am
- Korean pharmaceutical and biotech companies set out to participate in the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which is just 5 days away. At ASCO 2025, LG Chem's U.S. subsidiary Aveo Oncology, along with Tium Bio, Onconic Therapeutics, and ImmuneOncia, will each present clinical trial results about their anticancer drugs. Lunit plans to introduce a large number of results on the accuracy of AI-derived treatment response predictions for anticancer drugs. ASCO 2025 will be held from the 30th of this month to the 3rd of next month in Chicago, U.S. It is recognized as one of the world's three major cancer academic conferences, along with the American Association for Cancer Research (AACR) and the European Society for Medical Oncology (ESMO). Every year, over 400 companies from 120 countries around the world participate to present the latest cancer data. LG Chem subsidiary Aveo Oncology to announce Phase III trial results for kidney cancer drug Fotivda According to industry sources on the 26th, LG Chem, Tium Bio, Onconic Therapeutics, ImmuneOncia, and Lunit are among the domestic pharmaceutical and biotech companies that will present clinical results at this year's event. LG Chem will present the latest data on its independently developed kidney cancer treatment ‘Fotivda (tivozanib)’ through its US subsidiary Aveo Oncology (AVEO). Aveo Oncology received approval for Fotivda from the European Medicines Agency (EMA) in 2017 and the U.S. Food and Drug Administration (FDA) in 2021. LG Chem acquired Aveo Oncology in 2022 for USD 571 million (approximately KRW 700 billion). The study being presented this time is the global Phase III TiNivo-2 trial. It evaluates the efficacy of Fotivda in combination with Opdivo (nivolumab) or as monotherapy as a second-line treatment for patients with metastatic renal cell carcinoma who have previously received treatment with Opdivo (nivolumab)+Yervoy (ipilimumab) or VEGF TKI +immunotherapy. Given that the previous Phase III clinical trial on the same Fotivda+Opdivo combination failed to meet the primary endpoint, attention is focused on whether the reattempt made by the company with a different clinical strategy succeeded. Aveo Oncology stated that the results of the control group receiving Fotivda monotherapy in the clinical trial confirmed the drug’s potential as a second-line treatment. The company explained that the PFS endpoint demonstrated clinical significance with Fotivda monotherapy. Aveo Oncology will also announce the results of a Phase III trial for its head and neck cancer treatment candidate, ficlatuzumab. Ficlatuzumab is a monoclonal antibody-based targeted anticancer drug that inhibits the action of hepatocyte growth factor (HGF), which promotes tumor growth. LG Chem will present the results of a Phase III trial comparing the combination therapy of ficlatuzumab and Erbitux (cetuximab) with Erbitux monotherapy as a control group for the treatment of head and neck cancer. In addition, the company will present a poster on the Phase Ib dose-escalation trial of AV-380, an anti-GDF15 antibody for the treatment of cancer cachexia. Tium Bio, Onconic Therapeutics, and ImmuneOncia to present interim clinical results Tium Bio will present the interim results from a Phase II clinical trial of its candidate drug 'TU2218' that targets biliary tract cancer and head and neck cancer, in combination with the immunotherapy drug 'Keytruda (pembrolizumab)’ for the first time. TU2218 is an oral dual inhibitor that simultaneously blocks the signaling pathways of 'transforming growth factor (TGF-β)' and 'vascular endothelial growth factor (VEGF),' which are involved in cancer cell growth and metastasis, thereby maximizing the response rate of immunotherapy agents like Keytruda. The company explained that the dual-target mechanism that targets TGF-β and VEGF improves the tumor microenvironment (TME), thereby enhancing the sensitivity. Tium Bio is conducting a Phase II clinical trial on TU2218 to enter the market as a first- and second-line treatment for head and neck cancer and biliary tract cancer. Existing treatments for head and neck cancer and biliary tract cancer have a short overall survival (OS) of 6 months to 1 year. The company explained, “TU2218 has secured significant OS extension data in an with high unmet need.” Onconic Therapeutics will present two clinical data updates related to its next-generation dual-targeted anticancer drug candidate, nesuparib. The first presentation will be about the Phase Ib/II and Phase Ib trials in progress for metastatic pancreatic cancer. Pancreatic cancer is a representative intractable cancer with limited treatment options, and the company explained that the presentation is significant in that it explores the potential of nesuparib as a treatment option for this disease. The second presentation will be about the PENELOPE study, a Phase 2 investigator-initiated clinical trial in progress for endometrial cancer patients. This trial is exploring the combination of Nesuparib and the immune checkpoint inhibitor Keytruda as a new treatment option for endometrial cancer. An Onconic Therapeutics representative said, “The presentations show that nesuparib is receiving attention as a new option in the fields of pancreatic cancer and endometrial cancer, where treatment options are limited. We will accelerate development to benefit patients in need and demonstrate the value of nesuparib through the global oncology community.” ImmuneOncia has also announced plans to present clinical data at ASCO 2025. The presentation is expected to highlight promising results from the Phase Ib clinical trial of IMC-002, a monoclonal antibody targeting the immune checkpoint protein CD47. This drug works by blocking the CD47 and SIRPα signals, thereby enabling macrophages to eliminate cancer cells. Lunit announces AI-derived “anticancer drug response prediction technology” results Lunit will showcase a range of AI-derived technologies for predicting the response to anticancer drugs. Lunit announced that it will present 12 research findings utilizing its AI biomarker platform 'Lunit Scope' at ASCO 2025. The most notable data is the results of a study predicting the efficacy of Enhertu (trastuzumab deruxtecan) in patients with HER2-positive biliary tract cancer. Conducted in collaboration with Japan’s National Cancer Center East (NCCE), the study analyzed 288 immune histochemistry (IHC) slide images of HER2-positive bile duct cancer patients using Lunit Scope's 'uIHC' technology to quantitatively evaluate the intensity of HER2 expression and its distribution within cells (cell membrane, cytoplasm, etc.). The results demonstrated that Lunit AI not only accurately assessed the intensity of HER2 expression but also that the cell membrane specificity of HER2 expression was a better predictor of treatment response in patients. Among 29 patients treated with Enhertu, those with high HER2 cell membrane specificity had a median progression-free survival (mPFS) of 11.0 months, compared to 4.2 months in patients with low cell membrane specificity, indicating improved treatment outcomes. Among the patients identified by AI, additional patients who were not detected by conventional HER2 expression intensity measurement methods were included, suggesting that the AI-derived cell membrane specificity analysis method can identify more patients responsive to Enhertu treatment compared to the conventional method. Additionally, Lunit is presenting research results on AI-based prediction of claudin 18.2 (CLDN18.2) expression and immune phenotype in gastric cancer patients. According to Lunit, claudin 18.2-targeted therapy has emerged as a new alternative for gastric cancer treatment, but practical limitations have arisen due to sample shortages and the additional costs and time required. To address this, Lunit developed an AI model that predicts Claudin18.2 expression using only basic H&E slides. The model demonstrated a high AUROC value of 0.751, indicating its ability to predict Claudin18.2-positive patients in a gastric cancer patient population. Claudin 18.2 expression is also associated with the response to immune checkpoint inhibitors, and it has been confirmed that it significantly extends progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone. Generally, early clinical or preclinical results are presented at AACR, and late-stage clinical results at ASCO, rendering more active technology transfer and partnership discussions at the ASCO event. Given the commercial value of late-stage clinical data, the achievements of domestic pharmaceutical and biotech companies at the event are expected to serve as a stepping stone for their future global market entry.
- Company
- 'Wegovy' dominating the South Korean obesity drug market
- by Chon, Seung-Hyun May 27, 2025 06:17am
- Novo Nordisk's Wegovy has dominated the South Korean obesity treatment market, establishing a monopolistic competition with over 70% market share. In just six months since its launch in Korea, Wegovy generated a sensation, surpassing KRW 100 billion in cumulative sales. Wegovy's success has expanded the obesity drug market to its largest size ever, while sales of Saxenda, which previously led the market, sharply declined. According to pharmaceutical market research firm IQVIA, on May 26, the obesity drug market reached KRW 108.6 billion in the first quarter of this year, a 162.3% increase compared to KRW 41.4 billion in the same period last year. This is the first time the quarterly obesity drug market size has exceeded KRW 100 billion. Quarterly Obesity Treatment Market Size and Key Product Sales. Legend: Bars-obesity market, Black-Wegovy, Purple-Qsymia, Green-Saxenda (Unit: KRW 100 million, Source: IQVIA) Novo Nordisk's Wegovy clearly stood out. In the first quarter, Wegovy's sales recorded KRW 79.4 billion, accounting for a dominant 73.2% of the entire obesity drug market. Wegovy, which was approved by the Ministry of Food and Drug Administration (MFDS) in April 2023, is a GLP-1 analogue containing semaglutide, known to reduce HbA1c. Novo Nordisk developed Wegovy as a once-weekly obesity treatment using semaglutide after observing weight loss effects in patients during clinical trials of GLP-1 class diabetes drug candidates. Wegovy gained immense popularity immediately after its domestic launch in October last year. Despite its high price, prescription demand surged due to its significant weight loss efficacy. Wegovy's sales reached KRW 60.3 billion in the fourth quarter of last year, propelling it to the top of the obesity drug market. The obesity drug market size was KRW 47.4 billion in the third quarter of last year, but it soared by 97.9% to KRW 93.8 billion in just one quarter following Wegovy's launch. Wegovy held a 63.4% market share in the obesity drug market in the fourth quarter of last year, and its share has continued to rise this year. Under six months since its domestic release, Wegovy's cumulative sales reached KRW 139.8 billion, exceeding KRW 100 billion. Wegovy is thriving globally due to its groundbreaking weight loss effects. Wegovy's sales last year reached DKK 58.26 billion (approximately KRW 11.7 trillion), an 85.7% increase from DKK 31.343 billion in 2023. Demand for Wegovy surged to the point of shortages after its launch in the U.S. market. Even before its domestic launch, Wegovy gained global fame for shortages, having been rumored as the weight loss secret of international celebrities like Tesla CEO Elon Musk. Despite its high price of around KRW 500,000, Wegovy gained explosive interest immediately after its domestic release, leading to supply shortages. Even with the suspension of non-face-to-face prescriptions, demand for Wegovy continued to rise. Initially, Wegovy was actively prescribed through non-face-to-face medical consultations. When concerns were raised that Wegovy was being indiscriminately prescribed via non-face-to-face consultations regardless of a person's weight or obesity status, health authorities suspended non-face-to-face prescriptions for obesity treatments from December 16 of last year. The introduction of Wegovy has led to a reduction in sales of Saxenda and Qsymia, which previously dominated the obesity drug market. The presence of Novo Nordisk's Saxenda has significantly declined in the obesity drug market. Saxenda's first-quarter sales were KRW 4.2 billion, down 72.3% from KRW 15.1 billion in the same period last year. Compared to its KRW 24.2 billion sales in the second quarter of last year, its sales have sharply declined to less than 20%. Saxenda, launched in Korea in 2018, was the world's first obesity drug approved as a GLP-1 analog. Saxenda's active ingredient, liraglutide, is identical to Victoza's, prescribed for type 2 diabetes patients, differing only in dosage and administration. The analysis suggests that Wegovy, a GLP-1 class drug similar to Saxenda, has further taken Saxenda's market. With reduced domestic supply since Wegovy's launch, there are rumors of Saxenda's production being discontinued. After becoming the obesity treatment market leader with sales of KRW 42.6 billion immediately after its launch in 2019, Saxenda maintained its lead for five consecutive years until 2023. Saxenda's sales reached KRW 66.8 billion in 2023, accounting for 37.5% of the obesity treatment market that year. However, following the introduction of Wegovy, Saxenda's sales sharply declined, and its market share in the first quarter of this year was only 3.8%. The first-quarter sales of Alvogen Korea's Qsymia decreased by 3.9% year-on-year to KRW 8.6 billion. Launched in late 2019, Qsymia is a combination drug containing 'phentermine' and 'topiramate'. Alvogen Korea secured domestic marketing rights from U.S.-based Vivus in 2017. Alvogen Korea entered a co-promotion agreement with Chong Kun Dang in late 2019 and began full-scale sales in Korea. Qsymia recorded KRW 10.2 billion in sales in the third quarter of last year but fell to 9.3 billion KRW in the fourth quarter, when Wegovy was launched, and has further decreased this year.
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- Re-evaluation possibility of 'Bylvay' gathers attention
- by Eo, Yun-Ho May 26, 2025 05:57am
- Product photo of Ipsen KoreaAttention has been drawn to when 'Bylvay Cap,' the first medicine chosen for the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,' will be re-evaluated. Bylvay (odevixibat), Ipsen Korea's treatment option for progressive familial intrahepatic cholestasis (PFIC) in patients aged 3 months or older, received a decision of reevaluation at the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) meeting held in April. After that, the drug had not been considered for the DREC review in May so it will likely be considered for the upcoming review. As part of implementing the first concurrent approval-evaluation-negotiation pilot project since October, the government selected two medicines, including 'Qarziba (dinutuximab)' for treating rare disease in children and Bylvay, as the first drugs for the pilot project. The concurrent approval-evaluation-negotiation pilot project conducts the Ministry of Food and Drug Safety (MFDS)'s approval, HIRA's drug evaluation, and drug pricing simultaneously, expediting the insurance listing process, including approval, drug evaluation, and the Ministry of Health and Welfare (MOHW) reporting. However, Bylvay not being approved for reimbursement has raised questions about the validity of the expedited listing of selected drugs. Furthermore, Bylvay was challenged at the stage of setting the reimbursement criteria. It has been reported that the company poorly took the expert advice while setting the reimbursement criteria because the expert advice gathering process was reduced to merely a 'formality.' In response, the HIRA stated, "To facilitate DREC's efficient evaluation, HIRA operates a small committee for setting reimbursement criteria before a review. At the small committee meeting, HIRA was reviewed in depth by gathering advice from experts and academics regarding clinical usefulness and cost-effectiveness. It was not indeed a thorough process rather than merely a formality." It is to be watched whether Bylvay, which was selected for the concurrent approval-reimbrusement-drug price pilot project, is to be included in the reimbursement list. Meanwhile, the efficacy of Bylvay was demonstrated through the Phase 3 ASSERT study involving children and adolescent patients aged 17 years and below. The study results demonstrated that Bylvay reduced itchiness statistically significantly compared to a placebo, meeting the primary endpoint. Furthermore, Bylvay statistically improved the average serum bile acid concentration at the primary endpoint target time-points, at week 20 and week 24, than the placebo. This effect of Bylvay continued through 24 weeks of treatment.
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- Pfizer’s Lorviqua is granted reimbursement in Korea
- by Whang, byung-woo May 26, 2025 05:54am
- Lorviqua (lorlatinib), a treatment for ALK-mutated non-small cell lung cancer (NSCLC), has been approved for reimbursement as a first-line treatment, heralding a tectonic shift in the field. Experts saw this as a positive development in addressing unmet patient needs and improving access to treatment. In this sense, the presence of third-generation treatments for ALK-positive metastatic non-small cell lung cancer is expected to grow further. On the 21st, Pfizer Korea held a press conference to commemorate the expanded reimbursement of Lorviqua (lorlatinib), a first-line treatment for ALK-positive metastatic non-small cell lung cancer (NSCLC), highlighting the significance of the milestone. Ji-Youn Han, Professor of Hematology and Oncology at the National Cancer Center Lorviqua is a third-generation ALK tyrosine kinase inhibitor (TKI) designed to be effective against ALK mutations and to effectively penetrate the blood-brain barrier (BBB). In May 2022, it was granted reimbursement as a first-line treatment, 3 years after the indication was expanded to include ALK-positive metastatic non-small cell lung cancer as a first-line treatment. Patients with ALK-positive non-small cell lung cancer account for over 80% of all lung cancer cases and are characterized by relatively young age and a history of minimal or no smoking. Lorviqua’s efficacy as a first-line treatment was confirmed in the global Phase III CROWN trial. According to the 5-year follow-up results of the global Phase III CROWN clinical trial, Lorviqua demonstrated an 81% reduction in the risk of disease progression or death compared to the crizotinib group in patients with no prior treatment experience. Also, the median progression-free survival (PFS) for Lorviqua was not reached at 60.2 months of follow-up, regardless of brain metastasis status, while the median PFS for crizotinib was 9.1 months at 55.1 months of follow-up. According to a 5-year analysis of the CROWN trial, this is the longest progression-free survival rate achieved among ALK-positive non-small cell lung cancer treatments to date. Ji-Youn Han, Professor of Hematology and Oncology at the National Cancer Center who presented at the event, said, “Among non-small cell lung cancer, which accounts for the majority of lung cancer cases, treatment for ALK-positive non-small cell lung cancer, a major genetic mutation, has progressed from the first-generation crizotinib to the third-generation Lorviqua. According to the five-year follow-up analysis of the CROWN study, this is the treatment with the longest median progression-free survival (mPFS) among ALK-positive NSCLC treatments to date.” Han added, “There are studies showing that 25-30% of patients with ALK-positive metastatic non-small cell lung cancer do not receive later-line treatment and that the main cause is rapid clinical deterioration due to tumor progression. The reimbursement of Lorviqua as a first-line treatment is significant in that it addresses unmet needs and greatly improves access to treatment.” Furthermore, the efficacy and safety profile of Lorviqua was consistently demonstrated in studies involving patients in Asia, including Korea. In a study of Asian patients, after 5 years of follow-up, the median PFS for Lorviqua was not reached, while the median PFS for crizotinib was 9.2 months. Furthermore, Lorviqua demonstrated a 99% reduction in the risk of disease progression and death compared to crizotinib at the 5-year mark. However, some have expressed concerns about the risk of central nervous system side effects associated with Lorviqua. One percent of patients who experienced cognitive impairment as an adverse reaction after receiving Lorviqua discontinued treatment. Nevertheless, given that Lorviqua demonstrates superior efficacy compared to existing treatments, Han believes it can become the preemptive choice as a first-line treatment. He stated, “Based on the data, Lorviqua shows positive results in patients with over 5 years of follow-up, so there seems to be no room for second-generation treatments. While there may be cases where the drug is replaced due to CNS side effects, using Lorviqua, which maintains PFS for over 5 years, as a backup and using second-generation treatment first is something patients would not agree to.” In fact, Lorviqua was included in the 2025 National Comprehensive Cancer Network (NCCN) guidelines (recommendation level: Category 1), the 2024 American Society of Clinical Oncology (ASCO, recommendation level: Strong), and the 2023 European Society for Medical Oncology (ESMO, recommendation level: Tier I-A) guidelines as one of the first-line treatments for ALK-positive metastatic non-small cell lung cancer.
- Company
- Accomplishments of the approval-drug price pilot project
- by Eo, Yun-Ho May 23, 2025 05:52am
- Winrevair·Fintepla·Limcato expected to be commercialized With the drugs that were reviewed for approval and drug prices simultaneously about to be commercialized, the industry gathers attention. The Ministry of Health and Welfare (MOHW) has been running the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations' since 2023 to improve treatment access for life-threatening severe·rare diseases. The project conducts approval, reimbursement evaluation, and drug price negotiations simultaneously, aiming to shorten the time required for new drugs to be included in the National Health Insurance list. The first pilot project is at the final stage, showing accomplishments. Three drugs were selected in the second pilot project, which recently completed the selection of items. Typically, it takes approximately 330 days for a new drug to be introduced into the market. This pilot program aims to significantly reduce the time for ▲Product Approval (Ministry of Food and Drug Safety, MFDS) for 120 days ▲DrugReimbursement Evaluation (Health Insurance Review & Assessment Service, HIRA) for 150 days ▲ Drug Price Negotiation (National Health Insurance Service, NHIS) for 60 days. The two drugs selected for the first pilot program (2023) are either already on the reimbursement list or nearing their evaluation process's completion. Following this, ten drugs were submitted for the second pilot program, launched in 2024, and three new drugs were selected. These three are 'Winrevair (sotatercept),' a pulmonary hypertension treatment from MSD Korea; 'Fintepla (fenfluramine),' a Dravet syndrome treatment from UCB Pharma Korea; and 'Limcato,' a large B-cell lymphoma treatment from the Korea-based company Curocell. All three drugs are currently expected to be commercialized in Korea this year. Among them, Winrevair is receiving particular attention. This drug is a first-in-class innovative new drug with a novel mechanism, marking its appearance 20 years after 'Sildenafil', which targeted the NO-sGC-cGMP pathway, in 2005. As of 2023, the number of pulmonary hypertension patients in Korea is approximately 3,600. The average age of these patients is in their 40s, a demographic that plays a crucial role in society and family. Although the 5-year survival rate has significantly improved compared to the past, 3 out of 10 Korean pulmonary hypertension patients still die within 5 years. Furthermore, most patients experience significant difficulties performing daily activities such as housework, childcare, and light outings. Pulmonary hypertension is a rare, intractable, and progressive disease, where delaying the worsening of the condition directly impacts patients' quality of life and survival. To date, no cure through drug treatment has been discovered, and the mechanism of existing drugs primarily aims to alleviate symptoms by relaxing thickened pulmonary arteries. It remains to be seen how quickly drugs undergoing the concurrent approval-evaluation process, including Winrevair, will be listed. The selection criteria for the second pilot program considered drugs that met all of the following conditions: ▲ drugs for which approval and reimbursement decisions can be applied by June 2025 ▲ drugs with sufficient efficacy intended for treating life-threatening diseases with a life expectancy of less than one year, or for rare diseases ▲drugs for which no existing treatment is available or that show clinically significant improvement over current treatments ▲drugs that have been designated for or are eligible to apply for, MFDS's Global Innovative Products on Fast Track (GIFT) program. The MOHW announced December 2024 that it had selected three drugs for the second pilot program. This selection considered factors such as disease severity, availability of alternative drugs, urgency, treatment efficacy, and expert opinions from the submitted applications.
- Company
- CKD-Novartis new drug advances to the next phase trial
- by Chon, Seung-Hyun May 23, 2025 05:52am
- Chong Kun Dang (CKD)'s new drug candidate out-licensed to Novartis is entering the next clinical stage. CKD has secured its first milestone payment of KRW 7 billion, 1 year and 6 months after the technology export contract. CKD announced on May 22 that it expects to receive a milestone payment of USD 5 million (KRW 7 billion) from Novartis, upon the achievement of a stage-based milestone for CKD-510. As Novartis submitted its Investigational New Drug (IND) application for a Phase 2 clinical trial of CKD-510 to the U.S. Food and Drug Administration (FDA), the condition for the milestone payment, as per the contract, was met. CKD is set to receive an additional milestone payment for the first time since the CKD-510 technology export. CKD-510 is a new drug candidate that CKD out-licensed to Novartis in November 2023. It was a blockbuster technology export agreement with a non-refundable upfront payment of USD 80 million. The maximum milestone payment, contingent on development and approval stages, reaches up to USD 1.225 billion. CKD-510 is a new drug candidate researched and developed by CKD. It is an HDAC6 inhibitor developed using a highly selective non-hydroxamic acid (NHA) platform technology. In preclinical studies, the efficacy of the candidate was confirmed in various HDAC6-related diseases, including cardiovascular diseases. Its safety and tolerability were demonstrated in Phase 1 clinical trials conducted in Europe and the United States. CKD has completed the European Phase 1 trial of CKD-510 for Charcot-Marie-Tooth (CMT) disease. CMT is a hereditary peripheral neuropathy where motor and sensory nerves are damaged due to gene mutations, making normal walking and daily life difficult. It is a rare disease, but there is currently no definitive treatment. CKD has strategized to derive optimal drugs for various diseases based on the fundamental structure of HDAC6 inhibitors. CKD is developing new drugs applying its HDAC6 platform technology to CMT disease, Huntington's disease, Alzheimer's disease, hematologic cancers, and autoimmune diseases. Novartis enters a Phase 2 clinical trial for the first time since in-licensing CKD-510. However, Novartis has not disclosed the target indication for CKD-510.
- Company
- Won-dollar rate lowest in 6mths... industry mixed
- by Kim, Jin-Gu May 23, 2025 05:51am
- With the won-dollar exchange rate falling below KRW 1,400, pharmaceutical and biotech companies are experiencing a mix of anticipation and concern. If the prolonged high exchange rate returns to previous levels, API imports and overseas clinical trial costs are expected to decrease, leading to an improvement in the cost structure. On the other hand, some predict that the asset value of pharmaceutical and biotech companies with a high proportion of drug exports will decline. Won-dollar exchange rate falls below KRW 1,400... Will the burden of API purchases and overseas clinical trials decrease? According to industry sources on the 22nd, the won-dollar exchange rate closed at KRW 1,392.60 on the 21st, down KRW 5.40 from the previous trading day. This is a 6.1% (KRW 90.30) decrease from the KRW 1,482.90 on the 10th of last month when concerns over the U.S.’s mutual tariffs were at their peak. The won-dollar exchange rate has remained high for a long time since entering the KRW 1,300 range in March 2023. It rose further to over KRW 1,350 from the middle of last year and broke through KRW 1,400 after the martial law crisis at the end of last year. With mutual tariffs by the US adding to the concern, the exchange rate soared to exceed KRW 1,480 at the beginning of last month. However, the won-dollar exchange rate has been falling this month amid expectations that trade tensions between the US and China will ease. In particular, the exchange rate has remained in the KRW 1,300 range for 4 consecutive trading days since the 16th, raising expectations that the prolonged high exchange rate trend will return to normal levels. KRW to USD exchange rate The pharmaceutical industry is hopeful that the decline in the won-dollar exchange rate will continue, leading to an improvement in the cost structure. Over the past 2 years, the rise in the won-dollar exchange rate has had a negative impact on the cost structure of domestic pharmaceutical and biotechnology companies. Due to their high dependence on imported APIs, the exchange rate increase directly led to higher manufacturing costs. Additionally, since these companies purchase APIs from China and India, with a high import dependency, they were significantly affected by the rise in the won-dollar exchange rate. As of 2023, the self-sufficiency rate for domestically produced APIs for pharmaceuticals stands at 25.4%. Among these, imports of APIs from China account for 30.5% of the total, while those from India make up 15.2%. Together, these two countries account for nearly 50% of the total API imports. Although manufacturing costs rose due to the increase in the won-dollar exchange rate, unlike other consumer goods, the price of finished drugs cannot be arbitrarily set by companies. As a result, the deterioration of the cost structure in the pharmaceutical industry has become more pronounced over the past 2 years. Additionally, the burden of clinical trial costs conducted overseas has steadily increased during the prolonged high exchange rate environment. Most clinical trials targeting the US and European markets are conducted locally. When the won-dollar exchange rate rises, global clinical trial costs also increase accordingly. In this situation, there are expectations that a decline in the won-dollar exchange rate will reduce the cost of importing APIs and the burden of global clinical trials, ultimately improving cost burdens. In the long term, improvements in the cost structure are expected to contribute positively to performance recovery. Asset value decline is inevitable for companies with high export ratios... Samsung Biologics to lose KRW 91.6 billion if exchange rate falls by 10% However, companies with high export ratios, such as Samsung Biologics and Celltrion, are expected to see their asset values decline due to the decline in the won-dollar exchange rate. These companies earn a large amount of assets in dollars overseas, so when the exchange rate rises, their asset values increase. Conversely, when the exchange rate falls, their asset values decline. Samsung Biologics had an overseas sales ratio of 96.5% in the first quarter. Of the KRW 1.2983 trillion in sales rendered in the first quarter, KRW 1.2528 trillion came from overseas. As the proportion of overseas sales is high, its performance is expected to be greatly affected by fluctuations in the exchange rate. Samsung Biologics explained in its quarterly report that a 10% increase or decrease in the won-dollar exchange rate would result in a KRW 91.6 billion increase or decrease in pre-tax income. Considering how the current won-dollar exchange rate has fallen by 1.5% compared to the average exchange rate (KRW 1,452.66) at the time of the quarterly report, the recent decline in the exchange rate is estimated to have reduced asset value by approximately KRW 14 billion. Samsung Biologics has seen an increase in cash and cash equivalents over the past 2 years due to the impact of high exchange rates. The figures were KRW 12.2 billion in 2023 and KRW 41.6 billion last year. This was due to the average won-dollar exchange rate rising from KRW 1,291.95 in 2022 to KRW 1,307.90 in 2023 and KRW 1,363.09 in 2024. The same goes for Celltrion and SK Biopharm. Given their high proportion of overseas sales, they are relatively more affected by fluctuations in the exchange rate. Celltrion saw its cash and cash equivalents increase by KRW 52.4 billion last year due to exchange rate changes. The company explains that, assuming all other variables remain constant, an 8% change in the won-dollar exchange rate would result in a KRW 33.8 billion increase or decrease in pre-tax profit. For SK Biopharm, the change in cash and cash equivalents due to exchange rate fluctuations last year amounted to KRW 3.6 billion. Based on the exchange rate at the end of last year, a 10% change in the exchange rate would result in an increase or decrease of KRW 14.1 billion in the company's pre-tax profit. It is expected that the fluctuation in pre-tax profit due to exchange rate changes will widen further this year if sales of Xcopri increase in the United States.
- Company
- Will Tibsovo be reimbursed for cholangiocarcinoma this time?
- by Eo, Yun-Ho May 22, 2025 06:10am
- Attention is focused on whether the targeted anticancer drug “Tibsovo” for cholangiocarcinoma and acute myeloid leukemia will be successful in its attempt to be reimbursed by health insurance in Korea. Servier Korea’s IDH1 (isocitrate dehydrogenase 1) genetic mutation targeting therapy recently passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee. The drug is indicated for use in IDH1-mutation-positive patients in combination with azacitidine for newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation in adults aged ≥75 years, or who have comorbidities that preclude use of intensive induction chemotherapy, or as monotherapy for locally advanced or metastatic cholangiocarcinoma in previously treated adults with IDH1 mutation. The dual AML indication passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee’s review in October last year, but the cholangiocarcinoma indication had not been approved until now. It remains to be seen whether Tibsovo will be submitted to the Drug Reimbursement Evaluation Committee and complete the reimbursement process in the field of cholangiocarcinoma, where treatment options are limited. Cholangiocarcinoma is a highly aggressive cancer with a poor prognosis, with a 5-year relative survival rate of just 28.9%. In particular, 65% of patients with intrahepatic cholangiocarcinoma are diagnosed at an advanced stage where surgery is not feasible. Tibsovo is the only targeted therapy recommended by the National Comprehensive Cancer Network (NCCN) in the highest category (Category 1) as a second-line treatment for bile duct cancer. According to the Phase III ClarlDHy trial, Tibsovo reduced the risk of disease progression by 63% compared to placebo, with a median progression-free survival (PFS) of 2.7 months (1.4 months in the placebo group). Additionally, the median overall survival (mOS) was 10.3 months in the Tibsovo group, more than twice as long as the 5.1 months in the placebo group. Do-Youn Oh, Professor of Hematology-Oncology at Seoul National University Hospital, stated, “The development of drugs for cholangiocarcinoma has accelerated significantly in recent years. As new drugs are being developed, many companies are also actively working on the development of treatments for cholangiocarcinoma. Patients with cholangiocarcinoma must follow the doctors’ guidance and receive appropriate treatment rather than feeling discouraged, so they can participate in clinical trials and access new treatment opportunities.” Meanwhile, in the Phase III AGILE study that enrolled patients with acute myeloid leukemia, Tibsovo demonstrated improved event-free survival (EFS) when used in combination with azacitidine, and also significantly improved overall survival (OS). The median OS in the Tibsovo-treated group was 24.0 months (7.9 months in the placebo group), and long-term follow-up results showed that the median OS with Tibsovo combination therapy was 29.3 months, over 3.7 times longer than with placebo combination therapy. Kyu-Pyo Kim, Professor of Oncology at Asan Medical Center, said, “Tibsovo is indicated for IDH1 mutation-positive cholangiocarcinoma and acute myeloid leukemia, and has demonstrated excellent efficacy and safety in clinical studies. Considering that both studies allowed crossovers, the significant improvement in survival is a very meaningful result.” He added, “Given the limited treatment options for cholangiocarcinoma and acute myeloid leukemia, the emergence of a new targeted therapy with promising efficacy is expected to contribute to improving treatment outcomes and quality of life for patients with these diseases in Korea.”
- Company
- SK Bioscience wins the '8-year Prevenar patent dispute'
- by Kim, Jin-Gu May 22, 2025 06:09am
- In a patent infringement trial against Pfizer involving SK Bioscience's export of 'SKYPneumo' raw solution, SK Bioscience has won after eight years. The latest ruling is expected to enable SK Bioscience's global export of its pneumococcal conjugate vaccine 'SKYPneumo' raw solution. Ruling that 'Exporting SK Bioscience's SKYPneumo raw solution does not infringe on the patent'…an opportunity has been presented to export According to SK Bioscience, on May 21, the Supreme Court of Korea ruled in favor of SK Bioscience in a legal dispute filed by Pfizer for 'Cessation of infringement of Pfizer's Prevenar 13 (PCV13) pneumococcal conjugate vaccine patent.' The Supreme Court recently upheld the second trial ruling, which ruled in favor of SK Bioscience. SK Bioscience and Pfizer long fought over whether the overseas supply of SKYPneumo's raw solution infringes on Pfizer's 'Prevenar 13.' This eight-year legal battle began in 2017 when Pfizer filed a patent infringement lawsuit. The Supreme Court ruled that "Producing and supplying PCV13 finished products for research purposes does not infringe on the patent," adding, "Individual conjugates that make up PCV13 do not fall within the scope of the patent claim." It is analyzed that the Supreme Court's final ruling favoring SK Bioscience is expected to open the door for SK Bioscience to export SKYPneumo raw solution overseas. SK Bioscience says, "While supplying PCV13 finished products is not permitted, the latest ruling presents an opportunity for supplying individual conjugates overseas," and added, "We plan to initiate a new project to supply raw solution of individual conguates to regions with high vaccine demand, such as Southeast Asia and Central and South America. We also intend to pursue technology transfer through local partnerships." SK Bioscience vs. Pfizer: Patent Invalidation·Infringement Lawsuits…3 out of 4 cases transferred to the Supreme Court In addition to this case, the dispute between SK Bioscience and Pfizer surrounding the Prevenar 13 patent has been ongoing for a long time, including 'patent invalidation' lawsuits filed by SK Bioscience and 'cessation of patent infringement' lawsuits counter-filed by Pfizer. First, SK Bioscience challenged two related patents after developing SKYPneumo, a follow-up product to Prevenar 13. SK Bioscience challenged two of Pfizer's Prevenar 13-related patents: ▲Expiring in March 2026, 'a novel formulation that stabilizes immunogenic compositions and prevents precipitation' patent ▲Expiring in April 2027, 'a multivalent pneumococcal polysaccharide-protein conjugate composition' patent. SK Bioscience filed invalidation trials for both patents. Among these, the patent expiring in 2026 was successfully invalidated. The Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of SK Bioscience in January 2020, and the decision was finalized without an appeal from Pfizer. On the other hand, the patent expiring in 2027 ultimately failed to be invalidated. SK Bioscience argued for the invalidation of this patent, but received a dismissal from IPTAB in June 2015. SK Bioscience also lost in the second trial, which proceeded with SK Bioscience's appeal, in November 2017. SK Bioscience decided to appeal to the Supreme Court. However, they again received a losing ruling from the Supreme Court in 2018. In conclusion, the patent expiring in March 2026 was successfully invalidated, while the patent expiring in April 2027 was not. Consequently, domestic sales of SKYPneumo are prohibited until April 2027. Pfizer counter-filed a patent infringement prohibition lawsuit against SK Bioscience during this process. In 2017, Wyeth LLC, the patent holder of Prevenar 13, and Pfizer Korea, the domestic distributor, filed a lawsuit claiming that SKYPneumo infringed on their patent rights. This lawsuit also went to the third trial. Ultimately, the Supreme Court issued a recommendation for settlement in 2019, essentially siding with Pfizer. The Supreme Court ruled that Pfizer's patent was valid and prohibited the production and launch of SK Bioscience's SKYPneumo until 2027. SK Bioscience voluntarily withdrew the product approval for SKYPneumo. However, they re-obtained approval for SKYPneumo in June 2021. The conflict between the two companies continued thereafter. Facing difficulties with the domestic launch, SK Bioscience signed a license agreement to transfer related technology to a Russian pharmaceutical company to develop vaccines in that region. SK Bioscience supplied raw solution for its self-developed pneumococcal vaccine and finished pharmaceutical products for research. Pfizer and Wyeth LLC also interfered with this, filing a cession of patent infringement lawsuit in 2020. SK Bioscience countered, arguing that supplying raw solution for research and testing purposes, not finished products, to overseas markets was outside the scope of patent infringement. In August 2023, Pfizer won in the first trial. SK Bioscience appealed, and ultimately, the Patent Court overturned the first trial ruling and sided with SK Bioscience. This time, Pfizer appealed to the Supreme Court after losing in the second trial. Finally, the Supreme Court upheld the original ruling in the appeal. The two companies engaged in a long-term battle, going to the Supreme Court for three out of four cases, including patent invalidation lawsuits and patent infringement lawsuits. With this, most disputes between the two companies concerning the Prevenar 13 patent have been concluded. However, a trade commission dispute remains. The Korea Trade Commission under the Ministry of Trade, Industry and Energy is investigating SK Bioscience's unfair trade practices. This is because Pfizer and Wyeth LLC have filed a complaint requesting a cessation on exporting SK Bioscience's pneumococcal raw solution. In the pharmaceutical industry, there is an outlook that the trade commission dispute surrounding the export of pneumococcal raw solution will also be concluded soon due to this Supreme Court ruling.
