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- 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.”
- 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.
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