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- 2026-09-11 12:24:30
- Company
- Lung cancer experts convene in Seoul…new results will be unveiled
- by Son, Hyung Min Sep 11, 2026 08:48am
- Domestic and international lung cancer experts are convening in Seoul. Beginning with the Korean Association for Lung Cancer International Conference (KALC IC) and followed by the World Conference on Lung Cancer (WCLC), the symposia will unveil the latest clinical breakthroughs spanning early detection, surgical intervention, molecular targeted therapies, immuno-oncology, and antibody-drug conjugates (ADCs).Professor Woo Hong-gyun, Chairman of the Board of KALC In particular, with the international thoracic oncology conference taking place in Seoul immediately after the domestic congress, the consecutive events are expected to offer conference participants a comprehensive look at the rapidly segmenting treatment landscape and emerging therapeutic paradigms.The Korean Association for Lung Cancer (KALC) is holding the '2026 KALC International Conference (KALC IC 2026)' over two days, beginning on the 10th at Lotte Hotel World in Seoul.Approximately 700 participants are attending this year's congress. Based on pre-registration data, the number of participating nations, including overseas attendees, expanded from 21 last year to 27 this year. A total of 141 abstracts were accepted, with submissions from 14 countries, up from 11 the prior year.Woo Hong-gyun, Chairman of the Board of KALC and Professor of Radiation Oncology at Seoul National University Hospital, stated, "This year, attendees from 27 nations confirmed their participation and abstracts were submitted from 14 countries. KALC IC continues to expand its global reach and stature as a premier international academic forum."Sessions present latest clinical insights on next-generation immuno-oncology and ADCsThis year’s KALC IC covers various topics from structural changes in lung cancer diagnosis and therapy to long-term translational research avenues.Plenary sessions are titled "Legacy of the Masters" program, featuring global opinion leaders who have driven landmark advancements in thoracic oncology.On day one, the "Shifting Paradigms in Thoracic Oncology" session reviews clinical advances across pathology, precision biomarkers, molecular targeted therapy in non-small cell lung cancer (NSCLC), and thoracic surgery. On day two, "The Global Impact" session examines translational oncology, stereotactic body radiation therapy (SBRT), and the past, present, and future trajectory of lung cancer care in South Korea.Professor In-Jae Oh, KALC Scientific DirectorIn-Jae Oh, KALC Scientific Director and Professor of Pulmonology at Chonnam National University Hwasun Hospital, explained, "The World Conference on Lung Cancer has played an instrumental role in shaping thoracic oncology, producing seasoned luminaries who have accumulated decades of clinical insight. This conference is structured to enable attendees to gain not only cutting-edge data, but also historical perspectives on therapeutic evolution through lectures by leading authorities in medical oncology, thoracic surgery, radiation oncology, and pathology."Notably, this year's program strongly reinforces a multidisciplinary framework in which clinicians across diverse specialties collaboratively evaluate unified lung cancer therapeutic strategies.Professor Oh added, "Because lung cancer fundamentally necessitates a multidisciplinary approach, we systematically constructed sessions where clinicians from various subspecialties can engage with identical topics and debate them from their respective disciplinary perspectives," adding, "The program was designed to encourage experts across diverse fields and generations to analyze lung cancer treatment paradigms from multifaceted viewpoints."The program on the 11th features dedicated sessions focusing on next-generation immune-checkpoint therapies and ADCs, perioperative treatment modalities, and DLL3-targeted precision therapeutics in small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC).Recently, thoracic oncology has advanced far beyond traditional oncogenic driver mutations to embrace combination immunotherapies, ADCs, and bispecific antibodies. Concurrently, systemic therapies that originally launched in metastatic lines are rapidly migrating to neoadjuvant and adjuvant settings, resulting in increasingly granular, stage-specific clinical algorithms.Topics on sustaining regionally integrated lung cancer careIn addition to topics on novel drug candidates and advanced modalities, this year's agenda includes domestic healthcare infrastructure and cancer delivery models.On the 10th, the Planning Committee hosted a session titled "Strategies to Implement Regionally Comprehensive Lung Cancer Care," discussing delivery frameworks that guarantee coordinated diagnosis and therapeutic continuity within provincial regions. The committee presented case studies from Chungbuk National University Hospital and Chonnam National University Hospital, along with evaluations of the functional roles of regional cancer centers and initiatives to establish decentralized patient referral networks.In Kyu Park, KALC Planning Director and Professor of Thoracic and Cardiovascular Surgery at Seoul National University Hospital, remarked, "With regional healthcare viability emerging as a critical socioeconomic challenge, resolving the logistical burden of lung cancer patients traveling to other regions for treatment is an imperative task," adding, "This session was designed to explore actionable measures not only from a health policy perspective, but also through professional academic initiatives."A survey on multidisciplinary care conducted by KALC among its membership revealed that while clinicians strongly concur on the clinical utility and necessity of multidisciplinary tumor boards, structural policy reforms remain imperative to ensure operational sustainability.Professor Park noted, "Under the current fee-for-service model, which mandates presence by multiple subspecialists to qualify for reimbursement, maintaining multidisciplinary clinics is challenging for staffing-constrained regional centers," adding, "A more flexible appraisal and reimbursement framework must be considered to accommodate remote consultations and virtual multidisciplinary tumor boards."The conference also highlights post-treatment survivorship and patient quality of life. On the 11th, KALC is hosting a "Lung Cancer Awareness Day" event geared toward patients, caregivers, and the public.This year's theme is "Life After Lung Cancer." The agenda is tailored to practical, real-world challenges patients face during and after treatment, with a strong focus on clinical nutrition, exercise oncology, and psychosocial mental healthcare.Professor Woo emphasized, "This year's Lung Cancer Awareness Day was developed around practical lifestyle areas of high patient interest, such as nutritional counseling, physical conditioning, and mental wellness," adding, "It is structured to foster deeper engagement and empathy with patients and their families."In parallel, the formal academic program has instituted a dedicated track for "Supportive Care and Survivorship."As overall survival prolongs and treatment options diversify, long-term survivorship management—encompassing nutritional integrity, functional recovery, and psychiatric support throughout chronic therapeutic regimens—is increasingly recognized as an essential pillar of comprehensive lung cancer clinical care alongside primary anti-tumor efficacy.Chairman Woo noted, "The declining number of young physicians choosing to specialize in thoracic oncology is an ongoing concern," adding, "During this WCLC period, we distributed official invitations to medical schools nationwide and will be holding an interactive colloquium with 11 prospective medical students."Key clinical trial outcomes of SCLC·NSCLC will be unveiled at the WCLC After the domestic symposium, the 2026 World Conference on Lung Cancer (WCLC 2026), hosted by the International Association for the Study of Lung Cancer (IASLC), will begin on the 12th at COEX in Seoul.At this year's WCLC, late-stage clinical trial outcomes poised to influence practice guidelines in both SCLC and NSCLC will be presented.The conference's key focus centers on small cell lung cancer.The SWOG S1827 'MAVERICK' trial evaluates prophylactic cranial irradiation (PCI) against an active surveillance protocol utilizing brain magnetic resonance imaging (MRI) in SCLC patients without baseline central nervous system metastases. Given the neurocognitive decline associated with conventional whole-brain PCI, significant industry interest is focused on whether MRI surveillance can validate itself as a safe, toxicity-sparing standard-of-care alternative.In relapsed/refractory SCLC, presentations on clinical results for B7-H3-directed ADCs are also scheduled. Late-stage clinical trials TAISHAN-302 and ARTEMIS-008 are featured as highlighted presentations, providing key efficacy and safety signals for novel ADCs versus standard chemotherapy options in subsequent-line settings.In non-small cell lung cancer, frontline regimens targeting EGFR exon 20 insertion mutations are drawing interests.The Phase 3 PAPILLON study evaluated amivantamab + chemotherapy as a first-line treatment for advanced NSCLC harboring EGFR exon 20 insertion mutations. Following prior results confirming progression-free survival (PFS) superiority, long-term follow-up analyses will shed light on overall survival durability.Within the same patient population, the REZILIENT 3 trial evaluating frontline zipalertinib is also featured prominently. As clinical evidence accumulates for this historically challenging target, the comparative readout will provide critical data to shape future first-line treatment algorithms.In resectable EGFR-mutated NSCLC, extended follow-up data from the landmark ADAURA trial will be presented. ADAURA demonstrated the definitive survival benefit of adjuvant osimertinib following surgical resection, anchoring the role of targeted maintenance therapies in early-stage disease.In ROS1-positive NSCLC, clinical results from the ARROS-1 trial evaluating the next-generation ROS1 tyrosine kinase inhibitor (TKI) zidesamtinib are also scheduled for presentation.
- Company
- Handok adds DTx and AI to insomnia drug… expands sleep business
- by Hwang, byoung woo Sep 11, 2026 08:48am
- RE:SLEEP media sessionBuilding adoption base is only first step; converting it into actual prescriptions remains…plans to expand into chronic disease management after sleepHandok is expanding its sleep business beyond prescribing insomnia medication to measuring patients’ sleep and assessing treatment outcomes.Rather than ending treatment with a prescription when a patient complains of insomnia, the company is adding digital cognitive behavioral therapy and artificial intelligence (AI)-based sleep analysis. In other words, the company seeks to bring the entire patient journey—from diagnosis and treatment to reassessment—into its business scope.Handok unveiled the strategy at its RE:SLEEP media session held on the 9th.Diagnosis that had been reliant on sleep diaries, treatment focused on drugs…connecting both ends of careHandok focused on the fact that amid the rising the number of patients with insomnia, the treatment process remains fragmented.According to figures presented by Handok based on data from the Health Insurance Review & Assessment Service, the number of patients with sleep disorders in Korea rose by about 26% over five years, from 1,037,396 in 2020 to 1,308,383 in 2024.At the diagnostic stage, however, diagnosis still mainly relies on interviews or sleep diaries based on the patient's memory. Polysomnography can be considered when objective testing is needed, but it involves cost and accessibility burdens.Treatment options also remain heavily weighted toward medication. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as first-line treatment for chronic insomnia. Still, its use in clinical practice is limited by the time and specialist personnel required for counseling, as well as reimbursement issues. There has also been no convenient way to determine whether a patient’s sleep actually improved after treatment outside the clinic.Handok has placed Stilnox, the insomnia treatment it has supplied since 2012, at the center of its strategy, positioning WELT’s digital medical device SleepQ and Asleep’s AI-based sleep analysis device ChronoTrack before and after treatment.Before treatment, ChronoTrack assesses the patient’s sleep patterns. Without requiring a wearable device, ChronoTrack uses AI to analyze breathing sounds captured through a smartphone microphone. Over 14 days, it records sleep onset, time to fall asleep, nighttime awakenings, and final wake time, then transmits the results to a dashboard for healthcare professionals.Joon-Ki Hong, Chief Technology Officer of Asleep, said, “In the past, we had to rely on patients' responses during interviews or sleep diaries. ChronoTrack automatically records sleep and turns it into medical data, functioning as a sleep gauge that allows objective comparison of changes before and after treatment.”At the treatment stage, SleepQ is offered as an option alongside medication. SleepQ is designed to guide patients through a six-week CBT-I program via a smartphone application, including sleep restriction, stimulus control, and cognitive restructuring.The program adjusts bedtime and wake-up time according to the patient’s actual sleep patterns and reduces the amount of time spent awake in bed. In effect, it brings CBT-I, which is difficult to provide sufficiently in hospitals, into patients’ daily lives.Sung-jee Kang, CEO of Welt, said, “Even though clinicians were well aware that cognitive behavioral therapy benefits patients, it was not easy to deliver it in actual clinical practice. SleepQ turns scientific evidence that has not been fully utilized in clinical settings into a software-based product.”After treatment, ChronoTrack is used to measure sleep again. Data collected at diagnosis are compared with post-treatment results to assess how medication or digital therapy has changed the patient’s sleep.Yoon-mi Kim, Senior Vice President of Handok’s prescription drug business division, explained, “It is difficult for patients and healthcare professionals to know exactly when treatment is needed with medication alone. We considered the entire treatment cycle from the perspective that sleep status needs to be visible to use either medication or digital therapeutics appropriately.”(From left) Yoon-mi Kim, Senior Vice President of Handok’s prescription drug business division; WELT CEO Sung-jee Kang; and Asleep CTO Joon-Ki HongAdoption alone will not drive prescriptions…clinical use and product integration are keyHandok has now established the basic framework for its sleep business, but converting product adoption into actual prescriptions and sustained use remains a challenge.The number of cumulative SleepQ registrations with the National Evidence-based Healthcare Collaborating Agency surpassed 1,000 in July. However, adoption or registration by healthcare institutions does not necessarily translate directly into actual prescriptions.Kang said, “Even if the product and treatment principles are available, patients first need to know about them before they are willing to use them, and clinicians also need to know the product before they can recommend it. Because prescriptions happen at the point where clinicians and patients meet, awareness needs to be raised on both sides.”To reduce inconvenience in the prescribing process, Welt has created a way to use SleepQ separately from electronic medical records (EMRs). Patients can take a photo of their detailed medical expense statement through a mobile application, and AI reads the prescription information and initiates treatment.Apart from bundling the three products into a single sleep business, further work would be required to integrate each product’s data in clinical practice. At the presentation, the companies did not disclose how or when SleepQ and ChronoTrack would be technically linked on a single platform.To broaden the clinical reach of its digital business, Handok established a digital business division in 2024 and moved the organization under its prescription drug business division in April this year. The move reflects a strategy of combining digital healthcare with its existing sales and marketing capabilities rather than operating it as a separate new business.Sleep is the first field in which Handok is applying this business model. After linking measurement, treatment and reassessment in insomnia, the company plans to expand the model and apply it to chronic diseases that require continuous management.Kim said, “Sleep management is not the final goal of Handok’s digital healthcare business, but the beginning. After the measurement, treatment, and reassessment are validated in insomnia, we plan to expand the model into chronic disease management.”
- Company
- Blockbusters face mixed fortunes in drug reassessment
- by Kim, Jin-Gu Sep 11, 2026 08:48am
- The release of the first round of listed drugs subject to reassessment has produced sharply different outcomes, depending on the product.Products included in Round 1 will face phased price adjustments beginning next year, while key products assigned to the second round or excluded from reassessment will avoid the immediate burden of price cuts.Reassessment of many major products including Rosuzet and Atozet shifted to second round…easing burden on companies with key brandsAccording to industry sources on the 10th, the Health Insurance Review & Assessment Service (HIRA) recently released its first-round reassessment list for previously listed drugs. Of the 22,045 products on the reimbursement list as of September this year, 14,013, or 63.6%, were identified as subject to the first round of reassessments.The government designated product groups in which multiple products with the same route of administration, active ingredient, and dosage form were listed as of Dec. 1, 2012, among others, for the first round, while the remaining products were generally classified for the second round. Price adjustments under the first reassessment will begin in April next year, while those under the second will start in October 2030. Innovative and semi-innovative pharmaceutical companies are eligible for special deferrals, pushing back the timing of their final price adjustments.Among the most notable products on the list are major drugs with substantial prescription sales that were classified for the second round.Hanmi Pharmaceutical’s Rosuzet is one prime example. According to pharmaceutical market research firm UBIST, Rosuzet generated KRW 227.9 billion in prescription sales last year, the highest figure in Korea’s outpatient prescription market. Had Rosuzet been included in the first round, its price would have been subject to phased adjustments to 51%, 49%, 47% and 45% beginning next year. Its inclusion in the second round, however, delays its first price adjustment until October 2030, easing the immediate price-cut burden on Hanmi’s flagship product.In addition to Rosuzet, ▲Organon’s Atozet, ▲JW Pharmaceutical’s Livalozet and ▲Yuhan Corp’ Rosuvamibe, all of which generated more than KRW 100 billion in prescription sales last year, were included in the second round. Daiichi Sankyo’s Lixiana, whose patent is set to expire in November with generic launches expected to follow, is also expected to be subject to second-round price adjustments.Among products with annual prescription sales of at least KRW 50 billion, ▲JW Pharmaceutical’s Livalo, ▲Boehringer Ingelheim’s Twynsta, ▲Gilead Sciences’ Viread, ▲AstraZeneca’s Crestor, ▲Boehringer Ingelheim’s Jardiance, ▲Novartis’ Exforge, ▲Gilead Sciences’ Vemlidy, ▲BMS’ Baraclude, ▲Boryung’s Kanarb and Dukarb, ▲Daiichi Sankyo’s Sevikar, ▲Hanmi Pharmaceutical’s Esomezol, ▲Daewon Pharmaceutical’s Pelubi and ▲HK inno.N’s Rovazet are also expected to undergo second-round reassessment.1,576 products excluded from first round…Yuhan’s Cough and Daewoong’s Diabex among themA substantial number of products were also excluded from the first-round reassessment. The government said exclusions apply to categories including orphan drugs, narcotics, biologics, drugs protected from market withdrawal, low-priced drugs, oxygen, nitrous oxide, radiopharmaceuticals, basic intravenous fluids, artificial perfusion solutions and products for which prices cannot be calculated.A total of 1,576 products fall into these categories. They include Yuhan Corp’s Cough and Daewoong Pharmaceutical’s Diabex. Based on last year’s prescription sales, Cough generated KRW 38 billion and Diabex KRW 20.9 billion. Seventeen products excluded from the first round recorded prescription sales of at least KRW 10 billion last year.The exclusions also include key products that have maintained strong prescription performance over many years. By avoiding the price-adjustment burden from this reassessment, these products are also expected to avoid revenue declines stemming from price cuts, assuming prescription volumes remain stable.By contrast, major blockbuster products including Viatris’ Lipitor, Handok’s Plavix, Daewoong Bio’s Gliatamin and Chong Kun Dang’s Gliatilin were included in the first round. These products will inevitably face pressure on prescription sales and their manufacturers’ performance as price cuts begin next year.The impact on individual pharmaceutical companies is therefore expected to depend less on how many of their products are subject to reassessment than on which round their key products fall into. For major products generating tens or hundreds of billions of won in annual prescription sales, the reassessment round can significantly alter when the burden of price reductions begins, making the classification of flagship products a key variable in pharmaceutical companies’ future performance.
- Policy
- Selective reimbursement to improve new drug access
- by Jung, Heung-Jun Sep 11, 2026 08:47am
- The government is moving to improve access to high-priced cancer and rare disease drugs by refining the selective reimbursement system for pharmaceuticals.It has set out to conduct a comprehensive review covering the scope of eligible drugs, patient cost-sharing rates, the establishment of a review committee and post-listing management measures.According to the Ministry of Health and Welfare (MOHW) and industry sources on the 7th, the review will be conducted by the Pharmaceutical Selective Reimbursement Division, a task force established within the Health Insurance Review & Assessment Service’s Pharmaceutical Benefits Management Office.A regulatory framework for selective reimbursement of pharmaceuticals is already in place. The system was introduced in 2018 under the Moon Jae-in administration as part of a policy to expand National Health Insurance coverage for previously non-covered services. Patient coinsurance rates of 30%, 50%, or 80% are applied depending on clinical utility, availability of alternatives, and social demand.However, the system has seen limited use for cancer and rare disease drugs. Selective reimbursement was applied to several cancer drugs in the early days of the program, but little progress has been made since, with few additional drugs gaining coverage under the scheme.Breast cancer treatment Perjeta also applied for selective reimbursement when seeking reimbursement expansion late last year, but the application was not placed on the agenda of the Cancer Disease Review Committee. The lack of sufficiently established selective reimbursement criteria was reportedly among the reasons.The government now plans to refine the system in greater detail and explore broader application to cancer and rare disease drugs, with the aim of improving access to new medicines.In particular, it will comprehensively examine ▲the scope and criteria for eligible drugs, ▲patient cost-sharing rates, ▲whether a separate review committee is needed, ▲post-listing negotiation and contracting arrangements, and ▲safeguards against companies withdrawing from the program or discontinuing supply or contracts midway through participation.Potential candidates could include drugs that fall into a reimbursement blind spot because their small patient populations make conventional cost-effectiveness assessment difficult, while opting for a cost-effectiveness assessment waiver is also not feasible.In other words, where patients have a clear treatment need, the government will consider improving access by allowing coverage at a higher patient cost-sharing rate, even if the 5% rate available under Korea’s special coninsurance reduction program cannot be applied.However, improving access is not the government’s only concern. It also plans to establish appropriate management measures to prevent indiscriminate use of selective reimbursement. Safeguards will be considered to prevent drugs admitted under the scheme from subsequently being withdrawn from supply.An MOHW official said, “We are reviewing the system comprehensively, including whether a separate review committee is necessary. Because there is also a possibility that drugs receiving selective reimbursement could suddenly withdraw midway through the program, we are comprehensively considering measures to prevent such cases.”However, as the initiative is still at the research and review stage, implementation is expected no earlier than next year.
- Policy
- Revoking the ODD status of immunostimulants remains unresolved
- by Lee, Tak-Sun Sep 11, 2026 08:47am
- AI-generated imageDiscussions over 'revoking the orphan drug designations' of major injectable immunostimulants, which came under intense scrutiny during last year's National Assembly audit over efficacy controversies and excessive prescribing, remain unresolved nearly a full year later.With this year's parliamentary audit scheduled for October, the Ministry of Food and Drug Safety (MFDS) is expected to face heavy legislative pushback if it fails to present concrete regulatory outcomes.On the 21st of last month, the MFDS convened an advisory session of the Central Pharmaceutical Affairs Council (CPAC) to discuss revoking orphan drug designations for injectable formulations of Viscum album (40 products) and immunocyanin (2 products). Under current pharmaceutical regulations, designated orphan drugs are exempt from mandatory clinical re-evaluation. Consequently, the regulator initiated preliminary administrative steps because the patient populations for their approved indications have surpassed the statutory orphan threshold of 20,000 patients.However, regulatory authorities have not yet reached a definitive conclusion. Both therapeutic agents remained on the updated orphan drug list gazetted earlier this month. In response, the MFDS stated, "We are currently reviewing whether to revoke the orphan drug designations while taking the advisory opinions of the CPAC into consideration".Industry sources report that the advisory council adjourned without reaching a clear conclusion, leaving the deliberation suspended. Without a definitive consensus from the expert advisory body, the MFDS will likely struggle to make a unilateral regulatory determination.Analysts observe that the CPAC wrestled intensely with the substantive validity of 'revoking orphan status.' Deliberations likely included contentious debate over the broader repercussions of mechanically enforcing the epidemiological prevalence criterion, as well as whether destabilizing formally approved indications to curb out-of-pocket, off-label prescribing conforms to the administrative legal principle of proportionality.The critical issue remains that while regulatory reviews remain stalled, the out-of-pocket, non-reimbursed prescription market continues to expand rapidly.According to a recent analysis of the "Second Half 2025 Non-Reimbursed Healthcare Reporting System" by the Ministry of Health and Welfare and the National Health Insurance Service, non-reimbursed medical expenses for thymosin alpha-1, which is an immunostimulant facing parallel efficacy challenges, reached KRW 27.4 billion in September 2025 alone. This marked a 67.1% surge within a single year, with prescribing heavily concentrated in long-term care and traditional medicine hospitals. Even after the National Evidence-based Healthcare Collaborating Agency (NECA) concluded that the therapy lacked sufficient clinical evidence and lawmakers repeatedly demanded efficacy reassessments, market prescription volumes remained entirely unchecked.The MFDS continues discussion internally. While the ministry took administrative steps under pressure from the parliamentary audit, internal voices acknowledge that shifting the burden of policing a KRW 200 billion non-reimbursed prescribing market onto pharmaceutical manufacturers by mandating costly clinical trials represents an excessive administrative overreach. The pharmaceutical industry has adopted an uncompromising defensive posture, preparing to pursue aggressive legal countermeasures, including petitions for injunctions to stay execution and formal administrative litigation, should the revocation and re-evaluation orders proceed.With sharp criticism from the National Assembly's Health and Welfare Committee anticipated in the upcoming audit, industry attention is focused on whether the MFDS, caught between regulatory enforceability and litigation risk, can reach a definitive resolution before the audit convenes.
- Company
- Ildong re-enters the migraine mkt with 'Nurtec' after Reyvow withdrawal
- by Kim, Jin-Gu Sep 10, 2026 08:44am
- Ildong Pharmaceutical is reentering the domestic migraine market through a partnership with Pfizer. As Ildong's migraine drug Reyvow is set for commercial discontinuation this December, Ildong is collaborating with Pfizer Korea to co-promote 'Nurtec (rimegepant).'Migraine drug Reyvow faces withdrawal at the end of this year…Ildong continues with the sales of NurtecAccording to industry sources on the 9th, Ildong Pharmaceutical announced on the 8th that it entered into a domestic distribution and co-promotion agreement with Pfizer Korea for Nurtec ODT. Starting this month, the two companies will jointly conduct product information for healthcare professionals and commercial sales activities.Ildong Pharmaceutical entered into a domestic distribution and co-promotion agreement with Pfizer Korea for Nurtec ODT.For Ildong Pharmaceutical, this partnership enables a portfolio transition from its existing migraine therapy, 'Reyvow (lasmiditan).' Back in 2013, Ildong secured regional commercial rights across eight Asian territories, including South Korea, from Reyvow’s original developer, U.S.-based CoLucid Pharmaceuticals. Although Eli Lilly acquired CoLucid Pharmaceuticals and gained global rights to Reyvow, Ildong retained its domestic marketing authorization and commercial rights.Reyvow drew significant attention as a novel mechanism-of-action oral migraine therapeutic designed to address the limitations of conventional triptan therapies. By selectively targeting the 5-HT1F receptor, it reduces concerns about vasoconstriction and related cardiovascular adverse events. Following regulatory approval in South Korea in 2022, Ildong commenced commercial distribution.However, Reyvow failed to secure National Health Insurance reimbursement listing. Disagreements over drug pricing during the domestic reimbursement appraisal ultimately led to an out-of-pocket, non-reimbursed launch. In the non-reimbursed market, Reyvow subsequently recorded an annual production value of merely around KRW 200 million.In June of this year, Eli Lilly decided to cease global manufacturing and supply of Reyvow. As a consequence, domestic sales of Reyvow are scheduled to terminate this December.Under these circumstances, co-promoting Nurtec enables Ildong Pharmaceutical to maintain continuity in its migraine franchise. Ildong has long maintained an established neurology sales and commercial network anchored by Sermion (nicergoline). Furthermore, navigating the domestic regulatory approval and commercialization of Reyvow allowed the company to accumulate dedicated operational expertise in novel migraine therapeutics.Differentiated from Reyvow by spanning scute to preventive Care...Can it clear the reimbursement hurdle?Nurtec is an oral calcitonin gene-related peptide (CGRP) receptor antagonist that operates via a mechanism distinct from Reyvow. In South Korea, it is approved for both the acute treatment of migraine attacks and the preventive treatment of episodic migraine in adults. As a single therapeutic agent, it targets both acute symptom relief during an attack and preventive therapy to reduce future recurrence.Administration convenience is a product strength. Formulated as an ODT that dissolves on or under the tongue without water, Nurtec is designed to make administration easier, even during an acute migraine attack.Product photos of Reyvow (left) and Nurtec (right).In global clinical trials, the drug also secured head-to-head comparative data against 'Emgality (galcanezumab),' a reimbursed injectable preventive therapy in South Korea. In the CHALLENGE-MIG study, which enrolled 580 patients and evaluated episodic migraine prophylaxis, 61% of patients in the rimegepant arm achieved a 50% or greater reduction in monthly migraine days, compared with 62% in the galcanezumab arm. This demonstrates that Nurtec delivers comparable preventive efficacy in a direct head-to-head comparison.Rimegepant’s efficacy has also been established in the acute treatment setting. In a separate placebo-controlled clinical trial, 19.6% of patients in the rimegepant group achieved pain freedom at two hours post-dose versus 12.0% in the placebo group. In comparison, 37.6% and 25.2% of patients achieved freedom from the most bothersome symptom (MBS), respectively.National Health Insurance reimbursement listing is expected to be the key variable driving market expansion.Pfizer commercially launched Nurtec as an out-of-pocket, non-reimbursed product on the 1st of this month, a rollout path similar to Reyvow's previous entry. Given that Reyvow delivered lackluster commercial figures after failing to clear the reimbursement hurdle, industry analysts emphasize that securing reimbursement coverage will be critical to Nurtec’scommercial scalability.In the acute migraine treatment sector, no therapeutic agent has successfully entered the national formulary. While anti-CGRP biologics such as Emgality and Ajovy (fremanezumab) have attained reimbursement listing in the preventive segment, their reimbursed indications and coverage criteria remain tightly restricted. Consequently, Nurtec’s potential reimbursement entry will require a comprehensive evaluation encompassing not only its clinical value but also its pricing and pharmacoeconomic cost-effectiveness.
- Product
- AI-driven imaging competition heats up at KCR
- by Hwang, byoung woo Sep 10, 2026 08:44am
- Competition in artificial intelligence (AI) for diagnostic imaging is expanding beyond lesion detection and interpretation assistance to encompass the entire imaging workflow.As AI becomes involved in everything from image acquisition and reconstruction to automated measurements and report generation, companies are increasingly competing not simply on diagnostic accuracy but on their ability to improve examination speed and consistency while reducing clinicians’ workload.This shift was on full display at the Korean Congress of Radiology 2026 (KCR 2026), held Sept. 9–12 at KINTEX Exhibition Center 2 in Goyang.KCR 2026 is being held from Sept. 9 to 12.AI incorporated into imaging equipment…automating the entire examination processThe theme of this year’s congress is “Humanity Through Imaging.” Participating companies emphasized the clinical value that healthcare professionals and patients can gain from technologies in actual examination settings, rather than focusing solely on technological performance.While last year’s KCR centered on the hardware specifications needed to support high-performance AI and the possibility of upgrading existing equipment, a new area of competition has emerged this year -- how AI can be integrated into the imaging workflow.Competition among global diagnostic imaging companies has shifted from obtaining clearer images alone toward simultaneously reducing the time required for image acquisition, reconstruction and measurement. AI, meanwhile, is moving beyond standalone interpretation software and becoming embedded in CT, MR and ultrasound systems themselves.In CT and MR, the integration of hardware with AI-based reconstruction technology was particularly prominent. Siemens Healthineers applied its high-quality Quantum Iterative Reconstruction (QIR) technology to the NAEOTOM Alpha photon-counting CT system, while Philips showcased the second-generation Spectral CT 7500, which acquires conventional CT images and spectral data simultaneously, as well as the 3.0T MR BlueSeal Horizon, which is yet to be approved in Korea.GE HealthCare, meanwhile, presented Sonic DL, which accelerates MR image acquisition, and AIR Recon DL, which reduces image noise.(Clockwise from top left) Siemens, Canon, GE HealthCare and Philips boothsIn ultrasound, where examinations depend heavily on operator technique, automated recognition and measurement technologies were a common feature.Philips’ EPIQ Elite VM14 highlighted technology that automatically measures the kidneys and spleen and selects optimal image frames. GE HealthCare’s LOGIQ series similarly uses AI to identify and measure structures including the common bile duct, kidneys and abdominal aorta, reducing repetitive steps of testing for healthcare professionals.Samsung Medison presented its Liver Total Solution centered on the premium R20 ultrasound system, which offers combined assessment of fatty liver, liver fibrosis and viscosity-related properties of liver tissue. Its EzSWI liver stiffness measurement technology uses AI to automatically designate the region of interest.A study by a research team led by Professor Jeong-min Lee of Seoul National University Hospital found that the technology reduced examination time by approximately 55% without a statistically significant difference in diagnostic accuracy compared with the conventional method.Ultimately, competition in imaging equipment is shifting beyond how clearly images can be produced toward how quickly and consistently images of equivalent quality can be acquired.Young-beom Cho, Director of Domestic Sales Team at Samsung Medison, said, “Advances in imaging technology should go beyond providing more functions and ultimately help healthcare professionals make more reliable decisions while enabling patients to undergo examinations more efficiently.”Medical AI expands beyond detection…supports follow-up and reportingKorean medical AI companies placed greater emphasis on tasks performed after image acquisition. Their technologies are expanding beyond diagnostic assistance that flags lesions to encompass comparison with previous examinations, follow-up management, review of interpretation results and report generation.Lunit departed from the conventional approach of focusing on brochures and product presentations, instead setting up an interactive booth where visitors could experience the AI-assisted interpretation process firsthand.Through the Lunit INSIGHT Challenge, visitors could interpret chest X-rays and mammograms themselves and then compare their findings with the AI results. At the product demonstration area, the company showcased the interpretation workflows of Lunit INSIGHT CXR4, Lunit INSIGHT MMG and Lunit INSIGHT DBT, its AI solution for 3D mammography interpretation.“Sung-ho Back, a Lunit manager, explained, “AI solutions are much easier and faster to understand by experiencing them firsthand than by simply hearing an explanation. We designed the booth so visitors could interpret images themselves, compare their findings with the AI results and experience firsthand the role AI can play in an actual interpretation environment.”(Clockwise from top left) Samsung Medison, Lunit, DEEPNOID and Coreline Soft boothsCoreline Soft presented chest CT-based medical imaging AI solutions and clinical and screening applications under the theme “AI in Radiology: Beyond Detection.”Its AVIEW LCS Plus integrated lung cancer screening solution supports comparison with previous images and longitudinal follow-up in addition to lung nodule detection and quantitative analysis. The system enables clinicians to assess nodule size and changes according to consistent criteria across repeated examinations and link the findings to subsequent examinations and care.DEEPNOID, meanwhile, incorporated generative AI into the interpretation process. Eight abstracts in the chest and brain imaging fields being presented by the company at KCR 2026 evaluated how accuracy, efficiency and consistency change when AI is integrated into clinicians’ interpretation workflows.In chest imaging, the research covered a double-reading approach in which AI identifies cases that may have been missed after a physician’s initial interpretation and recommends them for review, as well as the use of generative AI to draft chest X-ray reports.While Coreline Soft has expanded its clinical reach into post-screening follow-up management and Lunit has focused on direct comparisons between clinicians’ interpretations and AI results, Deepnoid has extended AI into the selection of cases for re-review and report generation.Reducing only unnecessary repeat scans…will start real-time management from NovemberMeanwhile, the Korean Society of Radiology agreed with the need for stronger management of CT and MRI imaging histories but stressed that not all repeat imaging should be regarded as unnecessary duplicate testing.Beginning in November, the Health Insurance Review & Assessment Service (HIRA) will pilot a system that manages patients’ CT and MRI imaging histories in real time through its medical reimbursement benefits history verification system. Once the program is implemented, medical institutions will be required to review a patient’s imaging history from the previous year before performing a scan and submit relevant information to HIRA immediately afterward.KSR said repeat imaging may be medically necessary when performed to monitor changes in a patient’s condition or treatment outcomes, or when additional scans are needed because previous images were inadequate in quality or did not sufficiently cover the required anatomical area. By contrast, it said examinations repeated without medical justification despite usable existing images should be reduced.Joon-il Choi, Director of the KSR’s Policy and Advocacy Institute (KSR-PAI) and professor of radiology at Seoul St. Mary’s Hospital,said, “Not every repeat CT or MRI examination should be regarded as unnecessary duplicate imaging. The policy should focus not on indiscriminately reducing the number of repeat examinations, but on accurately identifying and reducing repeat scans that lack medical justification.”At a press briefing, the Korean Society of Radiology emphasized the importance of accurate screening rather than indiscriminately reducing the number of repeat examinations.The society proposed measures including entering reason codes for repeat imaging, facilitating the exchange of imaging information among medical institutions, establishing objective image-quality assessments and creating reimbursement for storing outside images in picture archiving and communication systems (PACS).On reimbursement for medical AI, the society also offered a pragmatic assessment that the National Health Insurance budget alone would be unlikely to provide compensation at the level expected by the industry.Given Korea’s relatively low medical fees, healthcare institutions have difficulty translating productivity gains from AI adoption into additional revenue. With the government also pursuing reductions in reimbursement for diagnostic imaging, the society said it would be difficult for the National Health Insurance system to provide additional reimbursement for AI usage fees.Choi said, “We need to fundamentally reconsider why the cost of medical AI should be borne by National Health Insurance,” and suggested that if the objective is largely to foster the industry and support exports, the government could also consider using separate funding from the industry or science and technology sectors.
- InterView
- [Reporter’s View] Rare disease drugs flock to 100-day listing pilot program
- by Son, Hyung Min Sep 10, 2026 08:44am
- More pharmaceutical companies than expected have applied for the government’s fast-track pilot program aimed at listing rare disease treatments for National Health Insurance reimbursement coverage within 100 days.A total of 14 rare disease treatments from Korean and multinational pharmaceutical companies were submitted for the recently closed pilot program. The government had initially planned to select five products. With applications reaching nearly three times the number of available slots, the program appears to have generated strong interest even before its launch.Under the program, the cost-effectiveness assessment normally conducted before reimbursement listing will be shifted to a post-listing evaluation, while procedures related to drug pricing and expenditure caps will be substantially streamlined based on a price benchmark of around 90% of the lowest adjusted price in the A8 countries. Reimbursement procedures will also begin before regulatory approval, with the goal of completing final National Health Insurance listing within 100 days of approval. The plan is intended to cut the listing process, which can currently take up to 240 days, by more than half.What deserves attention, however, is not simply that 14 products were submitted, but why pharmaceutical companies were so eager to participate.The conditions were not entirely favorable to drugmakers either. Five years after early reimbursement listing, treatment outcomes will be reassessed based on real-world data (RWD), with the possibility of a price reduction or a switch to full out-of-pocket payment depending on the results. Companies are also required to submit a “patient treatment continuity assurance plan,” a new requirement not included in the existing reimbursement listing system. In other words, companies gain faster market access in exchange for taking on considerable uncertainty.Nevertheless, 14 products were submitted. This suggests that demand for faster reimbursement access is substantial. At the same time, it also underscores just how long pharmaceutical companies and patients have had to endure the “wait” under the existing reimbursement process.This is not the first attempt to shorten the reimbursement listing period for new drugs. The government previously introduced a regulatory approval-assessment-price negotiation linkage program, under which regulatory approval, reimbursement eligibility assessment and price negotiations proceed in parallel, with the goal of shortening a process that could take more than 300 days to around 150 days.In practice, however, the process has not moved as quickly as intended. The first pilot program, launched in 2023, took about two years to complete, with some drugs taking more than a year to secure reimbursement coverage. The second pilot, launched in December 2024, has not been markedly different. Fintepla, the first drug to enter price negotiations, passed the Drug Reimbursement Evaluation Committee only about a year and a half after being selected for the pilot.Winrevair, a treatment for pulmonary arterial hypertension, was also included in the second pilot of the linkage program, but prolonged delays in the reimbursement process prompted a patient advocacy group in March to publicly question the program’s effectiveness. In other words, there was a gap between the program’s stated goal of “fast-track” access and the point at which patients could actually receive the drug with reimbursement.Of course, the new 100-day fast-track listing pilot program is not structured in the same way as the existing approval-assessment-negotiation linkage program. While the latter seeks to shorten timelines by running the existing approval, assessment and negotiation procedures in parallel, the new program goes further by substantially reducing pre-listing requirements themselves, including deferring the cost-effectiveness assessment until after listing.This can be seen as a stronger signal of the government’s determination to address reimbursement delays. On the other hand, given the gap between target timelines and actual processing times under previous fast-track listing initiatives, the success of this program will ultimately be judged by its results rather than its design.It is therefore too early to judge the program’s success based on the 14 applications alone. What matters is whether the selected treatments actually obtain National Health Insurance coverage within the timeframe promised by the government.For patients with rare diseases, the time required to obtain reimbursement coverage is more than an administrative processing period. Even after a treatment receives regulatory approval, its high cost can restrict actual access to treatment until reimbursement coverage becomes available. The government’s push for faster listing is ultimately intended to narrow this gap between regulatory approval and actual treatment access.The unexpectedly high number of applications for the 100-day fast-track listing program reflects strong expectations for the initiative. At the same time, the figure also highlights the “time delays” that the existing reimbursement system has failed to resolve promptly.The 14 applications may be a measure of the program’s popularity, but they are not a measure of its success. This time, the true test of the “fast-track listing” program should be not its name, but how long patients actually have to wait before gaining access to treatment.
- Policy
- MOHW has announced potential regulations concerning 'OTC overdose'
- by Lee, Jeong-Hwan Sep 10, 2026 08:44am
- Amid growing societal concern over adolescents overdosing on over-the-counter (OTC) drugs to achieve hallucinogenic effects, South Korea's Ministry of Health and Welfare (MOHW) has drawn the pharmaceutical industry's attention by announcing plans to overhaul the dispensing and distribution oversight system for OTC products in community pharmacies.In a written response to a legislative inquiry submitted by Representative So Byung-hoon of the Democratic Party to the National Assembly’s Health and Welfare Committee on the 1st, the MOHW stated that it agrees on the necessity of establishing safeguards within the pharmacy retail system to prevent adolescents from intentionally overdosing on specific OTC products for recreational or hallucinogenic purposes.Under the current Pharmaceutical Affairs Act, OTC medicines may be purchased without a prescription. However, Article 6 of the Enforcement Rule of the Pharmaceutical Affairs Act (Code of Ethics for Pharmacists and Oriental Herbal Pharmacists) strictly prohibits selling quantities exceeding an appropriate therapeutic dosage to minors or other individuals when there is a risk of misuse or abuse. Violations can result in administrative sanctions, including the suspension of a pharmacist's professional license.To terminate adolescent OTC overdoses, the MOHW has stepped up proactive surveillance by requesting formal cooperation from the Korean Pharmaceutical Association (KPA) on two separate occasions, in January and March of this year.Specifically, these administrative measures included ▲issuing directives to verify the intended indication of drugs carrying hallucinogenic risks while enforcing rigorous medication counseling (issued in January by the Mental Health Policy Division) ▲restricting excessive sales of abuse-prone medicines to adolescents and mandating strict compliance with ethical dispensing standards (issued in March by the Division of Pharmaceutical Policy).The MOHW plans to formulate actionable regulatory measures aligned with the legislative intent of the Pharmaceutical Affairs Act amendment bill introduced by Representative So.Representative So’s proposed amendment centers on mandating pharmacist medication counseling for OTC products susceptible to misuse or abuse, legally prohibiting the dispensing of quantities exceeding standard therapeutic regimens to minors, and requiring pharmacists to verify purchaser personal details and maintain transaction logs.An official from the MOHW’s Division of Pharmaceutical Policy stated, "The MOHW will comprehensively evaluate the positions of the primary regulatory authority, the Ministry of Food and Drug Safety (MFDS), and pharmacies represented by the KPA," and emphasized that "The ministry will establish a workable, pharmacy-level OTC management framework."While concurring with the legislative intent behind mandating OTC medication counseling, the MFDS pointed out that the bill partially conflicts with the nation’s existing pharmaceutical classification framework.Under Korea’s current regulatory system, the "drugs subject to misuse·abuse control" designation is applied exclusively to prescription-only medicines (ethical pharmaceuticals, or ETCs). Products with low potential for abuse are categorized as OTCs. Consequently, statutory provisions authorizing the MFDS Minister to designate a separate subset of OTCs as drugs subject to misuse or abuse create structural friction with the binary ETC/OTC classification system.The proposed measure cited the Pharmaceutical Affairs Act as the statutory basis, which legally defines OTC drugs as therapeutics with a low risk of misuse or abuse and that can be expected to demonstrate safety and efficacy even when administered without a physician's prescription.The MFDS stated, "Mandating the Minister to designate specific OTC drugs vulnerable to misuse or abuse warrants careful legal review, Rep. So's proposal diverges from the drug classification criteria established under the same statute," and concluded, "However, defining conditions for repeated OTC purchases by minors and prescribing pharmacist counseling standards fall within the administrative jurisdiction of the MOHW. The ministry will actively cooperate on necessary regulatory follow-ups."
- Policy
- Lipitor and Plavix face 51% price cuts next year
- by Jung, Heung-Jun Sep 10, 2026 08:44am
- A large number of major products, including Lipitor and Plavix, have been included in the first round of reassessment of previously listed drugs. Beginning with a reduction to 51% next April, reimbursement price ceilings will be lowered in stages, leaving even long-established blockbuster drugs exposed to price cuts.According to the first-round reassessment list released by the Health Insurance Review & Assessment Service (HIRA) on Sept. 8, a total of 12,437 products are currently included without exception.Hanmi Pharmaceutical and Chong Kun Dang each have more than 200 products classified for the first round of reassessment. Around 40 companies have at least 100 products on the list, including Daewoong Bio, Hutecs Korea, Hana Pharm, Reyon Pharmaceutical, Shin Poong Pharmaceutical, Myung In Pharm, Dongkook Pharmaceutical, Hanlim Pharm and Yuhan Corporation.More important than the number of products, however, is their sales volume. Price cuts imposed on one or two blockbusters with annual prescription sales exceeding KRW 100 billion could have a far greater impact on a company's actual revenue than dozens of low-sales products.Products in the first round of reassessment will initially be subject to a 51% price ceiling next year, followed by phased reductions to 45% by 2030. AI-generated imageNotable products included in the first round are Viatris' hyperlipidemia treatment Lipitor, Handok's antiplatelet drug Plavix, Daewoong Bio's cognitive function enhancer Gliatamin and Chong Kun Dang's cognitive function enhancer Gliatilin.According to pharmaceutical market research firm UBIST, all of these products have consistently generated annual sales exceeding KRW 100 billion.Viatris has only 36 products subject to the first reassessment after those marked as exempt are excluded, but all four strengths of its high-grossing Lipitor—10 mg, 20 mg, 40 mg and 80 mg—are included on the list. Lipitor is a major product with annual sales exceeding KRW 170 billion.Because the adjustment will be based on the highest price among identical formulations on the September reimbursement list, Lipitor, whose price has already been lowered, is expected to see only a modest reduction next April. The amount reduction will become greater from 2028, however. For Lipitor 10 mg, the current price of KRW 638 will fall to KRW 631 next year and KRW 607 in 2028.The outlook was mixed for Hanmi Pharmaceutical's major products. Amozaltan was included in the first round of reassessment, while Rosuzet, which generates more than KRW 220 billion in annual sales, was assigned to the second round.The government will use the September 2026 highest price for identical formulations, currently set at 53.55% of the reference price, as the basis for adjustments. For ordinary companies, the reimbursement ceiling will then be lowered in stages to 51% in 2027, 49% in 2028, 47% in 2029 and 45% in 2030. However, if a product's current ceiling price is already below the adjusted price for a given year, no additional reduction will be made that year.As a result, some blockbuster products may avoid a price cut next year because their prices are already low. Daewoong Bio's Gliatamin is included in the first round of reassessment, but its price has already fallen to around the 49% level, meaning its next reduction will likely begin in 2029.An industry official said, “It is difficult to simply compare the impact on individual companies based on the number of products alone. The reassessed prices of each company's key products need to be compared individually to gauge the actual impact.”
