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- 2026-07-22 16:36:04
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- Adding amiloride effective in resistant hypertension
- by Son, Hyung Min Jul 09, 2025 06:08am
- Sungha Park, Professor of Cardiology, Severance Hospital A new treatment option has been proposed for patients with resistant hypertension that cannot be controlled even with the existing triple combination therapy for hypertension. A regimen combining an olmesartan-based triple combination therapy with the potassium-sparing diuretic ‘amiloride’ demonstrated similar blood pressure-lowering effects to spironolactone, which was previously recommended as a fourth-line treatment, with fewer side effects. The SPARE study, led by Professor Sungha Park of the Department of Cardiology at Severance Hospital, was published in the international medical journal JAMA, attracting significant attention. During an interview with Dailypharm, Professor Park emphasized that the amiloride-based combination therapy has established clinical evidence supporting its broader use in real-world clinical settings for resistant hypertension. Difficult-to-treat ‘Resistant Hypertension’...Need for use of amiloride highlighted There are approximately 12.3 million hypertension patients in South Korea, of whom 10 -15% are classified as having “resistant hypertension,” which is defined as failing to achieve target blood pressure despite the use of three or more antihypertensive medications. Patients who fail to control their blood pressure even with up to 5 antihypertensive medications are classified as having “refractory hypertension,” accounting for less than 1% of all patients. According to National Health Insurance Service data, approximately 7.4% of hypertensive patients in South Korea are diagnosed with true resistant hypertension. Patients with true resistant hypertension have a 1.5 to 2 times higher risk of developing cardiovascular diseases compared to general hypertensive patients, making active blood pressure control crucial for managing their prognosis. Resistant hypertension is treated by adding an antihypertensive drug to the three antihypertensive drugs used to control blood pressure in general hypertensive patients: calcium channel blockers, RAS blockers, and diuretics. For patients whose blood pressure remains uncontrolled even with the four-drug combination, spironolactone is recommended in the fourth line as an additional drug. Spironolactone is a diuretic that acts as an aldosterone receptor antagonist, inhibiting sodium reabsorption to lower blood pressure. If blood pressure remains uncontrolled even then, vasodilators such as beta-blockers, alpha-blockers, minoxidil, and hydralazine may be used. Professor Park stated, “The biggest issue with spironolactone is its side effects. Although spironolactone is an aldosterone antagonist, it can block sex hormones, leading to fatigue, gynecomastia in men, and menstrual irregularities in women. The most serious concern is the high risk of hyperkalemia.” He added, “Due to concerns about such side effects, its use is restricted in elderly patients or those with impaired renal function, and compliance may be low. Although spironolactone is recommended as a fourth-line drug in various clinical guidelines, it is not widely used in practice.” Professor Park said, “While spironolactone has been recognized as a typical potassium-sparing diuretic due to its proven efficacy in reducing the risk of cardiovascular disease after heart failure or myocardial infarction, amiloride has been relatively overlooked. Amiloride is a drug that was widely used in the past, as it acts as a diuretic while also increasing potassium levels.” Amiloride demonstrates non-inferiority to spironolactone To verify this, Professor Park's research team and 14 other domestic institutions conducted a study to confirm the non-inferiority of spironolactone and amiloride. This clinical trial is the first head-to-head trial comparing the two drugs. Professor Park explained, “Guidelines recommend considering amiloride for patients with poor tolerability due to spironolactone’s side effects. However, there was no randomized controlled trial (RCT) data to support this recommendation. Against this backdrop, we decided to conduct a randomized controlled trial comparing spironolactone and amiloride.” He added, “Amiloride is a potassium-sparing diuretic that directly acts on the epithelial sodium channel (ENaC) in the distal convoluted tubule to block sodium reabsorption and preserve potassium. Unlike spironolactone, which blocks aldosterone receptors, its different mechanism of action does not cause hormone-related side effects such as fatigue, gynecomastia, or menstrual irregularities.” The study, named SPARE, targeted patients whose blood pressure remained uncontrolled despite taking existing triple antihypertensive medications. The study focused on patients whose systolic blood pressure remained at or above 140 mmHg after a 4-week introductory treatment with Sevikar HCT (active ingredients: olmesartan, amlodipine, and hydrochlorothiazide), The research team then divided the patients into two groups and compared them for 12 weeks: one group additionally received amiloride 10 mg and the other additionally received spironolactone 25 mg. After 12 weeks of treatment, the average home systolic blood pressure and the rate of achieving target blood pressure in the clinic were measured. Professor Park emphasized the importance of selecting “true resistant hypertension patients” to ensure more accurate results during this process. Professor Park explained, “We focused on patients who had uncontrolled blood pressure despite taking three or more conventional antihypertensive medications. We noted that a single combination therapy drug was effective in improving medication adherence, so we administered Sevikar HCT, a three-drug combination therapy containing olmesartan, amlodipine, and hydrochlorothiazide, at an appropriate dose tailored to each patient's condition for four weeks.” He added, “Sevikar HCT has already been proven to be an effective combination with excellent blood pressure-lowering effects and target blood pressure achievement rates among olmesartan-based triple combination drugs. It is a combination with proven clinical evidence.” The study results showed that amiloride demonstrated non-inferiority to spironolactone in terms of blood pressure-lowering effects. More specifically, the average home systolic blood pressure at week 12 compared to baseline was reduced by 14.7 mmHg in the amiloride group and 13.6 mmHg in the spironolactone group. The difference in blood pressure reduction between the two groups was -0.68 mmHg, which was not statistically significant. Additionally, spironolactone was particularly effective in individuals with elevated aldosterone levels, whereas amiloride demonstrated consistent efficacy across all patients, regardless of aldosterone to renin ratio. It is known that an abnormally activated aldosterone-to-renin ratio can lead to elevated blood pressure. Professor Park stated, “Considering drug characteristics such as medication adherence, ease of use, and side effects, amiloride could serve as an alternative to spironolactone. However, further long-term follow-up studies and expanded application in practice would be necessary.” He continued, “It is uncertain whether this study can be directly applied to Caucasians, but at least in East Asian populations such as Koreans and Japanese, amiloride can be expected to provide sufficient blood pressure-lowering effects. Although it was only a three-month study, side effects were significantly reduced. There were no cases of hyperaldosteronism, and the incidence of hyperkalemia was low. These findings also relay an important message. Professor Park noted, “While amiloride has not been actively recommended in the past, major guidelines may likely incorporate this finding in the future.” The Korean Society of Hypertension is currently revising its guidelines, and there is a high likelihood that the updated guidelines will reflect this information next year. Since the study involved domestic patients, the findings will likely be reflected. The guidelines may include recommendations to use amiloride as an option for resistant hypertension when spironolactone cannot be used. I believe it may also be reflected in other guidelines as well.”
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- Novo Nordisk's injectables are in short supply
- by Nho, Byung Chul Jul 08, 2025 06:35am
- Product photo of NovoRapid injNovo Nordisk's diabetes insulin injections are experiencing a short-term shortage, causing supply difficulties in prescribing settings in Korea. The products with limited supply include NovoRapid Flexpen·Novomix Flexpen·Levemir Flexpen. Novo Nordisk sent a notice to distributors, pharmacies, hospitals, and clinics late last month, informing them of the supply limited period (April·May) and the expected resolution period (August·September). According to pharmacies, product supply has been inconsistent since around March, and despite efforts to secure stock, safety reserves are already depleted. Consequently, even if prescriptions are issued over the next two months, a substitute prescription will be unavoidable. Considering that diabetic patients are typically sensitive to medication changes, the inconvenience for doctors, pharmacists, and patients due to alternative dispensing is expected to increase significantly. One anonymous pharmacist in Yongsan-gu, Seoul, stated, "The current shortage seems to be caused by adjustments in production volume of existing products due to the explosive increase in demand for Wegovy." He asked Novo Nordisk to provide clear explanation. The basis for this speculation among medical professionals lies in the phenomenal popularity of the obesity drug Wegovy, which was launched domestically in October of last year. According to IQVIA data, Wegovy's sales of KRW 60.3 billion in Q4 of last year quickly climbing up to the top of the obesity drug market. The obesity drug market size in Q3 2024 was KRW 47.4 billion, but it surged by 97.9% to KRW 93.8 billion in just one quarter following the launch of Wegovy. In Q1 of this year, Wegovy's sales reached KRW 79.4 billion, capturing a 73.2% share of the overall obesity drug market. Wegovy, which received FDA approval in April 2023, is a GLP-1 analog containing semaglutide, confirmed to reduce HbA1c. Novo Nordisk developed Wegovy, a once-weekly obesity treatment using semaglutide, after observing weight loss effects in patients during clinical trials of GLP-1 class diabetes drug candidates. Wegovy, which received FDA approval in April 2023, is a GLP-1 analog containing semaglutide, confirmed to reduce HbA1c. Novo Nordisk developed Wegovy, a once-weekly obesity treatment using semaglutide, after observing weight loss effects in patients during clinical trials of GLP-1 class diabetes drug candidates. Regarding the overall situation, Novo Nordisk stated, "This supply shortage is due to reduced production at a filling plant caused by technical issues at some overseas manufacturing facilities and is unrelated to quality·safety." Novo Nordisk added, "We are making our utmost efforts to normalize product supply as soon as possible through close and active cooperation between the headquarters and our Korean subsidiary."
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- PCV21 emerges…evidence-based vaccination policies discussed
- by Whang, byung-woo Jul 07, 2025 06:10am
- "To improve pneumococcal disease prevention in Korea, an evidence-based pneumococcal vaccination policy is essential. It's crucial to evaluate the efficacy of existing vaccines and conduct cost-effectiveness assessments for new vaccines based on domestic data." Despite the implementation of the National Immunization Program (NIP), pneumococcal disease remains a significant public health issue in South Korea. Therefore, experts emphasize the need to strengthen vaccine strategies, particularly targeting high-risk populations. Dr. Jung Yeon Heo, a professor at Ajou University HospitalDr. Jung Yeon Heo, a professor at Ajou University Hospital's Infectious Diseases Department, an expert in the field, emphasized the need for a 'dual protection strategy,' which involves the direct vaccination of high-risk adults in addition to pediatric pneumococcal vaccination. Pneumococcal infection is known to be fatal for elderly people, causing not only pneumonia but also various invasive diseases such as bacteremia and meningitis. Specifically, adults aged 65 and older face a greater risk of pneumococcal pneumonia and invasive infection. The risk of infection further increases for adults with chronic diseases compared to healthy adults of the same age. Dr. Heo explained, "Invasive Pneumococcal Disease (IPD) primarily occurs in high-risk groups, including adults aged 65 and older, immunocompromised individuals, and patients with chronic kidney disease or heart disease," and added, "Generally, the prevalence of these chronic or immunocompromised conditions increases with age, leading to a higher risk of pneumococcal infection in elderly people." Since 2013, South Korea has provided protein conjugate vaccines (PCV) for children and 23-valent polysaccharide vaccines (PPSV23) for adults (aged 65 and older) through the NIP. However, while the pediatric PCV vaccination rate is high at approximately 97%, the PPSV23 vaccination rate for adults aged 65 and older is only about 54.5%. Currently, there are concerns about the intergenerational transmission of pneumococcal bacteria, as the number of grandparents caring for grandchildren increases. Regarding this, Dr. Heo stated that indirect effects of reduced adult pneumococcal infection can be expected from pediatric vaccination, based on domestic and international cases. However, he also emphasized the importance of direct vaccination for a sufficient preventive effect. Dr. Heo said, "While indirect effects of reducing pneumococcal disease in adults can be expected from pediatric vaccination, indirect effects alone are not sufficient for adequate prevention in adults," and stressed, "In addition to pediatric vaccination, adult pneumococcal vaccination is also crucial." The distribution of serotypes also highlights the importance of prevention in elderly people. According to Dr. Heo, the most common pneumococcal serotypes in Korean adults are 3 and 19A. Despite these two serotypes being included in the currently used 13-valent pneumococcal conjugate vaccine (PCV13), they still cause infections. Dr. Heo pointed out, "This shows that even though the domestic pediatric vaccination rate is high, nearing 95%, for some serotypes, pediatric vaccination alone is not sufficient for full prevention." He added, "For certain serotypes, indirect effects alone are insufficient for adequate prevention, providing evidence that adults also need pneumococcal vaccination." Discussion of sequential·single-dose vaccination strategies..."Vaccine characteristics must be considered" However, with the emergence of newly approved pneumococcal vaccines, there is also anticipation for expanding the scope of pneumococcal disease prevention. Recently, the Korean Society of Infectious Diseases issued revised recommendations, recommending sequential vaccination with PCV15 + PPSV23 or single-dose vaccination with PCV20 for all individuals aged 6 months and older, as well as for high-risk individuals aged 19-64. Regarding sequential vaccination, Dr. Heo explained, "Vaccination is needed to enhance the immunogenicity in high-risk groups for pneumococcal disease while including as many serotypes as possible. This strategy was proposed because combining PCV's strong immune induction effect with PPSV23's broad serotype coverage can lead to more comprehensive and potent preventive effects." He also stated, "If patient convenience is prioritized, a single injection of PCV20 might be a simpler approach." However, he added, "The main reason why the sequential vaccination strategy is recommended is due to considerations of PPSV23's efficacy and cost-effectiveness." Currently, PPSV23, provided free through the domestic NIP, is considered highly cost-effective as it can prevent a wide range of serotypes at a relatively low cost. Conversely, individuals who can afford to cover the cost may opt for non-reimbursed vaccination with a single dose of PCV20, which is not covered by insurance benefits. Dr. Heo advised, "For those who can bear the cost, a single-dose PCV20 strategy can be considered. However, for those who wish to benefit from the NIP, sequential vaccination with PCV15 and PPSV23 is a good choice." He further stated, "Since each vaccine has its pros and cons and overall effects are similar, it's difficult to conclude that one vaccine is superior to another." He added, "Physicians should thoroughly explain the characteristics and differences of each vaccine and then decide on the appropriate vaccination method together with the patient." "PCV21 vaccine is expected to be introduced...Expectation for adult prevention effectiveness" In this context, the 21-valent pneumococcal conjugate vaccine (PCV21) is expected to be approved this year. Regarding this, Dr. Heo explained, "Theoretically, the PCV21 vaccine can prevent the broadest range of serotypes in adults," and added, "At the Infectious Diseases Society conference, attendees showed a preference for PCV21 among the 15-valent, 20-valent, and 21-valent options." PCV21 is distinguished from existing vaccines by excluding serotypes included in the original PCV7 and incorporating the most non-vaccine type (NVT) serotypes whose adult incidence has increased due to serotype replacement phenomena following vaccine use. Dr. Heo stated, "Considering even the indirect effects of pediatric vaccination, the 21-valent vaccine could be the ideal vaccine." He added, "However, what strategy will be most effective for adults will need to be determined through real-world data from future field use." Dr. Heo also emphasized the establishment of an evidence-based vaccine policy to improve the pneumococcal prevention environment in South Korea. In South Korea, PPSV23 is currently provided free of charge to adults aged 65 and older. However, with the emergence of new vaccines, a multi-faceted review is necessary. Dr. Heo pointed out, "As new pneumococcal vaccines continue to be introduced, we need to closely analyze the efficacy of existing vaccines and domestic usage data. When introducing new vaccines, cost-effectiveness must also be reviewed." He added, "However, to respond to diverse serotype distributions and serotype changes resulting from vaccine use, a pneumococcal vaccine covering a broader range of serotypes is needed." Finally, Dr. Heo suggested, "While expanding the adult NIP is not easy at the moment due to cost issues, we have no choice but to follow the trend as vaccine technology advances. Systematic policy preparation considering complex factors is necessary."
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- PKU drug Sephience receives orphan drug designation in KOR
- by Eo, Yun-Ho Jul 07, 2025 06:10am
- Sephience, a new drug for phenylketonuria (PKU), a rare metabolic disorder, has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced so through a public notice. Specifically, the drug is indicated for the treatment of hyperphenylalaninaemia (HPA) in adult and pediatric patients with phenylketonuria (PKU). Sephience (sepiapterin), which was developed by U.S. biopharmaceutical company PTC Therapeutics, recently received marketing authorization from the European Commission and is currently undergoing approval procedures with the U.S. FDA. More specifically, the drug is an oral formulation of tetrahydrobiopterin, a critical enzyme cofactor involved in the metabolism of various biological substances. Tetrahydrobiopterin is known to reduce phenylalanine levels in the blood of patients with phenylketonuria. The efficacy of Sephience was confirmed in the Phase III APHENITY trial. In the trial, the phenylalanine levels in the sepiapterin arm decreased by an average of 63%. In detail, 84% of patients achieved phenylalanine levels below 360 µmol/L, which is the target level according to treatment guidelines, and the majority of participants successfully controlled their levels. Meanwhile, phenylketonuria is an autosomal recessive metabolic disorder caused by a deficiency of the enzyme that breaks down phenylalanine, which is present in proteins at levels of 2% to 5%. This deficiency leads to seizures and developmental disorders. Patients born with this congenital deficiency of the enzyme are known to have congenital impairments compared to the general population, resulting in intellectual disabilities, light brown skin and hair, and seizures. Early diagnosis and treatment during infancy are essential, and patients are required to follow a lifelong diet restricted in phenylalanine. If left untreated, elevated phenylalanine levels in the blood can lead to hyperphenylalaninemia, causing severe damage to the brain, liver, heart, and kidneys over time.
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- ‘Need to institutionalize reinvestment of funds into R&D'
- by Kim, Jin-Gu Jul 07, 2025 06:09am
- A recommendation was made for the implementation of a system that reinvests the savings from drug price reductions by pharmaceutical and biotech companies into R&D for new drugs and ensures a fixed price during the early stages of a new drug's market launch. Professor Jeonghoon Ahn of the Department of Convergence Health Sciences at Ewha Womans University stated in an issue report published by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on the 3rd, “Post-marketing price management and R&D support must be designed to achieve policy coherence,” and proposed, “A predictable environment must be established to build a virtuous cycle in the pharmaceutical and biotech industry.” “Reinvesting savings from drug price cuts into R&D…differentiated price cut rates should be applied based on investment scale” Professor Ahn emphasized the need to move away from the dichotomy of viewing drug price cuts as a simple cost-cutting measure. He explained that a system should be established to encourage companies to reinvest the funds saved from drug price cuts into R&D. Professor Ahn proposed the institutionalization of a “drug price cut reinvestment system” as an alternative. He predicted that this system would enable efficient fiscal management without stifling industrial growth. Specifically, he proposed ▲differentiating drug price reduction rates based on the scale of a company's R&D investment, ▲institutionalizing the reinvestment of funds saved through drug price reductions into R&D, and ▲establishing a new program where the government and private sector jointly support high-risk stages of research such as Phase III clinical trials and allow recover of a certain portion of their support through sales upon success. Ahn also said that a system to guarantee the initial drug price of new drugs for a certain period of time is necessary. Similar to Japan's “price maintenance premium” system, this system guarantees drug prices for a certain period of time after the launch of a new drug and limits excessive price reductions during the patent period. Ahn also suggested that government-funded R&D should be reflected in drug pricing by allowing cost-based pricing for new drugs, and that a risk-sharing agreement should be established to enable companies to recover their investment. “Failed research should also be granted tax credits... Overall improvement of tax incentives is necessary” Along with improving the drug pricing system, Professor Ahn diagnosed that overall improvement of tax policies is necessary. In particular, he emphasized that failed research should also be included in tax credits, considering the possibility of failure in new drug development. In addition, he argued that tax support should be expanded for costs incurred during Phase III clinical trials, such as patient recruitment, CRO contracts, and data analysis. Furthermore, he noted the need for flexibility across the board in the system, including: ▲recognition of costs for purchasing clinical trial drugs and animals as material expenses; ▲clarification of criteria for verifying overseas clinical trial costs; and ▲relaxation of registration requirements for research institutes engaged in commissioned or joint R&D. Additionally, they suggested that the following issues should be reviewed: ▲reflecting the payment structure for each clinical stage in tax laws; ▲applying an exception to the minimum corporate tax rate based on the scale of R&D investment; ▲expanding the scope of tax credit carryover; ▲applying preferential tax rates on patent revenues earned through the introduction of a patent box system; and ▲shortening the depreciation period for research equipment. Professor Ahn said, “Given the high level of uncertainty in the pharmaceutical and bio industry, there must be substantial tax incentives for companies to decide on bold investments from a long-term perspective,” adding, “Tax and drug price systems must be organically linked for a virtuous cycle of R&D reinvestment to function.” “Risks of new drug development must be mitigated through predictable systems…Post-marketing management system needs reform” Professor Ahn pointed out that the current post-marketing drug price management system causes uncertainty in companies' R&D decision-making. Ahn criticized that the price-volume price linkage system and the actual transaction price reduction system are operated in a fragmented manner, resulting in repeated price reductions for certain items. They also pointed out that the drug price calculation and reduction criteria are unclear, making it difficult for companies to predict. To address these issues, he emphasized the need for structural improvements, including: ▲integrating the implementation timeline of the post-marketing drug price management system; ▲introducing an “R-zone” in the actual transaction price-based price reduction system; and ▲mitigating the concentration of price reductions on specific drug formulations. Professor Ahn stated, “The drug price management system and tax support measures must be designed in a predictable form so that companies can confidently invest in new drug development. This could lead to the enhancement of technological capabilities and global competitiveness in the domestic pharmaceutical and biotechnology industry.”
- Company
- 'Tecentriq' reattempts at lung cancer adjuvant therapy reimb
- by Eo, Yun-Ho Jul 04, 2025 06:06am
- Product photo of Tecentriq 'Tecentriq,' immunotherapy for cancer, will be submitted again for expanded insurance reimbursement of adjuvant therapy for lung cancer. According to our press coverage, Roche Korea applied for expanded reimbursement of its PD-L1 inhibitor Tecentriq (atezolizumab) and is awaiting review by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review & Assessment Service (HIRA). It is their third attempt. The detailed indication that the company is applying for expanded reimbursement is 'adjuvant therapy after resection and platinum-based chemotherapy for Stage II-IIIA non-small cell lung cancer (NSCLC) where PD-L1 is expressed in 50% or more of tumor cells (TC).' Tecentriq was first submitted to the CDRC in May 2023; however, at that time, reimbursement criteria for the drug had not been established. Then, the company made a second attempt, but it did not pass the CDRC in July of last year. At that time, Roche presented overall survival (OS) improvement results at the American Society of Clinical Oncology (ASCO) meeting, but the company did not receive the outcome. Consequently, it is to be watched whether Tecentriq receives a different outcome at the third attempt. Meanwhile, Tecentriq is indicated for various types of lung cancer and was the first immunotherapy to be approved for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy). Furthermore, it continues to conduct various clinical studies to address unmet medical needs in advanced or metastatic NSCLC, either as a monotherapy or in combination with other targeted therapies, chemotherapy, or immunotherapies. NSCLC is a key lung cancer type that accounts for approximately 85-90% of lung cancer, which is the leading cause of cancer death in Korea. A significant number of patients are diagnosed at the locally advanced or metastatic stage, and about half of NSCLC patients who undergo complete resection still experience cancer recurrence after surgery. NSCLC poses a heavy burden on these patients.
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- Will the external reference pricing reevals be resumed?
- by Kim, Jin-Gu Jul 04, 2025 06:06am
- Tensions are rising in the pharmaceutical and biotech industry amid speculation that the external reference pricing reevaluations may be pushed forward again in the second half of this year. The industry is reacting sensitively, as the proposal previously discussed by the consultative body could lead to large-scale drug price cuts if adopted as is. External reference pricing reevaluation that was scheduled for this year... specific promotion schedule unclear According to industry sources on the 3rd, there is a possibility that the external reference pricing reevaluations will be pushed forward again in the second half of this year. Once the organizational restructuring is complete with the appointment of the Minister of Health and Welfare, it is expected that discussions on external reference pricing reevaluations will resume. The Lee Jae-myung administration has nominated Jeong Eun-kyung (60), former head of the Korea Disease Control and Prevention Agency, as Minister of Health and Welfare. With the appointments of the first and second vice ministers already finalized, the reorganization of the MOHW will be mostly complete once Jeong passes her confirmation hearing and is officially appointed as minister. This has led to speculation that the MOHW will accelerate its efforts to revive policies that have been effectively put on hold since the state of emergency was declared at the end of last year. Discussions on reevaluating foreign drug prices began in earnest at the end of 2023. The government formed a task force (TF) with the participation of the pharmaceutical industry and held a total of 10 meetings until July last year. The meetings discussed the foreign drug price reference standards, the targets for reevaluation, and the implementation date. It was decided to lower domestic drug prices in line with the adjusted average prices of the 6 countries with the highest and lowest prices among the A8 countries (the US, Japan, Germany, the UK, France, Switzerland, and Italy). The price cut will apply to 22,920 drugs listed on the drug reimbursement list, which will be divided into three categories and re-evaluated every three years. However, there were still some areas where no consensus was reached. These include the method of referencing Germany and Canada's drug prices. Ultimately, the pharmaceutical industry proposed to the government that the drug price reference standards for Germany and Canada be changed and that the drug price reduction rate be reduced by 50%. The government had originally planned to announce its final proposal by the end of last year and conduct the reevaluation in the first half of this year. It then planned to begin full-scale drug price adjustments in the second half of this year. However, all discussions were suspended after the state of emergency was declared at the end of last year. This situation continued until recently due to the impeachment of the president and early presidential elections. An industry official said, “As far as I know, there have been no official or unofficial discussions on the external reference pricing reevlautions since the last meeting last year. A new Director of the Division of Health Insurance Benefits has been appointed, but the situation remains the same.” Various scenarios proposed, ranging from “including integrated post-marketing management measures” to “excluding Germany and Canada” The pharmaceutical industry appears to be feeling burdened by the mere fact that related discussions may be restarted. An industry official said, “Although the continued uncertain state is unsettling, it is better than having a definite implementation schedule. There is an underlying hope that the discussions stay suspended for a long time.” With the implementation schedule and details still unclear, various scenarios are being raised. Some predict that the plan for the external reference pricing reevlautions will be included in the integrated post-marketing management plan and be renegotiated from scratch. This prediction is gaining traction given that President Lee Jae-myung promised to integrate and advance Korea’s post-marketing management of drug prices. In addition, there are predictions within and outside the MOHW that the government will partially accept the pharmaceutical industry's opposition. The government is expected to partially accept the pharmaceutical industry's opposition to the German and Canadian drug price reference methods and either exclude those two countries or change the reference method. On the other hand, there are also predictions that the government will push ahead with the reevaluation as originally planned. In this case, significant opposition is expected as considerable damage to the pharmaceutical industry is anticipated. A pharmaceutical industry official said, “Discussions on various pressing issues have been suspended. At present, it is difficult to predict when and how they will resume. However, it seems likely that discussions will resume in some form in the second half of this year.” The official added, “Among these, concerns about the resumed external reference pricing reevaluations are particularly high. If the re-evaluation proceeds as previously discussed, the damage is expected to be very significant. If the government decides to proceed with this, it must first once again engage in discussions with the pharmaceutical industry.”
- Company
- Lilly launches Ebglyss in Korea… sparks competition
- by Son, Hyung Min Jul 03, 2025 06:12am
- Professor Hyun-Chang Ko of the Department of Dermatology at Pusan National University Yangsan Hospital The official launch of Lilly's Ebglyss has expanded treatment options for atopic dermatitis patients in Korea. With the arrival of Ebglyss, the number of biological agents available for the treatment of atopic dermatitis in Korea has increased to three. Experts welcomed the emergence of diverse treatment options but emphasized that there is still room for improvement in terms of patient access, due to the inability to switch between different classes of drugs. On the 2nd, Lilly Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic launch of Ebglyss. Ebglyss is a new biological agent that selectively blocks interleukin (IL)-13, a cytokine that is a major cause of atopic dermatitis. This treatment was approved in August last year as a treatment for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older (weighing 40 kg or more) who are not adequately controlled with topical treatments or for whom these treatments are not recommended, and was granted reimbursement starting this month. Previous atopic dermatitis treatments included Dupixent, which inhibits IL-4 and IL-13, the Janus kinase (JAK) inhibitor Rinvoq, and Adtralza, which targets IL-13. However, the introduction of Ebglyss has expanded treatment options. As atopic dermatitis is a chronic condition with no cure and a long treatment period, diverse treatment options are essential. Ebglyss has demonstrated efficacy and safety in Phase III clinical trials, including ‘ADvocate-1,’ 'ADvocate-2,‘ and 'ADhere.’ In the ‘ADvocate-1’ and ‘ADvocate-2’ studies evaluating Ebglyss monotherapy, the Ebglyss group achieved an EASI-75 response rate of 58.2% and 52.1% during the induction period (0–16 weeks), compared to 16.2% and 18.1% in the placebo group. The EASI-90 rate was 38.3% and 30.7% in the Ebglyss group, respectively, while the placebo group was 9% and 9.5%. EASI measures the severity and spread of atopic eczema. Also, after one year of maintenance therapy, the EASI-75 achievement rate in the severity group at Week 52 was 81.7%, and the EASI-90 ratio was 66.4%. These figures were higher than those in the placebo group (66.4% and 66.4%, respectively). In terms of safety, the most common adverse reactions were conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eyes (1.4%). Most adverse reactions were mild or moderate and did not lead to treatment discontinuation. Professor Hyun-Chang Ko of the Department of Dermatology at Pusan National University Yangsan Hospital commented, “Dupixent can be administered at two-week intervals, but extending the interval tends to reduce its efficacy. Ebglyss demonstrated sustained clinical efficacy and safety even with monthly maintenance therapy. Its long-lasting therapeutic effect also offers the advantage of greater convenience in administration.” He added, “In particular, Dupixent had a high rate of erythema and conjunctivitis, and this rate was lower in the pivotal clinical trial for Ebglyss. In terms of safety, Ebglyss did not show any notable adverse reactions compared to the placebo group.” Despite the emergence of various treatments, unmet needs remain Ebglyss is the third biological agent to enter this market. With the introduction of Ebglyss, patients, following Dupixent from Sanofi and Adtralza from Leo Pharma. However, some experts say that despite the introduction of various treatments, there are still unmet medical needs. According to domestic atopic dermatitis guidelines, systemic treatment is strongly recommended for patients with moderate-to-severe atopic dermatitis. However, while the proportion of moderate-to-severe patients among domestic atopic dermatitis patients increased from 30.9% in 2002 to 39.7% in 2019, the prescription rate for systemic immunosuppressants in this patient group remained at just 5%. Professor Min-kyung Shin of the Department of Dermatology at Kyung Hee University Medical Center, Min-kyung Shin, a professor of dermatology at Kyung Hee University Medical Center, said, “The effectiveness and side effects of each treatment may vary depending on the age and immune status of patients with severe atopic dermatitis. We are treating patients in consideration of their response to side effects such as latent tuberculosis, as well as whether the treatment can help with comorbidities, patient preferences, and clinical phenotypes.” Shin added, “Even though biological agents and JAK inhibitors are reimbursed in Korea, many patients are unable to receive optimal treatment due to financial burdens. Although it is possible to switch between biological agents and JAK inhibitors, it is still not possible to switch between treatments within the same class, so there is room for improvement.”
- Company
- Will twice-yearly Bayer's 'Eylea' become available in KOR?
- by Eo, Yun-Ho Jul 03, 2025 06:12am
- Product photo of Eylea Twice-yearly administration of 'Eylea,' used to treat eye disease, is anticipated to be possible in South Korea. The Ministry of Food and Drug Safety (MFDS) is conducting a review of the expanded indication for the administration of Bayer Korea's high-dose Eylea (aflibercept) 8 mg at intervals of up to 6-months. The approval is expected in the second half of this year. The detailed indication under review is vision disorder due to neovascular or wet age-related macular degeneration (nAMD) or diabetic macular edema (DME). Eylea 8 mg is an anti-vascular endothelial growth factor (VEGF) with increased sustainability achieved by increasing the molar dose of the existing 2 mg product by four times. This drug's 6-month interval administration obtained expanded approval from the European Commission (EC). The efficacy of Eylea's long-term administration was demonstrated through the PULSAR study, which involved macular degeneration, and through the PHOTON study, which involved DME. In the extension period (weeks 96-156) of both studies, patients randomized to Eylea 8mg at week 0 maintained their vision and anatomical improvements. Notably, 24% of nAMD patients and 28% of DME patients maintained their final treatment interval at six months after three years. The safety profile of Eylea 8mg remained favorable throughout the three years in both studies, consistent with the established safety profile of Eylea 2mg. No new safety issues were observed in the long-term safety data from either study. The data includes patients who switched from Eylea 2 mg to 8 mg at week 96. Meanwhile, high-dose Eylea was approved in South Korea in 2024 and received insurance reimbursement starting in October of the same year. The current reimbursement criteria include patients with nAMD and DME who meet the conditions of Hemoglobin A1c (HbA1c) 10% or less and a minimum central retinal thickness of 300 µm. The current dosing interval involves monthly injections for the first three months, which can then be extended up to 16 weeks, based on the doctor's judgment, following the results of a vision or anatomical examination.
- Company
- Pharma tries to flip the returned out-licensing of new drugs
- by Son, Hyung Min Jul 03, 2025 06:11am
- New drug candidates from Korean pharmaceutical companies, which were previously returned after technology transfer, are now re-entering the clinical stage and proving their potential. Attention is focused on whether these candidates will re-label their past failures and demonstrate technological potential. According to industry sources on July 2, NOBO Medicine and Hanmi Pharmaceutical disclosed the Phase 2 clinical trial results for Poseltinib, a hematological cancer treatment under co-development. These results were presented last month at the International Conference on Malignant Lymphoma (ICML) held in Lugano, Switzerland. Poseltinib Revives after Technology Transfer Return...Targets Unmet Needs in Lymphoma Poseltinib is a Bruton's tyrosine kinase (BTK) inhibitor initially developed by Hanmi Pharmaceutical in 2010 and subsequently out-licensed to Eli Lilly in 2015 for up to US$690 million (approximately KRW 893 billion). BTK inhibitors are drugs that reversibly bind to the protein binding site of the BTK enzyme, which regulates the function of B cells and myeloid cells, thereby inhibiting its catalytic reaction. After in-licensing Poseltinib from Hanmi Pharmaceutical, Eli Lilly conducted a Phase 2 clinical trial in patients with rheumatoid arthritis but discontinued it due to a lack of confirmed efficacy. Poseltinib failed to demonstrate efficacy in clinical trials where key endpoints included improvement in rheumatoid arthritis symptoms and the incidence of drug-related adverse events. Consequently, Lilly returned the technology transfer rights to Hanmi Pharmaceutical in 2019. Hanmi Pharmaceutical signed a joint development agreement for Poseltinib with domestic biotech venture NOBO Medicine (formerly Genome Opinion) in October 2021, entering the hematological cancer treatment market. NOBO Medicine has been conducting investigator-initiated clinical trials for patients with relapsed and refractory Diffuse Large B-cell Lymphoma (DLBCL) using a triple combination therapy combining Poseltinib with Roche's Columvi and BMS's Revlimid at Seoul National University Hospital. The industry discussed the possibility of transitioning Poseltinib and developing it for hematological cancers, such as lymphoma and leukemia. It is because Janssen's BTK inhibitor Imbruvica was already launched as a treatment for mantle cell lymphoma, and sufficient safety and tolerability results had been confirmed for Poseltinib. The recently announced clinical results are from two studies: ▲Relapsed and refractory Diffuse Large B-cell Lymphoma (DLBCL) ▲Relapsed and refractory Primary Central Nervous System Lymphoma (PCNSL). DLBCL is the most common type of aggressive lymphoma, accounting for approximately 30-40% of all non-Hodgkin lymphoma patients. While the remission rate for first-line treatment is high, the prognosis is poor for relapsed or refractory patients who do not respond to existing therapies. Therefore, it has led to a continuous demand for treatments with new mechanisms of action. In the DLBCL trial, the Poseltinib combination therapy with Columvi and Revlimid achieved an objective response rate (ORR), measuring the proportion of patients who had a treatment response, such as tumor size reduction, of 84.1%. The complete response rate (CRR), representing the proportion of patients whose cancer completely disappeared, was 58.5%. In terms of safety, significant adverse events reported included Grade 3 or higher neutropenia (68.7%), cytokine release syndrome (4.8%), and cardiac arrhythmia (3.6%). RocheFor the PCNSL trial, the two companies replaced Columvi with Roche's antibody-drug conjugate (ADC) drug Polivy, an anti-cancer agent. PCNSL is a rare type of non-Hodgkin lymphoma that originates in the central nervous system, specifically in the brain and spinal cord, accounting for the majority of CNS lymphomas. This disease is difficult to treat, has a high recurrence rate, and treatment options are particularly limited in elderly patients. As it frequently recurs even after conventional chemotherapy or radiation therapy, there is a significant unmet medical need for new drug candidates with superior brain penetrability. Clinical results showed that the Poseltinib + Polivy + Revlimid combination therapy had an ORR of 55.6% and a CRR of 33.3%. The median progression-free survival (PFS), the period patients lived without their disease worsening, was 6.3 months. Although the number of enrolled patients was small at 10, these results are considered significant given the challenging indication of central nervous system lymphoma. The median overall survival (OS) has not yet been reached, and the 6-month survival rate was 88.9%. Patients were tracked without treatment discontinuation, and only one case of severe adverse event, neutropenia (11%), occurred. NOBO Medicine explains that Poseltinib, which works by selecting multiple kinases including BTK and TEC, demonstrates blockade of bypass pathways, high brain penetrability, and a low side effect profile. Yuhan·Daewoong·TiumBio, and Others Continue New Drug Clinical Trials Yuhan Corp, Daewoong Pharmaceutical, and TiumBio are also continuing clinical trials for their returned drug candidates, aiming for re-licensing or in-house commercialization. Yuhan Corp announced in March that it had received notification of termination of its technology transfer agreement and return of rights for 'YH25724', a MASH (Metabolic Dysfunction-Associated Steatohepatitis) new drug candidate, from Boehringer Ingelheim. In July 2019, Yuhan Corp signed a technology transfer agreement for YH25724 with Boehringer Ingelheim. YH25724 is a dual agonist that simultaneously targets GLP-1 and FGF21, and a technology transfer agreement was signed at the preclinical stage. Yuhan Corp announced its intention to continue developing its MASH new drug. Yuhan Corp stated, "Based on the potential to address unmet medical needs of patients and positive safety results from clinical trials, we are considering continuing the development of this candidate." Daewoong Pharmaceutical is continuing the development of 'Bersiporocin', an idiopathic pulmonary fibrosis (IPF)treatment, which was previously out-licensed to China's CS Pharmaceutical. In March, CS Pharmaceutical notified Daewoong Pharmaceutical of its intent to terminate the contract. Bersiporocin is an anti-fibrotic new drug candidate that inhibits PRS, affecting collagen production, and works by suppressing the excessive production of collagen that causes fibrosis. IPF is a type of interstitial pneumonia characterized by progressive fibrosis of the lung parenchyma. Currently, available treatments offer only limited therapeutic effects, capable only of delaying the disease, thus leaving significant unmet needs. Bersiporocin's Phase 1 clinical trial, conducted in 2022 in Korea and Australia with a total of 162 healthy adults, confirmed its safety and characterized its pharmacokinetic properties, including absorption, distribution, and metabolism in the body. The following year, Daewoong Pharmaceutical received approval for a multinational Phase 2 clinical trial and is evaluating the efficacy and safety of Bersiporocin in IPF patients aged 40 and above. This trial includes patients who are currently receiving or have discontinued approved treatments. TiumBio was notified in March this year by the Italian pharmaceutical company Chiesi of the termination of their contract and return of rights for the respiratory disease treatment development program 'NCE401'. In 2018, TiumBio signed an agreement to transfer NCE401 to Chiesi, along with an upfront payment of US$1 million. NCE401 was being developed as a new drug candidate for respiratory diseases designed to target transforming growth factor-beta (TGF-ß). However, Chiesi reportedly failed to identify a suitable candidate molecule. TiumBio's clinical trials for TU2218, which is produced using the same platform and developed as an anti-cancer drug, are progressing smoothly. TU2218 simultaneously blocks the pathways of TGF-ß and vascular endothelial growth factor (VEGF), both known to hinder immunotherapy activity. This mechanism aims to maximize the efficacy of immunotherapies. TiumBio unveiled the results of its Phase 2 clinical trial for TU2218 in combination with MSD's immunotherapy 'Keytruda' at the American Society of Clinical Oncology (ASCO) meeting held in Chicago last month. The recently disclosed trial represents early cohort results from an ongoing study in patients with head and neck cancer and biliary tract cancer. Clinical results showed that the TU2218 + Keytruda combination therapy resulted in a partial response (PR), where tumor size decreased beyond a certain standard, in 7 out of 11 patients with head and neck cancer. Stable disease (SD), characterized by no significant change in tumor size or condition, was observed in one patient. In the biliary tract cancer cohort, 4 out of 23 patients showed PR, and 7 showed SD.
