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- 2026-07-22 00:20:59
- Company
- Pharma biotech 'corporate name change' moves…12 companies this year
- by Cha, Ji-Hyun Jul 21, 2026 08:26am
- Pharmaceutical, biotech, and healthcare companies in South Korea are changing their corporate names one after another. This year alone, 12 companies have rebranded. While these changes aim to enhance brand value and clearly signal shifts in business structures and growth strategies, critics point out that without financial performance and business outcomes, they could end up as a mere “company signboard swap."According to the Financial Supervisory Service on July 20, DA Information, an IT subsidiary of Dong-A Socio Group, announced on July 16 that it will change its corporate name to 'DAI' (pronounced D-A-I). With this rebranding, the company aims to transition from its traditional focus on IT system operation and maintenance to become an AX (AI Transformation) partner that revolutionizes corporate decision-making and workflows. DAI plans to nurture AI-driven drug discovery platforms, AI-based healthcare platforms, pharmaceutical-specific GMP solutions, and AI agents as its new growth engines.Aptamer Sciences held an extraordinary general meeting of shareholders on July 8 and changed its corporate name to 'Choolip & Sciences'. Its English name was also changed from 'Aptamer Sciences Inc.' to 'CHOOLIP & SCIENCES Inc.' Regarding the reason for the change, the company explained, "The corporate name was changed in accordance with changes in management objectives and business diversification strategies."On the same day, Woojung Bio also changed its name to 'Kolmar Biotech' at an extraordinary shareholders' meeting. This is a follow-up measure following Kolmar Holdings' push to acquire management control. Previously, in March, Woojung Bio pursued a transfer of management rights by issuing KRW 35 billion in convertible bonds to Kolmar Holdings and delegating the voting rights of the then-largest shareholder. Accordingly, the blueprint is to reflect the Kolmar Group's identity in the new corporate name and enhance its brand value.2026 List of Corporate Name Changes for Pharma, Biotech, and Health Companies: SCM Lifescience changed its name to 'Poongjeon Pharmaceutical'. UBcare also changed its name to 'GC Medieye'. Neofect changed its corporate name to 'Dynamic Solution' on March 25. Seers Technology shortened its name to 'Seers' on March 27. U2Bio changed its name to 'Jigu Holdings' on March 30. Kukjeon Pharmaceutical changed its name to 'Kukjeon' on March 31. 'Orion Atomics' to AdBiotech. 'BNC Korea Co, Ltd' to 'BNC KOREA, Inc.' CHA Vaccine Research Institute changed its name to 'AriBio LAB' on April 30. Solux changed its name to 'AriBio Holdings' on June 29. Aptamer Sciences changed its corporate name to 'Choolip & Sciences'. Woojung Bio also changed its name to 'Kolmar Biotech'These are not the only companies changing their names. It is estimated that more than 13 pharmaceutical, biotech, and healthcare companies have changed their corporate names so far this year.Solux changed its name to 'AriBio Holdings' on June 29. This is part of an effort to restructure its governance and business framework around bio ahead of its upcoming merger with AriBio. Solux incorporated AriBio as a subsidiary after AriBio CEO Choung Jai-jun acquired management control of the company in 2023. It is currently pursuing an absorption merger with AriBio to pivot its LED-lighting-centered business model toward degenerative brain disease drug development and healthcare. Ahead of the merger, the company plans to align the group's governance and identity through the name change, ultimately building a holding company system that encompasses drug R&D·commercialization, and biotech investment functions.CHA Vaccine Research Institute changed its name to 'AriBio LAB' on April 30. This is also an extension of the plan to reorganize the biotech affiliate system around AriBio. In the process of pursuing the merger with AriBio, Solux also decided to acquire management control of Cha Vaccine Research Institute. This followed a contract signed in March, in which Solux and three other parties acquired a 33.3% stake in CHA Vaccine Research Institute, held by CHA Biotech, for KRW 23.8 billion. With this move, the goal is to reposition CHA Vaccine Research Institute as an R&D-specialized affiliate within the group and further solidify its biotech business foundation.Rebranding by traditional pharmaceutical firms is also noteworthy. Kukjeon Pharmaceutical changed its name to 'Kukjeon' on March 31, dropping the word 'Pharmaceutical'. The decision was made to expand its business scope beyond its existing image, which was limited to medicines, and to build a new corporate image. Based on its active pharmaceutical ingredient (API) business, Kukjeon aims to leap forward into an advanced materials company beyond pharma by nurturing electronic materials for semiconductors and displays as a new growth axis.There are also cases where companies reverted to their previous names during the process of realigning their business identity. AdBiotech, an animal health company, changed its name to 'Orion Atomics' last September, only to revert to its original name this March, about six months later. Along with the reinstatement of its old name, the company removed numerous business objectives unrelated to its core business, such as nuclear power, energy, batteries, and virtual assets. It reorganized its business structure around its traditional livestock and bio sectors, re-clarifying its corporate identity.In the case of BNC Korea, it retained its Korean corporate name and standardized only its English business name. It changed 'BNC Korea Co, Ltd' to 'BNC KOREA, Inc.' This measure was taken to unify the English trade names that had been used interchangeably in practice. There are no other corporate name changes for this company within the past two years.In addition, U2Bio, Seers Technology, Neofect, SCM Lifescience, and UBcare have also successively changed their names this year. U2Bio changed its name to 'Jigu Holdings' on March 30. It reflected its identity as a holding company in its name in line with its physical split-off plan to transition into a venture holding company. Seers Technology shortened its name to 'Seers' on March 27 to clarify its strategic direction toward becoming a patient-centered, next-generation healthcare platform company, on the basis of its technology commercialization capabilities.Neofect changed its corporate name to 'Dynamic Solution' on March 25, citing an enhanced corporate image and strengthened competitiveness. SCM Lifescience changed its name to 'Poongjeon Pharmaceutical' on March 24, a move aimed at strengthening brand competitiveness and laying the groundwork for sustainable growth.UBcare also changed its name to 'GC Medieye' on March 24. This comes six years after the company was incorporated into the Green Cross (GC) Group when GC Green Cross Healthcare (currently GC Care) acquired management control for 208.8 billion KRW in 2020. This name change is interpreted as a move to bring the GC Group's identity to the forefront and emphasize its direction to transcend its existing electronic medical record (EMR) business and leap forward as an AI-based digital healthcare company.Changing a corporate name is an effective tool for companies to communicate their altered business structures and mid- to long-term strategies to the market while enhancing brand value. In particular, when an existing corporate name is tied to a specific technology or traditional manufacturing sector, changing it to a more scalable name can signal a strategic pivot toward becoming a comprehensive bio-healthcare enterprise externally.However, changing a corporate name does not alter a company's own competitiveness. Experts point out that even if a company changes its name as part of business diversification and entry into new markets, the move could be a mere "signboard change" that only inflates expectations if revenue expansion, profitability improvements, and R&D achievements do not follow. Given that there are already numerous cases where performance improvements or new business outcomes failed to materialize despite a name change, some argue that strengthening the competitiveness of the core business must take priority over a new name.
- Product
- Which drugs will fill Fotagel and Stavic’s void?
- by Kang, Hye-Kyung Jul 21, 2026 08:26am
- The market disruption that arose following the removal of pediatric indications for dioctahedral smectite products is beginning to subside in Korea.According to local pharmacies and industry sources, supplies of alternative products that experienced a surge in demand after Fotagel and Stavic Suspension were barred from use in children and adolescents have largely returned to normal.Supplies of Hidrasec, which had temporarily gone out of stock following increased demand after the pediatric indication for dioctahedral smectite products was withdrawn, have now stabilized.Both the prescription drug Hidrasec and the OTC product Seolmum Chew, which experienced temporary shortages because of the sudden spike in demand, have also normalized.Samjin Pharm, which distributes Abbott Korea's Hidrasec, said, "Temporary supply instability occurred due to a sudden increase in orders, but both the 10mg and 30mg strengths are now being supplied normally."Seolmum Chew, which also experienced temporary shortages in line with Hidrasec, has likewise returned to normal supply.More than 80,000 units of Hanmi Pharmaceutical's Seolmum Chew are currently in stock in the company's HMP Mall, indicating stable supply.Industry closely watches the shift in demandThe industry is closely watching how demand will be redistributed.The key question is which alternatives for patients under 19 years of age, who can no longer use dioctahedral smectite products, will benefit the most.Pharmacist communities expect prescriptions for Hidrasec (racecadotril) to increase.AI-generated imageA local pharmacist said, "Since Fotagel and Stavic can no longer be prescribed for children and adolescents, prescriptions for Hidrasec are increasing. As it can be used from 6 months of age, it is effectively the only prescription antidiarrheal available for pediatric patients."Products containing polycarbophil calcium, including Wellcon, Hylcon, Recxil, Silcon, Carcon, and Pilcon tablets, are approved for children aged 6 years and older and are expected to cover much of the market for patients aged 6 to 18 years.According to the Ministry of Food and Drug Safety, imports of Hidrasec totaled KRW 984.11 million in 2024 (10mg KRW 377.04 million, 30mg KRW 607.07 million)Among OTC products, demand is also expected to rise for Baekcho Syrup (licorice extract, gambir 20% ethanol extract, Coptis/Cortex Phellodendri 50% ethanol extract, ginseng fluid extract, cinnamon bark 70% ethanol tincture, Scutellaria root soft extract, and gentian ethanol extract) and Seolmum Chew (berberine tannate, Scopolia extract powder 33%, ursodeoxycholic acid, and bismuth subnitrate), both of which can be used in younger age groups.A pharmacist practicing near a pediatric clinic said, "With the pediatric indication for dioctahedral smectite removed, the antidiarrheal market is becoming segmented by age group. Even when customers are looking for an over-the-counter antidiarrheal, we now first recommend Baekcho Syrup or Seolmum Chew because they can be used in younger patients."
- InterView
- [Reporter’s View] Role of MRs at a crossroads
- by Son, Hyung Min Jul 21, 2026 08:26am
- Early retirement programs (ERPs) are no longer an unfamiliar sight at the Korean affiliates of multinational pharmaceutical companies.Major drugmakers have repeatedly implemented workforce restructuring around their sales organizations, rendering ERPs an ongoing trend.Following BMS, MSD, and Takeda, Novartis has also begun reorganizing its operations, prompting various interpretations inside and outside the industry about the future of pharmaceutical field sales and the role of medical representatives at multinational companies.Some view the trend as a sign of the declining role of medical representatives. The role of medical representatives was long expected to diminish with the expansion of digital marketing and the rise of artificial intelligence (AI). Improving operational efficiency and reducing costs are also key drivers behind the ERPs.Others, however, point to repeated ERP implementations at companies with improving financial performance. From this perspective, they argue that recent changes cannot be explained by cost-cutting alone.In the past, a pharmaceutical company's competitiveness largely depended on how many healthcare professionals it could reach and how effectively it could promote its products. During the era when blockbuster cardiovascular drugs dominated the market, sales networks and field activities were the primary drivers of commercial success. Effectively communicating a product's advantages and building trust with physicians were paramount.Today, the market operates by different rules.As high-cost medicines, including oncology and rare disease therapies, account for a growing share of the market, competition has shifted from sales capabilities to clinical evidence. Biomarkers, treatment guidelines, and increasingly detailed reimbursement criteria have become the key factors influencing treatment decisions. Rather than personal rapport, the clinical significance of trial results, differentiation from existing therapies, and reimbursement status now determine a product's competitiveness. The industry has entered an era in which a single promising new drug can drive a company's growth.This is why many multinational pharmaceutical companies are actively reshaping their portfolios toward highly specialized therapeutic areas. As product portfolios evolve, competitive strategies and the role required for MRs are evolving as well. This explains why field sales organizations have become the focal point of organizational change.The shift is naturally reshaping pharmaceutical company structures. Specialized functions such as Medical Affairs, Medical Science Liaisons (MSLs), and Market Access (MA), which engage with healthcare professionals and government authorities, are playing increasingly important roles. In other words, sales activity is not disappearing; rather, many of the functions traditionally handled by medical representatives are now being performed by more specialized teams.Recent ERPs should also be viewed from this context. More important than workforce reductions themselves is the question of what capabilities companies are strengthening to adapt to the changing market. The role of sales continues to evolve as evidence-based competition intensifies.Medical representatives are entering an era in which they will be judged not by how many physicians they meet, but by how sophisticated a scientific discussion they can lead. Ultimately, the question facing MRs at this crossroads of change is one of expertise.
- Company
- Kolon TissueGene’s osteoarthritis drug fails Phase 3 trial
- by Cha, Ji-Hyun Jul 21, 2026 08:25am
- Kolon TissueGene, Kolon Group’s biotechnology subsidiary, has failed to demonstrate improvements in pain and function in a US Phase III trial of its investigational drug for knee osteoarthritis.According to a regulatory filing disclosed to Korea's Financial Supervisory Service on July 20, the company announced topline results from the U.S. Phase III TG-G 15302 trial evaluating its knee osteoarthritis drug candidate ‘TG-C.’ At 12 months, TG-C failed to achieve statistical significance versus placebo on both co-primary endpoints: the Visual Analog Scale (VAS) pain score and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score.The VAS pain score decreased by an average of 38.7 points from baseline in the TG-C group and 39.2 points in the placebo group. The between-group difference was 0.5 points (p=0.8322). The WOMAC total score declined by 27.61 points in the TG-C group and 26.54 points in the placebo group. The between-group difference was -1.07 points (p=0.5701).The trial enrolled 531 patients with Kellgren-Lawrence Grade 2 or 3 knee osteoarthritis at 27 U.S. sites. Participants were randomized in a 2:1 ratio to receive a single intra-articular injection of TG-C or placebo and were followed for 24 months to evaluate efficacy and safety.No new or unexpected safety signals were identified. Treatment-emergent adverse events were reported in 83.9% of patients in the TG-C group and 78.1% in the placebo group, with most events classified as Grade 1 or 2. The overall rate of total knee replacement was 0.6% in the TG-C group compared with 5.3% in the placebo group.Kolon TissueGene plans to discuss the findings with the US Food and Drug Administration (FDA) after integrating the efficacy and safety results from this study with those from another ongoing U.S. Phase III trial.
- Policy
- Initiation of review for Mifegyne use standard·reimb of obesity drugs
- by Lee, Jeong-Hwan Jul 21, 2026 08:25am
- Product photos of Mifegyne and Mounjaro[데일리팜=이정환 기자] 보건복지부가 인공임신The Ministry of Health and Welfare (MOHW) plans to establish safety use standards for abortion pills following domestic approval, through consultations with the medical community.Regarding reimbursement under the national health insurance for severe obesity treatments such as Wegovy and Mounjaro, it has decided to continue reviewing their feasibility.Minister of Health and Welfare Jeong Eun Kyeong, who recently concluded her presidential work report, presented the policy direction for the second half of the year regarding abortion pills and severe obesity treatment injections during a pre-briefing held at the Sejong Government Complex the day before the report.This briefing reveals the administrative work regarding the domestic introduction of the abortion pill Mifegyne, mentioned by President Lee Jae Myung, and the reimbursement for Wegovy and Mounjaro, drugs that continue to show popularity.Regarding Mifegyne, the Ministry plans to establish criteria for its safe use and to communicate with medical professionals once the relevant legal amendments and approvals from the Ministry of Food and Drug Safety (MFDS) are completed.During the work report briefing regarding Mifegyne, Minister Jeong explained, "There was a constitutional nonconformity ruling regarding abortion related to pregnancy termination drugs, and a request was made for legislation overhaul. The government feels a sense of responsibility regarding the current lack of legislation,” and adding, “We will proceed by discussing necessary aspects such as the amendment of data and the Mother and Child Health Act with the National Assembly."Minister Jeong added, "In the event of domestic introduction, we are preparing to establish safety use standards, and we will formulate safe use standards, including clinical practice guidelines, in cooperation with the medical community so that patients can use them safely."Regarding health insurance reimbursement for severe obesity treatments, Minister Jeong stated that feasibility will be reviewed. However, Jeong made it clear that the priority is strengthening health insurance coverage for patients with rare and intractable diseases.Minister Jeong emphasized, “We continue to review the feasibility and necessity of coverage for severe obesity treatments, which are in high demand,” and added,”We are currently preparing measures to strengthen health insurance coverage. Furthermore, we plan first to announce plans to strengthen coverage for urgent, severe, rare, and intractable diseases."Minister Jeong added, "As there are demands for reimbursement of emerging health issues such as hair loss and severe obesity, we are preparing our approach through a comprehensive judgment."
- Company
- MSD develops first oral PCSK9 inhibitor
- by Son, Hyung Min Jul 20, 2026 08:51am
- MSD's launch of the world's first oral PCSK9 inhibitor is expected to reshape the dyslipidemia treatment market.The arrival of an oral therapy is likely to intensify competition over treatment convenience in a market that has until now evolved primarily by extending dosing intervals of injectable therapies.Oral PCSK9 inhibitor LipfendraAccording to industry sources, the U.S. Food and Drug Administration (FDA) approved Lipfendra (enlicitide) on July 16 for reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and heterozygous familial hypercholesterolemia (HeFH).Lipfendra is an oral PCSK9 inhibitor taken once daily at a 20mg dose as an adjunct to diet and exercise.PCSK9 inhibitors are indicated for patients whose LDL-C levels remain inadequately controlled despite lipid-lowering therapy, including high-intensity statins and ezetimibe, or for those requiring additional LDL-C reduction because of a high risk of atherosclerotic cardiovascular disease (ASCVD).All currently marketed PCSK9 inhibitors are injectables. Amgen's ‘Repatha (evolocumab)’ and Sanofi/Regeneron's ‘Praluent (alirocumab)’ are monoclonal antibodies administered every two weeks.Novartis' ‘Leqvio (inclisiran)’ is an siRNA therapy that suppresses PCSK9 production in the liver. After the initial administration, the second dose is administered after three months, and then every six months.While the PCSK9 inhibitor market has focused on reducing injection frequency and extending dosing intervals, Lipfendra has differentiated itself with oral administration.Lipfendra is a macrocyclic peptide-based oral PCSK9 inhibitor. It inhibits PCSK9 to increase hepatic clearance of LDL cholesterol and targets the same pathway as injectable PCSK9 inhibitors as an oral formulation.However, there are certain restrictions during its intake. Lipfendra may be taken with water, coffee, or tea, but patients must avoid eating for at least 30 minutes afterward to ensure adequate drug absorption.Approval supported by two global Phase III trialsLipfendra's approval was based on results from the CORALreef Lipids and CORALreef HeFH studies, part of MSD's global Phase III CORALreef program.CORALreef Lipids was a multicenter, randomized, double-blind, placebo-controlled Phase III trial involving 2,904 patients with hypercholesterolemia.Participants were those receiving stable lipid-lowering therapy, including moderate- or high-intensity statins that still required additional LDL-C reduction.In the trial, Lipfendra reduced LDL-C by 56% versus placebo at Week 24. LDL-C fell 57% from baseline in the Lipfendra group, while it increased by 3% in the placebo group.In the CORALreef HeFH study, which involved 303 patients with heterozygous familial hypercholesterolemia, Lipfendra reduced LDL-C by 59% versus placebo at Week 24. LDL-C declined 58% from baseline in the Lipfendra group but increased by 3% in the placebo group.Beyond LDL-C reduction, Lipfendra also lowered non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB), both associated with ASCVD risk.Among patients with hypercholesterolemia, Lipfendra reduced non-HDL-C by an average of 54% and ApoB by 50%. In patients with HeFH, the corresponding reductions were 52% and 48%, respectively.Overall safety was comparable to placebo. In the hypercholesterolemia study, adverse event rates were similar between the two groups. In the HeFH study, however, diarrhea and dizziness occurred more frequently with Lipfendra.Diarrhea was reported in 7% of patients receiving Lipfendra versus 2% with placebo, while dizziness occurred in 9% and 4%, respectively. Treatment discontinuation due to adverse events was similar between groups.Although Lipfendra has demonstrated robust LDL-C lowering, it has yet to demonstrate reduction in major cardiovascular events such as myocardial infarction, stroke, or cardiovascular death.MSD is currently evaluating its effects on cardiovascular events and mortality in the CORALreef Outcomes trial involving more than 14,500 participants. Patient enrollment has been completed.The overall CORALreef clinical program includes more than 19,000 patients with hypercholesterolemia. In addition to the cardiovascular outcomes trial, MSD is conducting long-term extension studies as well as trials in pediatric patients and combination therapy with Lipfendra.Lipfendra is also expected to play an important role in MSD's long-term growth strategy. Its oral formulation and relatively lower price may act in favor when seeking to expand into the injectable-dominated PCSK9 inhibitor market.Lipfendra is priced at USD 315 per month in the United States. This is lower than some of the currently marketed PCSK9 therapies.The market expects Lipfendra to become one of MSD's key growth drivers following the loss of patent exclusivity for Keytruda (pembrolizumab), with peak annual global sales projected at up to USD 5 billion.
- Product
- Korea first to recommend cuffless blood pressure monitors,
- by Hwang, byoung woo Jul 20, 2026 08:51am
- Cuffless blood pressure monitors, which measure blood pressure without inflating a cuff around the arm, have been included in Korea's hypertension treatment guidelines for the first time. The Korean Society of Hypertension (KSH) has become the first in the world to recommend cuffless blood pressure monitors for out-of-office blood pressure measurement, establishing a clinical framework for their use.The move is expected to accelerate clinical adoption, which is already increasing following reimbursement coverage, by reducing patient discomfort associated with conventional ambulatory blood pressure monitors and easing equipment burdens on healthcare providers. The society also plans follow-up clinical studies to strengthen the recommendation.At a press briefing on July 17, the KSH introduced the major updates in its sixth edition of the 2026 Korean Society of Hypertension Guidelines and their clinical implications.(from the left) Seonghoon Choi, Director of Public Relations at KSH (Hallym University College of Medicine); Kwang-il Kim, Chairman of KSH (Seoul National University Hospital); Sang-Hyun Ihm, Chair of the KSH Guideline Committee (The Catholic University of Korea College of Medicine); Eun Mi Lee, Secretary of the KSH Guideline Committee (Dongguk University College of Medicine)First positive recommendation…opens door to clinical useThe updated guidelines retain the existing recommendation to use validated cuff-based blood pressure monitors for office, home, and ambulatory blood pressure measurement while newly adding cuffless monitors as an option for out-of-office monitoring.Its use received a Class IIb recommendation with Level B evidence, meaning it may be considered in practice. This differs from U.S. and European guidelines, which do not recommend cuffless devices for clinical use.The society emphasized that this is the world's first positive recommendation for cuffless blood pressure monitors. While international discussions continue regarding their accuracy and appropriate use, the recommendation reflects growing validation data and real-world clinical experience accumulated in Korea.Kwang-il Kim, Chairman of KSH and professor at Seoul National University College of Medicine, explained, "There were concerns from overseas academia that Korea might be moving too quickly, but others viewed it as taking the lead in a new field. This is the first positive recommendation for cuffless blood pressure monitors anywhere in the world."In Korea, Sky Labs' CART BP, a ring-type blood pressure monitor, has already undergone validation against conventional 24-hour ambulatory blood pressure monitoring and is being used in clinical practice. Moving beyond being just a simple wearable device, its use has broadened as a clinical tool for ambulatory blood pressure monitoring.Major changes in the KSH hyperlipidemia treatment guidelinesSang-Hyun Ihm, Chair of the KSH Guideline Committee (Catholic University of Korea), said, "Given that the device is already being used in Korean patients and supporting evidence has accumulated, we concluded it would not be appropriate to classify it as a technology that should not be used. Although it has not reached Class I or IIa, we introduced it as a Class IIb recommendation that may be considered in clinical practice."Adoption expands following reimbursement…use expands across primary care clinicsThe inclusion of cuffless monitors in the guidelines is also expected to support the growing use of the technology following reimbursement coverage.Eun Mi Lee, Secretary of the KSH Guideline Committee, said, "We understand that the use of cuffless blood pressure monitors has increased significantly since its reimbursement listing. The convenience for both patients and healthcare professionals serves as a clear advantage."She noted, however, that additional validation is needed in certain patient populations, including those with thick finger joints, improperly positioned sensors, arrhythmias, or pregnancy.The society attributed the increase in use partly to broader adoption by primary care clinics. Traditional 24-hour ambulatory blood pressure monitoring requires dedicated equipment and repeated cuff inflation, placing burdens on both providers and patients. This had limited its use in smaller clinics.Seonghoon Choi, Director of Public Relations at KSH (Hallym University College of Medicine), said, “The rate of ambulatory blood pressure monitoring using conventional cuff-based devices has remained around 0.5% in Korea. The growing use of cuffless monitors suggests that primary care physicians, not just tertiary hospitals, are now participating in out-of-office blood pressure monitoring."Choi added, "The society has long emphasized that treatment decisions should not rely on a single office blood pressure measurement. The expansion of ambulatory blood pressure monitoring in primary care is therefore a very encouraging development."Cuffless monitors were newly introduced in practiceCan monitor blood pressure at night and in daily life… expands treatment dataOne of the main advantages of cuffless monitors is their ability to measure blood pressure during sleep and daily activities without repeated arm compression.Conventional ambulatory monitors inflate every 15 or 30 minutes, allowing patients to anticipate measurements and complain about sleep disturbances or discomfort during the night.Ring-type cuffless monitors can measure blood pressure more frequently without compressing the arm, potentially enabling more comprehensive monitoring beyond nighttime to routine daily activities.KSH President Kim said, "Conventional ambulatory monitors measure blood pressure every 15 or 30 minutes, whereas cuffless devices can collect readings at many more time points. They also offer advantages for nighttime and prolonged monitoring that exceeds one day."The technology may also benefit patients who have difficulty wearing arm cuffs, such as those undergoing hemodialysis or those who experience discomfort from repeated cuff inflation.For now, KSH sees the primary clinical role of cuffless monitoring in the follow-up of patients already diagnosed with hypertension, using the devices to assess treatment response, nighttime blood pressure, and diurnal variation while establishing interpretation criteria specific to cuffless measurements.Large clinical study involving over 1000 patents planned…. To prepare data to elevate the recommendation levelThe KSH is preparing an investigator-initiated clinical trial to strengthen the recommendation in future guideline updates.Chairman Kim said, “Whereas previous studies focused mainly on whether cuffless devices produced measurements comparable to cuff-based monitors, the next phase will evaluate whether treatment guided by cuffless blood pressure readings improves blood pressure control and patient outcomes."The evidence showing that cuffless monitors can generate values comparable to conventional ambulatory monitors supported the current Class IIb recommendation. Going forward, we need to demonstrate whether treatment based on cuffless measurements leads to better outcomes and predicts prognosis more accurately than existing methods."He added, "A single meaningful study could support a Class IIa recommendation, and consistent findings from both domestic and international studies could eventually lead to a Class I recommendation. Class IIb does not indicate a problem with the device -- it marks the beginning of a new clinical field."The planned study is expected to enroll more than 1,000 patients, with the final sample size depending on participating institutions and whether primary care clinics are included. The KSH aims to launch the study later this year after completing institutional reviews and protocol evaluations.The recommendation is not limited to any specific product. According to the KSH, any cuffless monitor that demonstrates sufficient accuracy and clinical evidence may receive the same level of recommendation.The updated guidelines also introduce isolated diastolic hypertension as a new category, strengthen blood pressure targets for high-risk patients, classify single-pill combination therapies, establish diagnostic and treatment algorithms for resistant hypertension, and emphasize more proactive management of hypertensive disorders of pregnancy. In particular, hypertensive disorders of pregnancy were identified as an area requiring efforts to bridge the gap between the guidelines and clinical practice, as the number of patients continues to increase while treatment options available in Korea remain limited.Chairman Kim said, "Gestational hypertension not only impacts maternal health but also the health of the child. The society will continue exploring policy solutions and providing the information needed to improve care."
- Policy
- Reimb expansion for Tevimbra’s five indications under drug price negotiations
- by Jung, Heung-Jun Jul 20, 2026 08:51am
- Product photo of Tevimbra BeOne Medicines Korea’s immunotherapy, Tevimbra Inj (tislelizumab), has entered drug price negotiations with the National Health Insurance Service (NHIS) to expand reimbursement coverage for five indications.Additionally, Roche Korea’s immunotherapy Tecentriq Inj (atezolizumab) has also entered negotiations for adjuvant therapy in non-small cell lung cancer (NSCLC).According to industry sources, on July 19, the Ministry of Health and Welfare (MOHW) issued price negotiation orders to the NHIS for Tecentriq and Tevimbra. These medications were recognized for their appropriateness for reimbursement expansion during the recent 5th and 6th Pharmaceutical Reimbursement Evaluation Committee (PREC) meetings.Tevimbra is the product that has secured the highest number of approved indications among the pharmaceuticals reviewed for reimbursement expansion during the 1st to 7th PREC meetings this year.The company is seeking to expand reimbursement across five indications, including monotherapy and combination therapy for non-small cell lung cancer, as well as first-line combination therapies for gastric cancer and esophageal cancer.Currently, the only reimbursed indication for Tevimbra is second-line combination therapy for esophageal cancer. In April last year, it successfully secured its initial reimbursement listing for esophageal cancer ahead of other immunotherapies with the same mechanism of action, such as Keytruda and Opdivo.Once this indication expansion is implemented, competition with blockbuster drugs like Keytruda and Opdivo is expected to intensify. Patient access to treatment is anticipated to strengthen as additional therapeutic options become available.However, price negotiations for multi-indication immunotherapies, which pose a heavy burden on the national health insurance budget, are rarely easy. Given that the share of oncological drugs within overall pharmaceutical expenditures is rising substantially, detailed negotiations regarding the application of complex Risk Sharing Agreements (RSAs) and refund rates will be the key determining factors.Yet, during its initial reimbursement listing last year, Tevimbra was well-received for enhancing patient access to a reasonably priced drug. As market competition intensifies, it can positively impact the insurance budget, a favorable factor in upcoming price negotiations.Product photo of TecentriqIf BeOne successfully clears the hurdle of NHIS negotiations, it is expected to proceed with a listing in the fourth quarter of this year.Roche Korea’s immunotherapy Tecentriq has also recently commenced price negotiations. In May, the PREC approved reimbursement expansion appropriateness as an "adjuvant therapy following resection and platinum-based chemotherapy in patients with early-stage non-small cell lung cancer."Tecentriq garnered significant attention in 2022 as the first immunotherapy to receive regulatory approval for adjuvant therapy in early-stage non-small cell lung cancer. It is now awaiting a reimbursement expansion after approximately four years.
- Policy
- Celltrion seeks Cosentyx biosimilar approval without pediatric indication
- by Lee, Tak-Sun Jul 20, 2026 08:51am
- AI-generated imageCelltrion has adopted an “independent strategy” to circumvent the original drug’s exclusivity as it prepares to launch a biosimilar of the blockbuster autoimmune disease therapy, Cosentyx (secukinumab), in Korea.Rather than seeking approval for all of the original Cosentyx's approved indications, the company has applied only for the core adult indications, excluding pediatric indications and hidradenitis suppurativa (HS).According to the Ministry of Food and Drug Safety (MFDS), a marketing authorization application for a secukinumab biosimilar that references Cosentyx products registered in Korea (Cosentyx SensoReady Pen and Cosentyx Prefilled Syringe, etc) was submitted on June 26. The reference product is believed to be a Cosentyx biosimilar in development by Celltrion.A notable aspect of the filing is Celltrion's move immediately prior to the application. On June 25, one day before submitting its application, Celltrion filed a scope confirmation trial with the Patent Court against Novartis, the holder of Cosentyx's patents.The move is viewed as a strategic step to secure first generic exclusivity under Korea's drug approval-patent linkage system. To obtain an exclusive sales period for a biosimilar, a company must both be the ‘first to challenge the patent’ and be the ‘first to submit a marketing authorization application.’The most notable aspect is the company’s decision to omit several of the original drug’s approved indications. The original Cosentyx is approved for adults with plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa, as well as for pediatric plaque psoriasis and juvenile idiopathic arthritis.However, the biosimilar application includes only three core adult indications: ▲Plaque psoriasis, ▲Psoriatic arthritis, and ▲Axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis). The application excludes adult hidradenitis suppurativa and all pediatric indications of the original drug.The move is regarded as an effort to avoid the original drug's remaining patents. The hidradenitis suppurativa and pediatric indications were added relatively recently, meaning their re-examination periods or patent terms still have considerable time remaining. Celltrion therefore appears to have opted to target the core adult indications that would enable the earliest market entry in Korea.Instead of seeking approval for a broader range of indications, Celltrion is taking the remaining key patents head-on. The patents Celltrion challenged on June 25 are Cosentyx's core patents.Cosentyx currently holds a method-of-use patent for the "treatment of psoriasis using an IL-17 antagonist," which is set to expire on October 7, 2031, and a formulation patent for "pharmaceutical products and stable liquid formulations of IL-17 antibodies," which is set to expire on December 21, 2035.In particular, the liquid formulation patent expiring in 2035 is considered a barrier that must be overcome to produce an injectable biosimilar. Through the scope confirmation trial, Celltrion plans to focus on demonstrating that its independently developed protein composition and formulation technology do not fall within the scope of the original drug’s patent.An industry official said, "Celltrion's application filing suggests that it intends to work around the patents essential to launching the product (psoriasis treatment method and formulation patents) through the patent trial, and launch the product immediately after the original’s substance patent expires on February 27, 2028, in an effort to gain a first-mover advantage in the Korean market."
- Opinion
- Samoh Pharm’s expansion after Voxzogo reimb…orphan drug portfolio
- by Hwang, byoung woo Jul 20, 2026 08:50am
- The reimbursement of 'Voxzogo (vosoritide),' the first treatment for pediatric achondroplasia in South Korea, under the national health insurance has opened a new treatment option for patients. At the same time, it has provided a turning point for Samoh Pharm to expand its rare disease business, spanning over 20 years, to the next level.Chang-Deok Ji, Managing Director of the Orphan Drug Business Unit at Samoh Pharm, who spearheaded the domestic introduction and launch of Voxzogo, sought to establish a new commercialization model through this project, connecting global innovative therapeutics with the domestic healthcare environment.DailyPharm met with Ji from Samoh Pharm's Orphan Drug Business Unit to discuss the significance of the Voxzogo launch, the company's rare-disease business strategy, and its future vision."Voxzogo is a project that takes our accumulated experience to the next level"Chang-Deok Ji, Managing Director of the Orphan Drug Business Unit at Samoh PharmDirector Ji evaluated Voxzogo as a project with a distinctly different nature from previous rare-disease drug launches.Over the past 20 years, Samoh Pharm has accumulated specialized expertise by introducing and supplying a range of orphan drugs in South Korea, including treatments for Fabry disease, Gaucher disease, Pompe disease, mucopolysaccharidosis (MPS), and phenylketonuria (PKU).Ji explained that while Voxzogo is an extension of this trajectory, its significance lies in the fact that it served as an opportunity to upgrade the company's business operations and commercialization capabilities rather than simply adding a new product to the portfolio."Rather than just being a single new product, Voxzogo is part of a project that implements our accumulated experience and know-how in a new way, and it marks a turning point for our rare disease business to leap forward to the next level," Ji said.Voxzogo is the first pharmacological treatment option approved in South Korea for pediatric patients with achondroplasia aged 4 months and older whose growth plates are not yet closed. It is recognized as an innovative therapeutic that regulates the FGFR3 signaling pathway through a CNP analog mechanism."While being the country's first treatment option is important, the greater significance lies in offering patients and caregivers the possibility that 'treatment is now a choice,'" Ji said. "Since achondroplasia accompanies not only short stature but also recurrent surgeries and various complications, we can expect long-term health management and improved quality of life beyond just growth enhancement.""Rare disease business is about creating a treatment setting, not just selling a product"Ji has built a 25-year career in the pharmaceutical industry, dedicating more than 15 years to the rare disease sector. He has led organizational setup and new product launches at global rare-disease enterprises, executing a range of commercialization projects. The Voxzogo project is an example of how to optimize and apply this extensive experience in the domestic medical landscape."Our role is to connect globally accumulated innovation with the domestic healthcare environment so that it translates into patient treatment," he explained.The Voxzogo business was implemented through close collaboration with BioMarin Pharmaceutical. The structure leverages BioMarin's R&D capabilities and global experience, alongside Samoh Pharm's domestic execution capabilities, to successfully integrate the innovative therapeutic into local clinical practice.However, Ji emphasized that the core of the rare disease business lies in building a comprehensive therapeutic environment rather than the product itself."The rare disease sector is not an area where a market is formed simply by launching a single product. From patient identification and diagnosis to the initiation of treatment and long-term management, every stage must be organically linked for the therapy to reach the patient successfully," Ji noted.Based on this philosophy, Ji established an operational framework within the Orphan Drug Business Unit that seamlessly connects medical affairs, marketing, and patient support functions."What matters more than the size of the organization is expertise and execution," Ji said. "Our competitiveness lies in providing rapid and sophisticated support to healthcare providers and patients based on a lean yet powerful organization.""Voxzogo is not the end, but a greater beginning"Ji assessed that the impact of Voxzogo extends beyond the performance of a single product, serving as a blueprint for the future direction of the rare disease business."What we confirmed through Voxzogo was not merely the market potential of a single innovative therapeutic," he shared. "Rather, it proved that we could realize a patient-centric rare disease commercialization model by establishing a sophisticated Pricing and Reimbursement (P&R) process based on a Risk Sharing Agreement (RSA), creating a performance evaluation framework utilizing Real-World Data (RWD), and securing agile execution through a lean and robust organization."Based on this milestone, Samoh Pharm plans to expand its commercialization capabilities by leveraging its accumulated rare disease expertise across its broader ethical drug (ETC) portfolio and pipeline.Furthermore, the company envisions continuously developing an integrated collaboration model that connects medical professionals, patients, the government, academic societies, and global partners.Ji said, "In the rare disease business, the process of connecting patients with treatment opportunities holds far greater meaning than short-term financial performance," and added, “We will continue collaborating with global partners so that more patients can gain access to innovative treatments."Ji concluded by noting, ”The very moment a patient begins their treatment is when our role begins,” and added, “Voxzogo is not just a single project, but a starting point for our new therapeutic opportunities for an even broader population of rare disease patients."
