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- 2026-06-13 22:24:46
- Policy
- GLP-1 obesity drugs may receive 'concern for misuse and abuse' designation
- by Lee, Tak-Sun Jun 09, 2026 10:01am
- AI-generated imageAs the Ministry of Food and Drug Safety (MFDS) pursues the designation of GLP-1 obesity treatments as 'drugs of concern for misuse and abuse,' it has released an analysis showing that the public interest benefits of protecting citizens' rights to know and to health are significant.Consequently, GLP-1 obesity treatments containing liraglutide, semaglutide, and tirzepatide are highly likely to be designated as drugs subject to concern for misuse and abuse following a collection of industry opinions. Once designated as a drug subject to concern for misuse and abuse, warning phrases will become mandatory on packaging, and sales without a prescription will be prohibited even in areas exempt from the separation of prescribing and dispensing.The MFDS issued an administrative notice on the 5th regarding a partial amendment to the "Regulations on the Designation of Drugs Subject to Concern for Misuse and Abuse," which features these primary measures. The MFDS has also concluded its economic and social feasibility review through a regulatory impact assessment report.6.3-fold increase in supply...severe safety insensitivity including inappropriate prescribing for pediatrics and pregnant womenThe background of the MFDS is to tighten regulatory oversight, which lies in the recent explosive growth of the obesity treatment market and the resulting indiscriminate misuse and abuse.According to the regulatory impact assessment report, the volume of GLP-1 receptor agonist obesity treatments (liraglutide, semaglutide, and tirzepatide) imported and supplied domestically increased by 6.3-fold (approximately KRW 901.0 billion) in just one year, skyrocketing from around KRW 169.9 billion in 2024 to approximately KRW 1.0709 trillion in 2025.The problem is that instances where these medicines are abused for simple cosmetic weight loss by individuals with normal body weights or are illegally distributed are surfacing consecutively. In fact, it was verified that 69 cases of inappropriate prescribing occurred for pediatric patients under the age of 12 and 194 cases for pregnant women. At the same time, crackdowns by relevant authorities revealed a sharp increase in the detection of online false or exaggerated advertisements and illegal distribution.Notably, pharmacy supply volumes in 'areas exempt from the separation of prescribing and dispensing', such as remote islands and mountainous regions lacking physicians, have also experienced a steep spike. For the flagship product 'Wegovy', supply volume to pharmacies in these exempt regions increased by 975.7% year-over-year.History of Designations for 'Drugs Subject to Concern for Misuse and Abuse'There are two core measures newly established through the introduction of this regulation. First, it restricts the sale of these obesity treatments so that they can be dispensed only upon a physician's prescription at pharmacies nationwide, including those located in areas exempt from the separation of prescribing and dispensing. The intent is to block indiscriminate acquisition channels that bypass prescriptions fundamentally.Second, pharmaceutical manufacturers and importers must clearly print the phrase "Drug Subject to Concern for Misuse and Abuse" on product containers, packaging, and package inserts. Through this, the agency plans to heighten awareness regarding drug misuse and abuse among both medical professionals and consumers.Direct costs to the pharmaceutical industry estimated at KRW 24 Million... "Public interest benefits overwhelmingly outweigh compliance costs"The MFDS found that the economic burden imposed on the pharmaceutical industry by this regulation remains marginal. Currently, there are a total of 24 authorized obesity treatment products containing the relevant active ingredients in South Korea. Upon calculating the costs of modifying labeling materials, such as replacing printing ink and copper plates, for the 12 items currently launched and actively selling in the market, it was estimated that a one-time direct cost of approximately KRW 2 million per product, totaling KRW 24 million (equivalent to an annualized net cost of KRW 2.9 million), would be incurred. Six products that have not yet been launched were excluded from the cost-incurring factors.The MFDS emphasized, "Compared to private losses such as material modification expenses for certain regulated entities or revenue declines for pharmacies, the public interest benefits of preventing side effects from inappropriate drug administration and protecting the citizens' right to know and right to health are significant."The MFDS plans to gather both positive and negative opinions on this administrative notice through June 26, 2026, and to implement the policy immediately. Consumers and the industry will be granted a one-year transitional grace period to use pre-manufactured packaging materials produced before the implementation date.
- Company
- Dupixent indication expanded to bullous pemphigoid and CSU
- by Son, Hyung Min Jun 09, 2026 10:01am
- Dupixent pre-filled penSanofi announced that its Type 2 inflammation-targeting therapy ‘Dupixent (dupilumab)’ has been approved for two new indications -- bullous pemphigoid (BP) and chronic spontaneous urticaria (CSU).With this approval, Dupixent has become the first and only targeted therapy approved in Korea for the treatment of BP. It also provides an additional treatment option for patients with CSU whose symptoms are not adequately controlled with H1-antihistamine therapy.With the approval, Dupixent pre-filled syringe and pre-filled pen 300 mg may be used for the treatment of bullous pemphigoid in adults aged 18 years and older, and Dupixent pre-filled syringe and pre-filled pen 200 mg and 300 mg formulations may be used for the treatment of CSU in adults aged 18 years and older and adolescents aged 12–17 years whose symptoms are inadequately controlled with H1-antihistamines.Dupixent demonstrated clinical efficacy in adults with moderate-to-severe bullous pemphigoid in the ADEPT Phase II/III clinical trial, which served as the basis for the approval.Patients received Dupixent 300 mg in combination with standard systemic corticosteroid therapy, followed by gradual tapering according to disease status. At Week 36, the proportion of patients who achieved sustained disease control without oral corticosteroids (OCS) was higher in the Dupixent group than in the placebo group.The recently published 2025 Canadian Dermatology Association (CDA) Guidelines included Dupixent as a first-line treatment option for extensive bullous pemphigoid. In addition, the 2022 S2K International Expert Consensus Guidelines issued by the European Academy of Dermatology and Venereology (EADV) recommend Dupixent as a biologic treatment option for treatment-resistant bullous pemphigoid.Dupixent’s indication expansion to chronic spontaneous urticaria was based on results from the Phase III CUPID trial, which enrolled biologic-naïve patients aged 6 years and older whose symptoms persisted despite H1-antihistamine therapy.The primary endpoint was the change from baseline in the Weekly Itch Severity Score (ISS7) at Week 24. Key secondary endpoints included changes in the Urticaria Activity Score over 7 Days (UAS7), achievement of symptom control (UAS7 ≤ 6), and complete remission (UAS7 = 0). In the study, patients treated with Dupixent experienced a statistically significant reduction in itch severity (ISS7) compared with placebo, and the reduction in UAS7 from baseline was 66% in the Dupixent group and 48% in the placebo group, respectively.Previously, first-line treatment for chronic spontaneous urticaria consisted of second-generation H1-antihistamines, which could be increased to as much as four times the standard dose. However, a substantial unmet need persists because nearly half of patients fail to achieve adequate symptom control with H1-antihistamines alone. To address this, the 2026 international guideline update formally included Dupixent alongside omalizumab as a targeted second-line therapy for H1-antihistamine-refractory chronic spontaneous urticaria.Kyung-eun Bae, General Manager of Sanofi Korea, said, “Through these two indication expansions, we hope that patients suffering from poor quality of life associated with bullous pemphigoid and chronic spontaneous urticaria will receive the best possible treatments, improve their quality of life, and receive a higher standard of care. We will continue our efforts to improve the treatment environment for these patients.”
- Company
- Is this the end of the era of animal testing?
- by Cha, Ji-Hyun Jun 09, 2026 10:01am
- After the US government unveiled its roadmap to systematically decrease reliance on animal testing in drug development, Europe has officially announced measures to reduce animal use in pharmaceutical safety assessments. This shift aims to address the ethical controversies surrounding animal experimentation while significantly enhancing the predictive accuracy of human physiological responses. As global regulatory transitions begin, South Korean domestic companies possessing non-animal testing technologies, such as organoids, are gaining attention.EU joins systemic elimination of animal testing…accelerating safety assessment transformationsAccording to sources in the pharmaceutical biotech industry, the European Commission (EC) selected a roadmap on June 1st to systematically eliminate animal use in safety assessments for chemicals, including pharmaceuticals. This roadmap includes 15 distinct regulatory domains, including industrial and consumer chemicals, biocides and pesticides, human medicinal products, food and feed additives, and biocompatibility assessments for medical devices.The EC stated, "This roadmap proposes clear and concrete steps for transitioning toward innovative, non-animal approaches. We plan to maintain the absolute reliability of safety assessments to ensure a high level of protection for human and animal health, as well as the environment."The strategic framework presented by the EU rests on three primary pillars. ▲Accelerating the development and validation of non-animal testing methodologies ▲Expanding the utilization of research alongside artificial intelligence (AI) and data-driven analytics ▲Strengthening collaboration between EU member states and the international community.To support the development of alternative methods, the EC intends to grant developers access to the European Reference laboratories (EURLs) at the Joint Research Center (JRC) and to introduce a structured framework to map non-animal testing methods required in real-world regulatory settings. The EC will also incentivize the development of both EU and international standards to ensure these non-animal approaches can be effectively integrated into routine safety evaluations.Within the pharmaceutical sector, the roadmap outlines strategies to reduce the need for repeat-dose toxicity (RDT) studies for advanced cancers and severe or life-threatening conditions. The blueprint envisions substituting animal models with in vitro assays and computational simulations, and using virtual control groups to minimize the number of control animals deployed in RDT research.The EC plans to immediately implement this roadmap along with member states, EU agencies, and relevant stakeholders. It will convene a high-level meeting in 2029 to evaluate operational progress and audit the implementation status of non-animal approaches across applicable legislative frameworks, including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.FDA animal testing policy timeline for new drug development (source: KOREABIO) The EU's latest initiative aligns seamlessly with the ongoing policy directives driven by the United States government to reduce animal experimentation. Through the enactment of the FDA Modernization Act 2.0 in December 2022, the US Congress removed the statutory mandate requiring animal testing in the new drug approval pipeline, establishing a robust legal foundation for the use of non-animal methods such as cell-based assays, organoids, organ-on-a-chip technologies, and computational modeling.Accordingly, in April last year, the US Food and Drug Administration (FDA) announced a systemic transition plan to reduce, refine, and replace animal testing, beginning with monoclonal antibodies and certain medicinal products. The FDA aims to reduce, refine, and replace animal testing using New Approach Methodologies (NAMs), such as organoid toxicity testing, organs-on-chips, and AI-based computational models, and to leverage relevant datasets in Investigational New Drug (IND) applications or Biologics License Applications (BLAs) for biosimilars.In the same month, the US National Institutes of Health (NIH) also unveiled plans to establish a new organization to expand the use of human-based research technologies. The NIH intends to support the development, validation, and expanded use of non-animal approaches, including organoids, tissue chips, computational models, and real-world data—centered around the Office of Research Innovation, Validation, and Application (ORIVA).On March 18th of this year, the FDA released a draft guidance document allowing the submission of NAMs data for novel drug approval reviews. This guidance states that testing methods not previously approved as animal testing alternatives may be submitted. That validation or qualification evaluations need not be completed in advance for non-clinical toxicity and safety assessments. Furthermore, the NIH plans to invest more than $150 million to support the development and validation of NAMs.4.59 million laboratory animals in South Korea…Ethical lontroversies and limitations in replicating human responsesThe background behind the United States and Europe starting on reducing animal testing stem from ethical concerns and the limitations of replicating human physiological responses.First, demands to resolve the ethical problems associated with animal testing have been continuously raised, primarily by animal protection organizations, civil society, and academia. According to the EU, the number of animals used in regulatory testing from 2015 to 2023 exceeded 15 million. Among these, approximately 40% were deployed in chemical safety assessments.The scale of laboratory animal use is also substantial in South Korea. According to the 2024 Institutional Animal Care and Use Committee (IACUC) Operational Performance Survey by the Animal and Plant Quarantine Agency, the number of laboratory animals used domestically last year totaled 4.59 million. Relevant organizations and experts argue that, since numerous animals are used in experiments worldwide each year, unnecessary animal sacrifice must be reduced and the use of alternative testing methods expanded.Number of animals used in EU toxicity and other safety tests (Source: KOREABIO)The limitations in connecting animal test results to actual human responses during the new drug development process are another factor accelerating the regulatory transition. Conventional non-clinical trials have served as an essential gateway to assess the toxicity and efficacy of candidate substances. However, criticisms persist that accurately predicting human drug responses solely from animal results has clear limitations. In particular, with the emergence of novel types of medicines, such as antibodies and cell/gene therapies, the problem that animal models alone cannot fully replicate human immune responses and disease characteristics has been highlighted.Announcing its plan to expand the utilization of human-based research technologies in April last year, the NIH said, "Some research institutions have failed to draw sufficient conclusions when applying animal model results to human diseases, such as Alzheimer's disease and cancer. These limitations may stem from differences in anatomy, physiology, lifespan, and disease characteristics between humans and animals. Even if humans and animals share genes, there can be differences in the functions of organs and bodily systems, which can create constraints in applying animal model results to human diseases."Even if a candidate substance confirms efficacy and safety in animal testing, its development can be discontinued if the expected effects do not manifest or unexpected toxicities are identified in human clinical trials. In such cases, years of research and development expenses, and the manpower invested in candidate discovery, non-clinical trials, and production process development, cannot be recovered, leading to the burden of delaying subsequent pipeline schedules. This is why regulatory bodies in various countries are rushing to introduce alternative testing methods.South Korea also accelerates alternative testing implementation…Korean organoid companies riseAlong with the global regulatory shift, the institutionalization and serialization of alternative testing methods are gathering full momentum in South Korea. Following the establishment of a foundational research base, the government is refortifying the legal basis for applications within the pharmaceutical sector and taking steps to preempt international standards for advanced alternative testing methods, such as organoids.In South Korea, the Ministry of Food and Drug Safety (MFDS) established the foundation for the development and validation of alternative testing methods by establishing the Korean Center for the Validation of Alternative Methods (KoCVAM) in 2009. In 2011, the MFDS joined the International Cooperation on Alternative Test Methods (ICATM) and has since participated in the development of international testing guidelines alongside regulatory agencies of major countries, including the United States and Europe.The MFDS has also officially begun to establish international standards. Last year, the MFDS launched the Committee for the International Standardization of Organoid Testing Methods and partnered with the Organisation for Economic Co-operation and Development (OECD) to develop international guidelines for organoid-based toxicity testing. The government plans to leverage the 14th World Congress on Alternatives and Animal Use in the Life Sciences (WC14), which will be held in Seoul in 2027, as an opportunity to enhance the regulatory utility of domestic technologies on the international stage.Collaboration between industry and research institutes has also begun. Last August, the 'K-Organoid Consortium' was launched, involving 27 corporations, including Samsung Biologics, Daewoong Pharmaceutical, and JW Pharmaceutical, as well as 18 research institutions. The consortium promotes standardization of testing methods, the development of industrial support infrastructure, and international cooperation, thereby supporting the global regulatory acceptance and market entry of domestic organoid technologies.Korean Companies Developing Organoids: JW Pharmaceutical, Kangstem Biotech, Gradient Bioconvergence, Next&Bio, Daewoong Pharmaceutical, ROKIT Healthcare, Samsung Biologics, MBD, OrganoidSciences, Ipsell, and T&R Biofab.As the reduction of animal testing and the adoption of non-animal testing methodologies spread globally, Korean companies with relevant technologies are garnering significant attention. Anticipation is growing that if global regulatory bodies expand the scope of utilizing non-animal testing datasets, such as organoids, organs-on-chips, and AI-based predictive models, it will lead to increased opportunities for technical validation and collaboration with global pharmaceutical companies for domestic firms.OrganoidSciences is regarded as one of the most active companies in the organoid field. Through its organoid-based drug evaluation platform 'ODISEI', the company replicates actual human organ architecture and disease microenvironments to evaluate the efficacy and toxicity of candidate compounds. It is also developing an organoid-based regenerative medicine pipeline called 'ATORM'; its lead asset, ATORM-C, recently secured Phase I IND approval from the MFDS for patients with Crohn's disease, successfully entering the clinical phase.MBD is developing patient-tailored workflows for predicting anticancer drug response using 3D cell culture technology. The company has proprietary automation technologies to uniformly mass-produce tumoroids (cancer mimics) from minimal patient specimens, alongside 'OncoCensi', a tumoroid-based assay evaluating chemosensitivity to anticancer therapies. Following a successful technical evaluation in November 2024, MBD filed a preliminary KOSDAQ listing review application with the Korea Exchange this past April, officially initiating its initial public offering (IPO) process.Samsung Biologics launched 'Samsung Organoid', an anticancer drug-screening service based on cancer-patient-derived organoids, in June last year. JW Pharmaceutical utilized human skin organoids to evaluate the hair follicle-generating efficacy of its alopecia drug candidate 'JW0061', and the candidate molecule is currently advancing toward entry into Phase I clinical trials. Daewoong is developing mass-production bioprocess technologies for organoid-based regenerative therapeutics with support from the Ministry of Trade, Industry and Energy (MOTIE). Its objective is to establish manufacturing protocols for therapeutics designed to assist in the regeneration of damaged organs and tissues, such as the heart, liver, and kidneys, and to expand its scope into treatments for intractable diseases.Lastly, Gradient Bioconvergence is operating oncology target discovery and drug response prediction businesses that pair AI and gene-editing technologies with a repository of approximately 1,000 patient-derived organoids and genomic datasets. Kangstem Biotech is engineering skin disease models based on skin organoids. Next&Bio is developing platforms for efficacy evaluation powered by patient-derived cancer organoids and microphysiological systems. Ipsell is advancing the commercialization of 'POLAR', an alternative testing platform leveraging induced pluripotent stem cells (iPSCs) and organoids. Concurrently, T&R Biofab is developing 3D bioprinting and vascularized tissue technologies, while ROKIT Healthcare is developing a patient-centric, personalized regenerative medicine platform.
- Opinion
- ‘Biologics have transformed Korea’s asthma treatment landscape’
- by Son, Hyung Min Jun 09, 2026 10:00am
- The treatment landscape for severe asthma is changing rapidly. In the past, patients whose symptoms remained uncontrolled despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) had few treatment options beyond oral corticosteroids (OCS).Patients who experienced repeated exacerbations, emergency room visits, and hospitalizations often had no choice but to depend on long-term steroid treatment. In the process, they were exposed to the risk of numerous complications, including osteoporosis, obesity, diabetes, and cataracts.However, the emergence of biologics targeting the inflammatory mechanisms underlying the disease has fundamentally changed the treatment paradigm. In particular, for Type 2 inflammatory severe asthma, which is characterized by eosinophilia and allergic responses, personalized treatment based on biomarkers and patient phenotypes has become possible, expanding treatment goals beyond simple symptom control to prevention of exacerbations, reduction of systemic steroid use, and even clinical remission.Dailypharm spoke with Professor Guy Brusselle of the Department of Respiratory Medicine at Ghent University Hospital in Belgium and Professor Yoo-sook Cho of the Department of Allergy and Clinical Immunology at Asan Medical Center to discuss changes in the global severe asthma treatment landscape, the clinical significance of biologics, and the challenges facing Korea’s treatment environment.Professor Guy Brusselle, Department of Respiratory Medicine, Ghent University Hospital, Belgium; Professor Yoo-sook Cho, Department of Allergy and Clinical Immunology, Asan Medical CenterThe Global Initiative for Asthma (GINA) recommends biologic therapy guided by Type 2 inflammatory biomarkers in patients with severe asthma that remains uncontrolled despite high-dose ICS-LABA treatment. Recent updates to the guidelines also place greater emphasis on early intervention and proactive disease control rather than responding only after exacerbations occur. In other words, treatment goals are shifting from “managing uncontrolled asthma” to “achieving remission.”Most asthma patients can control their symptoms with ICS, LABAs, and relievers. Severe asthma patients, however, continue to experience symptoms and repeated exacerbations despite optimized treatment using high-dose ICS and LABAs.In fact, biologics are being used more broadly and rapidly in real-world clinical practice globally. Using objective indicators such as blood eosinophil counts and fractional exhaled nitric oxide (FeNO) to classify patient characteristics and applying targeted therapies has become the standard among physicians. In some countries, switching between biologics based on treatment response is also widely practiced.Korea presents a somewhat different picture. Reimbursement criteria for biologics remain strict, and patients still face substantial out-of-pocket costs. Even when patients fail to respond adequately to a specific biologic, they often must meet reimbursement requirements all over again before switching to another treatment. This is why criticism continues to rise on how difficult it is to implement treatment strategies tailored to individual patient needs in practice.According to the International Severe Asthma Registry (ISAR), the global average biologic utilization rate is 25.4%, whereas Korea’s rate is only 1.4%. Experts view this gap as reflecting differences not merely in prescribing patterns but also in healthcare systems and reimbursement policies.Recently, there have been growing calls for severe asthma patients to be managed as a distinct disease population and for increased treatment access for the patient group. In other words, asthma requires support that reflects the disease burden and quality of life impact in a manner similar to cancer and rheumatic diseases.Both professors emphasized that as treatment goals in severe asthma evolve from symptom control toward remission, treatment environments should also evolve to accommodate such change.Q. What has been the most significant change in the severe asthma treatment landscape in recent years?Professor Yoo-sook Cho, Department of Allergy and Clinical Immunology, Asan Medical CenterProfessor Cho: The emergence of biologics itself represents the most significant change. Unlike how treatment options were limited in the past, patients with severe asthma who could not be adequately controlled with conventional inhaler therapies now have access to entirely new treatment options.Particularly with the addition of new biologics to the severe asthma section of the GINA guidelines, we are witnessing more than a guideline update—the treatment paradigm itself is changing.Professor Brusselle: Severe asthma is not simply asthma with severe symptoms. It refers to patients whose disease remains uncontrolled despite receiving appropriate treatment over a sufficient period of time. Approximately 5% of adult asthma patients fall into this category.Today, physicians can evaluate blood eosinophil levels and FeNO to determine whether Type 2 inflammation is present and then select an appropriate biologic. Compared with the past, this represents a tremendous advancement.Q. How has the severe asthma treatment environment changed with the introduction of biologics?Professor Brusselle: Before biologics were available, long-term systemic corticosteroid therapy was often the only next-step treatment option. However, oral corticosteroids can cause numerous complications, including obesity, osteoporosis, and cataracts, and long-term use may lead to irreversible damage.Biologics, on the other hand, help reduce steroid-related toxicity while providing safer disease control. Major biologics include ‘Fasenra (benralizumab),’ ‘Nucala (mepolizumab),’ and ‘Dupixent (dupilumab),’ all of which have demonstrated favorable efficacy and safety profiles.Professor Cho: In practice, there are patients whose asthma continues to worsen despite diligent inhaler use and aggressive treatment of comorbidities. These patients often become dependent on steroids.Biologics can reduce or even eliminate steroid use while also decreasing the frequency of exacerbations. That is why they can truly be described as game changers in severe asthma treatment.Q. How is the global treatment landscape evolving?Professor Guy Brusselle, Department of Respiratory Medicine, Ghent University Hospital, BelgiumProfessor Brusselle: The GINA guidelines have been continuously updated since 1993 and have evolved based on evidence from randomized clinical trials as well as real-world clinical data. One of the greatest strengths of these guidelines is that they address healthcare environments in both high-income and low-income countries, while also taking a multidisciplinary approach that extends beyond pulmonology to primary care settings.In the past, rheumatic diseases were often treated only after joint damage had already occurred. Today, however, treatment is initiated aggressively before irreversible damage develops.The same principle applies to severe asthma. Patients should be treated proactively before airway remodeling or lung function declines occur. In fact, a substantial proportion of patients receiving biologic therapy achieve clinical remission.Patients no longer talk about what asthma prevents them from doing. Instead, they talk about what they are able to do despite having asthma. Improving quality of life is also an important therapeutic goal.Q. What is the greatest limitation in Korea’s treatment environment?Professor Cho: The biggest issue is accessibility. Currently, only an estimated 10–20% of patients who meet indications for biologic therapy are actually receiving biologics in Korea.Even after reimbursement approval, patients often face monthly out-of-pocket expenses of approximately KRW 800,000–900,000. In addition, even when a patient fails to respond adequately to a particular biologic, reimbursement criteria must often be met again before switching to another therapy.As a result, cases occur where patients must wait for their condition to worsen to try a new treatment.Q. How do Korea’s reimbursement criteria and restrictions on switching between biologics affect clinical practice?Professor Cho: Restrictions on switching are currently considered one of the biggest challenges in Korea. Even if a patient does not respond sufficiently to a particular biologic, they must satisfy reimbursement requirements again before switching to another option. As a result, physicians sometimes find themselves waiting for a patient's condition to deteriorate before they can initiate a new treatment strategy.Initial treatment selection is also important. In Korea, differences in launch timing and pricing often result in the prior use of lower-cost biologics. However, in real-world practice, physicians frequently consider switching to Fasenra when patients fail to achieve adequate responses with Nucala or Cinqair (reslizumab).Professor Brusselle: In Belgium, switching between biologics is permitted. However, the most important factor is accurately identifying the patient’s phenotype and selecting the most appropriate drug. In this sense, collaboration with otolaryngologists is also extremely important. In patients with chronic rhinosinusitis accompanied by nasal polyps, upper airway disease status should also be taken into account when selecting a biologic.Q. What are your thoughts on special reimbursement calculation programs and measures to reduce patient burden being carried out in Korea?Professor Brusselle: In Belgium, patients with severe asthma benefit from low out-of-pocket cost structures similar to those available for patients with rheumatic diseases and cancer. By contrast, I was surprised that in Korea, patients with rheumatic diseases or atopic dermatitis often face co-insurance rates of around 5%, whereas patients with severe asthma do not receive any comparable support.Professor Cho: In Korea, asthma is relatively common, and symptoms differ broadly due to disease characteristics, which may explain why policymakers have adopted a more conservative approach.Recently, however, efforts have been made to classify patients with severe asthma under a separate disease code (Severe eosinophilic asthma, J82.12) and to manage them as a distinct patient population. This initiative is intended to more accurately identify the number of patients who genuinely require biologic therapy. Ultimately, the key issue is ensuring appropriate treatment access for patients who truly need these therapies.Q. What improvements are needed in the future severe asthma treatment environment?Professor Brusselle: Ideally, patients with severe asthma should face co-insurance rates below 5%, similar to patients with cancer or rheumatic diseases. Also, patient advocacy groups should have a stronger voice in healthcare policy decision-making processes.Professor Cho: Realistically, it may not be possible to provide unrestricted access to every biologic drug. However, patients with severe asthma should be guaranteed treatment opportunities comparable to those available for other severe immune-mediated diseases at the very least.The reality is that access to biologics for severe asthma patients remains lower than both the global standards and levels seen in other immune-related diseases within Korea. So priority should therefore be given to expanding special reimbursement programs and allowing switching between biologics.Pharmacoeconomic evaluations should also consider not only drug acquisition costs but also quality-of-life impairment, limitations on social activities, and the long-term costs associated with steroid toxicity.
- InterView
- [Desk’s View] Futile efforts to improve the rare disease drug system
- by Eo, Yun-Ho Jun 08, 2026 08:52am
- Calls for institutional reform to expand access to reimbursement for rare disease treatments have been raised so often that the annual requests have now become quarterly. The reimbursement listing process for orphan drugs remains difficult due to the difficulty of proving cost-effectiveness and the lack of financial predictability, either because the number of patients is too small or because the number of patients is slightly higher than the baseline during pharmacoeconomic evaluations.As of 2026, the National Assembly has been holding discussions roughly twice a month on expanding coverage for specific rare diseases. The Ministry of Health and Welfare and the Health Insurance Review and Assessment Service (HIRA) have also proposed improvement measures, but the dire need among healthcare professionals and patients persists.Why does it feel as though nothing has really changed? Within the current pharmacoeconomic evaluation calculation framework, the longer a chronic disease patient survives, the longer they must continue taking medications, which leads to an increase in the cost of medications that arise with the improvement in survival and quality of life.This creates a structure in which proving cost-effectiveness becomes increasingly difficult. In extreme cases, a paradox can arise in which a patient must become more severely ill before a treatment is judged to be cost-effective.In addition, most breakthrough therapies that are innovative enough to be considered for fast-track reimbursement listing do not have therapeutically equivalent alternatives available. In such cases, the comparator drug inevitably ends up being an inexpensive “old drug,” which naturally delays the reimbursement listing process.This is why growing voices argue that, if reimbursement rates for rare disease drugs are to genuinely improve, the evaluation system itself must undergo a fundamental change. Rare diseases are defined as conditions affecting fewer than 20,000 people, or diseases for which the number of patients is difficult to determine because the diagnosis itself is challenging. In many cases, the limited patient population makes conducting clinical trials difficult.Due to the small number of patients, profitability is difficult to achieve, making active new drug development less likely. Even when a company succeeds in developing a new treatment against all odds, it then needs to overcome the difficulty of proving cost-effectiveness through pharmacoeconomic evaluation. And the vicious cycle continues to repeat itself.Earlier this year, the government announced plans to strengthen support for rare, severe, and intractable diseases, stating that it would reduce the reimbursement listing period for rare disease treatments from more than one year to 100 days by simplifying reimbursement adequacy assessments and negotiation procedures.However, shortening the evaluation period does not guarantee rapid reimbursement listing. It merely shortens the period during which someone (a pharmaceutical company) submits an application and the authorities review it. The repeated excuse that “We have also made efforts” and “We will review the matter” holds no meaning. The time has come for the fundamental reconsideration of the evaluation framework itself, one that reflects current realities, and for concrete results to emerge from that effort.
- Company
- Rybrevant accelerates expansion into solid tumors
- by Son, Hyung Min Jun 08, 2026 08:52am
- ASCO venue (Source: ASCO).Johnson & Johnson’s EGFR-MET bispecific antibody Rybrevant (amivantamab) is expanding its development program beyond lung cancer into new solid tumor indications, including colorectal cancer and head and neck cancer.Major clinical data for Rybrevant in solid tumors were presented at the 2026 American Society of Clinical Oncology (ASCO 2026) Annual Meeting, which was held recently in Chicago.While Rybrevant has steadily expanded its presence in the treatment of EGFR-mutated non-small cell lung cancer (NSCLC), the company is now broadening its research focus to a variety of solid tumors in which EGFR and MET signaling pathways play important roles.In particular, attention is rising over the possibility of future label expansion, as meaningful clinical outcomes have been observed in patient populations with limited treatment options or in those who have not achieved sufficient benefit with existing EGFR inhibitors.High response rates in head and neck cancer… shows potential as a later-line treatment alternativeThe most notable findings came from a study involving recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).Although treatment outcomes for recurrent or metastatic HNSCC have improved following the introduction of immuno-oncology drugs and platinum-based chemotherapy, treatment options remain limited after disease progression. In particular, patients with HPV-unrelated disease tend to have poor prognoses, creating an ongoing need for new treatment alternatives.The Phase Ib/II OrigAMI-4 study evaluated subcutaneous (SC) Rybrevant monotherapy in 102 patients with HPV-unrelated recurrent or metastatic HNSCC whose disease had progressed after treatment with PD-(L)1-based immunotherapy and platinum-based chemotherapy.The analysis showed an objective response rate (ORR) of 47%. Four patients achieved a complete response (CR), while 44 achieved a partial response (PR). Tumor reduction in target lesions was observed in 79% of patients.Responses were also rapid. The median time to first response was 6.6 weeks, while the median duration of response (DOR) was 7.2 months. Median progression-free survival (PFS) was 6.8 months.Industry experts believe these results compare favorably with those of Merck’s EGFR-targeted therapy ‘Erbitux (cetuximab),’ which is currently used in this setting. According to previously published data cited by the investigators, Erbitux demonstrated an ORR of 24% and a median PFS of 3.8 months in a comparable patient population.The high rate of tumor shrinkage was also noteworthy. In the study, 79% of all patients experienced reductions in target lesions.The safety profile was consistent with that found in Rybrevant studies. The most common adverse events included hypoalbuminemia, rash, acneiform dermatitis, paronychia, stomatitis, and fatigue. Treatment-related reactions occurred in 13% of patients, but were all Grade 1 or 2. The treatment discontinuation rate due to treatment-related adverse events (TRAEs) was 6%.Company seeks to gain first-line indication for head and neck cancer … Phase III development underwayJohnson & Johnson is also conducting a global Phase III trial on Rybrevant’s use in the first-line treatment setting for recurrent or metastatic HNSCC.The OrigAMI-5 study is a Phase III trial evaluating Rybrevant in combination with Keytruda (pembrolizumab) and carboplatin in approximately 500 patients with HPV-unrelated recurrent or metastatic HNSCC. The regimen is being directly compared with the current standard-of-care combination of Keytruda, platinum-based chemotherapy, and 5-FU.Although Keytruda-based regimens are currently considered the standard first-line treatment for recurrent or metastatic HNSCC, response rates and long-term survival outcomes remain limited. Investigators are looking into whether adding Rybrevant could improve outcomes, given the high levels of EGFR and MET expression observed in head and neck cancer.The study will be conducted at approximately 205 sites across 22 countries worldwide. Co-primary endpoints are ORR and overall survival (OS). Additional endpoints include PFS, DOR, and patient-reported outcomes (PROs).Given that Rybrevant monotherapy achieved a 47% ORR in patients whose disease had progressed after immunotherapy and platinum-based chemotherapy in the OrigAMI-4 study, attention is now turning to whether the Phase III results could potentially alter future treatment strategies for head and neck cancer.Demonstrates activity in CMS4 colorectal cancer… Highlighting the potential of MET-targeted therapyJohnson & Johnson's ‘Rybrevant’In colorectal cancer, new data suggest that Rybrevant may help overcome some of the limitations associated with existing EGFR inhibitors.The OrigAMI-1 study evaluated Rybrevant monotherapy in patients with metastatic colorectal cancer lacking KRAS, NRAS, BRAF, and EGFR extracellular domain mutations, as well as HER2 amplification. All participants had previously received second- or third-line treatment in the metastatic setting.This analysis focused on Consensus Molecular Subtypes (CMS), one of the major molecular classification systems for colorectal cancer.CMS2 is a classic subtype characterized by high EGFR dependency and is known to respond well to EGFR inhibitors. In contrast, CMS4 exhibits mesenchymal characteristics associated with MET signaling activation and is known for its poor prognosis and generally limited responsiveness to EGFR inhibitors.Previous studies reported that disease control rates (DCR) with Erbitux monotherapy were 68% in CMS2 patients but only 29% in CMS4 patients.However, Rybrevant demonstrated relatively consistent efficacy across both subtypes.Median PFS was 4.2 months in CMS2 patients and 5.3 months in CMS4 patients. Median OS was 11.3 months and 13.5 months, respectively, showing no major differences between the groups.ORR was 26% in CMS2 patients and 16% in CMS4 patients, while DCR reached 83% and 74%, respectively. According to the investigators, treatment outcomes were also generally consistent regardless of tumor location.The researchers concluded that Rybrevant maintained antitumor activity even in CMS4 subtypes, which are less dependent on EGFR signaling, based on the drug’s dual-target inhibition effect that targets both EGFR and MET pathways.Because CMS4 is widely recognized as a subtype associated with resistance to conventional EGFR inhibitors, the findings are being viewed as evidence supporting the clinical value of a strategy that targets MET alongside EGFR.
- Policy
- ‘MFDS will review new drugs faster than the US and Europe’
- by Lee, Tak-Sun Jun 08, 2026 08:52am
- Joon-Soo Shin, Director General of Pharmaceutical Safety Division, delivers a keynote speech at the 2026 Spring Conference of the Korean Society of FDA Regulatory Science on June 5.“Even if a multinational pharmaceutical company submits applications simultaneously in the United States, Europe, and Korea, Korea could be the first country to grant approval.” The Ministry of Food and Drug Safety (MFDS) has set an ambitious goal of elevating its review capabilities and regulatory systems to a global top-tier level, to ultimately make Korea the first country in the world to approve innovative new drugs.On June 5, Joon-Soo Shin, Director General of the Pharmaceutical Safety Division at the MFDS, unveiled the agency’s Five-Year Comprehensive Plan for Pharmaceutical Safety Management during a keynote address at the 2026 Spring Conference of the Korean Society of Food, Drug and Cosmetics Regulatory Sciences, held at the Hoam Faculty House Convention Center of Seoul National University under the theme “Interdisciplinary Perspectives and the Immediate Markett Entry System in the AI Era.”During the speech, Shin repeatedly emphasized that the “240-Day Approval and Review System” would represent a major milestone not only for patients and pharmaceutical companies, but also for the MFDS as the regulatory authority.Shin said, “Achieving a 240-day review timeline is both highly challenging and highly significant for the MFDS. If a multinational pharmaceutical company were to submit applications simultaneously in the U.S., Europe, and Korea, Korea would be positioned to grant approval sooner than the U.S. (300 days) or Europe (365 days), which poses a significant burden on our part.”Shin continued, “To achieve this timeline, we must thoroughly prepare our review capabilities and build a system capable of completing the process within 240 days, including all periods required for supplementary submissions. We will ensure smooth implementation through close collaboration with industry, continuous review procedures, and greatly expanded pre-submission consultations.”To support this initiative, the MFDS implemented detailed operational guidelines on June 1 and has already begun applying them in practice. Rather than simply eliminating procedural steps, the agency introduced a process innovation that converts sequential reviews into parallel and simultaneous reviews. In addition, the dedicated review team was expanded from 15 to 20 personnel. A communication framework has also been established to improve predictability by providing checklists in advance and continuous feedback.The substantial reduction in review timelines is expected to maximize palpable benefits for both patients and pharmaceutical companies. Shin explained, “By reducing the average review period from 420 days to 240 days, patients with rare and intractable diseases gain 180 days, roughly 6 months,of valuable treatment time.” He added that, from an industry perspective, “In addition to the promotional advantages associated with accelerated approval, faster review timelines will be particularly beneficial for companies that develop biosimilars, as speed is of the essence in securing market competitiveness.”Addressing concerns raised by some observers regarding potential declines in review quality, Shin firmly rejected the notion. “This initiative does not involve omitting data reviews; rather, it is a procedural improvement. Therefore, this will not compromise review quality. We will allocate the majority of our personnel resources to safety evaluations.”In fact, the MFDS previously implemented an unprecedented expansion of its review workforce, hiring 195 full-time reviewers with the revenue generated by raising new drug application fees to KRW 410 million 2 years ago. Shin stated, “We were initially concerned about recruiting talent because the positions are based in Osong, but applications exceeded expectations, with competition among highly competent reviewers reaching 12-to-1. We will provide the support necessary for these reviewers to fully demonstrate their capabilities and plan to assign our most highly competent reviewers to handle approximately 80% of new drug evaluations.”
- Company
- Domestic surgical robot development speeds up
- by Hwang, byoung woo Jun 08, 2026 08:52am
- AI-generated imageNumerous companies in the Korean domestic medical device industry are targeting the surgical robot market. Efforts to integrate robotic technology continue across diverse fields, including laparoscopic surgical robots, orthopedics, neurosurgery, endoscopy, and vascular intervention.However, analysis suggests that, independent of increased market entry, core technological competitiveness remains limited compared to that of major countries. This is because competition in surgical robotics is shifting beyond the simple development of robotic arms or surgical instruments toward precision control, sensing, autonomous control, and data-driven surgical support technologies.The success of surgical robotics is 'precision control'According to the "Patent Trends Related to Precision Control of Surgical Robots" report published by the Korea Health Industry Development Institute (KHIDI), the global surgical robot market is projected to grow from approximately $9.2 billion in 2025 to around $38.4 billion by 2034. The compound annual growth rate (CAGR) is 17.2%.Drivers behind this market expansion include rising demand for minimally invasive surgery (MIS), the need for enhanced surgical accuracy, and technological advancements in integrating imaging, sensor, and control systems.In particular, recent surgical robots are evolving away from purely control-hardware systems toward intelligent platforms that combine imaging, sensors, artificial intelligence, and control algorithms.The core competitiveness of surgical robots is shifting toward precision control technology.Precision control is a technology that translates a clinician's manipulations into stable surgical motions through position·velocity control, force control, tremor compensation, and motion scaling. Because it directly influences surgical accuracy and safety, it is classified as a foundational technology that dictates product competitiveness.Surgical robot precision control technologies are categorized into sensing-based feedback control, interaction-based control, and autonomous navigation control.Source: Korea Health Industry Development Institute (KHIDI) reportThe importance of precision control is also confirmed in patent trends. According to the report, 4,097 patents related to detailed surgical robot precision control technologies were compiled from 2016 to 2025. Among these, interaction-based control accounted for 2,420 patents, representing 59.1%. Sensing feedback control accounted for 1,129 patents (27.6%), while autonomous navigation accounted for 548 patents (13.4%).While interaction-based control still commands the largest share, technical trends are shifting. Analysis indicates that while the proportion of interaction-based control is declining, the shares of sensing-based feedback control and autonomous navigation are on the rise.This means that surgical robots are moving beyond hardware that only transmits a clinician's movements, evolving into platforms that recognize and compensate for the real-time surgical environment.South Korea's patent applications stands at 4.5%...lowest among major nationsIn terms of patent applications, a distinct competitive landscape emerged, centered heavily on the United States and China. From 2016 to 2025, a total of 3,481 surgical robot precision control patents were filed across the IP5 patent offices (South Korea, the United States, Japan, Europe, and China).By country, the United States Patent and Trademark Office (USPTO) commanded the highest share of applications at 39.9%. China accounted for 29.8%, Europe for 14.0%, and Japan for 11.8%. South Korea recorded 4.5%, the lowest among major countries.South Korea's position was also limited in terms of qualitative patent competitiveness. Among the 3,481 patents published over the past decade, a comparison of patent competitiveness among major nations, focusing on the 1,011 patents registered with the USPTO, revealed that US patents accounted for 745 patents (73.7%).During the same period, Europe recorded 163 patents (16.1%), followed by ▲Japan with 38 ▲China with 20 ▲South Korea with 6.South Korea was presented with a forward citation count of 143, a patent family country count of 20, a patent citation intensity of 23.8, a Patent Impact Index (PII) of 0.0, and a Patent Market Power Index (PMPI) of 0.8. Considering these metrics, the country's overall technological impact and global scalability are evaluated as limited.Year-over-year rate of change in surgical robot precision control patent applications by country (Source: Korea Health Industry Development Institute (KHIDI) report)Gaps across detailed technology segments were also substantial. In the patent competitiveness analysis for sensing feedback control, South Korea held 5 patents, accounting for 1.6% of the total. In interaction-based control, it held 1 patent (0.1%), and in navigation autonomous control, it remained at 2 patents (1.3%).The United States showed a share exceeding 70% across all three sub-segments. It accounted for 238 patents (74.1%) in sensing-based feedback control, 547 patents (74.2%) in interaction-based control, and 118 patents (75.2%) in autonomous navigation control.Patent concentration by specific corporate players was also high. The share of applications by the top 10 companies across each detailed technology exceeded 50%: 53.3% for sensing feedback control, 55.3% for interaction-based control, and 57.3% for navigation autonomous control. This indicates that the surgical robot market is unlikely to be reshaped by simply launching a product.Technology accumulation is more critical than product launchThe prospects for Korean domestic surgical robot enterprises lie in technology accumulation rather than in market entry itself. Surgical robotics is a convergent industry integrating robotics, artificial intelligence, sensors, image processing, and control software.Fabricating robotic arms or localizing surgical instrumentation alone is insufficient to close the gap with global market leaders. Precision control technology directly dictates intraoperative safety. Product competitiveness is determined by how accurately the system reflects minute movements at the surgical site, how reliably it compensates for clinician hand tremors, and how sophisticatedly it manages the forces generated during tissue contact.A comparison of patent competitiveness among major nations, focusing on the 1,011 patents registered with the USPTO, revealed that US patents accounted for 745 patents (73.7%). During the same period, Europe recorded 163 patents (16.1%), followed by Japan with 38, China with 20, and South Korea with 6. (source: Korea Health Industry Development Institute (KHIDI) report)Joint development with clinical sites is also vital. Precision control technology cannot secure commercial viability based purely on laboratory-level performance. Parameters such as operability, stability, and fatigue reduction that clinicians can actively sense must be validated within real-world surgical environments.A global patent strategy must also be designed from the initial phases. Surgical robotics is an area where targeting only the domestic market is unsustainable. From early development, strategies are required to secure enforceable patents in major markets such as the United States and Europe while simultaneously deploying patent-circumvention tactics against competitors.It is challenging for domestic firms to compete head-to-head with global leaders across all domains. A realistic approach involves a field-targeting strategy focusing on precision control technologies tailored to specific surgical specialties, particular techniques, or distinct hospital requirements.An industry insider said, "As surgical robotics is a convergent industry combining robotics, artificial intelligence, sensors, image processing, and control software, securing global competitiveness is difficult through simple product development alone," and added, "The aim for domestic firms will be concurrently establishing real-world clinical validation and global patent strategies centered heavily around core precision control technologies."
- Policy
- Opdivo's reimbursement for gastric cancer set to expand soon
- by Jung, Heung-Jun Jun 08, 2026 08:52am
- Ono Pharma Korea's immuno-oncology drug Opdivo (nivolumab) has entered drug price negotiations for expanded reimbursement scope in gastric cancer.Opdivo will undergo the negotiation process alongside its competitor, MSD Korea's Keytruda (pembrolizumab), for the same indication.According to industry sources on the 5th, Keytruda and Opdivo, which passed the Health Insurance Review and Assessment Service (HIRA) Pharmaceutical Reimbursement Evaluation Committee last March, have entered negotiations for mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) gastric cancer.Opdivo was the first cancer immunotherapy to secure reimbursement as a first-line treatment for HER2-negative gastric cancer back in 2023. It was included in the reimbursement listing for gastric cancer, a field where therapeutic options had been limited. It dominated the market by specifically targeting HER2-negative patients, who take a significant proportion of gastric cancer cases.Keytruda, a competitor to Opdivo, expanded its reimbursement coverage last January across 11 indications spanning 9 cancer types, including gastric cancer. At that time, Keytruda expanded its reimbursement coverage to include both HER2-positive and HER2-negative gastric cancers in the first-line setting.The two cancer immunotherapies are continuously expanding their reimbursement scope in gastric cancer. Unlike the previous process for HER2 gastric cancer reimbursement, these drugs are both undergoing the listing process for the 'dMMR·MSI-H' gastric cancer population.Although dMMR·MSI-H patients account for a relatively small proportion of overall gastric cancer cases, this will add a therapeutic option for patients who previously failed to meet existing reimbursement criteria, such as specific PD-L1 expression thresholds.Notably, both dMMR and MSI-H represent genetic alterations that make this subpopulation among the most clinically challenging to treat within gastric cancer.If both Opdivo and Keytruda obtain expanded reimbursement, treatment access is expected to be strengthened for gastric cancer patients who have previously been left behind. For this reason, medical societies have reportedly submitted official opinions directly to the authorities, calling for the expansion of reimbursed indications for gastric cancer.Meanwhile, Opdivo is undergoing expansion of reimbursed indications beyond gastric cancer. During last April's Cancer Disease Review Committee (CDRC) meeting, reimbursement criteria were established for Opdivo combination therapy with Bristol Myers Squibb (BMS) Korea's Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC).The company also applied for an expanded reimbursement for this drug as a first-line combination therapy for non-small cell lung cancer (NSCLC), but it failed to pass the CDRC threshold.
- Company
- Envlo accumulates evidence in Asia through H2H SGLT-2 trial
- by Hwang, byoung woo Jun 05, 2026 09:36am
- Daewoong Pharmaceutical is accelerating efforts to accumulate real-world clinical evidence in Asian patients through a direct head-to-head clinical trial of its domestically developed diabetes drug Envlo (enavogliflozin) against other SGLT-2 inhibitors.The company announced on June 4 that it presented interim analysis results and the latest progress of the ENVELOP study at the 39th Korean Diabetes Association Spring Scientific Meeting, held from April 30 to May 2 at the Kimdaejin Convention Center in Gwangju.The ENVELOP study is a large-scale investigation led by Professor Sin Gon Kim of Korea University College of Medicine, with participation from a nationwide multicenter research network. The study was designed to evaluate whether Envlo, Korea's 36th domestically developed new drug, can generate clinical evidence supporting cardiovascular disease prevention and kidney function improvement in Asian patients with diabetes in real-world practice.In diabetes treatment, SGLT-2 inhibitors have expanded their role beyond glycemic control, based on their cardiovascular and renal protective benefits. As cardiovascular death and declining kidney function are major determinants of prognosis in patients with diabetes, integrated management of cardiovascular-kidney-metabolic (CKM) health has become increasingly important.Daewoong noted that while large global Cardiovascular Outcome Trials (CVOTs) have established the cardiovascular and renal benefits of the SGLT-2 inhibitor class, most were placebo-controlled studies. Consequently, evidence directly comparing agents within the class has remained limited, making treatment selection in actual clinical practice challenging.The ENVELOP was specifically designed to address this evidence gap. According to Daewoong, the trial directly compares Envlo with two SGLT-2 inhibitors—dapagliflozin and empagliflozin—with a primary objective of demonstrating non-inferiority.Importantly, the study employs a pragmatic clinical trial design, reflecting data generated in real-world clinical practice rather than a strictly controlled experimental environment. Conducted as a multicenter, prospective study involving endocrinologists from 55 institutions across Korea, it is expected to provide clinically meaningful evidence specific to Asian populations, including Korean patients, unlike existing global clinical data accumulated primarily around Western populations.The study is progressing smoothly. As of April 2026, approximately 88% of the target enrollment of 2,862 patients have been enrolled. The average age of the enrolled patients was 60.4 years, and the average body mass index (BMI) was 26.26 kg/m².Interim analysis showed no statistically significant differences versus comparator groups in key endpoints, including hemoglobin A1c (HbA1c), estimated glomerular filtration rate (eGFR), and urine albumin-creatinine ratio (UACR).Daewoong Pharmaceutical noted how this study was conducted based on an Asian patient population with an average BMI of approximately 26 kg/m². This is because it can reflect the characteristics of Korean and Asian patients, who have different profiles in terms of cardiovascular risk structures and renal disease prevalence compared to existing Western-centered global clinical trials. The company expects the findings to serve as important academic and clinical evidence for prescribing decisions throughout Asia.Professor Sin Gon Kim of Korea University College of Medicine said, "Although GLP-1 therapies have recently attracted significant attention, SGLT-2 inhibitors continue to demonstrate unique advantages in terms of proven cardiovascular and renal protection as well as cost-effectiveness. Through this study, we hope to generate long-term evidence for Asian patients and further elevate the global standing of Korean medicine."Hyung Chul Park, Head of ETC Marketing at Daewoong Pharmaceutical, stated, "The ENVELOP study holds particular significance as it generates differentiated clinical evidence for Envlo based on real-world clinical practice data. As the world's first direct comparison among SGLT-2 inhibitors, it has the potential to become an important academic asset that could influence treatment-selection criteria in Korea."He added, "We will continue strengthening data-driven marketing efforts in Korea and abroad while generating Korean-specific clinical evidence to provide optimal treatment options for patients with diabetes.”The study was unveiled at the 39th Spring Scientific Meeting of the Korean Diabetes Association, which was held under the theme ‘Challenges and Innovations for Overcoming Diabetes.’ During the event, a total of 63 sessions were held, featuring presentations by 213 domestic and international experts and 106 poster presentations
