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- 2026-03-10 02:16:21
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- Oral PNH drug 'Fabhalta' available at general hospitals
- by Eo, Yun-Ho Feb 09, 2026 07:33am
- Oral drug 'Fabhalta' for PNH is cleared to be prescribed at general hospitals.According to industry sources, Novartis Korea's Fabhalta (iptacopan), an oral treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), has passed the drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Seoul St. Mary's Hospital, and medical institutes, including Kyungpook National University Hospital, Wonju Severance Christian Hospital, Chungnam National University Hospital, and Chonnam National University Hwasun Hospital.Prescription areas of Fabhalta have been consistently expanded since the insurance reimbursement listing in July of last year.PNH is a rare disease that is estimated to occur in approximately 1.5 out of 1 million people globally.The treatment of this disease has relied on C5 inhibitors. 'Soliris (eculizumab)' was approved for the first time in Korea in 2010. 'Ultomiris (ravulizumab)' was approved in 2022 and has been used as a treatment for PNH. Both treatment options fall into the category of C5 inhibitor, which work by inhibiting the terminal component C5 within the complement system's alternative pathway. They are also intravenous injectables.In April 2024, 'Empaveli (pegcetacoplan),' a subcutaneous injection that inhibits the complement cascade by binding to C3 and C3b, was approved. In August of the same year, Fabhalta, an oral treatment that inhibits Factor B, emerged.The unmet need in PNH, due to the mechanistic limitations of C5 inhibitors, is extravascular hemolysis (EVH). PNH begins with a genetic defect in red blood cells, leading to both intravascular hemolysis (IVH) and extravascular hemolysis (EVH).Such hemolysis soon causes thrombosis and bone marrow failure, making it life-threatening. Therefore, it is crucial to control hemolysis in PNH treatment. While the current standard of care, C5 inhibitors, significantly controls IVH, they have mechanistic limitations in controlling EVH.This is why attention is gathering around the reimbursement listing for the Factor B inhibitor Fabhalta. Factor B exists further upstream in the alternative pathway than C5, C3, and C3b. By inhibiting this factor, both IVH and EVH can be comprehensively controlled.In fact, Fabhalta demonstrated efficacy in treatment-naive patients. According to the APPOINT-PNH study of treatment-naïve PNH patients, 19 of 33 patients reached a hemoglobin level of 12 g/dL or higher without red blood cell transfusions.Additionally, 92% of patients showed a clinically significant increase in hemoglobin of 2 g/dL or more, and 63% of patients sustained a hemoglobin level of 12 g/dL or higher without transfusion. During the 24-week study period, hemoglobin levels showed a trend of continuous increase, reaching normalized levels from week 20 and sustaining them through week 24. Furthermore, 98% overcame transfusion dependence.Professor Jun Ho Jang of the Department of Hematology-Oncology at Samsung Medical Center stated, "When C5 inhibitors first emerged, experts analyzed that the paradigm of PNH treatment had shifted. However, C5 inhibitors still have limitations in controlling EVH."Jang emphasized, "Fabhalta is a new drug that will lead to another paradigm shift in PNH treatment. Since the mechanism of Factor B inhibition works by involving Factor B located at the top of the alternative pathway, this drug can control both intra- and extravascular hemolysis, and has shown encouraging results through clinical trials."
- Company
- "Dupixent reimb for severe asthma… access to targeted therapy"
- by Son, Hyung Min Feb 09, 2026 07:33am
- The biological agent 'Dupixent' has secured reimbursement for severe asthma, expanding patient access. Given that many patients did not respond to existing treatments, the field evaluates that this will be a therapeutic turning point that addresses long-standing unmet needs.On the 5th, Sanofi-Aventis Korea held a press conference at the Lotte Hotel in Seoul to commemorate the reimbursement of Dupixent (dupilumab) in Korea. Professor Ji-yong Moon of the Department of Pulmonary, Allergy and Critical Care Medicine at Konkuk University Medical Center Dupixent is the first biological agent to target the signaling of interleukin (IL)-4 and IL-13, which are major drivers of Type 2 inflammation.Various immunce disease indications for Dupixent has been added, including severe asthma, atopic dermatitis, prurigo nodularis, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD). However, reimbursement had been limited to the treatment of atopic dermatitis.In December last year, patient accessibility was expanded as Dupixent became reimbursed for severe asthma. This comes about six years after the indication was added in 2020.The expanded reimbursement covers cases ▲where the blood eosinophil count is 150 cells/µL or higher, or fractional exhaled nitric oxide (FeNO) is 25 ppb or higher within 12 months before starting treatment, and at least four acute asthma exacerbations requiring systemic corticosteroids occurred within those 12 months ▲where oral corticosteroids equivalent to 5mg/day of prednisolone or higher have been continuously administered since six months before starting treatment.The evaluation method involves assessing the patient every year before and after drug administration (every six months for oral corticosteroid-dependent asthma), and the patient is approved if they meet one of the two conditions.Through the Phase 3 QUEST clinical study, Dupixent was confirmed to improve lung function and reduce exacerbation rates.The data show that the Dupixent group showed an annualized exacerbation rate reduction of more than 45% at 52-week compared to the placebo group. Additionally, significant improvement in lung function was observed from the second week of Dupixent administration. This effect was maintained throughout the 52 weeks.Notably, it significantly reduced the annualized severe asthma exacerbation rate compared with the placebo group in patients with baseline eosinophil (EOS) counts of 150 cells/µL or higher.Professor Moon stated, "Dupixent showed meaningful asthma control indicators and quality of life improvement in patients with increased Type 2 inflammatory biomarkers, and explained, "This reimbursement has opened the way for medical staff to select patients expected to respond to treatment based on clinical indicators such as blood eosinophil counts and FeNO, connecting them to targeted therapy at the appropriate time.""Symptom management is difficult to achieve with a single treatment…various options must be secured"An opinion was also presented that symptom control is difficult with a single treatment, necessitating the securing of various options. Type 2 inflammatory asthma is characterized by excessive cytokine activation, including IL-4, IL-5, and IL-13. It not only carries a high risk of repeated exacerbations and loss of lung function but also triggers various immune comorbidities, such as atopic dermatitis, chronic rhinosinusitis, and COPD, which generally diminish the patient's quality of life.Accordingly, various biological agents are being utilized for severe asthma, including interleukin-targeting Dupixent, Novartis's Xolair (omalizumab)', GSK's 'Nucala (mepolizumab)', and AstraZeneca's 'Fasenra (benralizumab)', as well as AstraZeneca's 'Tezspire (tezepelumab)', which targets thymic stromal lymphopoietin (TSLP).Unlike general asthma, severe asthma is difficult to control, and experts argue that more medications, such as oral steroids (OCS) or additional biological agents, must be secured. However, because OCS can cause various side effects, its use is currently declining.Biological agents have strengths in terms of safety and the ability to reduce dependence on oral steroids.Professor Moon stated, "Due to the characteristics of asthma, not all patients are treated with the same drug. Therefore, the Global Initiative for Asthma (GINA) guidelines recommend assessing for Type 2 inflammation when treating severe asthma and selecting the appropriate medication."Professor Moon added, "A significant number of patients undergoing treatments have a poor prognosis due to repeated acute exacerbations despite existing treatments," and emphasized, "The reimbursement of Dupixent, which targets the cause of disease, holds great clinical value in providing better treatment options to patients who experienced limitations of existing therapies."
- Policy
- MOHW ‘Limited impact’ vs Industry ‘₩3 trillion loss’
- by Lee, Jeong-Hwan Feb 09, 2026 07:33am
- Calls are growing for the Ministry of Health and Welfare (MOHW) to begin public–private consultations based on the results of its internal analysis of the impact of generic drug price cuts.The ministry is said to have concluded, based on its own quantitative analysis of the impact on each pharmaceutical company when drug price cuts are implemented, that the industry’s estimated losses of up to KRW 3 trillion resulting from the price cuts are inaccurate. However, the Ministry has not publicly disclosed the simulation results, drawing criticism from the pharmaceutical industry.The pharmaceutical industry maintains that the government should transparently disclose the results and analytical criteria of its own drug price reduction simulations and begin discussions on policy revisions directly with the pharmaceutical industry, the primary stakeholders. Attention is focused on whether the MOHW will accept this request.According to government and industry sources on the 6th, the MOHW began internal simulations to assess the impact of price reductions for already-listed generic drugs, a key element of the drug pricing reform plan announced on November 28 last year.Sources say the Ministry's simulation results show a significantly lower figure than the pharmaceutical industry's claim of ‘up to KRW 3 trillion in sales losses’.The Ministry of Health and Welfare's own analysis indicates that the projected revenue loss from drug price reductions per pharmaceutical company, calculated using the current 53.55% generic drug reimbursement rate and the discount/preferential rates to be applied during the drug pricing system reform (based on factors like each company's R&D expenditure relative to sales), falls significantly short of the industry's own estimates.The pharmaceutical industry fears that, based on these results, the MOHW will continue its stance that it can push through the previously announced reform plan with minimal changes, relying on its own simulation findings.Consequently, multiple pharmaceutical companies are raising the need for public-private discussions regarding the ministry’s simulation results.The argument is that implementing such a major drug price overhaul, the first in approximately 14 years since the 2012 blanket price reduction, without proper consultation procedures, finalizing and enforcing it just three months after announcement, constitutes excessive infringement on the industry’s right to express its views.In particular, industry stakeholders dispute the ministry’s claim that companies certified as innovative pharmaceutical companies or those with high R&D-to-sales ratios would be exempt from the negative impact of price cuts.The argument is that after the price reform, companies that have invested heavily to obtain innovative-company certification or to develop and manufacture high-quality generics may see little to no preferential treatment compared with those with low investment and those that merely contract manufacturing generics. In the worst cases, there could even be a reversal where profits decrease compared to non-investing companies.With the positions of the MOHW and pharmaceutical companies sharply at odds over the same reform proposal, attention is turning to whether public–private consultations can take place ahead of the plan’s submission and deliberation at the Health Insurance Policy Deliberation Committee later this month.A pricing manager at domestic pharmaceutical company A stated, “The Ministry of Health and Welfare validated its drug price reform plan based on its own simulation of pharmaceutical companies' sales losses from price cuts, yet it hasn't actually disclosed the simulation criteria or results. Only by initiating mutual discussions with pharmaceutical companies centered on the government’s analysis results would we be able to move closer to a reform that minimizes conflict.”A pricing manager from another pharmaceutical company, B, also pointed out, “The Ministry should fully incorporate the specific positions of direct stakeholders like pharmaceutical companies regarding the problems with the drug price reduction system, but so far, the Ministry hasn't been taking an active stance toward gathering opinions. The government and the industry may be using entirely different indicators to calculate the impact of price cuts. Without sharing the raw data, meaningful consultation is impossible.”He added, “Even R&D-focused or innovative pharmaceutical companies report that, based on their own simulations, the ministry’s proposed price cuts would not provide real preferential benefits and could even push operating profits into deficit. There is serious concern that this reform plan, which could undermine the will to contribute to new drug development and solving supply instability issues, might be finalized and enforced without modification.”
- Policy
- AbbVie’s Parkinson’s drug receives orphan drug designation in Korea
- by Lee, Tak-Sun Feb 09, 2026 07:32am
- A new Parkinson's disease treatment drug approved by the U.S. Food and Drug Administration (FDA) has been designated as an orphan drug in Korea.As orphan drug designation enables expedited review, potentially shortening the approval timeline, expectations are rising for the drug’s earlier commercialization.According to the Ministry of Food and Drug Safety (MFDS), the foscarbidopa/foslevodopa injection was officially designated as an orphan drug on February 3.The drug is indicated for adults with advanced Parkinson’s disease who experience severe motor fluctuations that are not adequately controlled with existing Parkinson’s therapies.The foscarbidopa/foslevodopa injection mentioned by the MFDS was Vyalev, AbbVie’s Parkinson’s drug approved by the FDA in 2024.Vyalev is the first and only 24-hour levodopa-based continuous subcutaneous infusion for treating motor fluctuations in adults with advanced Parkinson's disease.Patients with advanced Parkinson’s disease often struggle to manage motor fluctuations. Vyalev offers the benefit of continuous symptom control through continuous 24-hour drug delivery.In particular, the therapy is expected to reduce the number of times when the effect of oral medications wears off, and movement becomes difficult, thereby offering a new treatment option that can meaningfully improve quality of life for patients with advanced Parkinson’s disease.In October last year, Korea Parkinson’s Hope Alliance held a press conference urging the introduction of Vyalev in Korea. Although Vyalev has already been launched in 35 countries, including the United States, Europe, and Japan, it has not yet received formal approval in Korea.Once designated as an orphan drug, a product becomes eligible for conditional approval, reduced regulatory fees, exemptions from certain bridging data requirements, and priority review, all of which streamline the regulatory process and accelerate approval. Therefore, attention is now focused on whether this orphan drug designation will accelerate Vyalev’s introduction into the domestic market.Recently, the MFDS has relaxed orphan drug designation requirements, lowering the regulatory threshold. Previously, applicants were required to submit data demonstrating improved efficacy over alternative therapies, but under the revised criteria, such data are no longer mandatory for orphan drug designation.
- Company
- Roche Diagnostics bets on mass spectrometry for lab automation
- by Hwang, byoung woo Feb 09, 2026 07:32am
- Roche Diagnostics Korea has positioned its ‘automated mass spectrometry solution’ as the final piece of the laboratory automation puzzle.The vision is to extend the laboratory efficiency gained through existing core lab automation to mass spectrometry, delivering the most accurate results precisely when patients need them.The company particularly emphasized a strategy to organically connect automated and digital platforms within the clinical setting, which is in line with Korea’s trend of seeking infrastructure expansion.On February 6, Roche Diagnostics Korea hosted a media session titled “Beyond Data, To Certainty,” where it shared its vision for next-generation automated mass spectrometry solutions designed to maximize laboratory efficiency, alongside AI-driven digital insights.(from the left) Sungho Cho, Head of Core Lab & POC at Roche Diagnostics Korea; Muhwan Yoon, Head of Digital Insights at Roche Diagnostics KoreaFrom ‘isolated islands’ to automated tracks... the evolution of mass spectrometryAccording to Roche, mass spectrometry has traditionally functioned as an “isolated island” within diagnostic laboratories. While recognized as the gold standard for analytes requiring precise quantification, such as hormones and vitamin D metabolites, its complex process has necessitated highly skilled personnel performing manual processes in dedicated spaces.Sungho Cho, Head of Core Lab & POC at Roche Diagnostics Korea, who led the presentation at the event, said, “Until now, mass spectrometry testing was inevitably conducted in batch mode. Samples were collected and analyzed only on specific days or outsourced to external laboratories, which meant patients sometimes had to wait a full week for results.”Roche’s proposed solution is to integrate this ‘island’ into the automated laboratory track. From sample receipt and pre-analytical processing to analysis and result reporting, all steps are unified into a single automated workflow, seamlessly connecting mass spectrometry to core lab automation.At the forefront of this strategy is the company's newly introduced ‘cobas pro i 601 analyzer’. Its core feature is the direct connection of the mass spectrometry equipment to the same track as standard automated immunoassay/biochemistry analyzers, integrating the entire process from sample loading to result generation.Cho emphasized, “The era has arrived where random access (Anytime Testing) is possible for even mass spectrometry, allowing results to be confirmed on the day of testing and immediately reflected in treatment. This is the realization of Roche’s vision for a seamless, uninterrupted patient journey.”NAVIFY's smart lab vision… adding ‘certainty’ to dataWhile mass spectrometry completes the hardware connection, Roche’s digital insights brand, ‘NAVIFY’ aims to create clinical value by analyzing the data flowing across the infrastructure.Muhwan Yoon, Head of Digital Insights at Roche Diagnostics Korea, described NAVIFY as a comprehensive digital ecosystem encompassing diagnostics, clinical care, pathology, and molecular diagnostics. Roche’s digital strategy centers on AI-driven 3P principles: Prediction, Performance, and Personalization.Specifically, AI algorithms identify patients' chronic disease risks early and provide recommendations to clinicians, while predicting laboratory workload to optimize staffing and reagent allocation. The core objective is to connect this to deriving personalized treatment options tailored to each individual patient.NAVIFY-based solutions initially focused on clinical laboratories but have since expanded to include clinicians, pathology, and molecular diagnostics.Yoon emphasized, “NAVIFY integrates not only diagnostic testing but also clinical, pathology, and molecular diagnostic data into a single ecosystem. It will become the tool for delivering a ‘true smart lab,’ which reduces the time medical staff spend on administrative tasks and allows them to focus solely on patient care.”Cost and regulation remain challenges…but automation is inevitableLooking ahead, cost and regulatory barriers remain key challenges for the adoption of innovative technologies in real-world clinical settings.On this, Cho said, “Traditional manual workflows involve hidden costs such as high labor expenses for specialized personnel and management costs associated with human error. Roche’s automation systems reduce reliance on manual labor, significantly improving operational efficiency. In the long term, this represents a strategic investment that enhances both hospital profitability and diagnostic accuracy.”Kit Tang, General Manager of Roche Diagnostics KoreaYoon also stated, “We are lowering entry barriers by offering various options tailored to hospital situations, such as subscription models.”He added that the company is actively engaging with regulators to address challenges arising from the intersection of digital technologies and traditional medical device approval frameworks. There is a growing consensus in the field that digitalization is a matter of survival.In closing, Kit Tang, General Manager of Roche Diagnostics Korea, emphasized, “Roche’s mission is ‘Doing now what patients need next.’ Automating mass spectrometry and digitally connecting diagnostics are not merely for product launches. They represent our commitment to eliminating diagnostic uncertainty and providing confidence to patients.”He added, “True patient-centered care is achieved not by introducing individual technologies, but by ensuring those technologies are organically connected in the clinical setting and translated into tangible benefits for patients.”
- Company
- Biologics for atopic dermatitis, 'four-way race'
- by Son, Hyung Min Feb 06, 2026 06:43am
- The biologic market for atopic dermatitis is experiencing a new shift. Competition among interleukin (IL)-13 inhibitors has been previously centered around 'Dupixent.' As treatments with new mechanisms enter the race, multi-layer competition is intensifying, with drugs that differ in their immune pathways. (clockwise from left) Nemluvio, Dupixent, Adtralza, EbglyssAccording to industry sources on the 4th, Galderma Korea has recently received domestic approval for its biologic agent 'Nemluvio (nemolizumab).' The indication is for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis (PN). With the addition of Nemluvio to the previously approved treatments, including Sanofi and Regeneron's Dupixent (dupilumab), LEO Pharma's Adtralza (tralokinumab), and Eli Lilly's Ebglyss (lebrikizumab)—the therapeutic options in the Korean atopic dermatitis market have expanded to four.Nemluvio is the only IL-31 receptor inhibitor among the drugs approved in Korea, targeting a distinctly different immune axis compared to existing treatments that inhibit the Th2 axis related to IL-13.IL-31 is a neuro-immune cytokine that induces itch signals, sitting at the center of a vicious cycle in which it directly stimulates sensory nerves, exacerbating scratching behavior.Unlike existing drugs like Dupixent (IL-4/13) and Adtralza or Ebglyss (IL-13), which focus on inflammation control, Nemluvio's mechanistic differentiation lies in its direct blockage of itching, the core symptom of the disease burden.In clinical trials, Nemluvio, when combined with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), met all endpoints compared with placebo.Notably, the speed of itch improvement is rapid. In the global Phase 3 ARCADIA study, Nemluvio showed a statistically significant reduction in itching compared to placebo starting from 48 hours after administration, and at the 4-week and 16-week marks, more than twice as many patients compared to the placebo group experienced a clinically meaningful level of itch relief (PP-NRS improvement of 4 points or more).Regarding inflammation and lesion improvement, the Eczema Area and Severity Index 75% improvement (EASI-75) was 43.5% and 42.1% in ARCADIA-1 and ARCADIA-2, respectively, indicating a level of inflammation suppression similar to that of existing Th2 inhibitors.Administration convenience is also a strength. For atopic dermatitis, Nemluvio is administered at an initial dose of 60mg followed by 4-week intervals up to 16 weeks, and it is the only drug in Korea that can be switched to an 8-week dosing interval once a clinical response is confirmed.Considering that Dupixent and Ebglyss are both administered every 2 weeks, and Adtralza is administered every 2 or 4 weeks, Nemluvio is the first drug to provide a dosing interval optimization model based on clinical response.Analysis suggests that, given the essential role of long-term treatment for moderate-to-severe patients, this can significantly enhance market competitiveness by improving patient convenience and compliance.Clinical safety also showed no significant difference compared to existing treatments. Adverse events reported relatively frequently with existing biologics, such as conjunctivitis and herpes, showed no significant difference between the Nemluvio and placebo groups, and most adverse events were manageable at mild to moderate levels.New target competition intensifies… IL-22·IL-18 inhibitors are being developedAs atopic dermatitis is recognized as a multi-immune network disease that is difficult to explain by the inhibition of a single cytokine, new drug development is rapidly shifting from a Th2-centric approach to a multi-mechanism competition targeting various immune axes, such as IL-31, IL-22, and IL-18.Among these, the IL-22 inhibitor 'temtokibart,' being developed by LEO Pharma, is considered one of the most notable next-generation candidates.IL-22 is a key cytokine that induces epidermal proliferation, decreased barrier function, and chronic inflammation. IL-22 inhibition offers a distinct approach to existing Th2 inhibitors by simultaneously promoting skin barrier recovery and relieving inflammation.Temtokibart binds to IL-22RA1 (IL-22 receptor α1) to block IL-22 signaling and has the potential to inhibit the IL-20 and IL-24 pathways that share the same receptor. Thus, its strength lies in its upstream signal-inhibition mechanism, which regulates the entire epidermal barrier function and inflammatory pathways rather than blocking a single cytokine.In a Phase 2a study, temtokibart achieved EASI-90 in 30.8% of patients and EASI-100 in 20.9%, with broad reductions in systemic inflammatory proteins.Additionally, temtokibart was evaluated as the first mechanistic candidate to directly regulate epidermis-immune interactions, as it was shown to simultaneously inhibit the Th17/22, Th2, and Th1 axes and restore the expression of barrier genes such as KRT and CLDN.Another new drug candidate, camoteskimab from the U.S. biotech company Apollo Therapeutics, showed an 80% improvement in EASI scores in Phase 2a and maintained clinical responses even in the patient group that failed Dupixent.Since IL-18 is known as an upstream regulator of Th1, Th2, Th17, and Th22, it is expected to be a meaningful alternative for patients who did not respond to existing treatments. Korean company AprilBio and the U.S. drug development company Evommune have also entered Phase 2 clinical trials with this same mechanism.
- Policy
- HIRA to reinforce staff for post-listing evaluation
- by Jung, Heung-Jun Feb 06, 2026 06:43am
- The Health Insurance Review and Assessment Service (HIRA) has begun reinforcing post-listing evaluation by expanding personnel and restructuring its organization in preparation for shortened listing timelines for rare disease drugs.The existing Pharmaceutical Performance Assessment Department has been reorganized into the Rare & Severe Disease Pharmaceutical Performance Assessment Department within the Health Insurance Innovation Center, accompanied by staffing reinforcements.As evaluation procedures must be streamlined to shorten listing periods, post-listing assessment of clinical outcomes will be intensified.On the afternoon of the 4th, HIRA President Jung-gu Kang explained the plan to shorten the listing period for rare disease treatments, included in the proposed drug pricing reform plan, during a briefing with press corps reporters.The drug pricing reform plan reported to the Health Insurance Policy Deliberation Committee (HIPDC) in January includes a policy to enable fast-track reimbursement listing of rare disease drugs within 100 days.Kang stated, “We will simplify reimbursement appropriateness evaluation and negotiation procedures to shorten listing timelines and improve patient access. Conversely, to strengthen post-listing evaluation and ensure internal scalability, we have reorganized the existing Pharmaceutical Performance Assessment Department into the Rare & Severe Disease Pharmaceutical Performance Assessment Department within the Health Insurance Innovation Center and increased staffing.”In the first half of this year, HIRA also plans to commission research projects aimed at establishing cost-effectiveness evaluation criteria for new drugs.Kang said, “Through these research projects, we will develop an ICER threshold and adjustment framework suited to the Korean context, thereby building a rational and sustainable cost-effectiveness evaluation system.”Furthermore, to strengthen post-market evaluation for new drugs with unclear clinical evidence, plans are underway to utilize Real-World Data (RWD) and Real-World Evidence (RWE).Guidelines were developed based on the results of a research project conducted from March to November last year. Currently, registries for 12 drugs are being established to conduct performance assessments.The drugs under evaluation include Kymriah, Zolgensma, Spinraza, Evrysdi dry syrup, Luxturna, Qarziba, Bylvay capsules, Livmarli oral solution, Ilaris, Pemazyre, Zepzelca, and Isturisa film-coated tablets.Kang stated, “We revised detailed evaluation criteria to establish a solid foundation that enables outcome assessment using RWD. We will enhance the utilization of RWE generation guidelines, systematically manage registry quality to continuously verify clinical value, and strive to ensure patient safety.”Advancing health insurance payment reform… reviewing introducing a parallel fee scheduleBeyond drug-related issues, HIRA also outlined plans to develop a roadmap for reforming the national health insurance payment system. HIRA is reviewing a parallel payment model that combines fee-for-service and diagnosis-related group (DRG) payment system.For example, fee-for-service reimbursement would be maintained for physicians’ specialized surgical procedures and interventions, while hospital system usage fees, such as hospitalization charges or examination fees, would be compensated under a bundled payment system by DRG.HIRA also plans to further refine the Clinical Practice Evaluation Panel (CPEP) system, which precisely measures physician effort and equipment costs associated with individual medical services. The goal is to reassess and appropriately revalue services that have been historically undervalued.Kang explained, “Based on research recommendations, we are reviewing relative value payment reforms, including further refinement of CPEP to reform the current fee-for-service system. We are also considering the introduction of parallel payment models in relation to bundled payments.”He added, “We will shorten the cycle of the relative value score adjustment structure, which is a national policy task, and ultimately transition to a continuous adjustment system. This will help break away from the structure where profits increase only by performing many tests, and instead support a more realistic and sustainable reimbursement system.”
- Policy
- HK Inno.N enters Prolia biosimilar market
- by Lee, Tak-Sun Feb 06, 2026 06:43am
- HK Inno.N has joined the biosimilar market for the osteoporosis treatment Prolia (denosumab).It is the third company to obtain regulatory approval for a Prolia biosimilar, following Celltrion and Samsung Bioepis. Competition in the approximately KRW 170 billion market is expected to intensify.Korea’s Ministry of Food and Drug Safety approved HK Inno.N’s Izambia Prefilled Syringe (denosumab) on the 4th.Izambia is a biosimilar with the same efficacy and effects as the original drug, Prolia Prefilled Syringe, which contains the same active ingredient. It is indicated for: ▲ Treatment of osteoporosis in postmenopausal women ▲ Treatment to increase bone mineral density in men with osteoporosis ▲ Treatment of glucocorticoid-induced osteoporosis ▲ Treatment of bone loss in non-metastatic prostate cancer patients receiving androgen deprivation therapy ▲ Treatment of bone loss in female breast cancer patients receiving adjuvant aromatase inhibitor therapy.Izambia was licensed from Spain’s mAbxience. In January 2023, HK inno.N signed an exclusive domestic licensing agreement with mAbxience for denosumab biosimilars. Under the agreement, HK inno.N secured exclusive supply rights for two denosumab biosimilars, as well as domestic regulatory approval and commercialization rights.Denosumab is an antibody therapy that targets the ‘RANKL’ protein, which is critical for the survival and function of osteoclasts, thereby exerting potent inhibition of bone resorption. The original drugs are Amgen's osteoporosis treatment ‘Prolia’ and ‘Xgeva’, used for preventing skeletal-related events in patients with bone metastases and treating giant cell tumor of bone. Both products were launched in 2016.On the same day, HK inno.N also received approval for Denbrayce Inj, a biosimilar to Xgeva.Amgen’s ProliaProlia, which recorded annual sales of approximately KRW 174.9 billion in 2024 (IQVIA data), began facing biosimilar competition after its substance patent expired in March last year. Celltrion’s Stoboclo was the first biosimilar to launch, followed by Samsung Bioepis’ Obodence last year.Stoboclo is co-marketed by Daewoong Pharmaceutical, while Obodence is co-marketed by Hanmi Pharmaceutical. Given that the original Prolia is co-marketed in Korea by Chong Kun Dang and Amgen, the denosumab market has effectively become a battleground for major domestic pharmaceutical companies.With HK inno.N now entering the market, competition is expected to further intensify. The newly approved denosumab biosimilars from HK inno.N are expected to be launched within the first half of the year, following completion of reimbursement pricing procedures.
- Company
- Imdelltra can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Feb 06, 2026 06:43am
- The bispecific antibody anticancer drug Imdelltra is entering major hospital prescription lists in Korea.According to industry sources, Amgen Korea's Imdelltra (talatamab), a treatment for relapsed or refractory extensive-stage small cell lung cancer (SCLC), has passed the Drug Committee (DC) reviews at leading general hospitals, including Samsung Medical Center, Asan Medical Center, and Severance Hospital.However, Imdelltra has not yet been listed for reimbursement. In January, during the Health Insurance Review and Assessment Service’s first Cancer Drug Review Committee meeting of the year, the drug received a decision of “reimbursement criteria not established.”Therefore, it remains to be seen whether Imdelltra will secure reimbursement status and emerge as a treatment option in the underserved small-cell lung cancer field.Approved in Korea in May last year, Imdelltra is a bispecific antibody targeting delta-like ligand 3 (DLL3), which is expressed in approximately 85–96% of patients with small cell lung cancer. DLL3 is typically localized intracellularly in normal cells but is aberrantly expressed on the surface of tumor cells in SCLC and other neuroendocrine cancers.Imdelltra binds to both the DLL3 antigen on cancer cells and the CD3 antigen on T cells, redirecting T cells to induce tumor cell death. Crucially, it acts directly on the antigens of T cells and cancer cells, independent of Major Histocompatibility Complex Class I (MHC-1) expression, one of the key pathways cancer cells use to evade the immune system, making it effective even against immune-evading cancer cells.The efficacy of Imdelltra was demonstrated in the DeLLphi-301 clinical trial, a phase 2 study conducted in adult patients with extensive-stage SCLC whose disease had progressed after at least two prior lines of therapy, including platinum-based chemotherapy.In the study, Imdelltra showed a clinically meaningful objective response rate (ORR). Among 100 patients treated with Imdelltra 10 mg, the ORR was 40%, and 58% of responders (n=23/40) maintained their response for six months or longer.Furthermore, the median overall survival (OS) in the Imdelltra 10mg group was 14.3 months, and the median progression-free survival (PFS) was 4.9 months. Treatment-related adverse events in the Imdelltra 10mg group were mostly low grade, with grade 3 or higher adverse events occurring in 29% of patients in the clinical Parts 1-2 and 15% of patients in Part 3.Based on these results, the National Comprehensive Cancer Network (NCCN) recommends Imdelltra monotherapy as a preferred regimen for platinum-resistant patients and as another recommended regimen for platinum-sensitive patients. In addition, the American Society of Clinical Oncology (ASCO) has issued a strong recommendation for Imdelltra monotherapy in patients with recurrent disease after chemotherapy.Small cell lung cancer (SCLC) accounts for approximately 10-15% of all lung cancer patients and is characterized by rapid cancer cell proliferation, leading to widespread metastasis within a short period. It is known that 6 to 7 out of 10 patients are diagnosed at the extensive stage, where cancer cells have metastasized to the contralateral lung or distant organs.Current treatment options for extensive-stage SCLC are limited, primarily consisting of chemotherapy and immunotherapy. Therapeutic choices become even more restricted beyond third-line treatment. Although initial response rates to chemotherapy are relatively high, responses are often short-lived, with rapid disease progression. Particularly in refractory or resistant patients whose disease progressed within 6 months after the last chemotherapy treatment, the response rate to conventional chemotherapy drops below 10%, underscoring the substantial unmet need for new treatment options.
- Company
- 'Fintepla' reduces seizure freq…treating Dravet syndrome"
- by Son, Hyung Min Feb 06, 2026 06:43am
- Changes are emerging in the treatment landscape for Dravet syndrome, an ultra-rare pediatric refractory disease. With the domestic approval of a serotonin-based novel drug that has demonstrated efficacy in reducing seizure frequency, expectations are high for a shift in the treatment paradigm for an area with significant unmet medical needs.On the 4th, UCB Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul, to celebrate the approval of 'Fintepla (fenfluramine),' a treatment for Dravet syndrome, in Korea.Professor Hunmin Kim of Seoul National University Bundang Hospital Fintepla was designated as a drug for the second pilot project of the 'Approval-Evaluation-Negotiation Linkage System' in December 2024. This drug was officially approved in Korea last December, one year after its designation.The specific indication is an add-on therapy for the treatment of seizures in patients with Dravet syndrome aged 2 years and older. Given the nature of pediatric patients who may have difficulty swallowing pills, Fintepla is formulated as a syrup.Fintepla is a treatment that reduces seizures by stimulating multiple 5-HT receptor subtypes through serotonin release. It can decrease a patient's seizures through a dual mechanism that simultaneously activates serotonin receptors and sigma-1 receptors.Fintepla's clinical value was demonstrated in three randomized Phase 3 trials (STUDY 1–3).The analysis results of STUDY 1, which initially enrolled 119 patients, and STUDY 3, which included subsequently recruited patients, showed that the monthly average convulsive seizure frequency (MCSF) in the Fintepla-treated groups decreased by 62.3% and 64.8%, respectively. Notably, near-complete seizure freedom was confirmed only in the Fintepla-treated group.In STUDY 2, which consisted of a 6-week baseline, 3-week titration, and 12-week maintenance period for a total of 15 weeks, patients were randomly assigned 1:1 to either Fintepla or a placebo as an add-on to the existing standard of care, stiripentol (+ clobazam and/or valproate).In that study, the proportion of patients who showed a 50% or greater reduction in MCSF from baseline was 53.5% in the Fintepla combination group, compared with only 2% in the placebo group.In a 3-year open-label extension study, the reduction in seizure frequency with Fintepla was maintained. 64.2% of all patients showed a 50% or greater decrease in MCSF from baseline.In terms of safety, 216 patients with Dravet syndrome who received Fintepla showed a similar adverse event profile. The most commonly reported adverse events were decreased appetite (34.7%), diarrhea (19.9%), fatigue (19.0%), fever (18.7%), reduced blood glucose (14.4%), and somnolence (13.9%).Professor Hunmin Kim of Seoul National University Bundang Hospital explained, "Fintepla is a treatment that has consistently proven its seizure control effect and therapeutic value in multiple clinical trials, despite the difficult environment for patient recruitment due to the nature of ultra-rare pediatric severe refractory diseases."Professor Kim added, "Not only the mortality rate due to sudden death but also the all-cause mortality rate appeared lower in the Fintepla-treated group compared to values reported in existing literature."Limited treatment environment for Dravet Syndrome... Expectations↑ with new treatment optionProfessor Hoon-Chul Kang of the Department of Pediatric Neurology at Severance Children's HospitalDravet syndrome is a type of pediatric epilepsy that occurs in infancy. According to experts, the majority (80%) of this disease is caused by a mutation in the SCN1A gene.The disease develops around 12 months of age, and up to 15% of patients die during early childhood or adolescence. Dravet syndrome patients are at high risk for physical and mental comorbidities, such as physical stiffness, language development disorders, autism, intellectual disability, and ADHD.Caregivers also endure high caregiving stress and low quality of life due to 24-hour care burdens, career interruptions, and loss of income.Frequent long-term seizures in Dravet syndrome patients not only lower the quality of life for both patients and caregivers but also carry a risk of Sudden Unexpected Death in Epilepsy (SUDEP). Therefore, the primary goal of treatment is to reduce or stop seizures.However, existing anti-epileptic drugs have limitations in controlling seizures, and some medications can even worsen them, leaving a significant unmet need in the domestic treatment environment.Professor Hoon-Chul Kang of the Department of Pediatric Neurology at Severance Children's Hospital stated, "Treatment for Dravet syndrome should aim beyond reducing seizure frequency to managing non-seizure comorbidities and minimizing drug side effects, but this has been difficult to achieve in the current treatment environment."Professor Kang emphasized, "There is an unmet need for treatment options that can more effectively control seizures, reduce cognitive decline and long-term disability, and improve the quality of life for patients and caregivers. Fintepla functions to prevent seizures. Seizure-freedom effects can also be expected. As it works differently from existing drugs, expectations are high."
