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- 2025-12-21 12:35:45
- Policy
- Lee ‘promises support for essential medicine companies’
- by Kang, Shin-Kook May 29, 2025 05:50am
- Jae-Myung Lee, presidential candidate for the Democratic Party of Korea, promised to support pharmaceutical companies producing essential medicines. On the 28th, Lee posted on his social media, “The state will take responsibility for supporting the supply of essential medicines. Over the past 5 years, the supply of over 100 essential medicines has been discontinued due to poor sales and deteriorating profitability. If essential medicines are not supplied on time, the damage will ultimately fall on the people.” He also stated, “We will expand the emergency introduction of essential medicines through the Korea Orphan & Essential Drug Center and push for support for domestic pharmaceutical companies.” Additionally, Lee noted, “Last year, there were 370,000 patients with rare diseases and 750,000 patients with severe and intractable diseases. This represents a 27.4% increase over the past 5 years.” He emphasized, “For these patients, what’s even harder to bear than the disease itself is that there is either no treatment available or the existing one is too expensive to afford?” He added, “The state must stand close to the pain of its people. We will ensure that patients with rare and intractable diseases are diagnosed early and receive timely treatment. We will strengthen the medical safety net with broader and thicker coverage.” The candidate promised to reduce the burden of medical expenses for patients with rare and intractable diseases. Currently, the out-of-pocket maximum system reimburses medical expenses exceeding a certain annual threshold, but this remains a significant burden for patients and their families who must pay large sums upfront. The candidate emphasized, “We will gradually reduce the out-of-pocket coinsurance rate under the health insurance special calculation system for rare and severe intractable diseases from the current 10%. We will alleviate concerns about treatment costs.” He also stated, “We will expand health insurance coverage for treatments for severe and rare intractable diseases. Currently, only about half of rare drugs are covered by health insurance. We will expand coverage to improve access to treatment and reduce the economic burden.” Additionally, he declared, “The primary responsibility of the state is to protect the lives of its citizens. We will build a country that does not give up on rare diseases or turn away from intractable diseases.”
- Company
- Global expansion in sight for organoid leader CellArtgen
- by Whang, byung-woo May 28, 2025 05:58am
- Organoids, miniature organs composed of cells, are emerging as a technology to replace animal testing in the pharmaceutical and biotechnology industry. With the field of organoids gaining attention, the activities of CellArtgen, which was founded by Cho Seung-woo, a leading expert in the field and professor at Yonsei University's Department of Biotechnology, have also been drawing attention. Based on its core platform technology patents, the company has been expanding its presence by building advanced drug evaluation platforms, including the organoid disease platform 'ORANOSCREEN.’ Seung-Woo Cho. CEO of CellArtgen (Professor of Biotechnology, Yonsei University) CellArtgen was founded by Seung-Woo Cho, one of the world's leading experts in advanced biomaterials and organoid technology. As the company was established with an academic foundation, the company's strong point lies in its extensive portfolio of proprietary technologies. Dailypharm met with CellArtgen (a member of the KoreaBIO) to discuss the company's vision and strategy. The technical strengths of the CellArtgen organoid platform lie in the integration of “extracellular matrix (ECM)-based microenvironment creation technology” and “microfluidics chip technology.” Cho explained, “We remove cells from tissues or organs and introduce the remaining ECM into organoid culture. By using organ-specific ECM, we create an environment similar to actual organs, thereby enhancing the performance of organoids.” For example, to create heart organoids, the ECM matrix obtained from decellularized hearts is used to produce organoid models that not only include tissue-specific cellular components but also recapitulate the inherent microenvironment, including immune cells and vascular cells, on a standardized platform with high efficiency. In particular, CellArtgen highlights its “multi-organoids-on-a-chip” technology, which connects organoids from multiple organs onto a single chip to mimic the human body's digestive, respiratory, and nervous systems. Cho stated, “When direct interaction between organoids is required, we apply ‘assembloids,’ which combine different organoids. The fact that we have independently secured ECM materials, organ chips, and multi-organ integration technology and integrated them into a single platform is the differentiating factor of CellArtgen’s technology.” FDA regulatory changes… organoid technology gains attention The company has been gradually increasing sales and expanding its customer portfolio based on its proprietary technology. Last year, the first year of commercializing its technology, CellArtgen achieved sales of KRW 200 million, and this year, it expects sales of approximately KRW 3 billion by combining ECM products and organoid-based drug evaluation services. The market environment is also becoming more favorable for CellArtgen. The U.S. Food and Drug Administration (FDA) removed the mandatory animal testing requirement for new drug approvals at the end of 2022 and officially announced its plan to phase out animal testing last month, signaling changes in the new drug evaluation system. According to Cho, in addition to the long-term regulatory changes, the overall sentiment of pharmaceutical companies is also changing. He mentioned, “Pharmaceutical companies are showing more interest in organoid technology than before, and there is a growing movement on its practical use in the industry. The change in the atmosphere is palpable.” Cho believes that changes may occur faster than expected, particularly because global pharmaceutical companies are taking more proactive steps than large Korean pharmaceutical companies. Cho added, “Major pharmaceutical companies in the US and Europe have already made significant preparations, such as acquiring organoid companies and recruiting experts to form dedicated teams. While domestic pharmaceutical companies are still observing the situation, CellArtgen is striving to secure a leading position in line with global trends.” He also noted that the extent to which CellArtgen, which is still a bioventure, can accumulate successful cases will serve as a benchmark for its strategy to survive the global competition. In this regard, CellArtgen has already begun providing organoid model services for difficult-to-treat diseases such as MASH (metabolic dysfunction-associated steatohepatitis) and IPF (idiopathic pulmonary fibrosis) to domestic pharmaceutical companies, accumulating initial results. Cho emphasized, “Some of the major domestic pharmaceutical companies that have utilized our services have expressed satisfaction to the extent that they have requested CellArtgen’s organoid experiment services again, and are currently preparing to forge long-term partnerships. Since the service was launched less than a year ago, we have not yet accumulated many cases, but we plan to thoroughly accumulate domestic cases by the first half of next year and then begin full-scale cooperation with overseas big pharmas.” Two-track strategy of diversifying business for revenue while targeting IPO by 2027 However, while organoid services for new drug development have significant long-term potential, the company also faces the limitation of being difficult to generate substantial revenue in the short term. In response, CellArtgen has adopted a realistic strategy. The company has chosen to commercialize ECM materials, with a particular focus on expanding into the cosmetics and medical device sectors. Cho explained, “While the company's ECM technology was originally developed for organoid culture, we identified its potential to achieve a certain level of regenerative therapy effects without cells and applied it to products for wound treatment and cosmetic purposes. For example, skin ECM can be used as a wound treatment agent or in cosmetics or as skin boosters, while cartilage ECM can be utilized as a cartilage filler or a treatment material for osteoarthritis.” In other words, the company is pursuing a two-track strategy to simultaneously achieve short-term revenue and technological validation by applying ECM-based materials developed for organoid culture to wound dressings (wound treatments) and skin beauty injections. While CellArtgen’s moves might seem like a bio-venture's foray into unfamiliar territory, the company is attracting attention for its technology, as evidenced by active discussions on development partnerships with major and mid-sized domestic pharmaceutical and biotech companies. First, the company launched its ECM-based cosmetic brand, Cellumé, in the first half of the year and is currently collaborating with the cosmetics industry. Cho stated, “A major domestic cosmetics ODM company has also taken notice of CellArtgen’s ECM raw material technology, conducted sample tests, and is currently requesting product supply. Additionally, we have been selected as the finalist in an open innovation competition hosted by a top-tier domestic medical device company and have begun discussions on joint development of next-generation medical devices utilizing ECM.” CellArtgen is pursuing a business strategy centered on collaboration. After demonstrating potential through the launch of its own brand, the company is placing emphasis on open innovation by partnering with capable companies. In the medical device sector, the company is actively utilizing external projects while continuing its development. CellArtgen aims to commercialize an ECM-based Class 2 wound dressing by the end of this year and then a Class 4 cartilage regeneration filler through government projects to launch it in 2027 after clinical trials. With its dual focus on organoid services and ECM-applied products, CellArtgen plans to pursue an IPO on the KOSDAQ market around 2027. The company aims to achieve sales of approximately KRW 3 billion this year, followed by KRW 5 billion in 2026, KRW 11 billion in 2027, and then KRW 50 billion by 2030. More than half of this is expected to come from sales of the aforementioned ECM cosmetics and wound dressings. However, while securing short-term sales and attracting investment is important, the company plans to maintain its identity as a regenerative therapy company based on its organoid platform technology, which is the company’s foundational technology that could revolutionize the paradigm of new drug development. Cho added, “We believe that CellArtgen’s organoid model has global competitiveness in areas such as antifibrotic therapy and metabolic diseases, and our goal is to replace animal testing and become a game-changer in the regenerative medicine field. We have a roadmap aimed at developing regenerative therapies for intractable liver diseases.”
- Policy
- 'Cabometyx' for ncRCC, failed to nego for expanded reimb
- by Lee, Tak-Sun May 28, 2025 05:57am
- Product photo of Cabometyx The anticancer drug Cabometyx tab (cabozantinib, Ipsen Korea), a treatment of kidney cancer, did not pass the expanded reimbursement during negotiations with the National Health Insurance Service (NHIS). Cabometyx tab gatherered attention following reimbursement for the first-line treatment of patients with non-clear renal cell carcinoma (ncRCC), which account for 10-15% of all kidney cancer. However, it will take more time due to the current failed negotiation. On May 26, the National Health Insurance Service (NHIS) announced on its website that 'Cabometyx' had failed to negotiate. This drug was determined to have appropriateness for expanded reimbursement by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review & Assessment Service (HIRA) in February, provided that the company accepted a price below the evaluated amount. After that, the pharmaceutical company accepted a price below the evaluated amount, and drug price negotiations withthe NHIS have been ongoing since March. Cabometyx was initially listed for reimbursement in February 2019 as a monotherapy for patients with advanced renal cell carcinoma who had previously received VEGF-targeted therapy. As of March 2022, it was reimbursable in combination therapy with the immuno-oncology drug nivolumab (Opdivo) in patients with advanced renal cell carcinoma. The company continued to push for further expanded reimbursement. In August of last year, the Cancer Disease Review Committee (CDRC) reviewed its use as a 'monotherapy in patients with locally advanced or metastatic differentiated thyroid cancer (DTC) who have previously received VEGF-targeted therapy or whose disease has progressed during treatment, and who are ineligible for or refractory to radioactive iodine therapy (RAI)' and 'first-line monotherapy in patients with non-clear cell renal cell carcinoma.' However, reimbursement criteria were not established at that time. However, in February of this year, DREC approved the ncRCC indication. Clear cell renal cell carcinoma (ccRCC) accounts for 80-85% of kidney cancers, with the remaining 10-15% being ncRCC. Despite ncRCC having a poorer treatment response compared to clear cell, there are currently few drugs covered for reimbursement. However, Cabometyx has emerged as a targeted therapy, gaining attention as a next-generation treatment option. The problem is the lack of reimbursement. With the breakdown of these negotiations, it is expected to take more time for Cabometyx to obtain reimbursement for ncRCC. Meanwhile, the NHIS announced that it is in negotiations with Novartis for 'Leqvio pre-filled syringe.' This drug, intended for the treatment of primary hypercholesterolemia or mixed dyslipidemia, passed the DREC in April.
- Company
- KDDF successfully holds 2025 KDDF Global Biotech Showcase
- by Whang, byung-woo May 28, 2025 05:55am
- 2025 KDDF Global Biotech Showcase Group Photo [The Korea Drug Development Fund (KDDF, CEO Yeong-Min Park) announced on the 27th that it will hold the '2025 KDDF Global Biotech Showcase' to attract overseas investment for excellent new drug candidates developed in Korea. The showcase, which will be held over two days from May 27 to 28 at the Fairmont Ambassador Seoul Hotel, will focus on 1:1 partnering meetings with venture capitalists (VCs), where companies and investors will meet directly to discuss specific cooperation plans, to inject practical vitality into the domestic new drug development ecosystem. Additionally, the event will focus on strengthening domestic pharmaceutical and biotech companies’ presence in the global market and accelerate new drug development through collaboration with investors. Even in the current contracted global investment environment, it is crucial to provide domestic pharmaceutical and biotech companies with opportunities to connect with global investors and pharmaceutical firms through trusted platforms. This approach lays the groundwork for overseas expansion and technology transfer while building trust through ongoing communication with investors. The opening ceremony was attended by Chang-Yune Lee, 1st Vice Minister of Science and ICT, who expressed the government's high level of interest and support. In his congratulatory address, Deputy Minister Lee said, “The Korean government recognizes the pharmaceutical and biotechnology industry as a core industry that will determine the future competitiveness of the country. I expect today's event will serve as an important catalyst for the development of the industry.” Now in its third year, the event has seen a significant increase in participation from global VCs as well as domestic VCs and CVCs (corporate venture capital). The event strategically expanded the investment value chain by structuring it to enable follow-on investment discussions that connect early-stage funding, commercialization, and entry into domestic and global markets. A total of 67 investors, including global and domestic VCs and CVCs, will participate in various programs such as panel discussions, special lectures, roundtable meetings, and one-on-one partnering meetings. Park said, “We anticipate that this event, where domestic and international investors gather in one place, will serve as a turning point for domestic new drug development companies and institutions to secure substantial investments.” He emphasized, “The KDDF will further strengthen its role as an industrial ecosystem platform that accelerates the Korean companies’ entry into the global market.” The participating global VC and CVC institutions are as follows: ▲AbbVie Inc. ▲Johnson & Johnson Innovation ▲Boehringer Ingelheim ▲Boehringer Ingelheim Venture Fund ▲Novo Holdings ▲ARCH Venture Partners ▲L illy Ventures) ▲Roche ▲Roche Accelerator ▲Solasta Ventures ▲YAFO Capital ▲Playground ▲Panacea Venture ▲Pivotal BioVenture Partners ▲Avidity Partners ▲DCI Partners (DCI Partners Co., Ltd.) ▲Mass General Brigham Innovation ▲Qiming Venture Partners ▲Humboldt fund ▲JLABS ▲Ascenta Capital ▲Astellas Venture ▲Lexington Partners. Domestic VC/CVC participating institutions are as follows. ▲IMM Investment ▲Mirae Asset Capital ▲Partners Investment ▲Woori Venture Partners ▲Intervest ▲ Widwin Investment ▲KB Investment ▲CKD Venture Capital Inc ▲HLB Investment ▲Daewoong Investment ▲Scale Up Partners ▲LSK Investment Co., Ltd ▲Stonebridge Ventures ▲KB Securities ▲Kakao Ventures ▲ Korea Technology Finance Corporation ▲Samil PwC ▲Celltrion ▲SK Biopharm ▲LG Chem ▲Huons ▲Huons Global ▲GC Cell (Green Cross).
- Company
- Novartis Korea holds Cosentyx symposium at KCR 2025
- by Whang, byung-woo May 28, 2025 05:54am
- Novartis Korea Novartis Korea announced on the 27th that it held a luncheon symposium at the 45th Korean Congress of Radiology Annual Scientific Meeting (KCR 2025) to highlight the clinical value of Cosentyx (secukinumab) as a treatment for ankylosing spondylitis. The luncheon symposium was moderated by Professor Yong-Beom Park of the Department of Rheumatology at Severance Hospital, with Dr. Lianne S. Gensler, Professor of Clinical Medicine at the University of California San Francisco (UCSF), serving as the presenter. Dr. Gensler presented on the topic “Secukinumab in Ankylosing Spondylitis: Improving Patient Outcomes Through IL-17 Inhibition,” and shared key clinical data and treatment insights from real-world practice. First, Dr. Gensler explained, “Cosentyx is a representative interleukin-17A inhibitor that has demonstrated high treatment response compared with placebo in patients with ankylosing spondylitis who have no prior treatment experience with biological agents, establishing itself as an important early treatment option.” In the MEASURE 2 study, a representative clinical trial evaluating the efficacy and safety profile of Cosentyx in ankylosing spondylitis, patients with no prior experience with biologic agents demonstrated a significantly higher ASAS20 response rate (Assessment of SpondylArthritis international Society 20% response criteria) at week 16 compared to the placebo group. Additionally, the 5-year long-term follow-up study of the same trial confirmed sustained symptom improvement, demonstrating the drug's long-term efficacy. On the same day, Dr. Gensler presented the results of the SURPASS study, which targeted patients with ankylosing spondylitis who had high CRP levels (C-reactive protein levels) of 0.5 mg/dL or higher and at least one syndesmophyte (bone-like bony growth originating inside a ligament) at baseline, indicating a high risk of disease progression. The primary endpoint of the study was the proportion of patients without radiographic progression at week 104, and there was no significant difference between treatment groups. Dr. Gensler said, “In the SURPASS study, patients with ankylosing spondylitis who had no prior experience with biologic therapy received either Cosentyx (150 mg, 300 mg) or adalimumab biosimilar 40 mg, and both treatment groups demonstrated high levels of disease control.” Dr. Gensler also presented real-world data from the FORSYA study, which examined differences in treatment maintenance rates based on the timing and sequence of Cosentyx administration in ankylosing spondylitis, showing that using Cosentyx as the first biologic agent resulted in higher 1-year treatment maintenance rates. Dr. Gensler emphasized, “These results are significant as using Cosentyx as early as possible may lead to more sustained treatment effects and improved patient adherence.” Professor Yong-Beom Park, who attended as the moderator at the luncheon symposium, said, “Ankylosing spondylitis is a condition where early diagnosis and treatment are crucial for symptom control and prevention of joint damage. Fortunately, effective treatment options have been developed, allowing us to anticipate better treatment outcomes for patients compared to the past. Since Cosentyx has established itself as a first-line biologic therapy for ankylosing spondylitis in Korea, and we have been able to recognize its clinical value on-site thereafter, it was meaningful to share the latest treatment insights on Cosentyx at today's symposium.”
- Company
- Will JAK inhibitors for inflammation expand mkt presence?
- by Moon, sung-ho May 28, 2025 05:54am
- It has been confirmed that Janus kinase (JAK) inhibitors are more effective at rapidly and powerfully controlling inflammatory responses in atopic dermatitis compared to biologics. Now that switching therapies between different drug classes is allowed, this finding is expected to serve as a key basis for drug selection in clinical practice. According to the pharmaceutical industry, on May 26, the Ministry of Health and Welfare (MOHW) revised reimbursement criteria as of March, allowing for the switching of therapies between JAK inhibitors and biologics for the treatment of atopic dermatitis. Subsequently, clinical settings will have to consider treatment strategies following reimbursement approval for switching between drug classes. Recently, the results of sub-analysis studies, Heads Up and Level Up clinical trials, were reported. The study involved a comparison between the JAK inhibitor Rinvoq (upadacitinib, AbbVie) and the biologic dupilumab. This research not only showed that Rinvoq rapidly and strongly suppresses Type 2 inflammatory responses, a core pathogenesis of atopic dermatitis, but also effectively controls other significant inflammatory responses related to atopic dermatitis, such as Type 1 and Type 17/22 responses. Specifically, in the sub-analysis of the Heads Up study, at week 2 of treatment, the gene expression patterns (transcriptomes) in the skin of the Rinvoq group were approximately 66.5% similar to those of normal skin. In contrast, dupilumab's transcriptome normalization was only 2.0% (P < 0.001). At week 16 of treatment, the level of transcriptome normalization was 104.4% for the Rinvoq group and 62.9% for the dupilumab group, with the Rinvoq group showing significantly higher efficacy (P
- Policy
- Expanded reimb for Jardiance's CKD indication imminent
- by Lee, Tak-Sun May 27, 2025 06:19am
- Jardiance Tab It is to be watched whether the SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) will be approved for expanded reimbursement to include chronic kidney disease (CKD) indication, in addition to diabetes and chronic heart failure indications. The evaluation by the Health Insurance Review & Assessment Service (HIRA) is expected to be nearing end following the reimbursement expansion filed in the first half of last year. According to industry sources on May 26, HIRA is reportedly reviewing expanded usage scope and pre-drug price reduction system for Jardiance's CKD indication. The pre-drug price reduction system for expanded usage scope drugs is designed to quickly enhance patient access to treatment by omitting the cost-effectiveness evaluation and applying a pre-reduction rate table, with a maximum 5% reduction in the ceiling cap, considering the estimated additional claim amounts due to the expanded reimbursement criteria. Once the pharmaceutical company submits financial impact analysis data and HIRA determines the pre-reduction rate through practical review, the Drug Reimbursement Evaluation Committee (DREC) will deliberate. If the pharmaceutical company accepts the deliberation results, the revised reimbursement criteria notification is completed after negotiation with the National Health Insurance Service (NHIS). The company applied to HIRA for reimbursement expansion for Jardiance's CKD indication in the first half of last year. Jardiance was the first SGLT-2 inhibitor to file. The approved indications for Jardiance 10mg tablets are: 1. Type 2 diabetes mellitus, 2. chronic heart failure, and 3. chronic kidney disease. Jardiance Tab, which were listed for reimbursement as a diabetes treatment in 2017, have also been reimbursed for chronic heart failure since February 2024. Since January, the reimbursement criteria have been expanded, allowing patients with heart failure with preserved ejection fraction (HFpEF) who have symptoms and signs of heart failure and a left ventricular ejection fraction exceeding 40% to receive national health insurance benefits. Currently, the only SGLT-2 drugs covered for diabetes and chronic heart failure patients, besides Jardiance, are Forxiga (dapagliflozin) and HK inno.N's DapaN Tab, which transferred Forxiga's indications. However, there is currently no drug reimbursable for CKD. If the reimbursement expansion procedure for Jardiance is completed, it is expected to be the only SGLT-2 drug with CKD reimbursement coverage. The efficacy of Jardiance has been demonstrated through clinical trials, showing a statistically significant 28% relative risk reduction in the progression of kidney disease or cardiovascular death compared to placebo. The competition in the market for SGLT-2 has been intensified due to the expiration of dapagliflozin patent in 2023 and the launch of generic drugs, Jardiance's expanded reimbursement scope to include CKD will give Jardiance a competitive advantage. Generic drugs are expected to launch following Jardiance's substance patent expiration in October. However, Jardiance's heart failure and kidney disease indications are expected to remain protected, so expanded reimbursement is anticipated to minimize the impact of generic entry. The pharmaceutical industry anticipates that the reimbursement expansion for Jardiance's CKD indication will be approved after July or by the end of the year.
- Company
- 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.
- Company
- 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.
- Policy
- Rinvoq reimbursed for active progressive psoriatic arthritis
- by Whang, byung-woo May 27, 2025 06:18am
- Pic of Rinvoq AbbVie Korea's Rinvoq has become the first oral JAK inhibitor to be covered by insurance for psoriatic arthritis in Korea. On the 26th, AbbVie Korea announced that Rinvoq (upadacitinib), a once-daily oral treatment and selective JAK inhibitor, will be reimbursed for the treatment of active and progressive psoriatic arthritis in adults starting June 1, in accordance with the Ministry of Health and Welfare’s official notification. With the reimbursement decision, adult patients with active and progressive psoriatic arthritis who have been treated with two or more types of disease-modifying antirheumatic drugs (DMARDs) for a total of six months or more (at least three months each) but have not responded adequately to treatment or have discontinued treatment due to side effects will now be eligible for Rinvoq’s use with insurance reimbursement. An initial evaluation will be conducted three months after administration of Rinvoq, and if the number of active joints is reduced by 30% or more, insurance coverage will continue, with evaluations conducted every 6 months thereafter. In addition, if treatment with tumor necrosis factor inhibitors, interleukin inhibitors, or phosphodiesterase-4 inhibitors is ineffective or cannot be continued due to side effects, or if medication compliance needs to be improved, insurance reimbursement will be granted even if the patient has switched to Rinvoq. In such cases, a treatment recommendation form for the switch must be attached, and the patient is recommended to maintain the use of the new treatment for at least 6 months after the switch. Seung-Jae Hong, Professor of Rheumatology at Kyung Hee University Hospital said, “Psoriatic arthritis greatly affects the quality of life of patients, but many patients still struggle to find treatment options to reduce disease activity. Rinvoq, which has been approved for insurance reimbursement, has been shown in clinical studies to improve joint symptoms and significantly improve the quality of life of patients by restoring physical function and reducing fatigue.” Professor Hong also noted, “With the convenience of once-daily oral administration, we anticipate that this treatment to become a practical and useful option in practice.”, This insurance reimbursement was approved based on Rinvoq’s efficacy and safety confirmed in SELECT-PsA 1 and SELECT-PsA 2, which are phase III, multicenter, randomized, double-blind, placebo-controlled clinical studies in patients with moderate-to-severe adult active and progressive psoriatic arthritis. SELECT-PsA 1 included patients who had an inadequate response to or were unable to tolerate one or more non-biologic disease-modifying antirheumatic drugs (DMARDs), while SELECT-PsA 2 included patients who had an inadequate response to or were unable to tolerate one or more biologic disease-modifying antirheumatic drugs.
