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- 2025-12-20 06:13:52
- Policy
- "MFDS' data-based drug shortage response"
- by Lee, Jeong-Hwan Sep 02, 2025 06:09am
- Jeong Eun Keong, Minister of Health and Welfare The Ministry of Health and Welfare (MOHW) announced that it will address drug shortages by utilizing information from the "Pharmaceutical Production, Supply, and Prescription Data-based Supply Risk Prediction System," which is currently being established by the Ministry of Food and Drug Safety (MFDS). The MOHW has also proposed drug shortage response strategies, including domestically producing the raw materials and sub-materials for medicines and vaccines, as well as expanding a production support program for drugs with unstable supply to include up to four pharmaceutical companies. The MOHW also stated that the introduction of abortion drugs could only be expedited after the scope of legal abortion is defined through amendments to the Mother and Child Health Act and the Criminal Act. The following Q&A is based on the MOHW's responses to written inquiries from People Power Party Representative Han Ji-a and Democratic Party of Korea Representative Nam In-soon of the National Assembly's Health and Welfare Committee on August 27. "Responding to unstable supply by linking production, supply, and prescription systems" The MOHW's Division of Pharmaceutical Policy and Division of Health Industry Promotion responded to Rep. Han Ji-ah's inquiries about policy plans to strengthen the drug supply chain. First, the MOHW stated that "securing a stable drug supply chain is essential for protecting and maintaining public life and health, and is an essential task directly related to health security." The Ministry explained that it is "monitoring drugs with supply interruptions or shortages in cooperation with the MFDS, and taking customized measures through a public-private consultative body when necessary." The MOHW also stated that it would create countermeasures by linking its system with the one being developed by the MFDS for drugs with unstable supply. The MFDS is currently building a data-based drug supply risk prediction support system to enhance the prediction of unstable supply situations. The system is designed to comprehensively analyze drug production, supply, and prescription information. In particular, the National Assembly has a pending amendment to the Pharmaceutical Affairs Act that would strengthen the linkage of information on drugs with unstable supply between the MOHW and the MFDS. The Ministry expressed its commitment to support this legislation to address drug shortages actively. The National Assembly also promised to make efforts to produce drug and vaccine raw materials and sub-materials domestically, support the production of drugs with unstable supply, and stockpile essential medicines. The plan is to expand the project that provides budget support for pharmaceutical companies producing drugs with unstable supply from one to four companies. To respond to human infections of avian influenza and bioterrorism, the Ministry plans to prioritize the introduction of the latest overseas vaccines and stockpile them with domestically developed vaccines after their development is complete. It will also focus on national cooperation to diversify the sources of imports for active pharmaceutical ingredients (APIs) from China and India. "Introducing abortion drug requires an amendment to both Mother and Child Health Act and the Criminal Act" The MOHW states that amendments to the Mother and Child Health Act and the Criminal Act are essential for the domestic approval of abortion drugs like Mifepristone. It stated that to create a safe abortion environment, the scope of abortion must be established through amendments to the Criminal Act. While the Constitutional Court's ruling in April 2019 that the abortion ban was unconstitutional effectively nullified the relevant penal provisions, a legislative void has persisted for over six years due to the failure to pass supplementary legislation. As a result, the MOHW's stance is that it is difficult to carry out abortion-related administrative tasks. The MOHW plans to work closely with relevant ministries, including the Ministry of Justice and the MFDS, to support future legal and institutional improvements. Minister Jeong Eun Keong gave the same response during a questioning session with People Power Party Representative Cho Bae-sook at the National Assembly's Special Committee on Budget and Accounts on August 27. Minister Jeong explained, "As the Criminal Act and Mother and Child Health Act have not been amended since the unconstitutional ruling, there are safety issues." She added, "While there are no approved drugs in Korea, most countries in the world use approved drugs." And added, "The World Health Organization (WHO) also provides recommendations based on gestational age." Minister Jeong said, "I will consult with the MFDS on safe usage methods. We will consider both the fetus's right to life and the woman's right to health in a balanced manner."
- Company
- How will fate fare for Roche’s two anticancer drugs?
- by Eo, Yun-Ho Sep 01, 2025 06:05am
- The industry’s eyes are on whether Roche's two anti-cancer drugs, which have faced repeated failures, will succeed in securing reimbursement listing this time. According to industry sources, Roche Korea's treatment for refractory diffuse large B-cell lymphoma(DLBCL), ‘Polivy (polatuzumab vedotin)’ and the PD-L1 inhibitor-based immunotherapy ‘Tecentriq (atezolizumab)’ passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee last month and are currently under discussion for submission to the Drug Reimbursement Evaluation Committee. Both drugs failed to clear the Cancer Disease Deliberation Committee hurdle twice before finally passing on their third attempt. Therefore, it remains to be seen whether Roche, a pharmaceutical company specializing in anticancer drugs that has particularly struggled with Cancer Disease Deliberation Committee approvals since last year, can now achieve progress simultaneously in solid tumors and hematologic malignancies. Polivy originally aimed for reimbursement in 2021 for its first indication - third-line therapy in combination with BR therapy (bendamustine and rituximab), but failed to clear the CDDC hurdle. In the first half of 2023, Roche submitted a reimbursement application for Polivy’s use as first-line therapy in combination with R-CHP therapy (rituximab + cyclophosphamide, doxorubicin, prednisone). However, this application also faced rejection by the CDDC in February of last year. However, there is still hope. Polivy added the 60.9-month follow-up analysis results from the POLARIX study, which evaluated the efficacy of the Pola-R-CHP combination therapy as first-line treatment for DLBCL last year. In the case of Tecentriq, the drug’s reimbursement was first submitted to the Health Insurance Review and Assessment Service (HIRA) for review in May 2023, but it failed to set the reimbursement criteria. Its second attempt was again rejected by HIRA in July last year. At that time, Roche failed to secure reimbursement standards despite presenting additional results showing improved overall survival (OS) at the American Society of Clinical Oncology (ASCO) meeting. Meanwhile, the Polarix follow-up study of Polivy, presented at the American Society of Hematology (ASH) Annual Meeting 2024, is considered the first clinical trial in 20 years to expand the standard first-line treatment for DLBCL. Key results show that the Polivy combination therapy group demonstrated a clear improvement in overall survival (OS) compared to the control group treated with the existing standard therapy, R-CHOP. The lymphoma-related mortality rate was 9.0% in the Polivy combination therapy group and 11.4% in the R-CHOP control group. Approximately 5 years after treatment initiation, the risk of death in the Polivy combination therapy group decreased by 15%, an improvement over the previous 3-year follow-up result (6% risk reduction). In the case of Tecentriq, the 5-year follow-up study of IMpower010 showed that in patients with stage 2-3A non-small cell lung cancer (NSCLC) with PD-L1 expression ≥50%, who underwent complete resection and platinum-based chemotherapy, the Tecentriq adjuvant therapy arm resulted in an OS of 82.7%, which was significantly higher than that of the best supportive care (BSC) arm (65.3%).
- Opinion
- [Reporter's View] New opportunities have emerged for K-Bio
- by Son, Hyung Min Sep 01, 2025 06:04am
- In the global antibody-drug conjugate (ADC) market, the rapid rise of Chinese pharmaceutical companies is being noticed. Just five to six years ago, China was considered a 'technology follower.' However, with massive capital and swift clinical development, it has quickly become a key player in the global market. Chinese pharmaceutical companies are transforming the global landscape by establishing a comprehensive new drug development system, encompassing initial candidate discovery, clinical entry, late-stage trials, regulatory approval, and large-scale manufacturing. These companies are rapidly securing an increasing number of approvals in the US and Europe, while also inking major technology transfers with global pharmaceutical giants. The fact that Chinese companies can run their clinical and sales cycles on the strength of their domestic market alone is a point that Korean companies cannot easily match. With rapid clinical trials based on thousands of patient populations and strong policy support from regulatory authorities, China's 'volume offensive' is demonstrating immense power. In contrast, Korean ADC companies are exploring a different path. LigaChem Biosciences made major technology transfer deals with global pharmaceutical companies by developing a pipeline of over 20 candidates. Orum Therapeutics is accelerating its clinical development with a unique linker-payload technology. ABL Bio aims to expand into the ADC field based on its bispecific antibody platform, while IntoCell explores new ADC targets using its novel platform. In short, while China focuses on 'scale and speed,' Korea is emphasizing 'platform differentiation' with the global market in mind. This differentiated new drug development strategy is not just a competitive dynamic; it also opens up opportunities for collaboration. The production infrastructure and clinical networks of Chinese companies can serve as valuable resources for Korean firms. Indeed, some Korean companies are already trying to enter the market by partnering with Chinese Contract Research Organizations (CROs) to accelerate clinical trials or by forming strategic alliances with Chinese investors. Technology transfer also presents opportunities with Chinese pharmaceutical companies. For instance, LigaChem Biosciences transferred its technology to China's Fosun Pharma, and the HER2-targeted ADC from that deal is currently awaiting approval in China. However, collaboration with China doesn't come without risks. China's volume offensive can quickly drive down the price of a specific modality. With numerous antibodies, novel payloads, and diverse platforms entering the market simultaneously, competition is intensifying. From the perspective of global pharmaceutical companies, they will inevitably weigh the 'cost-effectiveness' of Korea versus China. If Korean companies' platform differentiation is not sufficiently proven, there is a significant risk that their technology will be viewed as a mere consumable commodity. Therefore, Korean companies' strategies must become more sophisticated. The companies need to secure differentiated data at each clinical stage, diversify partnerships with global pharmaceutical companies, and simultaneously manage a relationship of both 'competition' and 'collaboration' with China. Ultimately, how well they solidify their position in the US and European markets will determine the success or failure of the Korean ADC industry. China's rapid emergence in the pharmaceutical sector is both a threat and an opportunity for Korea. It has too much potential for collaboration to be dismissed as just a competitor, yet the risk of market encroachment is too significant to be viewed solely as a partner. The global challenge of the K-ADC will ultimately be judged by how it navigates this delicate balancing act. It is a critical time to clearly understand that even if Korea falls behind in a war of attrition and speed compared to China, there are still opportunities in platform differentiation and strategic partnerships.
- Company
- COVID-19 response more important for high-risk groups
- by Whang, byung-woo Sep 01, 2025 06:04am
- While COVID-19 has entered an endemic phase and become a resident disease in daily life, it remains a significant threat to high-risk groups like the elderly. In fact, the outbreak of COVID-19, which had slowed down for a while, has been showing an upward trend again. According to the Korea Disease Control and Prevention Agency's Infectious Disease Portal, signs of sporadic resurgence have emerged, such as the number of patients hospitalized for COVID-19 increasing from 139 to 220 within a week in early August. Hyun Jong Lee, Vice President of Academic Affairs, Korean Society of Otorhinolaryngology-Head and Neck Surgery (Director of Lee & Hong ENT Clinic), emphasized the importance of rapid diagnosis and treatment, stating, “Although public awareness has significantly declined since COVID-19 became endemic, the fatality rate remains high for high-risk patients if they become infected.” COVID-19 response remains critical for the elderly… proactive measures needed COVID-19 has shown a recurring pattern of outbreaks during the summer and winter seasons since entering the endemic phase. In clinical practice, the actual number of patients is reported to be higher than the official statistics. Lee explained, “Many hidden cases go undetected because COVID-19 is often mistaken for a common cold or air-conditioner-related illness. For those not considered high-risk, testing is not covered by insurance, so patients often don’t feel the need to get tested. In addition, many people who have had a previous infection assume, on their own, that ‘this time it can’t be COVID-19,’ which is not uncommon.” As a result, testing is carried out more actively only among patients aged 65 and older, those in poor general health, or when high-risk family members are living in the same household. Lee stated, “When recommending testing to suspected patients, only about 20-30% of those under 65 get tested, while about 50-70% of those aged 65 and older do.” He interpreted this as “likely because insurance covers diagnosis and treatment for those over 65, and they have greater health concerns.” Indeed, for those aged 60 and above, COVID-19 treatments are covered through reimbursement, allowing prescriptions to be issued upon a positive test result, which is why medical professionals actively recommend testing. However, for those under 60, both testing and treatment are out-of-pocket expenses unless specific risk factors exist, making it difficult for doctors to recommend them readily. Nevertheless, doctors unanimously agree that proactive measures are necessary for the elderly and those with underlying conditions who face a high risk of severe illness. According to Statistics Korea data, individuals aged 65 and older accounted for 91.9% of domestic COVID-19 deaths in 2022, and the fatality rate for those aged 65 and older was approximately 40 times higher than for those under 65. Lee emphasized, “For patients aged 65 and older, those with weakened immunity due to cancer, or those with serious underlying conditions, a COVID-19 infection still carries a very high risk of progressing to severe illness or death. When endoscopic examinations show clear signs that the condition may progress to bronchitis or pneumonia, physicians strongly recommend testing.” Paxlovid transforms COVID-19 response..."Contributing to Reduced Early Mortality" Currently, the mainstay of antiviral treatment for mild-to-moderate COVID-19 cases in Korea is Paxlovid (nirmatrelvir/ritonavir). Developed by Pfizer, this oral therapy has been proven effective when administered early in patients at high risk of severe disease progression. Lee evaluated, “Paxlovid is a very good drug that works by suppressing viral replication. It has demonstrated excellent effects when given in the early stages. Between 2023 and 2024, with stable supply and growing clinical experience, its use has expanded significantly, and we confirmed that it contributed to reducing early mortality.” The outstanding therapeutic effect of Paxlovid is also evident in patient experiences. According to Lee, “Elderly patients who had struggled greatly during previous COVID-19 infections now report a dramatic improvement after taking Paxlovid, saying they ‘feel much better.” Unlike when taking common cold medicine, patients reported feeling the effects directly after taking antiviral drugs, such as fever and pain subsiding much faster. These clinical observations are supported by research data. In the global EPIC-HR clinical trial, early administration of Paxlovid reduced the risk of hospitalization and death among COVID-19 patients by up to 86%. Similarly, a domestic study analyzing about 1.94 million patients reported that confirmed cases aged 60 or older who took Paxlovid within five days of symptom onset had a significantly lower risk of severe progression and death compared with those who did not. The prescription environment for oral COVID-19 treatments recently reached a major turning point. The government provided Paxlovid free of charge until last year, but starting this year, it transitioned to being reimbursed by national health insurance, meaning patients now bear part of the cost. Regarding this, Lee explained, “During the period when it was provided free of charge, some patients did not take the medication even after receiving a prescription because they didn't realize its value since they weren't paying for it. However, the shift from free to paid supply, introducing patient coinsurance, has brought one positive change: increased medication adherence.” “Reimbursement limited for the elderly and high-risk groups...Reimbursement criteria must be expanded” Nevertheless, this hasn't resolved all concerns on the site. Criticism persists that Paxlovid's current insurance reimbursement criteria are overly restrictive, potentially causing some high-risk patients to miss treatment opportunities. Lee emphasized, “Paxlovid currently faces many reimbursement restrictions. An infection that young family members might brush off lightly can be difficult for those in their 70s and 80s to recover from, potentially leading to death. Reimbursement should be lowered to include those aged 50 and above, and if safety is not an issue, it should also be expanded to include pediatric patients with underlying conditions.” In other words, experts believe that the current prescription system, centered on those aged 60 and above, should be expanded to include those in their 50s. They also advocate allowing healthcare providers to apply antiviral drugs at their discretion to middle-aged and older adults with underlying conditions. Finally, Lee urged high-risk COVID-19 patients and their families to adhere to two principles: prevention and prompt treatment. He advised, “As The Art of War states, ‘The best victory is one won without fighting,’ avoiding infection is paramount in COVID-19 management. Alongside hygiene protocols, establishing a primary defense line through vaccination in consideration of one's immune status is necessary.” Lee further added, “For those who cannot get vaccinated or fail to develop antibodies after vaccination, there is now Paxlovid. Since rapid diagnosis and treatment are crucial for its use, early testing and prompt treatment are a must for high-risk groups.”
- Company
- Capvaxive release imminent in the pneumococcal vaccine mkt
- by Whang, byung-woo Sep 01, 2025 06:03am
- MSD's adult-specific 21-valent protein-conjugated vaccine Capvaxive was granted marketing authorization in Korea by the Ministry of Food and Drug Safety and has emerged as a new competitor in the domestic adult pneumococcal vaccine market. With Prevenar 20 now launched in the market previously contested by Prevenar 13 and Vaxneuvance, Capvaxive is expected to target the market based on its unique selling point as an adult-specific vaccine with the broadest serotype coverage. Pic of Capvaxive Capvaxive is the first adult-specific vaccine designed to prevent invasive pneumococcal disease and pneumonia in adults. Unlike existing PCV vaccines targeting both children and adults, it covers a total of 21 serotypes, including 8 unique serotypes, reflecting the epidemiological characteristics of the adult population. This covers the serotypes responsible for 85% of invasive pneumococcal disease in adults aged 65 and older (based on U.S. data), and is expected to fill a prevention gap in the rapidly aging Korean market. Capvaxive’s influence has been growing steadily in global markets where it has already received approval. The U.S. Food and Drug Administration (FDA) approved Capvaxive in June 2024, and it is being quickly introduced on-site.. Based on MSD's announced earnings for this year, Capvaxive recorded USD 107 million in Q1 and USD 129 million in Q2, totaling USD 236 million (KRW 328.2 billion) in sales in the first half of the year. Considering it has been about a year since its full launch, its sales are expected to continue to grow. According to industry sources, MSD is expected to launch Capvaxive in the first half of next year. Considering how Vaxneuvance received approval in the second half of 2023 and launched in April the following year, its launch in Q1 is likely.. In this case, the adult pneumococcal market is also expected to undergo restructuring. Currently, the vaccinations available in Koera for adults include Prodiax 23 (PPSV23), Prevenar 13 (PCV13), Vaxneuvance (PCV15), and Prevenar 20 (PCV20). As Prodiax 23 is included in the National Immunization Program, effectively, three vaccines are competing in the non-reimbursement market. However, as Prevenar 20 and Capvaxive are the respective follow-up vaccines to Prevenar 13 and Vaxneuvance, the competitive landscape is expected to center on the competition between the two. As Chong Kun Dang partnered with Pfizer to distribute Prevenar 20 following Prevnar 13, the industry anticipates that Boryung Biopharma, which handles sales of Vaxneuvance, will distribute for Capvaxive in terms of continuity. Amid rising demand for preventive vaccines among the elderly and high-risk groups, attention is focused on whether the domestic introduction of Capvaxive will bring changes to future vaccine policies, such as Korea’s National Immunization Program (NIP), and market strategies. A vaccine industry insider explained, “With the balance shifting this year from Prevenar 13 to Prevenar 20 for adult pneumococcal vaccines, and now another vaccine with even more serotypes emerging, marketing competition to differentiate their product amongst the wide range of choices is set to intensify.”
- Company
- CKD says, "New ADC drug enters first clinical trials"
- by Son, Hyung Min Sep 01, 2025 06:03am
- Changsik Lee, Head of Chong Kun Dang Research Center Chong Kun Dang is accelerating its development of a new c-Met-targeted Antibody-Drug Conjugate (ADC). With its newly entered clinical candidate, 'CKD-703,' the company is aiming to secure a best-in-class ADC and is seeking a differentiated strategy in a globally competitive landscape. On August 29, Samsung Medical Center and Aimed Bio co-hosted the 3rd ADC Conference at Samsung Hospital's main auditorium. Chong Kun Dang's research director, Changsik Lee, introduced the ADC new drug candidate CKD-703, which has entered the clinical stage. Since 2019, Chong Kun Dang has been collaborating with the Dutch company Synaffix on ADC discovery. In February of last year, it acquired non-exclusive rights to Synaffix's ADC platform technology in a deal valued at $132 million. Synaffix is currently partnering with several key domestic bio-companies on its platform technology. Using this technology, Chong Kun Dang successfully developed CKD-703. CKD-703 is a drug that targets the hepatocyte growth factor receptor (c-Met), which is overexpressed in cancer cells, and is being developed for solid tumors, including non-small cell lung cancer (NSCLC). Last month, the U.S. Food and Drug Administration (FDA) approved Chong Kun Dang's Investigational New Drug (IND) application for a Phase 1/2a clinical trial of CKD-703. This is the first time Chong Kun Dang has entered a global clinical trial for an ADC. c-Met targeted by CKD-703 is a protein expressed by the epithelial-mesenchymal transition (MET) gene. As a key signaling protein, c-Met is a well-known oncogene linked to the development of various solid tumors, including NSCLC, colorectal, gastric, and liver cancers. It is known that the c-Met mutation occurs in 6% of NSCLC patients. Currently, AbbVie's Emrelis (telisotuzumab vedotin) is the only commercially available ADC that targets the c-Met mutation. Emrelis received accelerated approval in the U.S. in May for NSCLC. In its Phase 2 clinical trial involving 84 patients with c-Met overexpression, the objective response rate (ORR) was 35%, and the duration of response (DoR) was 7.2 months. Lee noted, "In clinical trials, Emrelis's efficacy was primarily observed in patients with c-Met overexpression, with an ORR of 35%. We believed there was a significant unmet need that could be addressed in patients with low expression and in terms of response rates." Synaffix (Netherlands) However, competitors continue to emerge. Celltrion is also focusing on c-Met-targeted ADCs, having received approval for its CT-P70 Phase 1 clinical trial in Korea and the U.S. this year. Chong Kun Dang plans to differentiate itself from global competitors in areas such as toxicity management and treatment response rates to prove its commercialization potential. Lee stated, "We have confirmed that CKD-703 has a high yield of over 85%, which poses no issues for its progression to clinical trials," and added, "The payload was the main concern, but there was no reason to change it from the one used in Elahere to achieve a better effect. We used MMAE, a microtubule inhibitor payload, which is also applied in Emrelis." And added, "CKD-703 has the potential for improvement over existing treatments in terms of efficacy and safety." Lee analyzed, "In preclinical monkey models, the incidence of thrombocytopenia, a condition where platelet counts drop below the normal range, was lower for CKD-703 compared to Emrelis." Lee emphasized, "We are dedicating our utmost corporate resources to the development. In this clinical trial, we expect CKD-703 to demonstrate a higher efficacy than existing treatments in patients with c-Met overexpression, and also prove its efficacy in patients with low and intermediate expression. Our goal is to secure a best-in-class treatment, and we are open to the possibility of combination therapy with immunotherapies."
- Policy
- Industry requests incentives for rare and orphan drug supply
- by Lee, Hye-Kyung Aug 29, 2025 06:07am
- The pharmaceutical industry has voiced the need for incentives to expand supply support, such as official certification, for companies supplying rare and essential drugs. The Ministry of Food and Drug Safety (MFDS, Minister Yu-kyoung Oh) visited the Korea Orphan & Essential Drug Center on the 28th to review the center's current projects supporting the supply of rare and essential medicines. It then held an ‘On-site discussion forum to support drug supply’ with the Korean Organization for Rare Diseases, the Korean Society of Health-System Pharmacists, the Korean Society of Cardiology, Huons, Korea United Pharm, and Sinwon Chemical. Pharmaceutical companies attending the meeting reportedly proposed measures such as incentive schemes and ways to shorten the emergency introduction period for rare and essential medicines. Patient groups requested guidance on the supply plans for medicines that had recently experienced supply disruptions, resulting in treatment difficulties. MFDS Minister Yu-Kyoung Oh said, “We will actively support and continuously communicate with the industry and patient groups to ensure the stable and prompt supply of rare and essential medicines needed for treating patients with rare and intractable diseases.” Young-Rim Kim, Director of the Korea Orphan & Essential Drug Center, said, “We will work with the MFDS to reflect the opinions provided by patient groups and pharmaceutical companies in the operation of the rare and essential medicines supply support project and ensure these medicines are safely supplied to patients.” The Ministry of Food and Drug Safety (MFDS), together with the Korea Orphan & Essential Drug Center, is working to supply rare disease medicines in a timely manner and reduce patient burden by rapidly introducing orphan drugs and operating patient support programs. The center is also pursuing self-sufficiency and reducing reliance on foreign countries by utilizing the technological development of raw and finished drugs for essential national medicines that are taken daily through consignment production with domestic pharmaceutical companies. The MFDS plans to continue communicating with patient groups and industry stakeholders to identify and implement various policies ensuring the stable supply of medicines in need. Meanwhile, this forum was arranged to thoroughly explore government support measures for the stable supply of medicines to patients with rare and intractable diseases, an issue raised during the ‘Food and Drug Policy Connection Open Forum (Medical Products Sector)’ held on July 22. Opinions presented at the meeting will be actively reflected in future policies for the stable supply of medicines.
- Company
- Ozempic adds indication for patients with diabetes and CKD
- by Son, Hyung Min Aug 29, 2025 06:07am
- Novo Nordisk Novo Nordisk Korea (General Manager: Kasper Roseeuw Poulsen) announced on the 28th that Ozempic has been approved as a treatment for type 2 diabetes with chronic kidney disease. With this approval, Ozempic is now indicated for: ▲ Use as an adjunct to a two-drug regimen (either alone or in combination with other diabetes medications), in adults with type 2 diabetes whose condition is not adequately controlled. ▲Reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and confirmed cardiovascular disease. This approval expands its indications to encompass the broadest patient base among GLP-1 receptor agonist (GLP-1RA) type 2 diabetes treatments launched in Korea. Ozempic has further solidified its position as a comprehensive treatment option for adult patients with type 2 diabetes, not only offering glycemic control but also a reduction in the risk of major adverse cardiovascular events (MACE), sustained reduction in estimated glomerular filtration rate (eGFR) in adults with type 2 diabetes and chronic kidney disease, and reduction in the risk of reaching end-stage kidney disease and cardiovascular disease mortality. The expansion of Ozempic's indication to chronic kidney disease was based on results from the FLOW study. The FLOW study was a multinational, multicenter, placebo-controlled, double-blind, 1:1 randomized study evaluating the efficacy and safety of Ozempic versus placebo in 3,533 adult patients with type 2 diabetes and chronic kidney disease. The primary endpoint of this study was a composite endpoint consisting of a sustained 50% or greater decline in estimated glomerular filtration rate (eGFR) from baseline, occurrence of end-stage kidney disease, or death due to cardiovascular or renal disease. The median follow-up period was 3.4 years, and the Ozempic group demonstrated a 24% reduction in the risk of the composite endpoint compared to the placebo group. Furthermore, serious adverse events reported in this study occurred in 877 patients (49.6%) in the Ozempic group and 950 patients (53.8%) in the placebo group, showing similar rates between the two groups. Kasper Roseeuw Poulsen, General Manager of Novo Nordisk Korea, stated, “The expansion of Ozempic's indication for chronic kidney disease marks a turning point, signaling that diabetes treatment has entered a new era where treatment goes beyond simple blood glucose control to comprehensive management of cardiovascular and renal risks. “As a company that has led diabetes care for over 100 years, Novo Nordisk is setting new standards in type 2 diabetes treatment based on its scientific innovation and accumulated experience. Moving forward, Novo Nordisk will continue to serve as a trusted partner for patients and healthcare professionals across all areas of diabetes care, and lead the future of integrated treatment in diabetes.”
- Opinion
- [Reporter's View] Innovativeness and trust in healthcare AI
- by Whang, byung-woo Aug 29, 2025 06:07am
- As the innovation of Artificial Intelligence (AI) is robustly developed in the healthcare sector, concerns related to both utilization and implementation are arising. In Korea, the cost required for AI utilization in medical institutions is considered the number one priority for discussion. Additionally, 'awareness' has also been brought to attention recently. In this context, Philips Korea recently launched the "Future Health Index 2025 Korea Report,' highlighting the issue of building 'trust.' According to the report, 86% of the healthcare professionals answered that healthcare AI will improve the medical field, whereas only 60% of the patients responded positively. This indicates a trust gap over 26%. For instance, answers such as 'AI enhances work efficiency' and 'patients still have concerns' suggest that there are conflicting responses. In this regard, the hospital cases presented by Dr. Kim Eun-kyung, Director of Yongin Severance Hospital at Yonsei University, are worth considering. Since its opening, Yongin Severance Hospital has advocated for an AI-based digital hospital. The use of AI in healthcare has shown promising results through various applications, including assisting with chest X-ray interpretation, tracking the movements of infected individuals, and enabling digital pathology and voice-recognized medical records. Notably, tracing contacts in just 10 minutes, a task that previously took half a day for infection control, truly demonstrates the value of AI. However, there is a recurring concern. "The irony of needing to hire more people to support a digital system that's supposed to be for people." This is because integrating AI into systems like EMRs (Electronic Medical Records) is a costly endeavor. There's also the administrative burden of obtaining patient consent repeatedly. Although there is a designation of Innovative Medical Technology group, its procedures and costs are often criticized for hindering progress. The fundamental issue lies in the regulatory framework. While healthcare professionals agree that AI is helpful, there's a lack of clarity regarding legal responsibility. The question of who is liable for a misdiagnosis made by AI has not been clearly defined. A report found that 74% of Korean healthcare professionals expressed concern about this issue. The key discussion surrounding AI ultimately narrows down to 'trust'. The core challenge is not just the technical performance of AI, but how regulations and systems can support it. This includes the implicit guarantee of government financial support. For patients, transparent explanations and safety nets are essential. Healthcare professionals require clear rules of liability and cost compensation, and companies need a sustainable policy. The speed of technology is already sufficient. Now, it's time for a framework that can institutionally support trust to follow suit. For innovation to be implemented, regulations must be able to keep up. It is essential to consider how to enable AI to fulfill its inherent role of providing efficiency and allowing for the reinvestment of human resources.
- Policy
- Next year’s reimb reevaluations to be discussed further
- by Lee, Tak-Sun Aug 29, 2025 06:07am
- The government has decided to continue discussions on the 2026 reimbursement adequacy reevaluation plan. While the reevaluation was initially expected to be approved this month through the Health Insurance Policy Deliberation Committee review, it is reported that disagreements remain unresolved regarding selection criteria, procedural improvements, and the ingredients targeted for 2026. Some suggest the findings from an ongoing post-listing drug control study commissioned by the MOHW may be incorporated. According to industry sources on the 28th, the ‘Plan to Promote Drug Reimbursement Adequacy Reevaluations’ reported to the HIPDC subcommittee was not placed on the agenda for the HIPDC plenary session on the 28th. The government stated it would continue discussions. The plan reported to the subcommittee shows that the selection criteria for evaluation will change from the current threshold of an increase of 0.1% or more of the average claim amount over three years (approximately KRW 20 billion) to claims of KRW 10 billion or more. Furthermore, the condition for “'listed reference countries' will be expanded from the current requirement of fewer than 2 countries to fewer than 3 countries. The seven drug ingredients subject to reevaluation in 2026 are: Ginkgo biloba extract that was approved in 1989, Calcium dobesilate hydrate, Calladinogenase, Meglumine gadoterate, Diacerein, Afloqualone, and Octilonium bromide. The level of reimbursement will also be differentiated based on evaluation results. For drugs with unclear clinical utility but high social necessity, a 50% selective reimbursement rate will apply; for those with low social necessity, an 80% selective reimbursement rate will apply. Additionally, if the drug cost is high compared to its alternatives, an additional price cut will be applied. Previously, decisions only excluded drugs from reimbursement or maintained reimbursement, with drug prices adjusted through voluntary reductions by manufacturers to demonstrate cost-effectiveness. The pharmaceutical industry has clearly stated its opposition to this plan. Specifically, the argument is that the late selection of next year's reevaluation targets has rendered insufficient time to prepare data, making the 2026 reevaluation unfeasible. This is because it takes about a year for drug efficacy to be included in textbooks. Additionally, opinions have emerged that the selection of ginkgo biloba extract preparations as next year's target ingredients is unreasonable. So the pharmaceutical industry has expressed temporary relief as the government decided to further discuss the reevaluation plan. It is known that the government authorities were not in agreement regarding this reevaluation plan at the Drug Reimbursement Evaluation Committee and the Health Insurance Review and Assessment Service subcommittee level. Particularly, it is reported that further discussion would be needed regarding changes to the criteria. Some predict that the reimbursement reevaluation plan will be revisited based on the ‘Study on Integrated Post-listing Control of Drug Prices’ currently underway as an MOHW research project. This study is scheduled to be conducted by the Catholic University of Daegu Industry-Academic Cooperation Foundation (Director Hyeop-sang Yoon) until November. It is anticipated that the study conducted last year by the Korea Institute for Health and Social Affairs will include implementation plans related to integrated post-listing control measures. An industry official explained, “Given that the post-listing control study is currently underway, it appears the new administration will comprehensively review the post-listing control system. Consequently, there are projections that the finalization of the reevaluation plan may extend beyond this year.”
