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- 2026-04-27 03:07:20
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- "A paradigm shift in ulcerative colitis treatment"
- by Whang, byung-woo Jul 29, 2025 06:04am
- The treatment strategy for ulcerative colitis is rapidly evolving with the emergence of new global drugs. Global guidelines recommend a rapid transition to advanced therapies (ATs) early on if 5-ASA treatment fails. In line with these recommendations, Korea also needs a shift in its treatment paradigm. However, the early utilization of high-efficacy treatments is limited due to factors such as insurance reimbursement criteria. In a meeting with DailyPharm, Professor Sang-Bum Kang of Daejeon St. Mary's Hospital (Chairman of the Korean Association for the Study of Intestinal Diseases' Insurance Committee) emphasized the need for re-establishing ulcerative colitis treatment standards and improving the reimbursement system. Ulcerative Colitis Treatment Paradigm Shifting from 'Sequential Therapy' to 'Treat-to-Target' Approach Ulcerative colitis is a chronic inflammatory disease of unknown cause that primarily affects the large intestine, potentially spreading inflammation from the rectum upwards. Professor Sang-Bum Kang of the Department of Internal Medicine at Daejeon St. MaryNotably, uncontrolled ulcerative colitis can be associated with an increased risk of colectomy and hospitalization. Therefore, in moderate and severe cases, strategies involving the early use of treatment options, such as biologics or small-molecule drugs, are being considered to achieve remission. Professor Kang explained, "Ulcerative colitis symptoms have a vast spectrum, and the course of the disease, including the extent of inflammation and disease activity, can continuously change, making it difficult to determine a patient's condition with fragmented numerical values definitively." According to Professor Kang, ulcerative colitis treatment usually begins with 5-ASA agents. However, if a patient has high severity at the time of diagnosis and multiple risk factors, it is a principle to use Advanced Therapy (AT) from the early stage. In this process, Professor Kang emphasizes a personalized treatment strategy tailored to the patient's specific condition. Previously, a 'step-up' approach was typical, where patients who did not respond to conventional treatments, such as 5-ASA, would progressively move to steroids, immunosuppressants, and then ATs. However, recently, the standard has shifted to 'Treat-to-Target (T2T),' which involves setting clear treatment goals from the beginning and pursuing aggressive treatment accordingly. Professor Kang explained, "The current ultimate goal of ulcerative colitis treatment is 'mucosal healing,' confirmed endoscopically. Patients who achieve mucosal healing have a lower risk of relapse and can expect a good long-term prognosis. Therefore, rapid achievement of mucosal healing and maintenance of a relapse-free remission state are key indicators of treatment success." The problem is that conventional drugs alone have limitations in achieving mucosal healing. In contrast, ATs are considered core options in ulcerative colitis treatment due to their higher mucosal healing rates and better response and maintenance effects in mucosal healing. Indeed, the American Gastroenterological Association (AGA) also, in its latest guideline revision, recommended the early use of proven high-efficacy treatments rather than dose escalation if 5-ASA treatment fails, explicitly naming Zeposia, an S1P modulator, as one of the high-efficacy treatment options. "Paradigm shift in ulcerative colitis treatment, potential for oral therapy zeposia" Based on this evidence, Professor Kang emphasized the importance of the initial treatment strategy. He stated, "Realistically, it's not possible to try every treatment sequentially, and it's meaningless to look back after failing the first treatment and think 'what if I had used something else first'." He stressed, "Above all, it's crucial to make an accurate judgment in initial treatment to select the optimal drug and achieve maximum effect." Some reports indicate that 70-80% of all ulcerative colitis patients can achieve symptom control with first-line treatment alone, suggesting the need for a strategy that deploys the best "weapon" tailored to the patient's characteristics. During the treatment paradigm shift, the once-daily oral new drug Zeposia (ozanimod) is also gaining attention as a new alternative for ulcerative colitis treatment. Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator, featuring an innovative mechanism that inhibits inflammation by blocking the migration pathways of inflammatory immune cells. Professor Kang stated, "Zeposia is expected to be effective when used as a first-line treatment for moderate ulcerative colitis patients who have failed conventional therapies like 5-ASA agents." He added, "This efficacy was proven in Zeposia's Phase 3 clinical trials, and consistent results have been confirmed in long-term follow-up and real-world data." Professor Kang also shared an experience where a patient who had previously used biologics but showed insufficient efficacy was switched to Zeposia, and their prognosis significantly improved within 8 weeks. He also said, "Among various AT options, Zeposia is evaluated as a less burdensome drug that can be used long-term. When considering treatment effects, patients who are typically young and actively engaged in socioeconomic activities are suitable for Zeposia treatment." "Diversified ulcerative colitis treatment options require reimbursement system support" While the emergence of new drugs like Zeposia has further diversified treatment options for ulcerative colitis, there's a growing call for the insurance reimbursement environment to support their practical utilization. Regarding this, Professor Kang pointed out, "In Korea, reimbursement is only approved for ATs if patients have tried steroids or immunosuppressants and shown no effect or experienced side effects," and added, "The currently applied reimbursement criteria were established 20 years ago, creating a significant disparity from both the latest treatment trends and clinical reality." Currently, domestic reimbursement criteria stipulate that patients must score 6 points or more out of 12 on the Mayo Scoring System for Assessment of Ulcerative Colitis Activity. However, experts evaluate that some assessment indicators, such as stool frequency and the presence of bloody stools, rely heavily on patient statements and exhibit significant variations in physician assessment, resulting in a lack of objectivity. Professor Kang emphasized, "Ulcerative colitis, an unpredictable, intractable disease, requires flexible treatment access. However, due to rigid reimbursement conditions, the latest treatments cannot be utilized appropriately." He stressed, "While it's impossible to accommodate all demands with limited finances, reimbursement criteria must be adjusted to match current clinical standard so that severe patients can receive high-efficacy treatment on time." In line with these demands, the Korean Association for the Study of Intestinal Diseases is working on a revision of its ulcerative colitis treatment guidelines to reflect the evolving treatment landscape. Professor Kang stated, "We have formed a TF team within the association and are working on new guidelines." He added, "We plan to prepare more practical treatment guidelines by differentiating recommendation grades and evidence levels, similar to the AGA." He explained that they are particularly considering factors like the national health insurance reimbursement system to tailor the recommendations to the Korean context. Professor Kang said, "It has already been 5 years since the ulcerative colitis guidelines were released, and during that time, various new drugs have emerged, significantly changing the treatment environment. I believe now is the opportune time to re-establish treatment standards and push for improvements in the reimbursement system." Finally, Professor Kang said, "In the future, research on personalized treatment should be strengthened, selecting the optimal treatment for each patient based on biomarkers such as intestinal microbes or genetic information." He concluded, "We plan to strive not only for the introduction of the latest treatments but also for the advancement of precision medicine and the training of next-generation specialized personnel."
- Company
- Fewer drugs reimbursed 5 years into pricing reform
- by Chon, Seung-Hyun Jul 29, 2025 06:04am
- Over the past five years, 4,500 drugs have been removed from the reimbursement list in Korea. The number of new drugs entering the market has decreased significantly with the introduction of generic drug price reforms and joint development regulations. The number of prescription drug approvals has decreased by more than 80% compared to 5 years ago. Pharmaceutical companies rushed to enter the generic market ahead of the tighter regulations, and new market entries plummeted after changes were made to the approval and drug pricing systems. With more products being withdrawn than entering the market, the total number of listed prescription drugs began to decline. Reimbursed drugs down 17% in 5 years... Decline continues after drug price reform According to the Health Insurance Review and Assessment Service on the 28th, as of the 1st of this month, a total of 20,277 drugs were listed on the health insurance reimbursement list. Although this is an increase of 44 from the 21,983 last month, it is a decrease of 1,000 from 23,027 in July last year. This means that the number of drugs listed on the reimbursement list has decreased by an average of 83.3 per month over the past year. Approvals for prescription drugs decreased by 84% this year compared to 5 years ago... Joint development regulations accelerate sharp decline in approvals The number of approvals for prescription drugs has significantly decreased since the reform of the drug pricing system. As of June this year, the number of approvals for prescription drugs was 315, with a monthly average of 52.5. Although this is 4.2 drugs more than last year's monthly average of 48.3, it is 23.8 fewer than the 76.3 in 2023, marking a decrease of 23.8 in 2 years. In the first half of 2020, a total of 2,015 prescription drugs were approved, averaging 335.8 per month. This is an 84.4% decrease in the monthly average number of prescription drug approvals over 5 years. The average number of prescription drugs approved per month in 2021 and 2022 was 133.3 and 93.2, respectively, which was significantly higher than the average number approved this year. No. of prescription drugs approved every month (Source: HIRA) The analysis is that the attempts to enter the generic drug market, which accounts for the largest share of new entries in the prescription drug market, have decreased significantly. The rise in the regulatory barriers for approval significantly dampened the market entry momentum. Since July 2021, the revised Pharmaceutical Affairs Act has limited the number of incrementally modified and generic drugs that can be approved on a single clinical trial. The new regulations, known as the “1+3 rule,” restrict the number of incrementally modified drugs and generics that can be approved based on a single clinical trial. If a pharmaceutical company manufactures its product at the same facility with the same formulation and manufacturing process as the product for which it conducted its own bioequivalence study, the use of that data is limited to three. In other words, only four generic drugs in total can be approved based on a single bioequivalence study. Similarly, clinical trial data can be shared with and applied to only 3 other products besides the one directly conducted by the company. In the past, when one pharmaceutical company obtained approval for a generic drug after bioequivalence testing, dozens of other pharmaceutical companies could obtain approval for their own generic drugs using the same data. However, due to the joint development regulations, “unrestricted replication of generic drugs” is no longer possible. The number of prescription drugs, which had been increasing annually, turned to a decline. According to the MFDS, the number of prescription drugs approved last year was 15,893, a decrease of 739 from 1,6632 in 2023. This means that 739 more products had their approvals expire than those approved as prescription drugs in a single year. The number of prescription drug items had increased every year until 2023, since recording 9,572 in 2010. During that period, the number of new products entering the market exceeded the number of products withdrawn from the market every year. However, due to the decrease in prescription drug approvals, an unusual situation occurred last year, with the total number of items decreasing. The number of prescription drug approvals has increased explosively since 2019, but has turned to a decline since 2020. In 2018, 1,562 prescription drugs were approved, averaging 130 per month, but in 2019, the number jumped to 4,195, averaging 350 per month, more than double the previous year. In May 2019 alone, 584 prescription drugs were approved in that single month. From October 2018 to July 2020, more than 100 prescription drugs were approved each month, but in August 2020, the number of approvals fell below 100 for the first time in 23 months. Since January 2023, when 216 prescription drugs were approved, the number of prescription drugs approved each month has fallen below 100 for two years and five months. Companies indiscriminately entered the market in 2019 and 2020 before the introduction of tightened regulations... Repeated mass withdrawals due to non-production and non-claiming The surge in prescription drug approvals in 2019 and 2020 has been attributed to government policies. The government's move to tighten regulations on generics led to a surge in generic approvals. In 2018, 175 items containing the high blood pressure drug valsartan were banned from sale due to excessive impurities. At that time, the MOHW and MFDS formed a “Generic Drug System Improvement Council” and began to develop measures to curb the proliferation of generics. When the government signaled its intention to strengthen regulations, pharmaceutical companies moved to secure generic products in advance, leading to a temporary surge in generic drug approvals. The number of generic drug approvals surged in response to the government's plans to tighten regulations, but returned to previous levels after the system was revised. At the time, there were numerous cases of pharmaceutical companies withdrawing their generic products from the market without selling them after indiscriminately obtaining approval. In November last year, over 1,000 drug items were removed from the health insurance reimbursement list due to non-production and non-claims. Health authorities will remove drugs from the reimbursement list if there have been no insurance reimbursement claims in the last 2 years or no production or import reports in the last 3 years. This means that 1,000 items were removed from the reimbursement list despite being approved by the Ministry of Food and Drug Safety and being listed for reimbursement because they had no production or sales for a certain period of time. No. of reimbursement discontinuation drugs due to lack of claims or production by year of approval as of November 2024 (Source: MFDS): Many of the drugs that were removed from the reimbursement list in November last year were approved in 2019 and 2020. Among the 1,000 drugs removed from the reimbursement list in November last year, 334 were approved in 2000, and 187 in 2019. Products approved in 2019 and 2020 accounted for more than half of all products removed from the reimbursement list, being 521 products in total. This means that more than half of the drugs whose reimbursement was revoked were new products that had been on the market for less than 5 years. Among the drugs whose reimbursement was discontinued due to lack of claims or production, 47 were approved in 2015, and 39 were approved in 2016 and 2017, which was significantly lower than in 2019 and 2020. Only 24 products approved in 2018 were removed from the reimbursement list, compared to how the number of products withdrawn from the market skyrocketed among drugs approved in 2019 and 2020, Pharmaceutical companies indiscriminately obtained generic approvals in response to the government's strengthened regulatory measures, but many products ended up disappearing from the market without being sold. The companies pursued an indiscriminate policy of securing as many generic products as possible before the government strengthened its regulations, leading to an unusual phenomenon where products were withdrawn from the market in large numbers after a certain period of time.
- Company
- 1st drug to win 2nd concurrent approval·pricing program
- by Eo, Yun-Ho Jul 28, 2025 06:08am
- As the first drug has been approved under the 2nd concurrent approval·drug pricing program, the process for insurance reimbursement is garnering attention. MSD Korea's 'Winrevair (sotatercept),' a new drug for pulmonary arterial hypertension (PAH), recently obtained final approval from the Ministry of Food and Drug Safety. As it has been selected for the concurrent approval-evaluation-negotiation pilot program, Winrevair will soon be subjected to reimbursement review. The Ministry of Health and Welfare has been running the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations' since 2023 to improve treatment access for life-threatening severe and rare diseases. The project conducts approval, reimbursement evaluation, and drug price negotiations concurrently, aiming to shorten the time required for new drugs to be included in the National Health Insurance list. The first pilot project is in its final stage, showing accomplishments. The Ministry of Health and Welfare recently completed selecting items, and three drugs were chosen. Three drugs chosen for the second pilot project are 'Winrevair (sotatercept),' a pulmonary hypertension treatment from MSD Korea; 'Fintepla (fenfluramine),' a Dravet syndrome treatment from UCB Pharma Korea; and 'Limcato,' a large B-cell lymphoma treatment from the Korean company Curocell. Winrevair is a first-in-class innovative new drug with a novel mechanism of action, emerging 20 years after 'Sildenafil,' which targeted the NO-sGC-cGMP pathway in 2005. As of 2023, the number of pulmonary hypertension patients in Korea was approximately 3,600. The average age of these patients is in their 40s, a demographic that plays a crucial role in society and families. Although the 5-year survival rate has significantly improved compared to the past, 3 out of 10 Korean pulmonary hypertension patients still die within 5 years. Furthermore, most patients experience significant difficulties performing daily activities such as housework, childcare, and light outings. Pulmonary hypertension is a rare, intractable, and progressive disease, delaying the worsening of the condition directly impacts patients' quality of life and survival. To date, no cure through drug treatment has been discovered, and the mechanism of existing drugs primarily aims to alleviate symptoms by relaxing thickened pulmonary arteries. It remains to be seen how quickly drugs undergoing the concurrent approval-evaluation process, including Winrevair, will be included to the list. Meanwhile, the approval of Winrevair was based on the 'STELLAR' clinical study. This study evaluated the efficacy and safety of Winrevair in 323 adult patients with pulmonary hypertension (WHO-FC II or III). During the 24-week study period, patients received either Winrevair or a placebo in combination with their existing therapy, administered once every three weeks. As a result, Winrevair increased the 6-minute walk distance by 40.8m (Hodges–Lehmann estimate) compared to placebo at the 24-week mark and reduced the risk of clinical worsening or death by 84%. Additionally, significant improvements were confirmed compared to the placebo in eight secondary efficacy endpoints, including the WHO-FC, pulmonary vascular resistance (PVR), and NT-proBNP levels, a biomarker for heart failure. Wook-Jin Chung, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Hospital), stated, "Winrevair is a new mechanism treatment that normalizes modified pulmonary vascular structures. It's also presented as a combination therapy option for use in early treatment stages, as outlined in updated global clinical guidelines, based on the latest evidence. This approval has widened the range of treatment options for pulmonary hypertension patients in Korea."
- Opinion
- [Reporter’s View] AI-assisted diagnosis and its hurdles
- by Whang, byung-woo Jul 28, 2025 06:08am
- Advanced technologies such as AI-assisted diagnosis and robotic surgery are being actively introduced into the domestic medical field more than ever before. Robotic surgery, which was first introduced 20 years ago, has now become the standard treatment in many fields. For example, the Da Vinci Robotic Surgical System, introduced in 2005, has since performed a cumulative total of approximately 370,000 robot-assisted surgeries in Korea, and currently, more than 200 systems are in operation in Korea. This quantitative growth is the result of the efforts of medical professionals and their willingness to embrace innovation. In fact, robotic surgery has demonstrated clinically significant benefits, such as a 75% reduction in blood transfusions during surgery, a 44% reduction in postoperative complications, and a 46% reduction in mortality, and is recognized as one of the global standards for minimally invasive treatment. AI-assisted diagnostic technologies are also being developed, with domestic medical AI startups such as Lunit, Vuno, and Neurophet gaining prominence. The global medical AI market is rapidly expanding, with the market size expected to grow from approximately USD 1.3 billion in 2023 to USD 3.7 billion by 2028. In Korea, innovative medical devices such as AI software for early cancer diagnosis are garnering attention as a potential next-generation industry. Although resistance to innovative technology has decreased compared to the past, conservative views still remain in the medical community. In other words, the view is that advanced technology should only play a supporting role rather than a leading role. In fact, at a briefing held by a global medical device company that this reporter attended, while emphasizing the company's achievements, the company was cautious in answering questions about the possibility of such devices completely replacing doctors. In particular, the word “assistant” was mentioned in the press material, highlighting how robots would play an “assistant role” rather than replacing doctors. "Even with cutting-edge technologies, the company’s approach reflects the industry’s cautious stance, which emphasizes that technology should not overtake the role of physicians, given the unique nature of medicine." Behind this cautious attitude in the medical field lie concerns about safety and reliability. In fact, when AI is applied to actual clinical practice, there are cases where its accuracy falls short of expectations. For example, there is a domestic report that an AI diagnostic solution, which was evaluated with an “excellent” rating with a sensitivity of 91.7% and a specificity of 88.6%, had a sensitivity of only 54.9% in actual field diagnosis. In addition, the possibility of AI misdiagnosis, vague anxiety about the replacement of medical personnel, and the unclear accountability in the event of a malfunction are some of the key concerns raised by the medical community. Such discrepancies between laboratory performance and actual clinical outcomes inevitably lead to a lack of trust among medical staff, which explains why a degree of skepticism remains. However, there are also opinions that we should not miss opportunities for innovation due to vague fears about technology. Although concerns about AI doctors replacing human doctors have been raised since the beginning, AI introduced into clinical practice has been proven to improve the quality of medical care and benefit more patients as an auxiliary tool. By serving as an extension of doctors' hands and eyes, AI is bringing about better outcomes for patients. Ultimately, the key lies not in the technology itself, but in the attitude and approach toward accepting it. Innovation and conservatism are always in a tense balance, even more so in the field of medicine, where human lives are at stake. However, for the sake of a better future for patients, it is sometimes necessary to take bold steps toward change. It is this reporter’s hope to see a future where innovation is embraced, but only with the wisdom to thoroughly evaluate and mitigate its risks."
- Policy
- Eun-kyung Jeong “will review limited INN prescriptions”
- by Lee, Jeong-Hwan Jul 28, 2025 06:08am
- Minister of Health and Welfare Eun-Kyung Jeong plans to review a plan to allow limited adoption of international nonproprietary name prescriptions for essential medicines with unstable supply. However, she drew a line on the full introduction of INN prescriptions in place of brand-name prescriptions as a measure to address issues such as the proliferation of generic drugs and illegal rebates, saying that it would constitute a violation of the agreement on the prescription-dispensing separation system. As this is one of President Jae-Myung Lee’s campaign pledges, it will be interesting to see how the MOHW will partially introduce INN prescriptions in the future. Minister Jeong responded to an inquiry from Democratic Party of Korea lawmaker Rep Young-seok Seo on INN prescriptions on the 25th. Minister Jeong said, “I believe it is necessary to consider introducing INN prescriptions for essential medicines with unstable supply in order to protect the health of the people,” adding, “However, as there are differing opinions within the medical community, sufficient discussion would be necessary during the implementation process.” She further noted, “Issues such as the proliferation of generic drugs and widespread rebates stem from various causes, including distribution structures, corporate ethics, competitive environments, and drug prices, so a comprehensive approach is necessary to resolve such issues. The full implementation of INN prescriptions would involve changing the consensus reached during the separation of pharmaceuticals and medical services, so sufficient consultation with medical and pharmaceutical associations, experts, and others is necessary regarding the necessity and effectiveness of such a measure.”
- Company
- Alopecia areata drug Litfulo lands in the Big 5 hospitals
- by Eo, Yun-Ho Jul 28, 2025 06:07am
- Litfulo, a new drug for alopecia areata, may now be prescribed at tertiary hospitals in Korea.. According to industry sources, Pfizer Korea's new Janus kinase (JAK) inhibitor Litfulo (ritlecitinib) has passed review of Drug Committees (DCs) at major medical institutions, including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, and Pusan National University Yangsan Hospital. Jeonbuk National University Hospital and Chungnam National University Hospital. Since the drug’s launch in March, its prescription area has been steadily expanding. Approved in Korea in September last year, Litfulo is the first drug approved for the treatment of alopecia areata in adolescents in Korea. Alopecia areata is an autoimmune condition that causes patchy or complete hair loss on the scalp, face, or other parts of the body. It occurs when the immune system attacks the hair follicles, causing hair loss. The number of patients diagnosed with alopecia areata in Korea has increased over the past decade, from 154,380 in 2013 to 178,009 in 2023. In general, most cases of alopecia areata with mild symptoms tend to recover naturally or respond well to treatment, but also recur frequently, with approximately 40–80% of patients experiencing recurrence within one year. Professor Chong-Hyun Won of the Department of Dermatology at Asan Medical Center Seoul, said, “The launch of this new treatment option brings new hope for patients who have long suffered from alopecia areata and have unmet needs. It is also significant for us medical professionals as it provides a new and safe option.” Meanwhile, Litfulo has demonstrated its efficacy through the global ALLEGRO IIb/III trial. Its primary endpoint, which evaluated the proportion of patients with a Severity of Alopecia Tool (SALT) score of 20 or below, 23% of the treatment group achieved a SALT score of 20 or below at Week 24, compared to 2% in the placebo group, demonstrating statistically significant treatment efficacy. At Week 48, the proportion of patients in the Litfulo 50 mg treatment group with a SALT score of 20 or below was 43%, compared to 10% in the placebo group, confirming significant efficacy. This suggests that the efficacy of Litfulo increases over time. The incidence of adverse events in these patients was similar to that in the placebo group, with no deaths.
- Policy
- Measures to ban imports of psychotic dietary supplements
- by Lee, Hye-Kyung Jul 28, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) announced on July 25 that the Ministry is designating '7-Hydroxymitragynine,' an ingredient that is narcotic (antipsychotic), as a prohibited material and ingredient for import into South Korea. This measure was implemented to ban overseas direct purchase of dietary supplements, gummies, or drink mixes containing '7-Hydroxymitragynine.' The newly designated 7-hydroxymitragynine is an ingredient classified as a psychotropic substance under 'The Narcotics Control Act.' It is an alkaloid component present in small amounts in the Southeast Asian plant Mitragyna speciosa (scientific name), commonly known as Kratom. It is known to pose a serious risk to human health if misused or abused. The Ministry of Food and Drug Safety is strengthening the safety management of overseas direct-purchase foods. To this end, it designates ingredients and raw materials (such as narcotics, medicinal and traditional Korean medicine ingredients) in overseas direct-purchase foods that pose a risk to public health and need to be blocked from domestic entry, as raw materials/ingredients subject to domestic import blockage. Furthermore, considering that consumers find it difficult to identify harmful ingredients/raw materials, MFDS also provides an easily understandable list of products containing harmful ingredients (3,800 items). Therefore, it is vital for consumers first to check the 'Overseas Direct Purchase Foods' section on the 'FoodSafetyKorea' website before purchasing overseas direct-purchase foods. MFDS stated, "We plan to continue providing consumers with information on precautions and harmful substances when purchasing overseas direct purchase foods."
- Company
- Mounjaro launch set for August in Korea
- by Whang, byung-woo Jul 25, 2025 06:11am
- The launch date for Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, has been set, signaling the start of full-fledged competition in the obesity treatment market in Korea. Lilly Korea announced on the 23rd that it will launch Mounjaro 2.5mg and 5mg/0.5mL in mid-August for patients with type 2 diabetes and obesity in Korea. Mounjaro is the first and currently only dual GIP (glucose-dependent insulinotropic polypeptide)/GLP-1 (glucagon-like peptide-1) receptor agonist. It is a single-molecule injection designed to selectively bind to and activate the GIP receptor and GLP-1 receptor with once-weekly administration. It helps lower blood glucose levels by promoting insulin secretion, improving insulin sensitivity, and reducing glucagon levels, as well as reducing food intake and body weight through delayed gastric emptying. Domestic and international clinical guidelines, as well as the World Health Organization (WHO), classify Mounjaro as a distinct class of therapy apart from existing GLP-1 receptor agonists based on its mechanism of action and the results of the Phase III SURPASS and SURMOUNT clinical trials. Mounjaro is currently indicated in Korea as an adjunct to diet and exercise (monotherapy or combination therapy) for improving blood sugar control in adult patients with type 2 diabetes, and for chronic weight management in adults with obesity (initial BMI ≥ 30 kg/m2) or overweight (initial BMI 27 kg/m2 ≤ BMI) with at least one weight-related comorbidity.
- Company
- Verzenio fails to pass third CDDC review for reimb in KOR
- by Eo, Yun-Ho Jul 25, 2025 06:10am
- Unfortunately, the third time was not the charm. The breast cancer treatment Verzenio is facing difficulties in expanding insurance reimbursement for early breast cancer in Korea. On the 23rd, Lilly Korea’s CDK4/6 inhibitor Verzenio (abemaciclib), which sought to secure reimbursement for its early breast cancer indications, failed to pass the Health Insurance Review and Assessment Service's Cancer Disease Review Committee (CDRC). This is already the company’s third failed attempt.. The reason for the committee not establishing Verzenio's reimbursement criteria is believed to be the lack of overall survival (OS) data. However, OS data is difficult to obtain for drugs with early-stage cancer indications such as Verzenio. In fact, overall survival (OS) has been the main reason many drugs fail to pass the CDRC review. This has become one of the biggest points of contention among pharmaceutical companies with oncology portfolios regarding the committee’s evaluation criteria. Verzenio faced difficulties in being reviewed by the CDRC in its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDRC in May 2023, but the result was “reimbursement criteria not set.” Five months later, in October, Lilly resubmitted the reimbursement application to HIRA, and in March last year, it was submitted to CDRC for review, facing the same results. The reimbursement of Verzenio for early breast cancer has been a long-standing hope among patients. In fact, a national petition calling for the expansion of reimbursement for Verzenio has garnered more than 50,000 signatures. The 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress reaffirmed the drug’s clinical efficacy for early breast cancer. This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium and Lancet Oncology in December 2022. Results showed that the gap between the Verzenio arm and the control arm (endocrine therapy alone) in the primary clinical endpoints of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) widened further in year 5 compared to year 4. At year 5, the primary endpoint, the difference in invasive disease-free survival (IDFS), was approximately 8% between the two arms. This data suggested that even for those who received treatment with Verzenio for the limited period of 2 years after surgery, the treatment benefit persisted on to year 5. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug available for HR+/HER2- type early breast cancer. The drug’s indication was expanded on November 18th, 2022, as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, the drug is indicated for a very limited range of patients at high-risk of relapse: ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes and a tumor size of 5 cm or larger, or ▲histological grade 3 disease. Professor Keun Seok Lee from the Breast Cancer Center of the National Cancer Center said, “The Verzenio+endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”
- Opinion
- [Reporter's View] Denmark's corporate model, Wegovy success
- by Jul 25, 2025 06:10am
- I recently had the opportunity to visit the biotech industry in Denmark. I toured facilities like Novo Nordisk, which rose to stardom with its GLP-1-based obesity treatment Wegovy, as well as LEO Pharma, with its 117-year history, and Lundbeck, a powerhouse in the central nervous system field. What struck me was that all these companies, without exception, cited their 'foundation-owned governance structure' as the secret to Denmark's biotech industry competitiveness. Denmark has Europe's most structured foundation-owned model. Approximately 1,300 companies in Denmark operate under a foundation-owned structure. Pharmaceutical companies like Novo Nordisk, LEO Pharma, and Lundbeck, as well as the toy company Lego, brewery Carlsberg, and shipping giant Maersk, all adopt governance structures where a foundation is the largest shareholder. Examining the governance structure of these companies reveals that non-profit foundations run them. A foundation controls an intermediate holding company, which is also a professional investment firm. This holding company, in turn, oversees various operating companies. It can be summarized as 'Foundation → Holding Company → Operating Company,' where the foundation indirectly controls its subsidiaries through a holding company-style investment firm. Foundations support the life sciences field in all-in efforts. The Novo Nordisk Foundation boasts one of the largest asset sizes globally, with Assets Under Management (AUM) reaching approximately $140 billion (KRW 194 trillion). Thisfigure is more than twice the AUM of the Bill & Melinda Gates Foundation, North America's largest private foundation, which stands at $69 billion. Such investment strengthens Denmark's scientific foundation nationwide and effectively attracts top talent from around the world to Denmark. A unique aspect of the Danish foundation-owned model is that the founding family does not serve as the largest shareholder of the operating company, nor do they directly hold equity. While some foundations may have founding family members play a symbolic role on the board, they do not exercise substantial control over the organization. Denmark has thus created a corporate ecosystem that perpetuates the founder's philosophy through a foundation while separating equity ownership from operational management. Due to this clear separation of ownership and management, companies can consistently pursue long-term strategies without being influenced by short-term performance. Being free from the pressures of short-term profits from external investors or shareholders creates an environment where companies can concentrate on long-term research and development (R&D) while delivering public value. Unlike private equity funds, which seek short-term returns based on profit, foundations can respond flexibly regarding equity maintenance or exit timing. In my opnion, this Danish case could offer significant implications for the direction the Korean pharmaceutical industry should take as it faces a transition in its governance structure. With the succession to the 3rd or 4th generation of founders gaining momentum, many Korean pharmaceutical companies are seeking solutions that simultaneously satisfy transparency in governance and continuity in management. Listed pharmaceutical companies find themselves in a situation where they must find a 'sustainable governance' middle ground between companies seeking to continue family management and succession, and shareholders demanding accountability and transparency. It doesn't imply that owner-management or professional management is better, or that the Danish model is superior. Korean companies cannot simply replicate the Danish model. Denmark has a highly sophisticated legal framework for foundation-owned companies, whereas South Korea lacks clear public interest foundation laws or a tax incentive structure. In Korea's case, a strong perception exists that public interest foundations are often a means for illegal succession, due to past instances of irregular successions by some companies. However, the Danish model can serve as a meaningful reference point for the Korean pharmaceutical industry when redesigning its governance structure. The key is to reinterpret the Danish model and integrate it into a feasible structure that aligns with Korean culture, institutions, and management realities. In the pharmaceutical industry, where a long-term vision is essential, the sustainability of the entire industry could be jeopardized without careful consideration of governance. New ideas and discussions about new structures are urgently needed for the development of "K-made Wegovy."
