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- 2026-09-12 19:08:10
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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.
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- 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.”
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- 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.
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- 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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- Expectations and concerns around 'Opakalim,' in-licensed at KRW 1T
- by Cha, Ji-Hyun Sep 09, 2026 12:26pm
- SK BiopharmaceuticalsExpectations and concerns have surfaced around Opakalim, an epilepsy drug candidate that SK Biopharmaceuticals has in-licensed for about KRW 1 trillion. While it is projected to surpass $2 billion in net sales by 2042 following a 2029 U.S. launch, SK Biopharmaceuticals must pay sales royalties post-commercialization to both its contracting counterpart, Biohaven, and the original developer, Knopp Biosciences.According to the biotech industry on the 8th, SK Biopharmaceuticals valued the assets it evaluated during the in-licensing of the epilepsy drug candidate 'Opakalim (BHV-7000),' potassium channel (Kv7) activator compounds, and the Kv7 discovery platform at $909.6 million (KRW 1.2581 trillion). This is about 14% higher than the maximum deal value SK Biopharmaceuticals signed.The valuation was conducted by calculating free cash flow after deducting cost of goods, research and development (R&D) expenses, selling, general and administrative (SG&A) expenses, and working capital from projected revenues generated by Opakalim, and then discounting it to present value by reflecting clinical success probabilities and the time value of money. It incorporated the risks of drug development failure on top of the standard discounted cash flow (DCF) model.Previously, on the 26th of last month, SK Biopharmaceuticals signed an agreement with Biohaven Bioscience Ireland to secure exclusive worldwide development and commercialization rights for Opakalim, Kv7 activator compounds, and the Kv7 drug discovery platform. The total contract value is up to $795 million (KRW 1.0995 trillion), including a non-refundable upfront payment of $400 million (KRW 553.2 billion KRW). Royalties based on product sales are separate.Summary of the epilepsy drug candidate 'Opakalim (BHV-7000)': mechanism of action-Kv7.2 and Kv7.3 potassium channels regulating neuronal excitability in the brain, indication-adult patients with focal seizures, clinical stage-undergoing global 'RISE2' and 'RISE3' Phase 2/3 clinical trials, Original developer-Knopp Biosciences.Opakalim is an oral anti-seizure candidate that selectively activates Kv7.2 and Kv7.3 potassium channels regulating neuronal excitability in the brain. Its mechanism of action stabilizes hyperexcited neurons to suppress seizures. Unlike certain conventional anti-seizure medications, it has relatively little influence on gamma-aminobutyric acid (GABA) receptors, and its potential to reduce central nervous system (CNS) side effects is cited as a competitive advantage.Knopp Biosciences in the United States originally developed Opakalim. Biohaven acquired the Kv7 platform and Opakalim by signing an agreement to acquire Knopp's subsidiary, Channel Biosciences, in February 2022 and completing the transaction in April of the same year. Knopp received $35 million in cash and $65 million worth of Biohaven shares, totaling $100 million in initial consideration. The deal also included milestone payments tied to development and regulatory approval, along with sales royalties.Currently, Opakalim is undergoing global 'RISE2' and 'RISE3' Phase 2/3 clinical trials in adult patients with focal seizures. RISE3 completed patient enrollment last June and is slated to announce top-line results in the second half of this year. In an open-label extension (OLE) study evaluating long-term efficacy and safety after the preceding Phase 2 trial, 54% of patients treated with the 75 mg dose showed a 50% or greater reduction in seizure frequency over six consecutive months.Shinhan Accounting Corporation, an external valuation firm, estimated future revenue and cash flows to calculate the asset value, assuming Opakalim successfully navigates clinical trials and regulatory approvals to launch in the United States in 2029. It assumed the compound annual growth rate of 2.6% in total U.S. focal seizure prescriptions from 2016 to 2025 would continue. Opakalim's market share was projected to rise from 0.1% in 2029, its first year of launch, to 0.4% in 2030, 1.9% in 2035, and 2.9% in 2040. The prescription price was estimated to increase by 4.6% annually from a baseline of $1,550.30, reflecting a 20.0% premium over the 2025 average price of four comparable products. Factoring in rebates and various discounts, actual net revenue was modeled at 52.0% of the prescription price.Based on these assumptions, Opakalim was projected to generate $21.14 million in net sales in its initial U.S. launch year in 2029 and peak at $2.07913 billion in U.S. net sales in 2042, the 14th year post-launch. Subsequently, reflecting loss of exclusivity (LOE) in 2043, market share was projected to decline to 1.6% and net sales to decrease to $1.06173 billion. Applying a cumulative probability of 71.9% for clinical development and marketing approval success through commercialization, alongside a discount rate of 14.4%, yielded the final asset valuation.Notably, projections that Opakalim will achieve operating profit margins exceeding 70% from the mid-post-launch period onward also drew attention. Shinhan Accounting Corporation anticipated that Opakalim's operating margin would reach 71.5% in 2040, 71.6% in 2041, and 72.3% in 2042. This is more than 30 percentage points higher than SK Biopharmaceuticals' operating profit margin of 39.3% recorded in the first half of this year.This high profitability reflects a low-cost structure. Shinhan Accounting Corporation applied 10.9% of sales to cost of goods sold and 17.3% to SG&A expenses, based on averages of comparable U.S. biotechs. The rationale is that because SK Biopharmaceuticals has already established a dedicated local sales organization of about 150 personnel and a distribution infrastructure through cenobamate, it can co-commercialize Opakalim without significantly increasing overhead costs.Analysis suggests that SK Biopharmaceuticals' move to secure rights to Opakalim —investing an upfront payment that approached nearly three times its annual operating profit from last year (KRW 203.9 billion)—was a strategic decision based on commercialization feasibility, revenue growth potential, and high profitability. This indicates that SK Biopharmaceuticals valued Opakalim as a high-margin blockbuster asset capable of exceeding $2 billion in annual sales while delivering operating profit margins in the 70% range.The two companies also entered into a mutual non-compete clause. SK Biopharmaceuticals and Biohaven agreed to restrictions prohibiting either party from independently developing, manufacturing, or commercializing competing Kv7 activator compounds, or supporting third-party research related thereto, in global markets for several years following the first commercial sale of the product.Currently, Xenon Pharmaceuticals is leading the Kv7 class with 'azetukalner'. Xenon announced Phase 3 clinical results for azetukalner last March and is scheduled to submit a marketing application to the U.S. Food and Drug Administration (FDA) in the third quarter of this year. If azetukalner is approved as planned, it will become the first Kv7-class therapy in the field of epilepsy. With azetukalner leading commercialization, this provision is interpreted as a safeguard to preserve the market value of the latecomer Opakalim and to support follow-on Kv7 pipeline candidates.SK Biopharmaceuticals must pay a separate mid-single-digit royalty to Knopp Pharmaceuticals. (source: Biohaven's Current Report (Form 8-K))However, contractual royalty obligations will increase as Opakalim succeeds in commercialization and scales revenue, which could burden future profitability.According to Biohaven's Current Report (Form 8-K) and the original license agreement filed with the U.S. Securities and Exchange Commission (SEC) on the 26th of last month, when SK Biopharmaceuticals sells Opakalim and certain anti-seizure products in the United States, it must pay Biohaven running royalties ranging from the mid-teens to low twenties across net sales tiers. For sales outside the United States, it pays a mid-single-digit royalty rate.In addition, the share owed to the original developer, Knopp, is separate. As SK Biopharmaceuticals assumed Biohaven's existing contractual obligations, it must pay a separate mid-single-digit royalty to Knopp on worldwide net sales of Kv7 products. This royalty is independent of the royalties paid to Biohaven and cannot be offset.In summary, when Opakalim generates revenue in the United States, SK Biopharmaceuticals must pay royalties in the mid-teens to low twenties to Biohaven, while simultaneously paying a separate mid-single-digit royalty to the original developer, Knopp. Together, the royalties SK Biopharmaceuticals must pay to both companies each time the drug is sold after commercialization could reach the mid-to-high 20% range. In this case, concerns are raised that even if Opakalim surpasses $2 billion in annual U.S. sales under the valuation scenario, the double royalty burden could reduce the actual profit margin to less than anticipated.
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- Ildong, Pfizer Korea sign co-promotion deal for migraine drug Nurtec
- by Kim, Jin-Gu Sep 09, 2026 12:26pm
- Ildong Pharmaceutical announced on the 8th that it has signed a domestic distribution and co-promotion agreement with Pfizer Korea for the novel migraine treatment Nurtec ODT (rimegepant).Under the agreement, Ildong will be responsible for domestic distribution of Nurtec ODT and will begin joint promotional activities with Pfizer Korea this month. Based on their partnership, the two companies plan to strengthen the provision of product information to healthcare professionals and contribute to improving the treatment environment for migraine patients in Korea.Nurtec ODT is a prescription drug containing rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. It is indicated for ▲the acute treatment of migraine with or without aura in adults and for ▲ the preventive treatment of episodic migraine in adults.In a clinical study evaluating Nurtec ODT for the acute treatment of migraine in adults, the proportion of patients experiencing pain relief was significantly higher in the rimegepant group than in the placebo group beginning one hour after administration, with the pain-relieving effect sustained for up to 48 hours.In a separate clinical study of the preventive treatment of episodic migraine in adults, rimegepant administered every other day reduced mean monthly migraine days (MMDs) by 4.3 days from baseline during Weeks 9 through 12, a significantly greater improvement than the 3.5-day reduction observed with placebo. In a subsequent open-label long-term extension study, the reduction was maintained at an average of 6.2 days through Month 16.Ildong Pharmaceutical CEO Jae-joon Lee said, “We have high expectations for expanding our partnership with Pfizer Korea through Nurtec ODT. We aim to achieve our shared objectives, combining the product's competitiveness with our marketing capabilities in the central nervous system (CNS) field.”Dong-wook Oh, Country Manager of Pfizer Korea, said, “This agreement represents a collaboration aimed at delivering the value of Nurtec ODT to migraine patients in Korea. We will do our utmost to improve patient access and contribute to enhancing their quality of life in Korea.
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- Cost-saving immunotherapy 'Tevimbra' nears expanded reimb
- by Eo, Yun-Ho Sep 09, 2026 12:26pm
- Product photo of TevimbraA large- scale expansion of National Health Insurance reimbursement standards for the cost-saving immuno-oncology drug 'Tevimbra' is expected.According to reports, BeOne Medicines recently closed drug price negotiations with the National Health Insurance Service (NHIS) for five additional indications of its PD-1 inhibitor Tevimbra (tislelizumab).The specific indications include ▲first-line combination therapy in patients with unresectable, locally advanced, or metastatic esophageal cancer ▲first-line combination therapy in patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma ▲two first-line combination therapies and one second-line monotherapy for non-small cell lung cancer.Consequently, attention is focused on whether Tevimbra will change the prescription landscape for immuno-oncology drugs.Successful drug price negotiations for Tevimbra are significant beyond the market entry of a new drug. While reimbursement for immuno-oncology drugs has recently expanded across multiple indications, increasing the fiscal burden on National Health Insurance, Tevimbra is considered a candidate that could provide cost savings through intra-class substitution.Currently, claims for immuno-oncology therapies, centered around 'Keytruda (pembrolizumab),' are estimated to be nearing KRW 1 trillion annually, with lung cancer and gastric cancer reportedly accounting for more than half of that total. If Tevimbra achieves meaningful substitution across these indications, fiscal savings of at least tens of billions of won are projected to grow as utilization increases.While immuno-oncology drugs are typically a high-cost drug class, intensified intra-class competition could lower drug prices.The company's strategy for obtaining reimbursement for Tevimbra is a phased expansion. It is structured to first secure marketing approval and reimbursement in second-line esophageal cancer, where unmet medical need was high due to the lack of reimbursed immuno-oncology drugs, and then expand into major indications such as lung cancer and gastric cancer.Tevimbra's clinical utility is also well established. Global treatment guidelines have already confirmed Tevimbra's therapeutic standing. Major guidelines such as the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) recommend Tevimbra as a treatment option on par with previously launched immuno-oncology therapies.Furthermore, this drug has a mechanistic distinction: an engineered structure that inhibits binding to Fcγ receptors, minimizing T-cell clearance and exhaustion. It is also highlighted as a potential 'improved PD-1' that is not merely a substitute drug.Meanwhile, Tevimbra received approval late last year for perioperative (neoadjuvant·adjuvant) therapy in non-small cell lung cancer and nasopharyngeal carcinoma, therapeutic areas where existing immuno-oncology drugs have been limited. It is expected to continue expanding therapeutic presence.
- Company
- 'Anzupgo' for CHE advances in obtaining reimbursement
- by Son, Hyung Min Sep 08, 2026 09:02am
- As the new chronic hand eczema (CHE) drug Anzupgo nears National Health Insurance reimbursement, it is emerging as an option that can bridge the treatment gap between conventional topical corticosteroids and systemic therapy.Until now, when chronic hand eczema did not achieve an adequate response to topical corticosteroids, patients had to consider systemic therapies such as phototherapy or oral alitretinoin. Because long-term non-steroidal topical options were limited, reimbursement for Anzupgo could expand access to treatment.According to the pharmaceutical industry on the 8th, LEO Pharma's topical Janus kinase (JAK) inhibitor Anzupgo (delgocitinib) recently received reimbursement appropriateness from the Pharmaceutical Reimbursement Evaluation Committee (PREC) of the Health Insurance Review and Assessment Service (HIRA). Consequently, the drug will proceed toward National Health Insurance listing following subsequent procedures, including drug price negotiations with the National Health Insurance Service (NHIS).Anzupgo secured reimbursement appropriateness from the PREC after demonstrating cost-effectiveness through a pharmacoeconomic evaluation.Recurrent hand eczema…Burden of long-term treatment increasestopical Janus kinase (JAK) inhibitor 'Anzupgo'Chronic hand eczema is a chronic inflammatory skin disease accompanied by pruritus, pain, and skin fissures. Because the hands are used continuously in daily routines and occupational activities, recurring symptoms substantially affect work performance and quality of life.Conventional treatment has primarily followed a stepwise approach, starting with basic skin care, including moisturizers, then moving to topical corticosteroids, and finally escalating to phototherapy or oral alitretinoin.However, long-term use of topical corticosteroids carries the burden of adverse effects such as skin atrophy, and oral alitretinoin also has limitations in continuous application across all patients due to adverse events like headache and dyslipidemia, as well as restrictions on its use in women of childbearing potential.In clinical practice, the issue of patients who do not respond adequately to topical corticosteroids repeatedly receiving the same treatment, thereby delaying the transition to systemic therapy, has particularly been highlighted as an unmet medical need.In fact, a study analyzing approximately 4,000 Danish patients with chronic hand eczema revealed that it took more than eight years for approximately 44% of all patients to reach their first systemic therapy.Experts argue that rather than repeating topical corticosteroid therapy that is ineffective, clinicians need a strategy to transition to the next step of treatment based on disease severity and response.A new option between topical therapy and systemic TreatmentAnzupgo is a non-steroidal topical pan-JAK inhibitor that inhibits JAK1, JAK2, JAK3, and TYK2. In South Korea, it was approved in September last year to treat adult patients with moderate-to-severe chronic hand eczema who have had an inadequate response to topical corticosteroids or for whom such treatments are inappropriate.Compared with existing treatments, Anzupgo is a new topical treatment option that can be used before transitioning to systemic therapy in patients who do not respond adequately to topical corticosteroids.In the global Phase 3 DELTA 1 and DELTA 2 studies, which served as the basis for Anzupgo's approval, administration for 16 weeks in adult patients with moderate-to-severe chronic hand eczema resulted in Hand Eczema Severity Index (HECSI) 75% or greater improvement (HECSI-75) rates of 49.2% and 49.5%, respectively.The proportion of patients achieving an improvement of 4 points or more in itch score was also 47.1% in DELTA 1 and 47.2% in DELTA 2, outperforming the vehicle/placebo arm rates of 23.0% and 19.9%, respectively. Pain reduction was also confirmed compared to placebo, and therapeutic efficacy and safety were maintained for up to 52 weeks in the DELTA 3 extension study.Anzupgo is currently prescribed as a non-reimbursed drug in Korea. The pharmacy acquisition price per 60 g tube is approximately KRW 690,000. The final non-reimbursed price set by healthcare institutions is around KRW 800,000.However, the actual duration of use varies widely depending on the extent of the patient's lesions. When applied thinly twice daily to affected areas of the hands and wrists, a single 60 g tube typically lasts about two months for patients with localized lesions.Under the current non-reimbursed status, patients may face drug expenses of hundreds of thousands of won per month, depending on individual usage. Once reimbursement is granted, the financial burden on patients requiring long-term treatment is expected to decrease.
- Company
- Novartis and Yuhan to co-promote Rhapsido in Korea
- by Son, Hyung Min Sep 08, 2026 09:01am
- Novartis Korea and Yuhan Corp will jointly market ‘Rhapsido’Novartis Korea (Country President: Byung-Jae Yoo) announced that the company has signed a strategic partnership agreement with Yuhan Corp for the domestic distribution, sales, and promotion of Rhapsido (remibrutinib), the first oral BTK inhibitor for the treatment of chronic spontaneous urticaria (CSU). The two companies held a ceremony on the 34rd to mark the signing of the final agreement.The agreement made this time was a strategic distribution and promotion partnership. In the partnership, Yuhan will take sole responsibility for distributing Rhapsido in Korea. Novartis Korea will handle promotional activities at general hospitals, with Yuhan being responsible for promotion at clinics.Through close collaboration, the two companies plan to effectively communicate the value of Rhapsido to patients with CSU and healthcare professionals in Korea.Byung-Jae Yoo, Country President of Novartis Korea, said, “Our partnership with Yuhan, which has extensive experience and a deep understanding of dermatology practice in the clinic setting, marks an important milestone in bringing Rhapsido closer to the patients who need it. By combining the expertise and capabilities of our two companies, we hope to provide new treatment opportunities to more patients and contribute to advancing the treatment environment for CSU in Korea.”Wook-je Cho, President and CEO of Yuhan, said, “We believe Rhapsido is an innovative therapy that can provide a new treatment option for patients with CSU. Drawing on Yuhan's sales and marketing capabilities and nationwide distribution network, we will do our utmost to effectively communicate the value of Rhapsido to healthcare professionals and patients and contribute to improving the treatment environment.”Rhapsido is an oral inhibitor targeting Bruton's tyrosine kinase (BTK). It was approved in Korea in April for the treatment of adults with CSU that is inadequately controlled with H1 antihistamines.CSU is a condition characterized by recurrent wheals, angioedema, and itching caused by histamine and other inflammatory mediators released during mast cell activation. Rhapsido works by highly selectively inhibiting BTK, which is involved in this process, thereby reducing the release of inflammatory mediators. While conventional antihistamines are used to control symptoms by blocking histamine receptors, Rhapsido offers a different treatment approach by targeting BTK, which is involved in the activation of mast cells and basophils.The approval of Rhapsido was based on results from the global Phase III REMIX-1 and REMIX-2 trials. At Week 12, Rhapsido produced significantly greater improvements from baseline in weekly Urticaria Activity Score (UAS7) versus placebo (REMIX-1: −20.0 vs. −13.8; REMIX-2: −19.4 vs. −11.7; P<0.001 for both), with the observed treatment effect remaining consistent through Week 24.In the 52-week analysis, improvements in itch and wheals were observed as early as Week 1 in the Rhapsido group and were sustained through Week 52. The safety profile over the 52-week treatment period was also consistent with that observed in the 24-week analysis.
- Company
- 14 drugs apply for ‘100-day fast-track listing’
- by Eo, Yun-Ho Sep 08, 2026 09:01am
- The number of pharmaceutical companies throwing their hats into the ring for the pilot program aimed at listing rare disease drugs within 100 days, has exceeded expectations.According to Dailypharm's coverage, a number of multinational pharmaceutical companies, including Leo Pharma Korea, Ipsen Korea, Novartis Korea, AstraZeneca Korea, MSD Korea and CSL Behring Korea, as well as Korean drugmakers G and S, submitted applications to participate in the pilot program by last month's deadline. Applications for a total of 14 products were confirmed to have been submitted.Under the original plan, only 5 of the 14 products would be selected for the pilot. However, health authorities are reportedly considering selecting additional products if they meet the eligibility criteria.The pilot program sets a target of 100 days for completing the reimbursement listing. It allows eligible drugs to be listed upfront without a pharmacoeconomic evaluation or price negotiation. Even negotiations over projected reimbursement claims are waived, with the initial reimbursement price set at around 90% of the lowest adjusted price among the A8 countries.In other words, once a valid application is submitted and coordination with the government is completed, the system can enable drugs to obtain reimbursement listing substantially faster.However, many had expected participation in the pilot to be limited, as several of its conditions were considered difficult for pharmaceutical companies to accept.The biggest concern was the post-listing evaluation based on newly generated evidence. The government planned to establish real-world registries to generate real-world evidence (RWE) on clinical outcomes. At the 5-year mark, following reassessment, a drug could retain its existing reimbursement status, face a partial price reduction, or be switched to full out-of-pocket payment.With debate over the reliability and use of RWE data still unresolved, a drug could therefore effectively lose reimbursement coverage after 5 years depending on the assessment outcome. For multinational companies, this raises the possibility of the Korean government effectively attaching an official label to one of their products suggesting that it ‘lacks efficacy.’Furthermore, the newly introduced requirement to submit a ‘patient treatment continuity assurance plan’ was something never previously been part of Korea's reimbursement listing system. With no detailed guidance yet available, the unfamiliar requirement has added to companies' hesitation. There are also concerns over expenditure caps, given that the pilot is for rare disease therapies, whose patients generally have longer life expectancies than cancer patients.Against this backdrop, applications for 14 products represent an encouraging result. Drugmakers appear to have been attracted primarily by the benefit of upfront reimbursement listing, while also placing expectations on how the program may evolve when it is rolled out on a full scale.“Simply expressing our intention to participate in the pilot can help demonstrate our commitment to the government,” an official at one applicant company said. “It may also allow us to actively provide input as the program is refined and help find common ground that is acceptable to both the government and industry.”
