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- 2026-03-10 05:37:53
- Company
- 'Elahere' launches in KOR…AbbVie's ADC success
- by Son, Hyung Min Dec 22, 2025 08:53am
- New ADC drug 'Elahere'AbbVie is rapidly expanding its oncology portfolio with a series of successful new Antibody-Drug Conjugate (ADC) commercializations.AbbVie secured the first ADC approval for ovarian cancer and is now addressing unmet needs in non-small cell lung cancer (NSCLC) with the approval of a c-Met-targeting ADC.According to industry sources on December 20, AbbVie obtained domestic approval for its new platinum-resistant ovarian cancer (PROC) ADC, 'Elahere (mirvetuximab soravtansine)', in South Korea on December 19.The specific indication is for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.Elahere is an ADC targeting FRα-expressing ovarian cancer, utilizing a mechanism that delivers the potent cytotoxic payload DM4 directly into cancer cells to induce tumor cell death. It is garnering significant attention as a new option for ovarian cancer patients who have developed resistance to platinum-based chemotherapy. As the first new mechanism-of-action drug for platinum-resistant ovarian cancer in approximately 10 years, it was designated as an orphan drug in South Korea this past January.Elahere is a first-in-class ADC that includes an FRα-binding antibody, a cleavable linker, and maytansinoid payload DM4, a potent microtubule inhibitor, designed to kill targeted cancer cells.In epithelial ovarian cancer, which accounts for 90% of all ovarian cancer cases, taxanes like paclitaxel and platinum-based agents like carboplatin and cisplatin are primarily used. However, in cases of recurrent ovarian cancer resistant to platinum agents, response rates to the current standard-of-care chemotherapy have been generally low, significantly limiting improvements in survival rates. Elahere proved to be a viable alternative through the Phase 3 MIRASOL study conducted on PROC patients.In the MIRASOL study, Elahere demonstrated a 35% reduction in the risk of disease progression or death compared to existing non-platinum-based chemotherapy.The median progression-free survival (PFS) was 5.62 months, an improvement over the 3.98 months in the control group. The objective response rate (ORR) was 42.3%, significantly higher than the 15.9% observed in the standard chemotherapy group.Median overall survival (OS) was 16.85 months, reducing the risk of death by 32% compared to the 13.34 months in the control group.Regarding safety, adverse events such as ocular reactions, fatigue, and abdominal pain were reported and generally considered manageable.Based on these clinical achievements, Elahere received approval in the U.S. in March of last year and in Europe in November of the same year.The U.S. NCCN guidelines recommend Elahere as a "preferred regimen" (Category 1) for the treatment of FRα-positive PROC patients, and the Korean Society of Gynecologic Oncology also recommends Elahere with the highest level of evidence (Level I, Grade A).Commercialization of c-Met-targeting 'Emrelis' in NSCLCNew ADC drug 'Emrelis'AbbVie also succeeded in ovarian cancer by commercializing an ADC for non-small cell lung cancer, following its success in ovarian cancer.In May, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the c-Met-targeting ADC 'Emrelis (telisotuzumab vedotin)' for adult patients with previously treated locally advanced or metastatic non-squamous NSCLC with c-Met protein overexpression.c-Met is a protein expressed by the mesenchymal-epithelial transition (MET) gene. As a protein that transmits signals to cells, c-Met is considered a major oncogenic driver and is associated with the development of various solid tumors, including colorectal, gastric, and liver cancers, as well as NSCLC. It is known that c-Met alterations occur in approximately 6% of patients with NSCLC.Currently, AbbVie’s Emrelis is the only commercialized ADC targeting c-Met alterations.Emrelis's approval was based on improvements in key endpoints, such as ORR and duration of response (DOR). It is expected to transition to full approval if clinical benefit is confirmed in a confirmatory trial.Analysis of 84 patients with c-Met overexpression in the Phase 2 LUMINOSITY study showed an ORR of 35% and a median DOR of 7.2 months in the Emrelis arm.Major adverse events included peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Grade 3–4 adverse events reported included lymphopenia, increased liver enzymes, and electrolyte imbalances.Based on this clinical data, Emrelis was also designated as a Breakthrough Therapy by the FDA in 2021.Currently, Emrelis is under another evaluation as a monotherapy in the Phase 3 confirmatory TeliMET NSCLC-01 study.
- InterView
- Korea Is a key market… will turn neuroscience innovation into reality”
- by Son, Hyung Min Dec 19, 2025 09:09am
- Brad Edwards, Managing Director of Lundbeck KoreaLundbeck, a global pharmaceutical company specializing in central nervous system (CNS) drug development, has established a solid foothold in Korea's mental health treatment sector through antidepressants like ‘Brintellix (vortioxetine bromide)’ and ‘Lexapro (escitalopram oxalate)’.Recently, it has expanded its portfolio beyond mental illness to include rare neurological disorders, further clarifying its identity as a neuroscience-focused company.Amidst this transformation, Lundbeck Korea appointed its first foreign Managing Director in April, 23 years after the company's establishment in Korea. The new leader is Brad Edwards. He is an expert with nearly 30 years of experience at global pharmaceutical companies, including Pfizer, Shire, and Takeda, having led operations across Australia, New Zealand, and other emerging markets. Most recently, he was based in Singapore as Takeda's Head of Plasma-Derived Therapies, Growth and Emerging Markets.Edwards stated, “While working in Singapore, I never anticipated I would be working in Korea, but Korea is an attractive market with scientific prestige and clinical capabilities. I am greatly inspired by the Korean Lundbeck team's efforts to make a tangible difference in patients' lives through brain health.”“Introducing innovative products... strengthens patient-centric approach strategy”Edwards assessed Korea as a key hub for realizing neuroscience innovation within Lundbeck's global strategy. He noted that Korea is one of Lundbeck's 12 designated core markets, possessing clinical trial capabilities, scientific infrastructure, a digital health environment, and progressively improving regulatory and reimbursement policies.Edwards explained, “The Korean government has recently introduced various forms of regulatory flexibility to improve access to innovative medicines, including faster approval pathways, conditional approvals, and risk-sharing schemes. Policies aimed at reducing out-of-pocket costs for patients with rare and severe diseases, as well as improving diagnosis rates, are also positive developments.”He noted that these environmental changes are laying the groundwork for Korean patients’ faster access to new innovative therapies.Lundbeck Korea’s strategy goes beyond simply launching new drugs. The company envisions redesigning the entire patient access pathway, strengthening collaboration with patient advocacy groups and medical communities while addressing institutional factors such as regulatory approval, reimbursement, and pricing. Preparations for new product launches, pending domestic approval, are already underway.Edwards stated, “Our top priority is introducing innovative new products to the Korean market and improving the lives of Korean patients with brain disorders. To achieve this, we plan to continuously strive to make not only the products themselves but also our approach to patients more efficient and truly patient-centric.”From an organizational perspective, Lundbeck Korea is also built on a stable foundation. Within a culture that emphasizes employee engagement and diversity, the company has earned Great Place to Work certification for two consecutive years, while maintaining a balanced organizational structure across gender and generations.Edwards stated, “This kind of organizational culture is a critical foundation for delivering sustainable, long-term performance. I hope to continue the successful operating practices that Lundbeck Korea has built over the years.”Focus on Neuroscience and Rare Diseases… Accelerates Portfolio TransformationNeuroscience and rare diseases are the most critical pillars of Lundbeck’s mid- to long-term strategy. Globally, the company is reshaping its portfolio around rare neurological diseases, with Korea positioned as a key part of this effort.Edwards said, “Many patients with rare neurological diseases remain undiagnosed, resulting in significant unmet medical needs. By pursuing new scientific approaches and driving neuroscience innovation, we aim to improve patients’ quality of life. This aligns directly with Lundbeck’s goal of expanding an innovative and specialized portfolio in rare neurological diseases.”He added, “Lundbeck is shifting its focus within neuroscience toward rare neurological disorders. Based on our extensive experience working in the rare disease field across multiple countries, we expect Lundbeck Korea to contribute to this transformation process.”The antidepressant business continues to be an important pillar for Lundbeck Korea. Brintellix and Lexapro remain flagship products and have been widely used in Korea’s mental health treatment landscape for many years.Edwards said, “Mental health is both a core business area and a long-term responsibility. We will continue to ensure stable supply, education, and digital support for antidepressant therapies through close collaboration with healthcare professionals and partners.”From a global strategy perspective, Edwards emphasized that Korea plays a crucial role in connecting global R&D capabilities with local innovation.He stated, “Korea has excellent clinical execution capabilities and strong scientific expertise, making it an ideal partner for advancing neuroscience innovation. The government’s willingness to improve regulatory and reimbursement systems is particularly meaningful.”Edwards identified healthcare, digital, and policy (PA) as key areas for Lundbeck Korea to strengthen. He emphasized the importance of expanding real-world evidence (RWE) and data-driven insights, and leveraging new technologies like artificial intelligence (AI) to communicate more effectively with healthcare professionals. This aligns with Lundbeck's global ‘Focused Innovator’ strategy.The new CEO's mid-to-long-term vision is clear: steadfastly realizing Lundbeck's mission in Korea—‘improving the lives of patients with brain disorders and growing into an agile, high-performing organization through focused innovation in neuroscience.’Edwards stated, “Rather than pursuing abrupt internal changes, we will achieve natural evolution as our pipeline progresses toward commercialization. I hope Lundbeck Korea will grow into an agile, results-driven organization that contributes not only to Korea but also globally.”He concluded, “Lundbeck’s achievements to date have been made possible through collaboration and feedback from many partners and stakeholders. All progress in neuroscience begins with listening to their experiences and insights, and we will continue to engage in close dialogue going forward.”
- Product
- MOHW to unveil list of 4K items subject to price cuts in JAN
- by Kim JiEun Dec 19, 2025 09:09am
- The South Korean government plans to pre-release a list of approximately 4,000 pharmaceutical products subject to price reductions effective January 1, 2026. The price reduction is due to the adjustment of the ceiling price of the actual transaction price.On December 17, an official from the Ministry of Health and Welfare (MOHW) confirmed to DailyPharm that the list of related items and their respective reduction rates will be provided to relevant associations within this week.Earlier this month, the MOHW issued an official notice, announcing 'a temporary allowance for paperwork-only returns when reporting of supply records following the price cuts', to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA), the Korea Pharmaceutical Distribution Association, and the Korean Pharmaceutical Association.The notice also informed that the ceiling prices of insurance price tags of approximately 4,000 pharmaceutical products are subject to price reductions effective January 1, 2026.However, concerns have been raised across the industry after the announcement. With less than 15 days remaining until the massive price cut of 4,000 pharmaceutical products takes effect, pharmacies and distributors lacked the specific data, such as exact items, quantities, and reduction percentages, needed to prepare.In response, the MOHW decided to provide the pre-list, including items subject to price cuts due to the actual transaction price ceiling price increase and the reduction rate, to minimize field confusion. Although the price reduction is scheduled to be officially announced on December 24, the MOHW plans to provide the list five days ahead, on December 20.An MOHW official said, "We are aware of the related issue in the distribution industry and pharmacies," and added, "For actual transaction price reduction, the MOHW plans to take administrative response in a way that minimize the field confusion."The official further added, "The affected documents are according to the official notice, but the MOHW will pre-lease the list of affected products to institutions," and added, "It will be announced by this Friday."In 2023, when over 7,600 items were subject to price reductions, the MOHW similarly pre-released the list after the field confusion.At that time, affected organizations, including the Korea KBPMA, the Korea Pharmaceutical Distribution Association, the Korean Pharmaceutical Association, and HIRA, received the pre-lease list files. Pharmacies could verify affected stocks through billing software integration and prepare for the financial impact well in advance.Meanwhile, affected organizations have argued that this pre-release of data to affected parties should be formalized, given the recurring large-scale price reductions.Regarding this issue, the MOHW announced that it is preparing to reform the current actual transaction price-based price reduction system. The ministry acknowledged that the current system imposes an excessive administrative burden on the field relative to its actual impact on health insurance financial savings, primarily because of the vast number of affected items.An MOHW official explained, "In the case of an actual transaction price survey, the number of products subject to investigation is immense, yet the predictability regarding which specific drugs will actually face a price cut is low, which appears to be confusing the field," and added, "For the actual transaction price investigation, we are looking to redesign the entire system of drug pricing and post-management instead of the current method of simple price reductions. We expect this will enhance predictability for the field."
- Company
- 'Cosentyx' reimb changes hidradenitis suppurativa strategy
- by Eo, Yun-Ho Dec 19, 2025 09:08am
- The treatment landscape for hidradenitis suppurativa (HS) in South Korea is at a turning point following approval of 'Cosentyx' for insurance reimbursement.In December 2023, the expanded indication for Novartis Korea's interleukin-17A inhibitor Cosentyx (secukinumab) was approved, making it a new biologic treatment option after approximately 8 years.However, Cosentyx has remained a non-reimbursed drug until now, while Humira has been the only biological agent patients can practically choose.Two years after approval, as of December 1, 2025, the reimbursement criteria for Cosentyx were set to treat adult patients with severe HS. Consequently, a reimbursement option is now available to the domestic HS market in approximately 10 years.The process of expanding reimbursement for Cosentyx has not been easy. The reimbursement application for Cosentyx was submitted soon after receiving indication approval in December 2023. However, the reimbursement review had been delayed due to an external issue. The company voluntarily withdrew the application and resubmitted an expanded reimbursement application in November 2024.Even after that, the review process was challenged by various external issues, including changes to the domestic drug pricing policy and discussions on Most Favored Nations (MFN). Given the evidence, such as large-scale global clinical data, international guideline recommendations, and unmet needs of domestic patients, the company succeeded in expanding reimbursement criteria 1 year after reapplication.Cosentyx is drawing attention for having different mechanisms of action compared with Humira. Whereas Humira blocks Tumor Necrosis Factor-alpha (TNF-α) to inhibit the inflammatory response, Cosentyx works by directly inhibiting IL-17A, which plays a key role in inflammatory immune diseases, thereby inhibiting the release of proinflammatory cytokines and chemokines. This drug reduces abscess and inflammatory lesions in HS.Improved treatment access to a new medicine with a mechanistic difference is meaningful because it not only provides a new option for patients in terms of treatment response conditions and drug tolerance, but also establishes a setting for potentially elaborate personalized treatment plans.Furthermore, it is encouraging that the reimbursement criteria for biological agents were updated during the Cosentyx review. Previously, reimbursement for biological agents in HS was limited to severe patients (Hurley Stage 3). The scope has now expanded to include patients with moderate-to-severe disease (Hurley Stage 2).Another significant change resulting from this expanded reimbursement is improved patient access and a broader range of treatment options. When the Special Case Medical Expense Coverage criteria are applied, the out-of-pocket cost for a single 300mg dose of Cosentyx is KRW 113,482. Cosentyx is administered once weekly for the first month of initiation, followed by dosing every 4 weeks thereafter. Excluding the initial month, patients will pay KRW 113,482 per month during the maintenance phase.In comparison, the out-of-pocket cost for a single 40mg dose of Humira is KRW 28,640, and it is administered every week or every two weeks. The monthly price (4 doses) is approximately KRW 114,560. During the maintenance period, the patient's financial burden is nearly identical for both medications, allowing patients to select and maintain therapies with different mechanisms of action without significant cost disparities.Professor Min Soo Jang, General Affairs Head of the Korean Acne and Rosacea Society (Professor of Dermatology at Kosin University Gospel Hospital), explained, "HS is a difficult disease to cure. There are cases in which the disease does not improve with conventional treatment, or symptoms progressively worsen. Strategic management is possible if a systematic treatment plan is established through biological agents."Professor Jang added, "However, unlike psoriasis or atopic dermatitis, where various biological agents with different mechanisms of action are available, HS treatment options have been limited to a single mechanism. With the expanded reimbursement of Cosentyx, treatment options have widened for patients who had insufficient responses to existing therapies or had to discontinue treatment due to side effects."Meanwhile, in the recently announced 4-year (204-week) extension of the SUNNY study, patients who achieved HiSCR at Week 52 and continued Cosentyx treatment showed a HiSCR achievement rate of 83.2% at Week 204. It was confirmed that the symptom-improvement effect is maintained for up to 4 years after starting treatment.
- Policy
- Moderna’s RSV vaccine gains expedited approval
- by Lee, Tak-Sun Dec 19, 2025 09:08am
- The Ministry of Food and Drug Safety (MFDS) announced on the 18th that it has approved mRESVIA Prefilled Syringe (respiratory syncytial virus [RSV] mRNA vaccine, Moderna Korea) as the first biologic drug to be authorized under the newly implemented ‘New Drug Marketing Authorization and Review Procedures’ implemented this year.The revised New Drug Marketing Authorization and Review Procedures, introduced earlier this year, include expedited review measures such as the formation of dedicated product review teams and prioritizing GMP reviews. These measures were established as follow-up actions to the increase in new drug approval review fees.For the approval of mRESVIA, the MFDS formed a dedicated review team consisting of 18 members, including specialists in new drug evaluation, conducted priority GMP reviews, and held individualized face-to-face meetings before and after the marketing authorization application. Through close communication with the applicant, the MFDS was able to complete the approval process in an expedited manner.The newly approved imported drug, mRESVIA Prefilled Syringe, is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older, as well as in high-risk individuals aged 18 to under 60 years. It is the first RSV preventive vaccine in Korea approved using an mRNA platform.Respiratory syncytial virus (RSV) is a virus that causes acute respiratory infections with symptoms similar to those of the common cold.Meanwhile, the first small-molecule drug approved under the new fast-track review system was Xcopri Tab (cenobamate) developed by Dong-A ST, which received marketing authorization in November.The MFDS stated that it plans to further enhance the new drug review system through in-depth preliminary assessments, item-by-item parallel reviews, and stage-specific tailored meetings during the new drug approval process. These efforts aim to facilitate rapid market entry of innovative medicines, provide patients with quicker access to treatment options, and support the growth of the biopharmaceutical industry.
- Policy
- Support grows for reform of aHUS reimb pre-approval system
- by Jung, Heung-Jun Dec 19, 2025 09:08am
- Concerns about improving the pre-approval review process for Soliris, a treatment for aHUS, has also been raised during last year's NA auditCalls to improve reimbursement access for treatments for atypical hemolytic uremic syndrome (aHUS) are gaining momentum, with the Anti-Corruption and Civil Rights Commission (ACRC) joining the National Assembly in pressing for institutional reform.Previously, the National Assembly had criticized the low approval rate of prior authorization for Soliris, an aHUS treatment, and urged regulatory relaxation.On the 17th, the ACRC has recommended system-wide improvements, including designating aHUS and other “ultra-urgent rare diseases” as a separate category and improving the system to ensure prior reviews are completed within 2-3 days.It ordered the establishment of a 48-hour fast-track review process for prior approval and the creation of a ‘Rare Disease Drug Review Committee (tentative name)’ to ensure such reviews are conducted swiftly.The ACRC has given the Health Insurance Review and Assessment Service (HIRA) an implementation deadline of December next year. If the recommendations are not implemented, the Commission plans to continue monitoring progress.ACRC investigator Joon-hyung Kim said, “We are aware of the issues raised by the National Assembly. We listened to the voices of medical professionals, patients with rare and severe diseases, and patient organizations. We also conducted an on-site investigation at HIRA this summer. Through stakeholder meetings, we consolidated opinions and finalized our recommendations. This is not limited to aHUS alone. There are several other ultra-rare diseases requiring immediate emergency care.“Kim added, ”HIRA is likely aware of the need for improvement, having conducted its own investigation. We have now communicated the recommendations along with a deadline for implementation by December next year."While these are recommendations without legal enforceability, the ACRC stated that it will actively follow up and encourage implementation if reforms are not carried out.Investigator Kim conveyed, “Even if it goes beyond December next year, we will continuously monitor whether implementation occurs and manage the situation to ensure improvements are made.”The prior approval system is a mechanism designed to obtain reimbursement approval before administering ultra-high-priced new drugs, considering the financial stability of the National Health Insurance budget.Last year's National Assembly audit pointed out low approval rates and review delays for treatments like atypical hemolytic uremic syndrome (aHUS) and spinal muscular atrophy (SMA).Meanwhile, the reimbursement criteria for aHUS treatments were partially relaxed this October.
- Company
- 'Mounjaro' confirmed to have reimb appropriateness
- by Son, Hyung Min Dec 17, 2025 09:51am
- There are ongoing concerns that the treatment landscape for Type 2 Diabetes (T2D) in South Korea is facing limitations.While this issue persists, the GLP-1/GIP receptor dual agonist Mounjaro has passed the initial hurdle for national health insurance reimbursement coverage for diabetes, drawing significant attention to whether it will lead to a paradigm shift in domestic treatment.According to industry sources on December 17, Mounjaro (tirzepatide) passed the initial stage for national health insurance reimbursement earlier this month. Consequently, Mounjaro's developer, Eli Lilly, will now enter price negotiations with the National Health Insurance Service (NHIS). Lilly has been pursuing reimbursement for Mounjaro since early 2024, achieving the positive result after approximately two years.Lilly confirmed that Mounjaro demonstrated improved clinical utility compared to comparator drugs. Following discussions on cost-effectiveness based on economic evaluation with the Health Insurance Review and Assessment Service (HIRA), Mounjaro was considered for the final Drug Reimbursement Evaluation Committee (DREC) meeting of the year and was received reimbursement appropriateness decision. Experts anticipate that the remaining steps will proceed quickly, given Mounjaro’s acknowledged clinical value, economic feasibility, and necessity within the domestic treatment environment.Type 2 diabetes treatment 'Mounjaro'T2D diabetes management becomes harder over time...demands for new treatment option↑Given rising obesity rates and an aging population, there is a growing demand for treatment options that can manage not only blood glucose but also body weight and overall metabolism. T2D is a chronic condition where prolonged disease duration leads to cumulative decline in insulin secretion function and increased insulin resistance, resulting in a significant number of patients failing to reach target blood glucose levels with conventional strategies alone.According to the 2025 Factsheet by the Korean Diabetes Association, 6 out of 10 diabetes patients in South Korea are not achieving the treatment goal of a hemoglobin A1c (H1A1c) level of 6.5%. T2D is a progressive disease with difficulty achieving remission. With prolonged disease duration, pancreatic insulin secretion deteriorates, worsening insulin resistance and leading to difficulties in glucose regulation.The prevalence of obesity is also rising. Over half of diabetes patients (52.4%) are also obese, and 61.1% have abdominal obesity. Conversely, the prevalence of diabetes among the obese population is 17.6%, about twice as high as in the non-obese population. Among the obese population aged 65 and over, one in three (31.6%) has co-morbid diabetes.The problem is that, in patients with high Body Mass Index (BMI), visceral fat contributes to insulin resistance, and inflammatory responses in adipose tissue impair insulin action. This not only makes blood glucose management difficult but also reduces overall metabolic function. Consequently, blood glucose regulation can be challenging with conventional oral treatments or insulin alone. Failure to control blood glucose in T2D patients increases the risk of various complications, including retinopathy, neuropathy, stroke, angina, and myocardial infarction due to arteriosclerosis. One study showed that T2D patients who fail to control their blood glucose have a 2–3 times higher risk of cardiovascular disease in men and 3–5 times higher risk in women compared to the general population.Thus, there is high demand among healthcare providers and patients for GLP-1 class treatments that offer benefits not only in blood glucose control and weight loss but also in overall metabolic health. Mounjaro, which can be administered once weekly, is the first and only therapeutic agent designed to bind to and activate both GLP-1 and GIP receptors selectively.Mounjaro has mechanistic advantages that stimulate insulin secretion, improve insulin sensitivity, lower glucagon levels to lower blood glucose, and delay gastric emptying to reduce food intake, leading to weight loss.Mounjaro demonstrated superior HbA1c reduction across all doses compared to all comparator arms in the five Phase 3 clinical trials (SURPASS 1–5) involving T2D patients. The achievement rate of the T2D treatment goal, which is HbA1c level below 6.5%, in the Mounjaro group was up to 95% (SURPASS-5, 10mg), and the achievement rate of HbA1c < 5.7%, indicating a near-normal blood glucose level, reached up to 62% (SURPASS-5, 15mg). Furthermore, since a weight reduction of over 10% significantly improves blood glucose in T2D patients, up to 69% of patients in the Mounjaro group achieved this goal (SURPASS-3, 15mg).Notably, despite effective blood glucose reduction, the risk of clinically significant or severe hypoglycemia did not increase compared to the control groups. This means that even patients whose treatment options were limited by hypoglycemia risk can now expect to reach their target blood glucose (HbA1c < 6.5%) and achieve higher levels of glycemic control with Mounjaro.Mounjaro recommended in major guidelines..."Effective strategy needed for long-term metabolic health"In October, the Korean Diabetes Association (KDA) issued a statement emphasizing the need to manage comorbid conditions in T2D. A key change in the KDA's newly proposed T2D management algorithm is the initial separate listing of the GIP/GLP-1 receptor dual agonist from existing GLP-1 receptor agonists. The KDA also specified the GIP/GLP-1 receptor dual agonist as a preferred medication for T2D patients with co-morbid obesity.Professor Byung-Wan Lee (Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University, Severance Hospital), who directed Guidelines for the KDA stressed, "T2D patients with co-morbid obesity require a more effective treatment strategy that includes weight loss and improved insulin sensitivity, in addition to overall and long-term metabolic health improvement."Professor Lee stated, "It is significant that, following the last guideline revision where Mounjaro was first listed as a distinct component name separate from existing GLP-1 receptor agonists to emphasize its efficacy in blood glucose and weight control, this algorithm update reconfirms the clinical utility of the GIP/GLP-1 receptor dual agonist in T2D patients with obesity."He added, "For T2D patients with obesity who failed to reach target blood glucose levels even with existing oral treatments or insulin, We hope access to Mounjaro is improved as quickly as possible so that these patients can benefit from Mounjaro's blood glucose and weight loss results."An algorithm for Type 2 diabetes management.Based on Mounjaro's clinical and practical value, domestic and international guidelines categorize it separately from existing GLP-1 receptor agonists. Furthermore, the World Health Organization (WHO) designated Mounjaro as an Essential Medicine in September for T2D patients with comorbid conditions such as obesity.This decision is significant as it officially recognizes Mounjaro as an essential, public-health-critical drug for T2D treatment with co-morbid obesity, underscoring the need to improve access through expanded insurance coverage.Professor Lee stated, "In a situation where the number of T2D patients with obesity is rising, ensuring accessibility to innovative treatments that can improve overall metabolic health beyond simple blood glucose reduction, regardless of economic status, is beneficial, both for individual patients and for long-term national health improvement," and added, "As Mounjaro has been recognized globally as an essential medicine for T2D patients with obesity, prompt policy action is needed so that it can be managed under the system and safely used by patients who critically need it."
- Company
- CKD and Bayer sign copromotion agreement for Eylea
- by Lee, Seok-Jun Dec 17, 2025 09:51am
- Chong Kun Dang Pharma (CEO Young-joo Kim) announced on the 16th that it has signed a domestic copromotion agreement with Bayer Korea (CEO JinA Lee) for the retinal disease treatment Eylea (aflibercept) at its headquarters in Chungjeong-ro, Seoul.Under the agreement, Chong Kun Dang will be responsible for sales, marketing, and distribution of both Eylea 2 mg and Eylea 8 mg, targeting clinic-level medical institutions.Bayer’s Eylea is an anti-vascular endothelial growth factor (anti-VEGF) therapy used to treat a range of retinal diseases, including wet age-related macular degeneration (AMD), diabetic macular edema, macular edema secondary to retinal vein occlusion, and vision impairment due to choroidal neovascularization associated with pathological myopia. Based on its innovative therapeutic efficacy and trust, Eylea has maintained its position as a standard of care for more than 10 years.In particular, Eylea 8 mg, the high-dose formulation that was launched last year, demonstrated comparable vision improvement and safety to Eylea 2 mg while allowing the dosing interval to be extended to up to 20 weeks, significantly improving treatment convenience for patients.Young-joo Kim, CEO of Chong Kun Dang Pharma, said, “Chong Kun Dang has already built extensive sales and marketing capabilities in the ophthalmology field through our diverse product lineup. Leveraging our expertise and sales strength in ophthalmic diseases, we will actively promote the excellence and stability of Eylea and further expand the market.”JinA Lee, CEO of Bayer Korea, stated, “Through our collaboration with Chong Kun Dang, we aim to further enhance patient access to Eylea, which has led the anti-VEGF market for over a decade. Building on our strong partnership, we will continue to provide reliable treatment options more smoothly to patients with retinal diseases and healthcare professionals in Korea, and contribute to improving patients' quality of life.”Chong Kun Dang and Bayer Korea have maintained a successful partnership, co-promoting the antibiotics Ciprobay and Avelox since 2005, and the type 2 diabetes-associated chronic kidney disease treatment Kerendia since 2024. In addition, Chong Kun Dang independently distributes Bayer Korea’s cardiovascular drugs Aspirin Protect and Adalat OROS, as well as the hepatocellular carcinoma treatments Nexavar and Stivarga.
- Policy
- Keytruda completes price negotiations for reimb in KOR
- by Jung, Heung-Jun Dec 17, 2025 09:50am
- MSD Korea’s immunotherapy drug Keytruda (pembrolizumab) has completed price negotiations with the National Health Insurance Service (NHIS), with reimbursement coverage expected to expand to additional indications starting next month.Keytruda previously received approval for reimbursement appropriateness for 11 indications, including gastric cancer and esophageal cancer, at the 9th Drug Reimbursement Evaluation Committee meetingAccording to industry sources on the 16th, MSD Korea has finalized a drug price agreement with the NHIS regarding the reimbursement expansion for Keytruda. Following review by the Health Insurance Policy Deliberation Committee (HIPDC), the Ministry of Health and Welfare is expected to issue a formal notice next month.The 11 additional indications approved by the Drug Reimbursement Evaluation Committee this time include gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small intestine cancer, and biliary tract cancer. Approximately 2 years after the initial reimbursement expansion request in 2023, the decision now awaits only the Health Insurance Review and Assessment Service (HIRA) resolution.Previously, Keytruda was granted reimbursement for seven indications across four cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma.For metastatic or unresectable recurrent head and neck squamous cell carcinoma, reimbursement was granted for first-line treatment as ▲ monotherapy in PD-L1-positive patients, ▲ combination therapy with platinum and fluorouracil-based chemotherapy.Keytruda to show strong momentum in both regulatory approvals and reimbursement expansion in head and neck cancer.In October, the Ministry of Food and Drug Safety approved an expanded indication for Keytruda as perioperative therapy (pre- and post-surgery) in patients with resectable locally advanced head and neck squamous cell carcinoma.Given this expanded approval in head and neck cancer, MSD is expected to pursue further reimbursement expansion for the approved indications. Beyond head and neck cancer, it holds 35 indications across 18 cancer types, leaving significant potential for additional reimbursement expansion.Keytruda’s annual claims exceed KRW 400 billion, and claims are expected to increase starting next year as additional reimbursed indications start being prescribed.
- Policy
- President Lee "Review reimb of hair loss·obesity drugs"
- by Lee, Jeong-Hwan Dec 17, 2025 09:50am
- President Lee Jae Myung has drawn attention by instructing the Minister of Health and Welfare, Jeong Eun Kyeong, to specifically review the possibility of extending National Health Insurance (NHI) coverage to hair loss and obesity treatments.President Lee stated, "I previously made a campaign pledge to support hair loss medication. Isn't hair loss also part of a disease? I hear many young people use it, so have you reviewed the possibility of coverage?" He added, "I would like you to examine the potential costs, and if unlimited support poses a financial burden, consider limiting the number of doses or imposing a total expenditure cap."President Lee asked, "I assume the reason for the lack of coverage is that genetic factors cause baldness. But isn't a genetic disease also caused by genetics? It becomes a matter of defining whether something is a disease or not." He concluded, "This does not seem logical."President Lee further added, "In the past, hair loss was viewed as a cosmetic issue, but these days, it seems to be perceived as a matter of survival." He then asked, "The same seems to be true for obesity treatment. Is coverage for severe obesity medication under review?"Minister Jeong responded that it is necessary to consider medical urgency or priority when covering hair loss medication.Minister Jeong explained, "NHI supports treatment for alopecia areata caused by medical reasons. NHI does not cover hair loss due to genetic factors because its link to medical treatment is considered low." She added, "It is true that many non-covered medical services include treatments for hair loss, acne, and obesity."Minister Jeong said, "Since they are not life-threatening diseases, other treatments deemed cosmetic are also not covered by the NHI," and added, "We will review [NHI coverage] for these conditions."Regarding coverage for obesity medication, Lee Jung-kyu, Director of the NHIS Bureau, replied, "For severe obesity, we currently provide partial coverage for surgical treatments based on the Body Mass Index (BMI) criteria."Minister Jeong further explained, "We are still reviewing these medications. Since an application for reimbursement has just been submitted, we need to proceed with the review for reimbursement appropriateness.
