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- 2026-04-28 13:12:41
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- Breast cancer drug 'Itovebi' prescriptions available at gen hospitals
- by Eo, Yun-Ho Apr 28, 2026 09:46am
- The new breast cancer drug 'Itovebi' is now available on the prescription lists of major general hospitals.According to industry sources, Roche Korea’s Itovebi (inavolisib), a treatment for PIK3CA mutation-positive, hormone receptor-positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-) breast cancer, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Asan Medical Center.Approved in South Korea in July last year, the specific indication for Itovebi is 'combination therapy with palbociclib and fulvestrant for adult patients with HR+, HER2-, and PIK3CA mutation-confirmed locally advanced or metastatic breast cancer who recurred during or within 12 months of completing adjuvant endocrine therapy.'However, if a patient has prior experience with CDK4/6 inhibitor treatment as an adjuvant therapy, more than 12 months must have elapsed since the completion of that treatment. For premenopausal women and male patients, an LHRH agonist is used in combination.Hormone receptor-positive breast cancer is the most common type, accounting for approximately 60% of all breast cancers, and it is estimated that about 40% of these cases carry the PIK3CA gene mutation. The activation of the PIK3CA mutation dysregulates the PI3K signaling pathway, often resulting in a poor prognosis, where existing treatments alone struggle to achieve sufficient efficacy.Itovebi demonstrated efficacy in the Phase 3 INAVO120 study. In a trial involving 161 patients with HR+, HER2-, and PIK3CA-mutated locally advanced or metastatic breast cancer, whose disease progressed during or within 12 months of adjuvant endocrine therapy and who had not received prior systemic therapy, the combination therapy of Itovebi with 'Ibrance (palbociclib)' and 'Faslodex (fulvestrant)' demonstrated a significant overall survival (OS) benefit compared to the control group (placebo + palbociclib + fulvestrant).At the median follow-up of 34.2 months, the median overall survival in the Itovebi group was 34 months, reducing the risk of death by 33%. The median progression-free survival (PFS) for the Itovebi group was 17.2 months, more than twice the 7.3 months observed in the control group, and the risk of disease progression or death was reduced by 58%. The objective response rate (ORR) was also more than two-fold higher in the Itovebi treatment group (62.7%) compared with the control group (28%).At the time of the final overall survival analysis, no new safety adverse events were observed, and the low rate of treatment discontinuation due to adverse events supported the drug's excellent tolerability.Professor Seock-Ah Im of the Department of Hemato-Oncology at Seoul National University Hospital stated, "PIK3CA mutation is an area with a significant unmet need for new treatments because it tumor growth and causes rapid disease progression, leading to a poor prognosis."Im added, "Through the INAVO120 study, Itovebi demonstrated a more than twofold extension in PFS compared to the existing standard of care for patients with the PIK3CA mutation, and it is the only PI3K inhibitor to confirm an OS extension."
- Company
- J&J medical device business grows in tandem
- by Hwang, byoung woo Apr 27, 2026 09:03am
- The two companies leading Johnson & Johnson Korea’s medical device business solidified their foothold in the domestic market last year by driving revenue growth.While Johnson & Johnson Medical Korea (J&J Medical) rebounded from negative growth in 2024, Johnson & Johnson Vision Korea (J&J Vision) reaffirmed its robust sales growth trend.‘Medical’ achieves v-shaped rebound… ‘Vision’ shows steady upward trendFirst, looking at J&J Medical’s revenue, sales have fluctuated over the past four years.Revenue, which stood at KRW 280.1 billion in 2022, rose to KRW 301.1 billion in 2023, surpassing the KRW 300 billion mark. However, in 2024, amid changes in the market environment and a temporary adjustment period, revenue fell to KRW 269.8 billion, down about 10.3% year on year.But last year, the Medical division successfully achieved a V-shaped rebound, recording revenue of KRW 301.6 billion, up about 11.7% from the previous year.Operating profit, which had fallen to KRW 13.4 billion in 2024, also showed a clear recovery in 2025, reaching KRW 17.1 billion, indicating improved profitability.By contrast, J&J Vision, established following the spin-off from Johnson & Johnson Korea, continued its upward sales trend and expanded its scale.After posting revenue of about KRW 26.5 billion in 2022, its first year following the business split, which reflected only three months of operations, J&J Vision recorded about KRW 156.5 billion in revenue in the full fiscal year of 2023. It then posted KRW 168.2 billion in 2024 and KRW 176.3 billion in 2025, maintaining stable growth each year.However, for J&J, the increasing burden of cost of goods sold has remained a drawback, as it reduced the quality of profitability despite top-line expansion.Cost of sales, which stood at KRW 81.9 billion in 2024, increased to KRW 110.6 billion in 2025, expanding the cost burden. This appears to have weighed on profitability despite revenue growth.J&J Vision’s SG&A expenses in 2025 were KRW 56.9 billion, down KRW 21 billion from KRW 77.9 billion the previous year. The largest decreases came from advertising and promotion expenses. Advertising expenses fell by KRW 2.2 billion, from KRW 7.9 billion in 2024 to KRW 5.7 billion in 2025, while promotion expenses fell by KRW 28.6 billion, from KRW 45.1 billion in 2024 to KRW 26.5 billion in 2025.Medical expands high-value treatment equipment…targets hospital marketJ&J Medical’s return to sales in the KRW 300 billion range is interpreted as the result of new product launches combined with infrastructure investment.Indeed, J&J MedTech Korea, which handles J&J Medical products, has been expanding its influence by introducing new technologies every year.In April 2024, the orthopedic surgical robot VELYS received domestic approval for total knee arthroplasty. In April and November last year, the company introduced the pulsed field ablation platform VARIPULSE and the ultra-small artificial heart pump Impella CP, respectively.Notably, along with new product approvals, the company opened a training center at its Seoul headquarters at the end of 2024, where Korean healthcare professionals can receive procedural education and training on the company’s latest therapeutic devices, aiming to create synergy.In addition, last year the company also opened the ‘Busan MedTech Lab,’ a procedural training center in Busan, expanding its procedural education infrastructure to regional areas.Changes in sales and revenue share by J&J medical device business entityThrough these two training centers, the company is focusing on increasing touchpoints for Johnson & Johnson MedTech’s flagship surgical medical devices, and these efforts are being analyzed to contribute to revenue growth.At the time, Jin-yong Oh, North Asia Area Managing Director of Johnson & Johnson MedTech, said, “With the opening of the training center, we hope to actively operate procedural education and training based on Johnson & Johnson MedTech Korea’s advanced medical devices and treatment solutions, thereby contributing to improving Korean healthcare professionals’ procedural capabilities. We will continue working to rapidly introduce innovative products to Korea that can help patients live healthier lives.”Ultimately, considering how J&J Medical’s major product groups are in knee replacement and atrial fibrillation, areas where patient numbers continue to rise along with population aging, the influence of high-value, hospital-based equipment is expected to grow further.Premium ophthalmology and lens strategy…profitability put to the testJ&J Vision’s growth trajectory is interpreted as the result of a strategy that maximized expertise in the ophthalmology specialty area, Surgical Vision, and the contact lens business.In particular, premium product lines played a key role by targeting both the increase in cataract patients amid the transition into a super-aged society and demand for vision correction among younger consumers.In fact, with the number of cataract patients in Korea reaching approximately 1.5 million as of 2024, J&J Vision has launched new products as the market shifts toward next-generation multifocal intraocular lenses (IOLs).In September last year, the company introduced TECNIS Odyssey, a next-generation multifocal intraocular lens for cataract surgery, and is actively targeting the market through the product.However, given that contact lenses, another major revenue pillar, are classified as a consumer medical device, the need to address rising cost pressures is expected to grow.Since the company already secured profitability last year by reducing SG&A expenses, its response measures this year are expected to become a key issue.Ultimately, the fact that both Medical and Vision share the challenge of rising cost burdens is likely to act as a variable affecting future performance.This is because Medical faces cost pressures due to its structure centered on high-priced equipment, while Vision is relatively more susceptible to cost fluctuations due to the nature of its contact lens-focused consumer goods business.Ultimately, future performance is expected to hinge not on the sheer scale of sales, but on the company’s ability to expand the share of premium products and manage its cost structure.
- Company
- Generic DOACs take over half of Xarelto mkt
- by Kim, Jin-Gu Apr 27, 2026 09:03am
- The KRW 260 billion direct oral anticoagulant (DOAC) market is seeing rapid generic penetration. Generic share has reached 49% for Xarelto (rivaroxaban) and 25% for Eliquis (apixaban).Industry attention is now focused on Lixiana (edoxaban), whose generics are expected to launch later this year. As the top-prescribed product, its generic entry is expected to reshape the entire DOAC market. Fifteen companies have already received approvals and are waiting to launch.DOAC market at KRW 60.8 billion in Q1…decline since Q3 2024According to market research firm UBIST, outpatient prescriptions in the domestic DOAC market totaled KRW 60.8 billion in Q1.Overall, the market has been declining since Q3 2024, due to patent expirations, generic launches, and the resulting price cuts.Xarelto’s patent expired in Q2 2021. Since then, 65 companies have launched Xarelto generics. These generics have rapidly increased their prescription volume since then. Since Q3 last year, they have maintained a market share of around 49% in the rivaroxaban market. This means that, just over four years after the launch of generics, their market share has expanded to a level comparable to that of the original product.Amid the rapid growth of generics, prescriptions for the original Xarelto have been steadily declining. Q1 prescriptions were KRW 7.2 billion, down 6% YoY, roughly half of the KRW 16.3 billion recorded in Q3 2021.Competition among generic products is also intensifying. As of Q1, Hanmi Pharm’s ‘Riroxban’ took the top spot among generics with prescription sales of KRW 2.2 billion, a 3% increase YoY. In contrast, the products ranked 2nd through 4th—Samjin Pharmaceutical’s ‘Rivoxaban,’ Chong Kun Dang’s ‘Riroxia’ and Daewoong Bio’s ‘Varelto’—all saw prescription sales decline by more than 10%.As competition intensifies, the number of companies withdrawing from the market is also increasing. Last year, 14 products from six companies left the market due to the expiration of their validity periods. This year, market exit appears to be accelerating, with the validity periods of 38 products from 14 companies set to expire.Eliquis generics reach 25% share just a year and a half after re-entryEliquis generics re-entered the market in Q4 2024. The generics were originally launched in June 2019. At the time, generic manufacturers released the products based on favorable rulings in the first and second instances of patent litigation. However, the situation reversed in April 2021 when the Supreme Court overturned the lower court rulings and ruled in favor of the originator, BMS. Generic manufacturers immediately withdrew from the market. This created a three-and-a-half-year gap in the market until the Eliquis composition patent expired last September.Since re-entering the market, Eliquis generics have been gradually increasing their market share. The combined prescription value for Eliquis generics in the first quarter was KRW 3.2 billion, representing a market share of approximately 25% in the apixaban-based DOAC market. This is higher than the market share just before withdrawal (24% in Q1 2021). As of Q1, Chong Kun Dang’s ‘Liquisia’ and Samjin Pharmaceutical’s ‘Elxaban’ recorded KRW 1.4 billion and KRW 1.2 billion, respectively, taking the top two spots among generics. Prescription sales for other products were less than KRW 300 million.In contrast, sales of the original Eliquis fell by 27% from KRW 13.5 billion to KRW 9.8 billion in just one year. Compared to the KRW 20.5 billion recorded in Q3 2024, just before the re-entry of generics, prescription sales have dropped to less than half in just a year and a half.Lixiana, the current market leader, faces patent expiration by the end of this year… DOAC market to be reshaped with the entry of genericsIndustry attention is now focused on the generics of Lixiana, the market leader. Lixiana’s composition patent expires this November. Generic companies have successfully circumvented the remaining patents.Currently, 15 pharmaceutical companies, including Nexpharm Korea, DongKwang Pharm, Dongkook Pharmaceutical, Samsung Pharm, Shinil Pharma, Shinpoong Pharm, Ahngook Pharmaceutical, HK Inno.N, Ildong Pharmaceutical, Genuone Science, Union Korea Pharm, Korea Prime Pharm, Handok, and Hanmi Pharmaceutical, are awaiting the patent expiration with 35 generic product approvals already secured. With a KRW 120 billion market at stake, expectations among generic drug manufacturers are reportedly high.Last year also saw a series of challenges to patents by generic companies. In 2023 alone, about 10 companies, including HLB Pharmaceutical, Daehwa Pharmaceuticals, Austin Pharma, CMG Pharmaceutical, Chong Kun Dang, Huons, Korea United Pharm, NBK Bio Korea Pharm, Myungmoon Pharm, and Boryung, filed patent invalidation suits and won their cases.Challenges to the Lixiana formulation patent were conducted on a large scale in 2018 and concluded with a victory for the generic drug companies. Analysts suggest that a significant number of companies that were unable to avoid the patent at that time subsequently filed patent challenges in order to launch Lixiana generics. The pharmaceutical industry forecasts that about 30 companies, including those that have already received approval, will join the competition.The original Lixiana further expanded its prescription volume ahead of the launch of generics. Lixiana’s prescription sales in Q1 reached KRW 31.8 billion, a 5% increase YoY. This marks the highest quarterly sales figure on record.Lixiana was the last of the DOAC class of drugs to be launched. In South Korea, Xarelto (rivaroxaban) was approved in 2009, followed by Pradaxa (dabigatran) and Eliquis (apixaban) in 2011, then Lixiana in 2015. In the early stages of its launch, Lixiana ranked third in the market, trailing behind Xarelto and Eliquis. However, after partnering with Daewoong Pharmaceutical as its domestic co-promotion partner, it rose to the top of the market in 2019 and has been steadily increasing its prescription volume ever since.
- Company
- Alcon rebounds after a 21% decline in sales
- by Hwang, byoung woo Apr 27, 2026 09:03am
- After a 21.4% decline in sales in 2023, Alcon Korea rebounded within two years, with simultaneous improvements in operating profit and net income.Beyond recovering its external scale, the company appears to have achieved both cost structure restructuring and a business portfolio realignment.2023 inventory optimization and 'selection and concentration'Alcon Korea's sales reached a peak of KRW 261.6 billion in 2022, up from KRW 238.3 billion in 2021, before decreasing by approximately 21.4% to KRW 205.4 billion in 2023.While no direct external factors for the sudden drop in sales are stated, some background can be inferred from changes in the asset structure, such as 'timing of revenue recognition' and 'changes in inventory assets,' as detailed in the indicators.In fact, 'revenue recognized at a point in time (primarily sales of products and goods),' which amounted to KRW 246.2 billion in 2022, dropped to KRW 189.9 billion in 2023.Additionally, purchases of goods decreased significantly from KRW 264.0 billion in 2022 to KRW 163.3 billion in 2023.Accounting treatments for inventory assets also affected gains and losses. In the 2023 audit report's adjustment items for operating cash flow, inventory valuation losses were indicated in parentheses, reflecting them as a reversal. Changes in the allowance for valuation losses on goods are also confirmed in the deferred tax notes.However, since the audit report does not explain this as the result of poor performance in specific items or inventory clearance, the 2023 sales decrease can be interpreted as a phase in which reduced product sales coincided with inventory and channel adjustments.After undergoing this process, sales is rebounding. After bottoming out at KRW 205.4 billion in 2023, sales rebounded to KRW 226.6 billion in 2024 and KRW 234.8 billion in 2025, recovering to 2021 figures.Alcon Korea's 5-Year Sales: After bottoming out at KRW 205.4 billion in 2023, sales rebounded to KRW 226.6 billion in 2024 and KRW 234.8 billion in 2025 (Source: FSS DART, Unit: KRW 100 million)Easing inventory burden while adjusting product salesNotably, profitability indicators improved significantly during the revenue rebound process.Generally, a decrease in revenue leads to lower profits due to fixed costs, but Alcon Korea has shown a trend of maintaining profitability.Looking at the trend in operating profit, the company posted KRW 7.2 billion in 2023, even as sales plummeted, compared to KRW 9.1 billion in 2022.In 2024, when the structural improvement was completed, the company recorded KRW 11.4 billion, a 57% surge from the previous year and the highest operating profit in the last five years, and continued its solid performance with KRW 10.6 billion in 2025.Net income also doubled from KRW 4.1 billion in 2023 to KRW 8.2 billion in 2024, then to KRW 9.1 billion in 2025, demonstrating a robust internal foundation.The factor that had the greatest impact on this profitability improvement was the control of selling, general, and administrative (SG&A) expenses. SG&A expenses, which reached KRW 83.6 billion in 2022, were significantly reduced to KRW 74.3 billion in 2023 and KRW 68.8 billion in 2024.Specifically, the efficiency of marketing expense targeting stands out. Advertising and promotion expenses decreased every year, from KRW 19.8 billion in 2022 to KRW 12.4 billion in 2023, KRW 8.3 billion in 2024, and KRW 7.5 billion in 2025.The fact that sales rebounded after 2024, despite cutting advertising costs by more than half, is considered a positive factor.Alcon Korea's 5-Year Operating Profit & New Income: GREEN-operating profit, BLUE- Net Income (Source: FSS DART, Unit: KRW 100 million)Expansion of the dual-axis portfolio…surgical and vision careAlcon is building an unrivaled eye care ecosystem through its 'Surgical Division,' which handles surgical equipment, and the 'Vision Care Business,' which handles lenses and other products.The biggest driver of the Surgical Division's momentum is 'PersonalEYES,' a comprehensive, personalized vision correction procedure launched in Korea in 2024.This system, which creates a unique 3D virtual eye model for each patient through Sightmap equipment, presented clinical results showing that all patients recovered 1.0 vision and 89% achieved 1.2 vision three months after surgery.Additionally, PanOptix, a trifocal intraocular lens launched in 2015, marks its 10th anniversary and become a major product, surpassing 3 million cumulative global implantations.Wojciech Michalik, Head of Alcon Korea Vision Care BusinessThe Vision Care Business is also steadily expanding its market influence through products such as the large-capacity daily-wear soft contact lens 'Precision1 for Astigmatism WSL & EasyFit,' launched in August last year.In fact, since 2022, the Alcon Korea Vision Care Business has been selected as the 'Alcon Affiliate of the Year' for three consecutive years, a first among Alcon's global branches.Accordingly, former CEO Bang Hyo-jeong, who led the explosive growth of the Korean market, was promoted to Cluster President for Europe, and Wojciech Michalik, a 15-year ophthalmology expert, took office as the new General Manager in 2025 to demonstrate new leadership.Roger Lopez, President of Alcon International Vision Care, stated, "As a global leader in eye care, Alcon strives to help internal talent grow into global leaders, and this personnel appointment reflects that strategic direction."Lopez added, "Based on the leadership and achievements demonstrated by both leaders in their respective regions, we expect them to promote sustainable business in new markets and contribute to further strengthening the capabilities of the International Vision Care Business"
- Company
- Leqembi may be prescribed at major hospitals in Korea
- by Eo, Yun-Ho Apr 27, 2026 09:03am
- The new Alzheimer's drug ‘Leqembi’ has secured prescription access at tertiary general hospitals in Korea.According to industry sources, Eisai Korea's Leqembi (lecanemab) has now been approved by the Drug Committees (DC) of major hospitals nationwide, including the Big 5 medical institutions—Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Severance Hospital in Sinchon—as well as Gachon University Gil Medical Center, Korea University Guro Hospital, Konkuk University Medical Center, Pusan National University Hospital, Busan Paik Hospital, Seoul National University Bundang Hospital, Chonnam National University Hospital, Jeonbuk National University Hospital, and Hallym University Sacred Heart Hospital.Since its domestic launch at the end of 2024, prescriptions have expanded rapidly.Leqembi selectively binds to beta-amyloid (β-amyloid, βA), known to be a causative substance of Alzheimer’s disease, and has been proven to slow disease progression and delay cognitive decline.However, Leqembi is not yet covered by insurance. The annual drug price is approximately KRW 35 million in the U.S. and about KRW 27 million in Japan. It is expected to take considerable time before being listed for reimbursement due to prolonged negotiations between the pharmaceutical company and the government.Leqembi demonstrated statistically significant results in both primary and secondary endpoints in the Clarity AD clinical trial. In particular, the Leqembi treatment group delayed clinical cognitive decline by 27% compared to the placebo group over an 18-month period.However, while the market for amyloid-targeted therapies like Leqembi generally acknowledges their effectiveness in delaying the onset of dementia, the characteristic side effects associated with their use are cited as a major obstacle.Amyloid-Related Imaging Abnormalities (ARIA), which is often cited as a problem, refers to abnormal signals such as brain edema or microhemorrhages detected via MRI following drug administration.Depending on the nature of the side effects, ARIA is classified into “ARIA-E,” characterized by cerebral vascular edema and extravascular extravasation, and “ARIA-H,” characterized by microhemorrhages and hemosiderosis findings.Meanwhile, last year, a special committee composed of 11 members from the Korean Dementia Association established and released domestic guidelines for Leqembi use.The guidelines include specific details on ▲ patient selection criteria ▲ necessary tests and preparations prior to administration ▲ administration methods ▲ monitoring, and management of drug-related adverse reactions ▲ counseling for patients and caregivers.
- Company
- Lokelma launches in Korea…targeting the gap in hyperkalemia management
- by Son, Hyung Min Apr 26, 2026 01:45pm
- A new drug capable of resolving the treatment dilemma of discontinuing RAAS inhibitors during hyperkalemia management has been introduced in Korea.The new potassium binder ‘Lokelma,’ supported by clinical evidence, is being presented as an option to support a strategy of maintaining RAAS inhibitors, raising the possibility of a shift in the treatment paradigm.On the 22nd, AstraZeneca Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul to mark the domestic launch of Lokelma (sodium zirconium cyclosilicate, SZC), a treatment for adult hyperkalemia.Lokelma is a new drug approved by the Ministry of Food and Drug Safety last November, and represents the first new treatment option in the hyperkalemia field in Korea introduced in about 40 years. Unlike existing organic polymer-based adsorbents, it is an inorganic crystalline potassium binder that selectively captures potassium throughout the gastrointestinal tract and excretes it from the body. In vitro studies confirmed that its potassium selectivity is more than 125 times higher than that of existing treatments, and its non-absorbable nature is also cited as a key differentiator.Hyperkalemia is defined as a serum potassium level exceeding 5.0 mmol/L and commonly occurs in patients with chronic kidney disease, heart failure, and diabetes. In particular, it occurs in 40–50% of patients with chronic kidney disease, and it is reported that approximately one in three (32.8%) patients taking RAAS inhibitors experience hyperkalemia at least once. If it progresses to a severe stage, it can lead to fatal outcomes such as arrhythmia and cardiac arrest.Bum Soon Choi, Professor of Nephrology at Eunpyeong St. Mary’s HospitalThe problem lies in conflicting treatment strategies. While RAAS inhibitors are key medications for protecting the heart and kidneys, their tendency to elevate potassium levels often leads to dose reduction or discontinuation when hyperkalemia occurs.Bum Soon Choi, Professor of Nephrology at Eunpyeong St. Mary’s Hospital, said, “Hyperkalemia is highly recurrent and must be managed as a chronic condition. However, reducing or discontinuing RAAS inhibitors for this reason can worsen the prognosis of cardiac and renal diseases. Since guidelines also recommend maintaining RAAS inhibitors whenever possible, we need treatment strategies that support this.”In fact, guidelines including those from KDIGO and the Korean Society of Nephrology also mention the use of potassium binders as an adjunct strategy to maintain RAAS inhibitor therapy.The presentation highlighted data on the clinical efficacy and treatment persistence of Lokelma.Professor Kim Se-jung of Nephrology at Seoul National University Bundang Hospital evaluated, “Lokelma has demonstrated potassium reduction within one hour of administration, long-term maintenance of potassium control, continuation of RAAS inhibitor therapy, and good tolerability.”Sejoong Kim, Professor of Nephrology, Seoul National University Bundang HospitalIn the Phase 3 ZS-003 study, 753 patients with hyperkalemia were administered 10 g of Lokelma. The results showed a significant decrease in serum potassium levels within one hour, and the proportion of patients reaching normal ranges within 48 hours was 86.4%, which was higher than the 47.8% observed in the placebo group.Furthermore, in the HARMONIZE (ZS-004) study, the mean serum potassium level decreased from 5.6 mmol/L to 4.5 mmol/L within 48 hours, and patients maintained stable, low potassium levels during the maintenance phase.The efficacy was also sustained in long-term data. In the ZS-005 study, 88% of patients maintained normal potassium levels after up to 12 months of treatment, and 87% of patients previously using RAAS inhibitors were able to continue or increase their treatment.In terms of tolerability, an overall favorable safety profile was confirmed in clinical trials involving approximately 1,760 non-dialysis hyperkalemia patients. The most common adverse event, edema, was mostly mild to moderate, and gastrointestinal symptoms such as constipation were manageable through dose adjustment or discontinuation.Professor Choi stated, “Existing chelate-based potassium binders had limitations such as slow onset of action and low compliance due to inconvenience in administration. There has been a continuous demand in clinical practice for new options that allow sustained treatment.”Professor Sejoong Kim emphasized, “Locelma is a treatment option that can help patients maintain RAAS inhibitor therapy without discontinuation when hyperkalemia occurs. Based on clinical evidence, it will serve as a meaningful alternative capable of changing treatment strategies in actual clinical practice.”
- Company
- Can rare disease access reforms resolve the blind spots?
- by Eo, Yun-Ho Apr 26, 2026 01:45pm
- Attention is focused on whether the government’s policy to strengthen access to rare disease drugs can be properly implemented in Korea.As many new drugs still remain unattended, in the “blind spots,” some are also expressing doubts about the effectiveness of the policy.Last March, the Ministry of Health and Welfare approved measures to improve the drug pricing system, and formalized its direction to increase patient access to treatments for severe and rare diseases and to appropriately evaluate the value of innovative new drugs.While the pharmaceutical industry views this as a meaningful first step toward lowering the reimbursement barrier for rare disease treatments in Korea’s health insurance system, it notes that innovative rare disease drugs subject to cost-effectiveness evaluations remain in a blind spot.The pharmacoeconomic evaluation is a stage that takes the longest in South Korea’s health insurance reimbursement evaluation process. New drugs that do not meet the criteria for exemption from pharmacoceconomic evaluation or for which the weighted average price of alternative drugs cannot be accepted must follow the existing procedure.One example is ‘Reblozyl (luspatercept),’ a treatment for anemia in myelodysplastic syndromes (MDS) and beta-thalassemia. Reblozyl, which was approved in Korea in 2022, has remained a non-reimbursed drug to date after failing to pass the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee in August 2023.This drug is the first erythropoiesis-inhibiting agent introduced in the MDS and anemia treatment landscape in decades. Based on the Phase III COMMANDS study, it is evaluated to have fundamentally reduced transfusion dependency by achieving a 1.7 times higher transfusion independence compared to existing treatment. A follow-up analysis published last year also suggested the potential for long-term survival benefits, including extended overall survival (OS).Reblozyl is facing structural limitations in the reimbursement entry process. This is because the current health technology assessment framework, which requires setting the low cost of blood transfusions as the comparator, makes it difficult to reflect the drug’s true value.Professor Joonshik Hong, Secretary of the Acute Myeloid Leukemia and Myelodysplastic Syndrome Research Group at The Korean Society of Hematology (Professor, Department of Hematology, Seoul National University Hospital) said, “Reblozyl not only practically changes the treatment paradigm by reducing prolonged hospital stays and the high burden of complications in patients who required repeated transfusions, but also has significant clinical meaning in that it is the first in the hematologic malignancy field to demonstrate long-term transfusion independence, thereby alleviating the burden on healthcare resources.”He added, “Although it is effectively the optimal alternative and the only hope for patients with MDS-related anemia at moderate risk or lower who require blood transfusions, delays in its inclusion in the national health insurance reimbursement list mean that patients are forced to bear the full burden of transfusions and complications.”In addition, in clinical practice, the need for a flexible evaluation system that reflects disease-specific characteristics is being raised for patients with de facto rare diseases who have difficulty making their voices heard within institutional blind spots.In the case of MDS, there are only about 1,700 new cases annually in Korea, and only a very small fraction of those require treatment for transfusion-dependent anemia. Last March, a petition urging reimbursement coverage for Reblozyl was posted on the National Assembly’s public petition platform, but due to such limitations, the agreement rate remained at around 2% until just before its closure.Professor Hong added, “The fact that MDS was excluded from the special calculation for rare diseases is merely because a separate review was not conducted due to it being applied a special designation for severe cancers. But it is, in fact, a rare disease. Just as paroxysmal nocturnal hemoglobinuria, which has a similar pathophysiology and requires chronic blood transfusions, is recognized as a rare disease, MDS also urgently requires flexible evaluation that takes into account its disease-specific characteristics.”
- Company
- Philips Korea's sales staggering…shift to service-centric
- by Hwang, byoung woo Apr 23, 2026 10:51am
- Philips Korea’s sales growth, which had been on a recovery trend since 2023, has stalled, with growth rates remaining in the 1% range.However, during the same period, operating profit increased significantly, showing an actual improvement in profitability. This is interpreted as the result of a shift in the sales mix, moving away from a hardware sales-centric structure toward services, including maintenance and software.Analysis suggests that amid intensifying competition in the large-scale medical equipment market, the future growth is shifting from hardware to software and solutions.Sales Growth 'Stalls,' Operating Profit 'ReboundsAccording to Philips Korea’s recently disclosed audit report, the company’s sales growth appears to have entered a period of stagnation.Specifically, sales, which recorded KRW 336.6 billion in 2021, decreased to KRW 316.1 billion in 2022 before rebounding to KRW 352.9 billion in 2023.Since then, however, sales reached KRW 361.6 billion in 2024 and KRW 364.6 billion in 2025, marking two consecutive years of growth limited to the 1% range following the 2023 rebound, maintaining a slowing growth.One of the primary reasons for this sales stagnation can be traced back to the large-scale business restructuring carried out in 2021. As of September 9, 2021, Philips Korea completed the divestment of its Domestic Appliances division, which was highly profitablePhilips Korea's 5-Year Sales & Operating Profit: BLUE-Sales, RED-Operating profit (source: audit report, unit: KRW 100 million)This was part of Philips’ global 'Selection and Concentration' strategy to focus on the healthcare B2B (business-to-business) sector.Considering that the Domestic Appliances division generated approximately KRW 41.8 billion in annual sales at the time, the separation of this core consumer cash cow is interpreted as a factor in the reduction of the company's overall scale.In contrast to the slowdown in top-line growth, profitability improved significantly. Philips Korea’s operating profit shifted from KRW 42.7 billion in 2021 to a loss of KRW -4.9 billion in 2022.After successfully returning to a surplus of KRW 1.8 billion in 2023, profit showed a recovery to KRW 7 billion in 2024, followed by KRW 36.4 billion in 2025, a more than five-fold improvement compared to the previous year.This indicates that focusing on internal stability and reorganizing the portfolio toward high-value-added businesses, rather than external expansion, has proven effective.Philips Diversifies the Profit Structure, Shift From Product Sales to 'Service'The primary reasons for the improvement in operating profit are cost reductions and lower selling, general, and administrative (SG&A) expenses.The cost of goods sold, which was KRW 270.7 billion in 2024, decreased to KRW 246.3 billion in 2025, and SG&A expenses also fell by approximately 2 billion KRW, from 83.8 billion KRW to KRW 81.8 billion. Essentially, while sales barely grew, profit rose by simultaneously reducing costs and expenses.Furthermore, the fact that the sales structure is increasing 'service sales,' which provides maintenance and software-linked solutions in addition to equipment delivery, appears to have influenced the improvement in profitability.Looking at Philips Korea’s sales structure by business segment (item), product sales decreased from KRW 242.9 billion in 2021 to KRW 219.6 billion in 2022, before recovering to ▲KRW 249.9 billion in 2023 and ▲KRW 254.6 billion in 2024.However, in 2025, product sales recorded KRW 253.6 billion, showing negative growth compared to the previous year.In contrast, service sales has been on a steady upward trajectory, with no negative growth. Service sales, which was KRW 93.7 billion in 2021, recorded KRW 96.5 billion in 2022, ▲KRW 102.9 billion in 2023 ▲KRW 106.9 billion in 2024 ▲KRW 110.9 billion in 2025.The share of service sales in total sales also expanded from 27.8% in 2021 to approximately 30.4% in 2025.Considering the characteristics of the Korean market, where replacement cycles for large medical equipment (MRI, CT, ultrasound, etc.) are long and large-scale orders following the establishment of new hospitals are limited, the expansion of service-oriented sales, such as software upgrades and Service Level Agreements (SLA) for pre-installed equipment, is analyzed to have played a key role in defending profitability.Philips is expanding its cooperation by signing smart hospital business agreements with major hospitals.Intensifying Imaging Competition… The Challenge of Growth DriversBecause of this, Philips Korea is also seeking a breakthrough by creating a digital healthcare environment centered on artificial intelligence (AI) technology.As global competitors such as Siemens Healthineers and GE HealthCare integrate AI solutions with hardware, Philips is moving to capture the early market.For example, Philips Korea is establishing smart hospital collaborations focused on AI-based improvements to ultrasound and imaging workflows.With the recent domestic medical environment emphasizing smart hospitals amid personnel shortages, Philips appears focused on embedding its portfolio, spanning diagnostic imaging·ultrasound·interventional procedure systems, into these systems.However, expanding the influence of diagnostic imaging equipment, which is the most fundamental driver of external growth, remains a challenge.In this context, Philips' next-generation spectral CT, the Verida system, which recently received U.S. Food and Drug Administration (FDA) clearance, could potentially provide a way forward.The core of Verida system is its spectral technology. While most CT scanners focus on providing structural information by imaging the human body at a single energy, spectral CT analyzes differences in tissue composition across multiple energy spectra.As it promotes clinical efficiency improvement rather than just simple image quality enhancement, there is potential for synergy with future smart hospital system construction.An official from the medical device industry stated, "While Philips Korea's new products and technological innovations, such as helium-free MRI and cardiac ultrasound, are receiving positive responses, hospital investment decisions are made on a mid-to-long-term basis due to the nature of the market," and added, "The impact of new products is more likely to be reflected in mid-to-long-term trends rather than short-term performance."
- Company
- Will Perjeta be reimbursed as postoperative adjuvant therapy?
- by Eo, Yun-Ho Apr 23, 2026 10:50am
- Insurance reimbursement criteria for the breast cancer drug Perjeta may be expanded to cover its use as postoperative adjuvant therapy.The breast cancer division of the Korean Society of Medical Oncology submitted an application to expand reimbursement for the postoperative adjuvant use of Roche Korea’s HER2-positive breast cancer drug, Perjeta (pertuzumab). The society has previously submitted a reimbursement application for the early-stage breast cancer indication of the CDK4/6 inhibitor ‘Verzenio (abemaciclib).’Perjeta’s adjuvant therapy indication was expected to be presented to the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service (HIRA) last October, but the discussion itself was canceled due to revisions to Korea’s positive listing reimbursement criteria.Consequently, it remains to be seen whether discussions regarding Perjeta’s reimbursement as postoperative adjuvant therapy will proceed this time.Currently, Perjeta is reimbursed for HER2-positive metastatic or unresectable locally recurrent breast cancer. In addition, Perjeta is reimbursed as neoadjuvant therapy in early breast cancer at a 30% patient co-insurance rate.However, postoperative adjuvant therapy, a critical treatment step to prevent recurrence, remains non-reimbursed (100% patient coinsurance rate) since the indication was added in Korea in 2018, limiting patient access.This is because its use as postoperative adjuvant therapy lacked long-term follow-up data or a high recommendation grade in global guidelines at the time of the 2019 review, unlike its use as neoadjuvant therapy (preoperative adjuvant therapy), which is covered with 30% selective reimbursement.However, the 10-year follow-up results from the global Phase III APHINITY study that was released last year are expected to fill this gap.According to the study, the Perjeta and Herceptin combination as adjuvant therapy demonstrated clear benefits, including a 21% reduction in the risk of death compared to monotherapy in patients with lymph node-positive early-stage breast cancer at high risk of recurrence.Meanwhile, the Perjeta-Herceptin combination therapy is currently recommended as Category 1 in the U.S. NCCN guidelines for postoperative adjuvant therapy in patients with HER2-positive early-stage breast cancer who have lymph node metastasis. It is also recommended as Category 1 for postoperative adjuvant therapy in high-risk patients with lymph node metastasis who achieved a pathological complete response (pCR) following neoadjuvant chemotherapy.
- Company
- 'Uplizna' to bring a shift to the NMOSD treatment strategy
- by Son, Hyung Min Apr 22, 2026 08:54am
- Tanabe Pharma Korea recently held the UPSTREAM Symposium at Voco Seoul Gangnam to celebrate the launch of NMOSD treatment Uplizna in South Korea.New treatment strategies are emerging for neuromyelitis optica spectrum disorder (NMOSD), a condition where a single relapse can lead to lifelong disability. This shift has been brought about by the introduction of 'Uplizna', a new drug targeting CD19 B cells, for NMOSD treatment in South Korea. Uplizna has been shown to significantly reduce the risk of relapse in AQP4 antibody-positive patients, and medical professionals anticipate that this treatment option will provide patients with a better choice in terms of mechanism and efficacy.Tanabe Pharma Korea recently held the UPSTREAM Symposium at Voco Seoul Gangnam to celebrate the launch of Uplizna (inebilizumab)in South Korea.Professor Ho Jin Kim of the Department of Neurology at the National Cancer Center served as the chairperson. Professor Ki Hoon Kim of the Department of Neurology at Severance Hospital and Professor Jeeyoung Oh of the Department of Neurology at Konkuk University Medical Center delivered lectures titled ▲Optimizing the treatment with inebilizumab after rituximab and ▲inebilizumab in practice: identifying appropriate patients, respectively.Uplizna is a targeted therapy for adult patients with AQP4 antibody-positive NMOSD. It works by targeting and depleting CD19+ B-cells, thereby reducing attacks (relapses) caused by the immune system targeting the optic nerve and spinal cord.The treatment received U.S. FDA approval in 2020 and was authorized in South Korea in 2021. Tanabe Pharma Korea is currently proceeding with the reimbursement listing process for the drug.During the symposium, Professor Ki Hoon Kim began by highlighting B-cells and the AQP4-IgG production pathway as core elements of NMOSD pathophysiology.The professor explained, "Plasma cells are directly linked to the clinical deterioration of NMOSD. Unlike rituximab, which targets only CD20, Uplizna depletes cells up to the pre-CD19 stage, allowing for an approach closer to the underlying cause of the disease."NMOSD is a rare autoimmune disease characterized by unpredictable, repeated relapses of optic neuritis and myelitis, leading to severe disabilities such as eye pain, blindness, and paraplegia. Approximately seven out of ten NMOSD patients are AQP4 antibody-positive; the formation of these antibodies activates the complement system, which can cause necrosis in the optic nerve and spinal cord.Notably, 80–90% of patients experience recurrent relapses, thus even a single event can result in fatal outcomes. These symptoms are often irreversible and difficult to recover from, necessitating rapid acute-phase treatment fully.Previously, NMOSD relapse relied on high-dose steroids or immunosuppressants to suppress symptoms or used rituximab or 'tocilizumab (product name: Actemra)' to prevent relapses. However, as the relapse suppression effects of these treatments were limited, there was a high demand for new options.Rituximab' clinical limitations have been pointed out. These include non-unified administration protocols, varying B-cell depletion and relapse risks based on FCGR3A genotypes, and high rates of infusion-related reactions (IRR) during the first administration. In contrast, evidence was presented that Uplizna is easy to manage with twice-yearly dosing, reduces the risk of relapse by more than 70% in clinical trials, and cuts the rate of worsening on the Expanded Disability Status Scale (EDSS) by more than half. Professor Kim summarized, "Uplizna is an option that can supplement the structural limitations for patients who do not respond to rituximab."In the second session, Professor Oh focused on the timing of switching therapies, which is a challenge in NMOSD treatment.Professor Oh emphasized, "Defining treatment failure based solely on clear relapses may cause us to miss patients." She presented various clinical patterns, including partial responses, incomplete recovery after severe relapses, and switching due to side effects or infections.Professor Oh also pointed out that due to strict domestic reimbursement criteria, some patients with "disability creep," where disability accumulates slowly without clear relapses, may miss the window for adjusting their treatment strategy.Based on actual patient cases, Professor Oh identified characteristics of patient groups requiring a switch from rituximab to Uplizna.The characteristics include ▲rapid repopulation of CD19+ B-cells, ▲incomplete response due to genotype influence, and ▲difficulty maintaining treatment due to infection burdens such as pneumonia.Professor Oh also highlighted data showing the sustained efficacy of Uplizna.The N-MOmentum study, which served as the basis for approval, was a 28-week randomized, placebo-controlled trial that faithfully reflected the NMOSD patient population in real-world clinical settings by including diverse racial and ethnic groups.In the trial, 89% of the Uplizna group remained relapse-free for 28 weeks, compared to only 58% of the placebo group.Long-term data also showed sustained efficacy, with an annualized relapse rate (ARR) of 0.03 for patients treated with Uplizna for at least 2.5 years, significantly lower than the approximately 1.0 ARR in the placebo group.However, because the open-label period (OLP) was non-blinded and uncontrolled, the results might appear more positive due to patient dropout among those with poor prognoses.Professor Oh assessed that "Uplizna is an option that is not merely as a substitute, but the one that ensures both efficacy and safety when a mechanistic switch is required."Professor Kim concluded, "Because NMOSD is a disease where a single minor relapse can lead to lifelong disability, establishing an initial strategy and determining the appropriate timing for a switch is paramount," adding, "This symposium was meaningful for refining our understanding of mechanism-based treatment and discussing customized decisions for each patient. The introduction of Uplizna will serve as an opportunity to advance NMOSD treatment strategies to the next level."
