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- 2026-04-28 13:12:37
- Policy
- Approval of new ulcerative colitis drug Velsipity near
- by Lee, Tak-Sun Apr 28, 2026 09:46am
- ‘Velsipity 2mg Tab (etrasimod),’ a new ulcerative colitis treatment being introduced in Korea by Everest Medicines Korea, cleared a key hurdle toward domestic marketing authorization.According to industry sources on the 26th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Velsipity Tab. As the safety and efficacy review is considered the most rigorous step in the new drug approval process, the likelihood of Velsipity receiving domestic marketing authorization within the year has significantly increased.Velsipity is a next-generation selective sphingosine-1-phosphate (S1P) receptor modulator developed by Pfizer. It works by blocking the release of lymphocytes from lymph nodes, thereby preventing their migration to inflamed areas in the gastrointestinal tract.It is indicated for adult patients with moderate to severe active ulcerative colitis. In particular, its once-daily oral dosing is considered a strong competitive advantage in a treatment environment traditionally dominated by injectable therapies.Velsipity has demonstrated efficacy through global Phase III trials (ELEVATE UC 52 and ELEVATE UC 12). According to trial results, it achieved significantly higher clinical remission rates compared to placebo at both week 12 and week 52.Currently, the domestic ulcerative colitis market is dominated by biologics as well as JAK inhibitors such as ‘Rinvoq’ and ‘Xeljanz.’ If approved, Velsipity is expected to form an S1P modulator market alongside the first-in-class drug Zeposia, providing patients with a new treatment option.Everest Medicines has secured commercialization rights in the Asia-Pacific region, including Korea, through an agreement with Pfizer and has been proceeding with the domestic approval process. With the completion of the safety and efficacy review, the company is nearing the acquisition of marketing authorization.An industry official said, “Passing the safety and efficacy review means that the MFDS has recognized the clinical value of the drug. Upon final approval, Velsipity is expected to have a significant impact in the ulcerative colitis treatment field, where there is a high preference for oral medications.”
- Policy
- Innovative Pharma Company certification reform…"application opens in August"
- by Lee, Jeong-Hwan Apr 28, 2026 09:46am
- The Ministry of Health and Welfare (MOHW) plans to begin accepting applications from pharmaceutical companies as early as August to implement the reformed "Innovative Pharmaceutical Companies" certification system, following the completion of remaining administrative procedures.As both domestic and multinational pharmaceutical companies have shown strong interest in the reformed certification system, the MOHW has decided to implement an absolute evaluation method, granting the designation of an Innovative Pharmaceutical Companies to all companies that score 65 points or higher.If applications are accepted in August as scheduled, the final list of certified pharmaceutical companies is expected to be officially notified (announced) by the end of December following the review process.On the 26th, Lim Kang-seop, director of the Pharmaceutical and Bio Industry Division at the MOHW, explained the administrative plan to reform the "Innovative Pharmaceutical Companies" certification system during a meeting with KSPA News.The MOHW has issued legislative and administrative notices regarding the enforcement decree·enforcement rules for related notifications of the "Special Act on Fostering and Support of Pharmaceutical Industry" as of the 26th of last month.The Ministry plans to finish gathering opinions by the 6th of next month, followed by an internal review, a regulatory review by the Prime Minister's Office, and a review by the Ministry of Government Legislation.The reform plan will be implemented immediately upon finalization and promulgation. The MOHW plans to start accepting applications for innovative pharmaceutical companies based on the new criteria as early as the beginning of or mid-August and continue through the end of September.Key indicators for the certification review include whether the R&D-to-revenue ratio meets the standards and whether any disqualifying factors exist. Disqualifying factors include illegal drug rebates and unethical conduct by executives or employees. Exceeding the threshold in these areas will result in failure to obtain certification.Lim explained that there will be no limit on the final number of innovative pharmaceutical companies, and certification will be granted through an absolute evaluation.Lim stated, "Certification as an innovative pharmaceutical company is possible if a minimum score of 65 points is achieved. The review will be conducted as an absolute evaluation," and added, "After the Korea Health Industry Development Institute (KHIDI) conducts an initial document review of the applicant companies, those that pass the criteria will undergo deliberation by the committee. We expect to be able to notify the final list by the end of December this year."Given the high interest from both domestic and foreign pharmaceutical companies, with over 100 companies expected to apply, the specific schedule for the official notification of the list may change.Lim plans to hold briefing sessions and public-private consultations regarding the certification system for domestic and foreign pharmaceutical companies between May and June.Lim also noted that further review by the MOHW is required regarding the specific evaluation methods and score allocations for new indicators, such as supply chain stabilization for medicines experiencing supply instability.Lim stated, "This time, both quantitative and qualitative indicators will be reviewed together. Quantitative indicators are being simulated on a 5-point scale, while qualitative indicators will be evaluated according to guidelines for the reviewers," and said. "We are working with the KHIDI to determine evaluation methods suited for new indicators like supply chain stabilization."Lim further stated, "Once the detailed review guidelines are established, we plan to provide briefing sessions or further guidance. A briefing session could be held around late May or early June," and added, "There are requests to include compliance management indicators related to pharmaceutical rebates in the review process, but these are already reflected in the qualitative indicators."Lim concluded by stating that "The qualitative evaluation already accounts for instances where a pharmaceutical company has independently adopted a Compliance Program (CP) and operated a compliance management program following the discovery of rebates," and added, "The legislative notice contains only the broad framework of review items, and the method of qualitative evaluation will be determined by the KHIDI's reviewer guidelines and the items in the documents submitted by the companies. Even if there were past rebates, companies will be able to appeal by demonstrating how they have since strengthened internal controls."Meanwhile, Semi-Innovative Pharmaceutical Companies are also expected to be reviewed and selected through an absolute evaluation based on R&D standards and disqualifying factors, similar to the process for Innovative Pharmaceutical Companies.
- Policy
- Implementation of fast-track listing pilot project imminent
- by Jung, Heung-Jun Apr 28, 2026 09:46am
- The list of drugs eligible for the fast-track listing pilot project for rare disease treatments, along with contract terms, is expected to take shape in the first half of this year.Among rare disease treatments, certain drugs will be selected for initial application, and follow-up measures reflecting reimbursement after post-evaluation will be included in contract terms.According to industry sources and relevant agencies on the 27th, the National Health Insurance Service (NHIS) and the Health Insurance Review and Assessment Service (HIRA) have begun working-level preparations for implementing the fast-track listing pilot project.Fast-track listing is a government plan to reform the drug pricing system by reducing the listing period for rare disease treatments from 240 days to 100 days, with the aim of improving patient access to treatment.The Ministry of Health and Welfare announced at the end of March, through the Health Insurance Policy Deliberation Committee, that it will prioritize the pilot project this year and institutionalize it starting next year. From 2028, it will be expanded to innovative new drugs.The pilot project is expected to include selected drugs among rare disease treatments, considering factors such as patient population. NHIS and HIRA are reviewing detailed selection criteria and negotiation contract conditions.Since there are already designation criteria for orphan drugs set by the Ministry of Food and Drug Safety, additional conditions are expected to be added to these existing standards.HIRA and NHIS need to significantly simplify the existing listing process. Since it is not possible to accommodate all rare disease treatments, HIRA is carefully reviewing the criteria for selecting items.In addition, HIRA is conducting a research project through the end of the year to evaluate clinical efficacy using real-world evidence (RWE). The results will be reflected in the institutionalization of the fast-track listing system next year.Both HIRA and NHIS share the view that post-listing mechanisms must be strengthened as the listing period is significantly shortened.NHIS is focusing on strengthening follow-up measures based on post-evaluation. While reducing the drug price negotiation period with pharmaceutical companies from 60 days to one month, fast-track listing negotiations will focus mainly on expenditure caps and supply obligations.NHIS is also reviewing including clauses in negotiation contracts with pharmaceutical companies that allow for price adjustments or the re-establishment of reimbursement criteria after post-evaluations.Consequently, reaching a concrete agreement on post-listing adjustment conditions during negotiations with pharmaceutical companies is expected to be a key issue.
- Company
- 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."
- InterView
- 'Insomnia can become chronic if left untreated'
- by Son, Hyung Min Apr 28, 2026 09:46am
- The importance of timely treatment of insomnia is being emphasized, as insomnia, once considered merely a lack of sleep, can develop into a chronic condition if it persists.While the number of patients diagnosed and treated in Korea remains at around 700,000, it is estimated that 20–30% of adults actually experience insomnia symptoms. As the gap between symptom experience and treatment persists, the need for early intervention is increasing.Professor Wonju Kim of the Department of Neurology at Gangnam Severance Hospital explained in a recent interview with Daily Pharm, “Insomnia does not simply mean having difficulty falling asleep. It is a disorder that also includes repeatedly waking up during sleep or waking up earlier than planned. We consider treatment necessary when these sleep problems persist and lead to impaired daily functioning, such as fatigue, decreased concentration, and daytime sleepiness.”He continued, “If appropriate intervention is not made, especially in the early stages, symptoms can become prolonged and progress into chronic insomnia. It is crucial not to miss the optimal timing for treatment.”Lack of sleep increases the risk of systemic diseases… the importance of insomnia management highlightedProfessor Wonju Kim, Department of Neurology, Gangnam Severance HospitalInsomnia manifests in various forms, including ▲ difficulty falling asleep, ▲ difficulty staying asleep, and ▲ waking up too early in the morning. It is classified as a medical condition, not merely a lack of sleep, but when it is accompanied by a decline in daily functioning.In particular, acute insomnia caused temporarily by external stress can progress to chronic insomnia lasting more than three months if left untreated.Professor Kim said, “The longer insomnia persists, the more difficult it becomes to treat, and the longer treatment may take. Active treatment in the early stage is important.”According to the HIRA Open Data Portal, the number of patients with insomnia in Korea increased from about 650,000 in 2020 to about 760,000 in 2024.Insomnia affects not only sleep but also overall health. Persistent sleep deprivation is known to be associated with reduced concentration, emotional dysregulation, as well as increased risks of cardiovascular disease, diabetes, and depression.Currently, insomnia treatment is divided into cognitive behavioral therapy and pharmacotherapy. Although cognitive behavioral therapy is recommended as the standard treatment, its use is limited in Korea, resulting in a treatment structure that relies heavily on medication in actual clinical practice.Professor Kim explained, “Cognitive behavioral therapy involves identifying a patient’s sleep habits, analyzing them, and continuously correcting inappropriate sleep behaviors. It also includes correcting the misconception that insomnia is an extremely severe disease. However, in Korea, such treatment is not widely implemented due to high manpower requirements and constraints such as insurance reimbursement.”New alternatives amid limitations of pharmacotherapy…DORA proposes an approach based on regulating the arousal systemPharmacotherapy typically includes benzodiazepines and non-benzodiazepine agents, as well as other drugs acting on the same receptors, melatonin, antihistamines, and antidepressants.Professor Kim said, “Existing drugs have proven efficacy, but there is a burden associated with long-term use due to tolerance and dependence issues. Both patients and healthcare providers often face difficulties in maintaining treatment.”He continued, “There is also the issue where efficacy gradually decreases with long-term use, leading to the need to increase the dosage. In elderly patients, there have been reports of the drug’s effects persisting into the next day or abnormal behaviors such as nightmares and sleepwalking. Such side effects are particularly prominent with zolpidem-class drugs.”Amid these limitations, a new treatment approach that regulates the arousal system, DORA (dual orexin receptor antagonist) class drugs, is gaining attention.DORA works by binding to and inhibiting orexin receptors (OX1R, OX2R), which are neurotransmitters responsible for maintaining wakefulness, thereby lowering arousal levels and inducing sleep. This is a fundamentally different approach from conventional methods that directly suppress the central nervous system to induce drowsiness.Professor Kim stated, “Unlike melatonin, which induces sleep, orexin is a neurotransmitter that maintains wakefulness. Sleep and wakefulness exist in a balanced relationship. When wakefulness increases, sleep decreases, and conversely, when sleep increases, wakefulness decreases.”Orexin is produced and secreted by neurons and plays an important role in maintaining wakefulness. A deficiency of this substance is associated with narcolepsy, a condition characterized by an inability to maintain wakefulness and sudden episodes of falling asleep, which is known to be associated with reduced orexin secretion.DORA utilizes this mechanism in reverse. It works by blocking orexin receptors to reduce excessive wakefulness, thereby inducing more natural sleep.This approach differs from existing benzodiazepine-class drugs in that it does not simply induce drowsiness but regulates the sleep-wake balance itself. In particular, while GABA-class sleep aids such as zolpidem affect sleep architecture, including slow-wave sleep and REM sleep, DORA is gaining attention for its ability to induce more physiological sleep without significantly disrupting sleep structure.Professor Kim stated, “DORA-class drugs lower arousal levels to induce more natural sleep. Another characteristic is that they do not significantly alter sleep structure. They hold the potential to alleviate the concerns of tolerance and dependence that have been problematic in existing treatments, and are meaningful in expanding the range of insomnia treatment strategies.”However, the most important factors in treating insomnia remain lifestyle adjustments and environmental modifications.Professor Kim added, “Insomnia often arises from a combination of lifestyle habits and psychological factors. Approaches that correct sleep habits must be combined with drug therapy. Above all, it is crucial for patients to recognize insomnia as a medical condition and begin treatment early. Not missing the treatment window determines long-term prognosis.”
- 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.
- Opinion
- "Vabysmo PFS shifts the retinal disease treatment persistence·efficiency"
- by Son, Hyung Min Apr 27, 2026 09:03am
- "The key to retinal disease treatment is not just in simple vision improvement, but in how stably and long-term the disease can be managed."As retinal disease treatment shifts from a short-term effect-centered approach to a long-term management strategy, the introduction of pre-filled syringe (PFS) formulations is shifting the practices.In particular, the 'Vabysmo (faricimab)' PFS formulation, launched as a reimbursed drug on the 1st of this month, is expected to lead to changes in treatment persistence and the clinical environment, including extended dosing intervals and improved procedural efficiency.Director Soon Il Choi of Nune Eye HospitalDirector Soon Il Choi of Nune Eye Hospital recently met with DailyPharm to highlight these changes, assessing that the retinal disease treatment paradigm is being reorganized around long-term management.At the center of this change are dual-mechanism therapies. Until now, treatments for wet age-related macular degeneration (nAMD) and diabetic macular edema (DME) were dominated by single-mechanism therapies that inhibit only VEGF.Before the emergence of high-dose formulations, the patient burden was significant, as dosing intervals were limited to about 2 months and required repeated direct intravitreal injections.Vabysmo is a bispecific antibody that simultaneously inhibits vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2), offering a differentiated approach compared to existing treatments. While VEGF-A is a key factor in angiogenesis, Ang-2 is known to promote vascular instability and leakage.Choi explained, "Blocking both pathways can contribute to maintaining blood vessels in a more stable state, going beyond simply inhibiting blood vessel formation."This mechanistic difference is highly likely to lead to improvements in anatomical indicators in clinical practice. Experts expect faster, more stable changes in reducing retinal fluid or normalizing macular thickness, which can lead to extended dosing intervals and sustained treatment persistence. The efficacy of Vabysmo has been confirmed in various clinical trials and real-world data.Choi stated, "Since the vision improvement effects of existing treatments have already reached a certain level, the perceived difference may be limited," and added, "How quickly and stably the retina maintains a dry state is a key factor determining long-term prognosis."Choi suggested that Vabysmo could be more actively considered for: ▲patients who relapse even with a slight increase in treatment intervals ▲patients with insufficient response to existing agents ▲patients with high retinal fluid or high volatility; ▲patients with repeated findings suggestive of vascular instability ▲patients who could previously maintain relatively long intervals but are seeing a shortening of the drug's duration of effect.Choi analyzed, "The advantages of Vabysmo can be expected in clinical situations requiring dual-pathway mechanisms, such as when stable disease control is needed. It can also be considered for patients with high intraretinal or subretinal fluid, high volatility, or those with concerns related to inflammation or fibrosis."As the central axis of treatment shifts from vascular inhibition to vascular stabilization, another change is simultaneously underway in the clinical environment: formulation changes."PFS formulation, significance in terms of procedure standardization and infection control"The Vabysmo PFS formulation, reimbursed since the 1st of this month, is evaluated as an element that changes the clinical process itself beyond just improving convenience.The existing vial formulation requires several steps, such as drawing the medication into a syringe, changing the needle, and removing air. The PFS is pre-filled with the medication and can be used immediately after opening.Choi emphasized, "Since an intravitreal injection is a procedure where medication is administered directly into the eye, even minor contamination can lead to serious complications. Reducing the preparation process is a very important change in lowering the risk of infection."According to Choi, although complications such as endophthalmitis do not occur frequently, prevention is critical because they can have a fatal impact on vision when they do occur. In this regard, simplifying the preparation process is meaningful for ensuring safety beyond mere convenience.In high-volume practices, this difference plays an even larger role. In ophthalmology clinics, tens of thousands of intravitreal injections are performed annually, making it crucial to minimize variables that may arise during repeated preparation steps.Choi stated, "Intravitreal injection is a frequently performed procedure. In our hospital, about 20,000 intravitreal injections are performed annually. In an environment with a high number of procedures, the effect of reducing a single step leads to system stability, not just saved time."Choi added, "Looking at overseas cases, there are reports that about 85% switched to PFS within about two months after the PFS formulation was released. If the reimbursement criteria are the same and there are no special restrictions on supply, most will likely switch to the PFS formulation."The PFS formulation also affects the actual procedural process.The Vabysmo PFS features an extra-thin-wall needle to deliver a higher flow rate at the same pressure. The injection process can be carried out more smoothly and quickly.Choi mentioned, "For elderly patients, it is not easy to keep the eye fixed during the procedure, so it is important that the injection process is fast and smooth. These factors affect the actual patient experience."Another characteristic of the Vabysmo PFS is that it comes with a filter needle. This structure filters out fine particles and contaminants, simultaneously increasing procedural precision and safety. This needle consists of a dedicated filter needle approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).Choi added, "Other products do not include a needle, but Vabysmo includes the needle in the product package. Maintaining consistent needle quality is a very important factor for medical staff," and added, "It can provide a consistent procedural environment in terms of handling and stability."This mechanistic evolution and formulation improvement ultimately converge in one direction: the treatment persistence.Macular degeneration and diabetic macular edema are diseases that must be managed over years or even decades. According to the Health Insurance Review and Assessment Service (HIRA), the number of patients with macular degeneration in Korea increased by more than 150% over the past five years, from about 200,000 in 2020 to about 560,000 in 2024.In this process, the treatment interval, procedural burden, and frequency of hospital visits are key variables determining patient compliance. Currently, Vabysmo has extended the dosing interval up to a maximum of 16 weeks. Choi believes this is highly significant because it can substantially reduce patients' long-term treatment burden.Choi said, "From the patient's perspective, receiving an injection directly into the eye is a significant psychological burden. Because this treatment must be repeated for a long time, it is important to determine whether the frequency of hospital visits and injections can be reduced. Receiving treatment every month versus every three months is a completely different experience for a patient. This difference determines whether long-term treatment is maintained."In conclusion, Choi emphasized, "For some treatments, inflammation issues can pose a clinical burden regardless of efficacy. Vabysmo is an option that can be used with relative peace of mind regarding safety and efficacy. In cases where preserving vision in one eye is critical, such as 'last eye' patients, safety is even more important than treatment effect, and Vabysmo can be a reliable treatment option in both aspects.
