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- 2026-10-12 18:18:23
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- Korean companies also adopt aggressive patent defense strategies
- by Kim, Jin-Gu Oct 12, 2026 08:36am
- An aggressive patent defense strategy once used primarily by multinational pharmaceutical companies is gaining traction among Korean drugmakers. Rather than waiting for generic competitors to challenge their patents, originator companies are increasingly initiating proceedings themselves.Traditionally, pharmaceutical patent disputes have begun with generic companies filing invalidation petitions or passive trials to confirm the scope of patent rights, which the originator responded to. Recently, however, Korean originator companies have also begun leveraging aggressive administrative trials as a means of patent defense.Chong Kun Dang files positive scope confirmation trials against GL Pharm Tech and other generic competitors...Hyundai Pharm filed similar petitions earlier this yearAccording to industry sources on the 10th, Chong Kun Dang recently filed positive trials to confirm the scope of patent rights against four companies, including GL Pharm Tech, that have obtained approval for generic versions of its hypertension combination treatment Telminuvo.A positive trial to confirm the scope of patent rights is a proceeding initiated by a patent holder to determine whether a competitor's product falls within the scope of its patent. It is the counterpart to a passive confirmation trial, typically initiated by a generic manufacturer seeking to establish that its product falls outside the patent's scope.Chong Kun Dang has asked the Intellectual Property Trial and Appeal Board (IPTAB) to determine whether the approved generics fall within the scope of Telminuvo's formulation patent. The petitions are understood to have been filed to clarify ambiguities in GL Pharm Tech's claim that its generic version does not infringe the patent.Telminuvo is a fixed-dose combination of telmisartan and S-amlodipine for hypertension. Since its approval in 2013, it has remained one of Chong Kun Dang's flagship products, generating annual prescription sales of approximately KRW 50 billion to KRW 60 billion. The company has recently strengthened the pipeline by adding a lower-dose combination to its lineup.Earlier this year, Hyundai Pharm also initiated positive confirmation trials to defend patents covering its dementia combination treatment DM Duo. It filed petitions against SS Pharm in January and Boryung Biopharma in March, although it withdrew both in April.Until now, such petitions by Korean originator companies have been sporadic. One of the few notable precedents dates back about a decade, when Daewoong Pharmaceutical took similar action.In October 2016, Daewoong filed a positive confirmation trial against Gastiin CR, a sustained-release mosapride tablet developed by Korea United Pharm, seeking confirmation that the product fell within the scope of its formulation patent. The petition was dismissed the following year, and the two companies subsequently settled the related patent dispute.Multinationals including Novartis, Regeneron, and Eisai have led aggressive patent defense strategies.Positive patent-scope confirmation trials have been relatively uncommon in Korea. Even those that have been filed have largely been initiated by multinational pharmaceutical companies seeking to counter the market entry of Korean competitors.In January 2022, Novartis filed positive confirmation trials against four companies—Kyongbo Pharmaceutical, Korea United Pharm, Ahn-gook Pharmaceutical and Ahngook New Pharm—that had launched generic versions of its diabetes treatment Galvus. Novartis sought a determination of whether those products fell within the scope of its compound patent.In March 2023, US-based Regeneron filed a positive confirmation trial involving a compound patent against Samsung Bioepis, which was developing a biosimilar of the age-related macular degeneration treatment Eylea. That June, Novartis filed two positive confirmation trials concerning formulation patents against Celltrion, which was developing a biosimilar of its asthma and urticaria treatment Xolair.In October 2024, Eisai filed a positive confirmation trial involving a method-of-use patent against Boryung, which had developed a generic version of the company’s cancer treatment Lenvima. The petition was withdrawn in May last year.Industry observers expect the use of positive confirmation trials to spread further among Korean pharmaceutical companies.Having grown largely through generics, Korean drugmakers have historically had relatively few occasions to challenge competing products as patent holders. But the landscape is changing as more domestic companies introduce independently developed new drugs, incrementally modified drugs and fixed-dose combinations. With a growing number of flagship products protected by proprietary patents, companies are increasingly turning to positive confirmation trials to protect those assets.Concerns over declining profitability following drug pricing reform may also be contributing to the trend. As price cuts for generics and previously listed drugs make it harder to sustain earnings, pharmaceutical companies have greater incentive to assert their patent rights to protect the markets for their independently developed products.Filing a positive confirmation trial does not automatically prevent a competing product from being sold. Nevertheless, the procedure is considered a proactive defensive tool because it allows patent holders to challenge whether a competitor's product falls within the scope of their rights and secure a basis for potential future enforcement.
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- Wegovy seeks reimbursement for adolescents and severe obesity
- by Eo, Yun-Ho Oct 12, 2026 08:36am
- The obesity drug Wegovy is seeking National Health Insurance reimbursement in Korea.According to Dailypharm's coverage, Novo Nordisk Korea recently submitted a reimbursement application for Wegovy to the Health Insurance Review & Assessment Service (HIRA).The application targets several of the drug's approved indications, including established cardiovascular disease (eCVD), adolescent obesity, and severe obesity.Wegovy (semaglutide), a once-weekly GLP-1 receptor agonist, was launched in Korea in October 2024. Initially approved for weight management in adults, the drug’s indication has since expanded to include cardiovascular risk reduction and obesity in adolescents aged 12 and older.Its cardiovascular indication covers the reduction of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, in overweight or obese patients with established cardiovascular disease and a body mass index (BMI) of at least 27 kg/m².The indication is supported by the SELECT trial, which enrolled 17,604 overweight or obese adults with established cardiovascular disease. Wegovy reduced the risk of major adverse cardiovascular events by 20% compared with placebo.The adolescent obesity indication was approved in Korea in October last year. In the STEP TEENS trial involving adolescents aged 12 and older with obesity, mean BMI declined by 16.1% at week 68 in the Wegovy group, compared with a 0.6% increase in the placebo group. The proportion of patients achieving at least 5% weight loss was also substantially higher with Wegovy, at 72.5% versus 17.7%.In the STEP 1 trial involving adults with obesity, mean weight loss at week 68 was 14.9% with Wegovy versus 2.4% with placebo.Whether the application will ultimately lead to reimbursement remains uncertain. Wegovy must undergo HIRA's assessments of clinical benefit and cost-effectiveness, and reimbursement eligibility criteria for each patient population and the potential impact on National Health Insurance finances are expected to be key.For patients with severe obesity in particular, details such as BMI criteria, comorbidity requirements and criteria for continued treatment are likely to be further specified during the upcoming evaluation process.A Novo Nordisk official said, “Obesity is a chronic disease associated with multiple conditions, including type 2 diabetes and cardiovascular disease, and has lasting implications not only for individuals' health and quality of life but also for public health as a whole.”The official added, “This application is a first step toward improving treatment access, particularly for patients with severe obesity and comorbidities. We will fully engage in the reimbursement review process and continue working to address the unmet treatment needs of patients with obesity in Korea.”
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- Drug price cuts push pharma to tighten workforce spending
- by Lee, Seok-Jun Oct 08, 2026 09:00am
- Drug price cuts are beginning to take a toll on pharmaceutical employment. Faced with mounting pressure on profitability, companies are scaling back new hiring and leaving positions vacated through natural attrition unfilled, while tightening performance management and overhauling compensation and pay structures. What began as a one-time “workforce expense diet” is increasingly becoming a permanent approach to labor-cost management.Under the drug pricing reform implemented in August, the maximum pricing rate for off-patent drugs and generics was lowered from 53.55% to 45%. The government has decided to apply the new standard to previously listed drugs as well, with prices for 13,958 products in the first reassessment round set to be adjusted from next April.AI-generated imageAccording to industry sources, some pharmaceutical companies have recently all but suspended entry-level recruitment or reduced hiring to a minimum. Companies are also leaving positions vacated through retirement and other natural attrition unfilled, instead redeploying existing employees.Rather than resorting to large-scale restructuring, companies are managing overall labor costs by restricting recruitment and not replacing departing employees. The trend is seen as an effort to reduce fixed costs as the risk of declining profitability from drug price cuts increases.Performance management of existing employees is also becoming more stringent. Industry sources say some companies are grading employees on scales such as A through D and subjecting those receiving lower ratings to closer management. Repeated low ratings can also have the effect of inducing voluntary retirement among employees, according to industry officials.The approach allows companies to gradually adjust workforce levels through performance evaluation and compensation systems rather than sharply reducing headcount through short-term restructuring. For employers, it offers a way to pursue continued workforce efficiency while reducing the burden associated with formal restructuring.Standards for incentive payments are also becoming tighter. In some cases, bonuses that had initially been expected have been eliminated, while employees who achieve as much as 95% of their targets receive no incentive if they fail to meet the 100% threshold.In other words, coming close to a target may no longer be enough to earn a reward. Cost controls are expanding beyond recruitment and headcount to compensation for existing employees.Wages are no exception. As pressure on earnings and profitability grows, companies may respond by limiting salary increases or revising their wage structures. The focus of cost management is thus broadening from the number of employees to the cost of each individual employee.Retirement plans are also emerging as a means of cost management. According to industry sources, some pharmaceutical companies have begun encouraging employees to switch from defined benefit (DB) retirement plans to defined contribution (DC) plans.Under a DB plan, the employee’s retirement benefit is determined in advance, with the employer responsible for managing the plan assets and paying the benefit. Under a DC plan, the employer pays a predetermined annual contribution into the employee’s account, while the eventual retirement benefit varies according to investment performance. From the employer’s perspective, a DC plan can make long-term retirement benefit obligations relatively easier to forecast and manage.However, because wage structures and retirement plan arrangements differ from company to company, a shift from DB to DC plans cannot necessarily be characterized as a direct cost-saving response to drug price cuts. It is more appropriately viewed as one of several changes occurring at some companies as they seek to manage labor costs and long-term financial obligations.Cutting ‘spending on people’...prolonged trend could weigh on competitivenessChanges in pharmaceutical workforce management illustrate where the cost burden from lower drug prices may ultimately be transferred. Lower prices may benefit patients and National Health Insurance finances, but pharmaceutical companies facing reduced profitability inevitably begin reviewing their internal costs.Labor is one of the most readily adjustable cost categories. What begins with reduced recruitment and unfilled vacancies is now extending to performance evaluations, incentives, wages, and retirement plans.The concern is what happens if the trend persists. A prolonged decline in entry-level recruitment could slow generational turnover within organizations. Repeated workforce adjustments and increasingly stringent performance management could also affect job security and employee engagement.The impact could be greater still if investment in core pharmaceutical personnel, including R&D and sales staff, is reduced. Efforts to protect profitability from drug price cuts could lead to lower investment in personnel, which in turn could weaken companies’ R&D and sales competitiveness.An industry official said, “When profitability declines because of drug price cuts, costs are ultimately the first thing companies tend to control. Practices such as reducing new hiring, leaving vacancies from natural attrition unfilled and improving the efficiency of the existing workforce will likely continue.”The official added, “The impact of drug price cuts does not end with drug prices. If reduced hiring, tighter performance management, workforce redeployment and changes to compensation and wage structures continue, it means pharmaceutical companies have begun reassessing even how much they spend on their people in order to protect profitability.”
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- Domestic approval of 'Vanrafia' is imminent…new IgAN drug entries expected
- by Son, Hyung Min Oct 07, 2026 04:20pm
- Novartis’ new IgA nephropathy (IgAN) drug, Vanrafia, is nearing regulatory approval in South Korea, signaling anticipated shifts in the treatment landscape.As regulatory approval for Vanrafia, which targets the disease's pathogenic and progression pathways, nears, the reimbursement status of the previously approved Nefecon is expected to become a critical factor shaping prescribing competition.Novartis’ VanrafiaAccording to industry sources on the 7th, Novartis Korea is currently pursuing domestic approval for Vanrafia (atrasentan). The company anticipates an approval decision as early as this month.Vanrafia selectively antagonizes endothelin A (ETA) receptors involved in renal damage, aiming to reduce proteinuria and slow declines in kidney function.Vanrafia is formulated for oral administration at 0.75 mg once daily and can be taken with or without food.Last year, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vanrafia based on clinical evidence of reduced proteinuria in patients with primary IgAN.In the Phase 3 ALIGN trial, which was the basis for approval, Vanrafia demonstrated significant proteinuria reduction, and subsequent long-term follow-up evaluated its nephroprotective effects.In the final analysis, Vanrafia demonstrated a 38.3% reduction in proteinuria compared with placebo at 9 months. In an analysis tracking patients over approximately 2.5 years, it reduced the rate of kidney function decline by approximately 34% versus placebo.Nefecon enters the Korean market first… Reimbursement status as the key variableAfter Vanrafia receives domestic approval, a new competitive landscape is expected to emerge in the IgAN therapeutic market alongside the previously approved Nefecon.Everest Medicines Korea’s Nefecon (micronized budesonide) secured approval from the Ministry of Food and Drug Safety (MFDS) in November 2024 for adult patients with primary IgAN who have a 24-hour urine protein excretion of ≥1 g/day or a urine protein-to-creatinine ratio (UPCR) of ≥0.8 g/g.Nefecon is a targeted-release formulation designed to deliver budesonide to specific regions of the distal ileum. Its mechanism of action differs from Vanrafia, which targets ETA receptors, by modulating the mucosal immune response implicated in IgAN pathogenesis.Dosing regimens also differ. Nefecon is indicated for 16 mg once-daily for 9 months, followed by a dosage taper before discontinuation.Because no direct head-to-head clinical trials exist between Nefecon and Vanrafia, a simple comparison of comparative efficacy remains challenging. However, because they target distinct pathophysiological pathways, clinical options can broaden based on individual patient characteristics.Reimbursement will determine actual market uptake.Everest Medicines Korea’s new IgA nephropathy (IgAN) drug, NefeconEverest Medicines suffered a setback last year in its initial bid for Nefecon’s reimbursement. In May of this year, the company submitted supplemental data to reapply, which is currently under review by the Health Insurance Review and Assessment Service (HIRA).Once Vanrafia is approved, the insurance coverage status and reimbursement criteria for each agent will directly govern real-world prescribing patterns.IgAN is a chronic, progressive disease requiring long-term clinical management. Even if therapeutics are approved, high out-of-pocket costs inevitably pose significant barriers to real-world patient access.The non-reimbursed price of Nefecon disclosed across major medical institutions stands at approximately KRW 50,000 to 60,000 per capsule. Converted to monthly treatment costs, this amounts to around KRW 7 million.The reimbursement outcome for Nefecon could serve as an initial benchmark for defining the future reimbursement scope of novel IgAN therapies. However, given the differing mechanisms of action and clinical evidence profiles between the two drugs, their reimbursement criteria and pharmaco-economic evaluation frameworks may diverge.Successive entry of novel therapeutics… Treatment options diversifyIgA nephropathy is characterized by the glomerular deposition of immunoglobulin A (IgA), which triggers progressive inflammation and renal damage. As renal function continually declines, a subset of patients progresses to end-stage renal disease (ESRD).Previously, standard of care centered on supportive therapy utilizing renin-angiotensin system (RAS) inhibitors to manage proteinuria and blood pressure. Recently, the successive emergence of therapies like Nefecon and Vanrafia, which directly target specific pathways involved in disease onset and progression, is transforming the therapeutic paradigm.Beyond Vanrafia, Novartis also holds Fabhalta (iptacopan), a complement pathway inhibitor, in its IgAN pipeline.Fabhalta received regular FDA approval in July of this year as a treatment to slow the decline of kidney function in adult patients with primary IgAN. In the Phase 3 APPLAUSE-IgAN trial, Fabhalta demonstrated an approximate 48% reduction in the rate of kidney function decline compared with placebo over two years.Additionally, novel mechanism-based therapies such as Filspari (sparsentan), a dual endothelin-angiotensin receptor antagonist, have already secured approval and utilization in the United States. Furthermore, with investigational candidates targeting the APRIL signaling pathway entering development, IgAN management is progressively shifting from conventional proteinuria mitigation toward precision targeting of underlying disease progression mechanisms.In contrast, few novel therapies have entered the domestic market to date. With Nefecon securing the initial approval and Vanrafia now preparing for subsequent market entry, clinically available options remain limited compared with the global market.
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- Biogen seeks to expand reimb for high-dose Spinraza
- by Eo, Yun-Ho Oct 07, 2026 08:52am
- The spinal muscular atrophy therapy Spinraza is seeking expanded reimbursement with its high-dose regimen.Dailypharm has found that Biogen Korea filed an application in July to expand National Health Insurance coverage for a high-dose regimen of its spinal muscular atrophy drug Spinraza (nusinersen), which consists of a 50 mg loading dose and 28 mg maintenance doses. The regimen has now entered a full reimbursement review by the Health Insurance Review & Assessment Service (HIRA).Korea’s SMA treatment landscape has diversified as gene therapies and oral treatments have gained reimbursement alongside Spinraza. However, reimbursement criteria for existing treatments remain restrictive, prompting continued calls to address gaps in care, including concerns over treatment discontinuation and improved patient access.More recently, SMA treatment goals have moved beyond simply prolonging survival or preserving function. Treatment is increasingly aimed at achieving meaningful improvements in quality of life and helping patients reach normal developmental milestones, creating demand for a more proactive approach that seeks to maximize recovery of neuromuscular function rather than merely slow disease progression. The high-dose Spinraza is designed to address these unmet clinical needs.High-dose Spinraza has demonstrated its clinical value in the global Phase II/III DEVOTE trial and the ONWARD long-term extension study.In DEVOTE, high-dose Spinraza produced a mean 15.1-point improvement from baseline on the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) in patients with Type 1 SMA whose symptoms emerged before six months of age, compared with an 11.1-point decline in untreated controls, demonstrating a significant improvement in motor function. It also reduced plasma neurofilament light chain (NfL), a marker of neuronal injury, by as much as 93%, indicating a reduction in neuronal damage.Positive findings were also reported in ONWARD, a multicenter long-term extension study evaluating the effects of switching patients from the conventional 12 mg dose to the high-dose regimen. After 302 days of follow-up, Hammersmith Functional Motor Scale–Expanded (HFMSE) scores improved in both ambulatory patients (mean 2.5 points from baseline) and non-ambulatory patients (mean 1.1 points). Revised Upper Limb Module (RULM) scores also showed clear overall improvement.Clinical experts view high-dose Spinraza not simply as a higher-dose formulation, but as a treatment option that could more strongly suppress neuronal damage and help optimize treatment for patients with SMA.As a result, some expect discussions on setting reimbursement criteria to be completed as early as this month, with the regimen potentially reaching the Drug Reimbursement Evaluation Committee within the year. Therefore, attention is now rising on whether the clinical benefits demonstrated with high-dose Spinraza will translate into timely reimbursement and broader patient access.
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- Fast-track listing for rare disease drugs off to a rocky start
- by Eo, Yun-Ho Oct 02, 2026 10:23am
- Korea’s pilot “100-day fast-track listing” program is hitting turbulence before it has even gotten off the ground.Dailypharm has learned that the Health Insurance Review and Assessment Service (HIRA) sent notices to applicant drugmakers on the 30th informing them of a delay in the selection of drugs for the “Pilot Program for Fast-Track Listing of Rare Disease Treatments,” originally scheduled to be announced in September, until October. The delay is widely expected to push the timeline back by roughly a month.The government plans to announce the evaluation results after holding presentation sessions with each applicant company in October. However, neither a detailed evaluation schedule nor guidelines for participating companies have yet been finalized.The pilot program targets a 100-day timeline through final reimbursement listing. It offers an expedited listing pathway by waiving both pharmacoeconomic evaluation and price negotiations, while also dispensing with negotiations over projected claims expenditure at a price set at around 90% of the adjusted lowest price among the A8 countries. Provided that a complete application is submitted and subsequent consultations with the government proceed as planned, the program is designed to enable substantially faster reimbursement listing. The government had previously announced that 5 drugs would be selected for the pilot program.Despite risks including post-listing evaluation, the program drew strong interest from the pharmaceutical industry. Fourteen products from 13 companies applied, including Ipsen Korea’s ‘Iqirvo (elafibranor),’ MSD Korea’s ‘Winrevair (sotatercept),’ Bristol Myers Squibb Korea’s ‘Reblozyl (luspatercept),’ CSL Korea’s ‘Hemgenix (etranacogene dezaparvovec),’ and SK Chemicals’ ‘Viljuvy (ataluren).’Some companies even voluntarily withdrew ongoing reimbursement evaluations and changed course to pursue the pilot program instead.Drugmakers that had spent September awaiting the selection results now face another month of uncertainty following the government’s unexpected change in schedule.An industry official said, “We had been waiting for the announcement, so receiving notice of the delay was disappointing. There are a lot of questions, including whether the number of selected drugs might be increased because more products applied than expected. We hope the pilot program can get underway as soon as possible so that patients in need of new treatments can benefit.”
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- 'Breztri' reimb adds long-term prognostic management option for COPD
- by Son, Hyung Min Oct 02, 2026 10:23am
- In the treatment of chronic obstructive pulmonary disease (COPD), the importance of long-term prognostic management, focusing on reducing the risk of acute exacerbations and death beyond simple management, is growing.In particular, it is pointed out that early diagnosis and active prevention of exacerbations are necessary for COPD, given the low diagnostic rate and the high prevalence of comorbidities such as cardiovascular disease among elderly patients in South Korea. Related to this, the single-inhaler triple therapy 'Breztri Aerosphere' has entered the National Health Insurance reimbursement sphere and is expected to be used as a treatment option.AstraZeneca Korea held a press conference at the President Hotel in Seoul on the 1st to commemorate the reimbursement listing of Breztri Aerosphere, introducing the domestic COPD disease burden, treatment landscape, and key clinical results.Breztri is a high-dose inhaled corticosteroid (ICS) / long-acting muscarinic antagonist (LAMA) / long-acting beta2-agonist (LABA) triple therapy that combines budesonide, glycopyrronium, and formoterol in a single inhaler. It is used as a maintenance treatment in adults with moderate to severe COPD that is not adequately controlled by existing ICS/LABA or LABA/LAMA dual therapies.The therapy was added to the reimbursement list this past September, approximately five years after receiving domestic approval in November 2021.Low diagnostic rates and recurrent exacerbations... COPD management gaps remainProfessor Yong Il Hwang of the Division of Pulmonary, Allergy and Critical Care Medicine at Hallym University Sacred Heart HospitalThe biggest challenge for domestic COPD is the failure to identify patients promptly. Because lung function decline often manifests as symptoms only after a considerable period of progression, there is a significant gap between the actual prevalence and the number of patients diagnosed and treated at medical institutions.Professor Yong Il Hwang of the Division of Pulmonary, Allergy and Critical Care Medicine at Hallym University Sacred Heart Hospital emphasized that COPD should not be viewed merely as a simple respiratory disease, especially in the domestic environment where the population is aging rapidly.This is because comorbidities such as cardiovascular disease are common, and recurrent acute exacerbations can impact the subsequent prognosis.COPD is a chronic disease characterized by persistent airflow limitation and respiratory symptoms due to structural abnormalities in the airways and alveoli. While smoking is known as a primary risk factor, the importance of non-smoking factors, such as various environmental and occupational exposures, is also being emphasized recently.As the disease progresses, lung function declines, symptoms such as dyspnea and coughing worsen, and acute exacerbations can recur. Particularly in the elderly population, multiple comorbidities, including cardiovascular disease, often present simultaneously, further increasing the disease burden.Professor Hwang stated, "COPD is a common disease, but many patients remain undiagnosed," adding, "In the National Health and Nutrition Examination Survey, among those who met the criteria for COPD through pulmonary function tests, the proportion who were aware they had actually been diagnosed with COPD was a mere 2.8%."The fact that COPD predominantly affects the elderly was also cited as a factor that will increase the future disease burden. As the domestic population ages rapidly, the burden of COPD patients and associated healthcare costs is likely to persist.In reality, the socioeconomic burden of domestic COPD is at a substantial level. In a Korean study, Professor Hwang reported that the socioeconomic costs of COPD and its comorbidities amount to approximately 1.4 trillion won annually.A particularly important metric in treatment is 'acute exacerbations.' When an acute exacerbation occurs, lung function, physical activity, and quality of life deteriorate, and the likelihood of subsequent exacerbations also increases. It can also impact the risk of cardiovascular events and death.Professor Hwang emphasized, "Patients who have experienced an exacerbation once are at a higher risk of exacerbating again," and "Ultimately, in COPD treatment, it is important to prevent the first exacerbation as much as possible."Recent global guidelines also reflect this direction. The GOLD guidelines include not only symptom improvement but also reduced acute exacerbation and mortality risks as treatment goals in COPD, and suggest triple therapy with an ICS, taking into account the patient's history of exacerbations and blood eosinophil counts.Professor Hwang noted, "In the past, there was a tendency to delay the use of triple therapy due to concerns about ICS side effects, but this can lead to patients experiencing recurrent exacerbations while being delayed from necessary treatments," adding, "It is crucial to screen patients in need and treat them at the appropriate time."Triple therapy, evidence accumulated for reducing exacerbation and mortality risksProfessor Sang Hyuk Kim of the Division of Pulmonary, Allergy and Critical Care Medicine at Korea University Guro HospitalProfessor Sang Hyuk Kim of the Division of Pulmonary, Allergy and Critical Care Medicine at Korea University Guro Hospital introduced the clinical evidence for Breztri.Representative studies include the phase 3 clinical trials ETHOS and KRONOS.In the ETHOS study, conducted over 52 weeks and involving approximately 8,500 patients with moderate-to-severe COPD, Breztri reduced the annual rate of moderate or severe COPD acute exacerbations by 24% compared with LAMA/LABA dual therapy. It also demonstrated a 13% reduction compared to ICS/LABA.In a pre-specified ETHOS analysis, Breztri was also associated with a reduced risk of all-cause mortality compared with LAMA/LABA. In a post-hoc analysis, the risk of severe cardiopulmonary events was also lower than with LAMA/LABA.Professor Kim explained, "While COPD patients often die from respiratory causes as the disease progresses to severe stages, cardiovascular disease can be a significant cause of death in relatively milder stages," adding, "This is why cardiopulmonary events must be managed together in COPD."The KRONOS study included over 74% of patients with no history of exacerbations in the previous year. In this study, Breztri also lowered the annual rate of moderate or severe COPD exacerbations by 52% compared with LAMA/LABA.Differences were also confirmed in lung function. In KRONOS, Breztri improved the 24-week FEV1 AUC0-4 by 104 mL compared to ICS/LABA.Professor Kim stated, "Breztri has confirmed its efficacy across multiple metrics, from improving lung function to enhancing symptoms and quality of life, and reducing exacerbations," noting, "Rather than escalating treatment after exacerbations worsen, it is important to initiate appropriate treatment in patients who need it."pMDI delivery method tailored for patients with low inspiratory flowBreztri's inhaler delivery method was also presented as a key feature.Breztri uses a pressurized metered-dose inhaler (pMDI) rather than a dry powder inhaler (DPI), which draws powder-form medication using the patient's inspiratory effort. The explanation is that because the medication is sprayed at a consistent pressure, patients with reduced inspiratory flow can still use it.Professor Kim introduced findings from a study on domestic COPD patients showing that about one-fifth of patients using DPIs failed to generate sufficient inspiratory flow rates. This suggests that inspiratory effort may be inadequate in certain patients, such as the elderly or women.However, because pMDIs also require coordinating actuation timing with inhalation, patients with impaired hand dexterity or cognitive function may have difficulty using them.Breztri uses 'Aerosphere' technology for drug delivery. This technology uniformly disperses the three active ingredients by binding the medication to porous, low-density phospholipid particles.Professor Kim also introduced a CT-based computational fluid dynamics simulation study. He explained that comparing the lung deposition patterns of Breztri with other triple-therapy inhalers showed Breztri had relatively lower oropharyngeal deposition and higher overall lung deposition.Professor Kim clarified that this study did not directly compare actual patient clinical outcomes.Professor Kim stated, "In the patient breathing patterns used in the simulation, Breztri demonstrated high deposition across the entire lung due to various engineering characteristics," adding, "Further research is needed in the future to understand how these deposition properties translate into actual clinical improvements for patients."
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- ‘Pharmaceutical spending reform should come first’
- by Son, Hyung Min Oct 01, 2026 09:36am
- Amid the rising national health insurance spending on new drugs for severe diseases, experts have called for the rationalization of budget expenditures by linking reimbursement to treatment outcomes rather than simply containing the prices of new drugs.With pharmaceutical spending under growing pressure from the introduction of high-priced new drugs and rising patient numbers, the argument is that Korea should create fiscal headroom by promoting competition in the off-patent drug market, while providing patients with faster access to treatments for severe and rare diseases and subsequently reassessing their value based on real-world treatment outcomes.At a forum held on the 30th at the National Assembly Members' Office Building titled 'Strategies for Expanding Access to Innovative Drugs for Severe Diseases and Optimizing National Health Insurance Finances,' discussions were held on ways to improve access to new treatments for severe diseases and efficiently manage national health insurance finances.Key topics included Korea’s pharmaceutical expenditure structure, the gap between regulatory approval and reimbursement for cancer drugs, early access to rare disease treatments, and systems for evaluating and post-listing management of new drugs.A forum on 'Strategies for Expanding Access to Innovative Drugs for Severe Diseases and Optimizing National Health Insurance Finances' was held at the National Assembly Members’ Office Building on Sept. 30.Promote market competition rather than imposing across-the-board price cuts...new drugs need outcomes-based reimbursementAlthough healthcare spending on severe diseases continues to rise in Korea, experts analyzed that the trend cannot be attributed solely to high-cost new drugs.According to Yong Jin Kwon, a professor at Seoul National University Hospital’s Public Medical Center, national health insurance medical expenditures increased from KRW 95.4 trillion in 2021 to KRW 116.2 trillion in 2024. Total pharmaceutical spending rose from approximately KRW 22 trillion to KRW 27.7 trillion over the same period.Drug spending for patients covered under the special copayment reduction program increased from KRW 5.6 trillion to KRW 7.5 trillion, while spending on drugs for cancer patients rose from approximately KRW 3.01 trillion to KRW 4.14 trillion.Kwon said the increase in pharmaceutical spending cannot be solely attributed to high-priced new drugs, as rising patient numbers, expanded treatment opportunities, and increased use of new drugs have all played a part.Kwon emphasized, “Before trying to curb spending on new drugs, we need to address the structure of the off-patent drug market, which accounts for a large share of total pharmaceutical spending.”Korea’s market for off-patent originator and generic drugs is worth approximately KRW 19.4 trillion. Kwon argued that unnecessary spending should be reduced by enabling price competition to function properly in this market, with the resulting fiscal headroom redirected toward improving access to new drugs for severe and rare diseases.Measures discussed to promote price competition included lowest-price generic substitution, reference pricing and tighter controls on rebates. For innovative new drugs, meanwhile, participants proposed maintaining the principle of cost-effectiveness assessment while combining faster reimbursement with post-listing evaluation to prevent excessive delays in patient access.Kwon said, “Drug pricing policy also needs to move away from uniform price cuts and be redesigned to reflect treatment outcomes and value.”Barriers persist from approval to reimbursement...improved access needed for cancer, rare disease treatmentsHee-jun Kim, professor of hematology-oncology at Chung-Ang University HospitalClinicians noted that substantial barriers remain to getting a new drug to Korean patients, even if it has received regulatory approval or is already in use overseas.Hee-jun Kim, professor of hematology-oncology at Chung-Ang University Hospital, pointed to the time gap between regulatory approval and reimbursement for cancer drugs as a key issue. Even after a treatment is approved by the Ministry of Food and Drug Safety (MFDS), patients must bear the high treatment cost themselves until national health insurance reimbursement is granted, and detailed reimbursement criteria can further limit treatment options.To address this, faster reimbursement of cancer drugs with demonstrated clinical utility, risk-sharing agreements, and conditional reimbursement were among the measures proposed.Kim said, “When treatment efficacy has been demonstrated in early clinical trials, but sufficient long-term data are not yet available, patients could first be given access to treatment, with the price or reimbursement conditions subsequently adjusted based on actual outcomes.”Kim also argued that assessments of a new drug’s value should look beyond the drug cost itself to include downstream benefits such as fewer hospitalizations and emergency room visits, reduced caregiving burden, and patients’ ability to maintain social and economic activity.Also, experts noted that issues can arise from the earliest stages of introducing rare disease treatments into Korea.Beom-hee Lee, professor of pediatrics at Asan Medical Center, noted that because rare diseases involve small patient populations and limited treatment alternatives, therapies developed overseas must pass through multiple steps before securing Korean approval, supply, and reimbursement.Pharmaceutical companies may have relatively little incentive to seek Korean approval and reimbursement, making it difficult for individual physicians or patients to resolve access issues on their own.Lee said, “We need to expand early access programs so patients can access treatments that are already used overseas but have yet to receive formal approval or reimbursement in Korea, while strengthening the governance role of the government and relevant agencies.”Industry calls for flexible fast-track listing, post-listing evaluation...MFN another variableDuring the panel discussion, participants called for managing the initial uncertainty surrounding new drugs through post-listing evaluation while also taking changes in the global drug pricing environment into account.A view of the forum on Strategies for Expanding Access to Innovative Drugs for Severe Diseases and Optimizing National Health Insurance Finances held at the National Assembly Members’ Office Building on Sept. 30.Inhwa Choi, Executive Director of the Korean Research-based Pharmaceutical Industry Association (KRPIA), said the characteristics of treatments for severe and rare diseases—including small patient populations and difficulty obtaining sufficient long-term data—should be taken into account. Rather than delaying reimbursement solely because of uncertainty in the initial evidence, she believed Korea should make more flexible use of fast-track listing, risk-sharing arrangements and outcomes-based agreements.In other words, Choi believes providing patients with treatment first and subsequently reassessing effectiveness and financial impact using data accumulated in real-world clinical practice could improve access while managing uncertainty.Participants also pointed to changes in global drug pricing policies as a factor that could make introducing new drugs into Korea more difficult.At the forum, Dailypharm reporter Yun-ho Eo relayed how the impact of policies such as the US most-favored-nation (MFN) drug pricing policy has led to cases where companies halt reimbursement at the global headquarters or regional headquarters level even after receiving Korean regulatory approval.Companies are abandoning reimbursement efforts even when their Korean affiliates want to proceed because of concerns that prices set in Korea could affect pricing in other countries.Eo explained, “There are more and more drugs for which local teams want to pursue reimbursement but are prevented from doing so at the headquarters level. Ultimately, this shows that access to new drugs in the Korean market is deteriorating.”Government agrees on need to improve access...‘Must consider the total patient population’At the forum, assessment authorities and the government agreed on the need to improve access to new drugs for severe diseases, while emphasizing that the overall pharmaceutical spending structure and the drugs’ impact on national health insurance finances must also be considered.So-young Lee, Director of HIRA’s Pharmaceutical Benefits Division, said delays caused by repeated requests for supplementary materials stemming from differences between industry and HIRA in interpreting evaluation criteria should be reduced.While agreeing that greater price competition in the off-patent drug market could improve spending efficiency, Lee said new drugs and generics cannot be viewed entirely separately. Prices and market shares of existing treatments affect the comparators and pharmacoeconomic evaluation used for new drugs, making it necessary to examine the overall pharmaceutical spending structure.Lee also supported the use of post-listing evaluation based on real-world data, while noting that cooperation from stakeholders, including pharmaceutical companies’ submission of data and assumption of related costs, would be necessary.Lee said, “HIRA has a role and responsibility when reviews are delayed by unnecessary requests for additional materials. We will work at the operational level to make meaningful improvements.”Min-jung Kim, an official with the Ministry of Health and Welfare’s Pharmaceutical Benefits Division, said the government is improving coverage for treatments for severe and rare diseases through measures including a pilot fast-track reimbursement program for rare disease drugs, flexible drug pricing agreements, risk-sharing agreements and exemptions from pharmacoeconomic evaluation.National health insurance spending on rare disease and cancer drugs has increased by an annual average of approximately KRW 410 billion over the past 5 years. The government also sees reimbursement coverage in these areas as having expanded rapidly over the same period.However, some high-priced therapies can place a substantial burden on national health insurance finances, making it necessary to determine how far the system should go in recognizing clinically effective treatments as cost-effective.The use of selective reimbursement as an intermediate option between full reimbursement and non-reimbursement was also discussed. The approach would provide an additional access pathway for drugs with recognized treatment needs that are difficult to cover fully, balancing patient costs against their financial impact on the insurance system.Kim said, “We need to achieve both faster reimbursement and appropriate recognition of the value of innovation. At the same time, we need to consider how to define a high-cost drug and how far we can go in recognizing cost-effectiveness.”
- Company
- Roche terminates development of obesity drug preserving muscle
- by Son, Hyung Min Sep 30, 2026 08:52am
- Roche, which has been working to expand into the obesity treatment market, has discontinued development of some of its pipeline.An anti-myostatin antibody, intended to offset muscle loss during weight loss when combined with incretin-based therapies, was assessed as unlikely to achieve the expected level of efficacy in an interim analysis of a Phase 2 clinical trial.However, the development of key obesity pipelines, such as the GLP-1/GIP dual agonist 'enicepatide' and the amylin analog 'petrelintide', is continuing. As these two candidates have recently yielded consecutive positive Phase 2 results, Roche appears to be streamlining its obesity pipeline.Termination of 'emugrobart' Development for Obesity IndicationAccording to industry sources on the 29th, Chugai Pharmaceutical, a Japanese pharmaceutical company under the Roche Group, announced it will terminate development of emugrobart (GYM329) for the obesity indication. Consequently, Roche will return its rights to emugrobart to Chugai Pharmaceutical.Emugrobart is a myostatin-targeted antibody therapeutic that was being developed as a subcutaneous injection formulation.Myostatin is a protein that inhibits skeletal muscle growth. By targeting it, the drug had been developed under a strategy to reduce the loss of muscle mass that can occur during obesity treatment.The decision to halt development resulted from a comprehensive evaluation of the data secured to date, including the interim analysis of the Phase 2 GYMINDA study currently being conducted in obese and overweight patients.The GYMINDA study evaluated the efficacy and safety of combining a GLP-1/GIP receptor agonist with emugrobart. Based on the interim analysis, Roche determined that achieving the pre-specified, clinically meaningful weight-loss goal would be difficult.However, safety issues did not cause the discontinuation of development. According to Chugai Pharmaceutical, emugrobart was well-tolerated, and no new safety signals were observed.Emugrobart is a candidate substance discovered by Chugai Pharmaceutical, and Roche has led its development. In the obesity field, Roche has been evaluating emugrobart as a combination strategy to add a muscle-preservation effect to the weight-loss effect of GLP-1 class drugs.In fact, when Roche announced the acquisition of the US biotech company Carmot Therapeutics in 2023, it highlighted the possibility of combining the incretin candidates it would acquire with its own pipeline aimed at preserving muscle mass.Although the development of emugrobart for obesity has been halted, the candidate substance itself is not disappearing.After regaining the rights from Roche, Chugai Pharmaceutical has begun preparing to resume development targeting spinal muscular atrophy (SMA). The company is also reviewing a possible out-licensing agreement (technology export). However, Roche suspended development of emugrobart for SMA and facioscapulohumeral muscular dystrophy (FSHD) in March.Key candidates under development... Phase 2 achievements of 'enicepatide'Despite discontinuing emugrobart development, Roche's key obesity pipeline has recently released consecutive positive clinical results.On the 22nd, Roche disclosed the results of the Phase 2 CT-388-104 study of the GLP-1/GIP dual receptor agonist enicepatide (CT-388).In overweight and obese adults with type 2 diabetes, the group administered 24 mg of enicepatide saw an average reduction in glycated hemoglobin (HbA1c) of 2.65 percentage points at week 48. In patients whose baseline HbA1c exceeded 8.5%, it decreased by 4.13 percentage points.At the same dose, the average body weight decreased by 15.5% over 48 weeks. Roche explained that weight loss had not plateaued even at the 48-week mark. Safety and tolerability profiles were similar to those observed with existing incretin-based therapies, and Roche identified no new safety signals.Enicepatide is a novel drug candidate acquired from Carmot Therapeutics. At the time of the acquisition announcement, Roche offered an upfront payment of $2.7 billion and up to $400 million in additional milestone payments. With the acquisition of Carmot, Roche secured an obesity and diabetes pipeline that includes not only enicepatide but also the oral GLP-1 candidate CT-996.The development of the amylin analog petrelintide is also ongoing.In March, Roche unveiled the results of the Phase 2 ZUPREME-1 study for petrelintide. Evaluated in 493 overweight and obese patients, the maximum average weight loss rate at week 42 was 10.7%. The placebo group showed a 1.7% reduction.At the maximum effective dose, no cases of vomiting occurred, and no patients discontinued treatment due to gastrointestinal adverse events. Roche is further developing petrelintide both as a monotherapy and as a combination therapy with other obesity treatments.
- Company
- AML therapy 'Vanflyta' available for prescription in general hospitals
- by Eo, Yun-Ho Sep 30, 2026 08:52am
- Vanflyta, a targeted therapy for acute myeloid leukemia (AML), has been added to general hospitals' prescription lists.According to industry sources, Daiichi Sankyo Korea's Vanflyta (quizartinib), a targeted therapy for FLT3-ITD-mutated acute myeloid leukemia (AML), has passed the Drug Committee (DC) reviews at 15 hospitals. This includes the "Big 5" medical institutions: Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Severance Hospital.Experts said that the introduction of Vanflyta is particularly significant because it provides a therapeutic option aimed specifically at patients with FLT3-ITD mutations, who face a high risk of relapse despite existing treatments.FLT3 mutations occur in about 37% of newly diagnosed AML patients, with FLT3-ITD accounting for about 80% of these cases. This mutation is known to promote cancer cell proliferation and elevate the risk of relapse, limiting the five-year survival rate to merely around 20%.The efficacy of Vanflyta has been demonstrated in patients with FLT3-ITD mutation-positive AML through the Phase 3 QuANTUM-First study. In this trial, patients were randomly assigned in a 1:1 ratio to either the Vanflyta group or the placebo group to receive concurrent treatment with induction and consolidation therapies, followed by maintenance therapy for up to three years.The study showed that the Vanflyta-treated group had a 22% lower risk of death than the placebo group. At a median follow-up of 39.2 months, median overall survival (OS) in the Vanflyta group was 31.9 months, more than double the 15.1 months observed in the placebo group.Additionally, the duration of complete remission (CR) was 38.6 months in the Vanflyta group, which was about three times longer than the 12.4 months seen in the placebo group, confirming meaningful improvement in disease control.Professor Shin Dong-Yeop, Professor in the Division of Hematology and Medical Oncology at Seoul National University Hospital, stated, "Vanflyta has shown consistent benefits not only in improving OS but also in prolonging the duration of complete remission and reducing cumulative relapse rates,"and added, "Vanflyta has the potential to lead to a paradigm shift in the treatment of FLT3-ITD mutation-positive AML."
