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- 2026-06-10 16:16:04
- Policy
- Abolishing illegal CSO·rebate…under 'National Normalization Project'
- by Kang, Shin-Kook May 26, 2026 03:21pm
- Shim Jong-seop, Director General for Government Operations at the Office for Government Policy CoordinationThe Korean government is launching comprehensive regulatory reforms and monitoring to eradicate illegal rebates and unlawful Contract Sales Organizations (CSOs), which have long been practiced within the pharmaceutical industry, and to rectify abnormal practices in the healthcare sector, such as fraudulent receipt of medical care benefits.The Office for Government Policy Coordination (Director General, Shim Jong-seop) announced on the 22nd that it has finalized 164 initial tasks under the 'National Normalization Project,' an initiative aimed at rectifying deep-seated, abnormal practices and systems across society, and will begin government-wide structural overhauls.This project was coordinated primarily by the 'National Normalization Task Force,' chaired by the Prime Minister, and includes numerous innovation initiatives in the medical and pharmaceutical sectors, led by the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS).◇ Transparent illegal CSOs and strengthening penalties for healthcare professionals receiving unlawful benefits...enhancing the effectiveness of punishments for pharmaceutical rebatesThe initiative's most prominent aspect involves measures to ensure transparency in the pharmaceutical distribution market. The government has resolved to eradicate illegal CSOs that have exploited legal loopholes to engage in non-compliant expedience. Under the leadership of the MOHW, institutional gaps will be closed with the mainstream, and transparency will be brought to CSO operations. Notably, the government plans to establish new penal provisions targeting healthcare professionals who accept illicit benefits from CSOs, and to launch a comprehensive, large-scale fact-finding investigation.Concurrently, the MFDS will intensively pursue the task of "eradicating pharmaceutical company rebates." The current system penalizes pharmaceutical companies caught providing rebates by suspending sales operations; however, it has been criticized for being ineffective due to rampant loopholes, such as companies pushing out massive sales volumes right before the suspension takes effect. In response, the government will devise measures to significantly improve the enforcement effectiveness of sales suspensions to block illegal rebating at the source.◇ Introducing special judicial police to the NHIS to detect 'fake treatments'... overhauling the reimbursement fee structure for laboratory testingAdministrative measures will also be strengthened to cut off unfair practices and malpractice at the clinical frontline. The MOHW plans to step up proactive prevention of fraudulent medical care benefit claims while introducing a Special Judicial Police system within the National Health Insurance Service (NHIS) to completely root out the leakage of health insurance funds caused by "fake treatments" and "fake patients."Furthermore, the government will completely overhaul the 'health insurance reimbursement fee structure for outsourced laboratory testing,' which has previously been flagged as a threat to patient safety. New differentiated reimbursement fees for outsourcing and consigned testing institutions will be established. Accreditation standards for consigned laboratories, quality-linked incentive systems, and penalty criteria will be upgraded to enhance testing quality and guarantee patient safety.The Korea Disease Control and Prevention Agency (KDCA) will also target abnormal non-profit organizations that may have suffered from lax oversight, identifying financial vulnerabilities and enhancing accounting transparency by upgrading systems and strengthening the management of secure media and assets.◇ Detecting 'Fake Ambulances' in Real-Time...Introducing GPS-Based integrated management 'Fake ambulances,' which have provoked public outrage due to incidents involving celebrities riding in them or other forms of unauthorized private use, are set to disappear. The government will introduce a GPS-based, real-time integrated operations management system for ambulances and rationalize emergency transport and treatment fees to improve oversight efficiency and establish a stable operational environment.In addition, to ensure the golden-hour for severe emergency patients, the National Fire Agency (NFA) and the MOHW will collaborate to extensively upgrade the patient transfer network between fire services and medical institutions based on regional medical resource availability.Shim Jong-seop, Director General for Government Operations at the Office for Government Policy Coordination, emphasized, "This National Normalization Project is not a one-off event but a systematization of the core duties that the government must perform." Shim added, "We will rigorously manage the process to deliver clear results that the public can see."
- Company
- Pulsed field ablation gains reimbursement in Korea
- by Hwang, byoung woo May 26, 2026 03:21pm
- Reference Material (AI-generated image)The atrial fibrillation ablation market has entered a full-scale competition following reimbursement coverage for pulsed field ablation (PFA).PFA has been garnering attention as a next-generation technology capable of replacing existing radiofrequency and cryoablation procedures, but its adoption was limited due to non-reimbursement barriers. However, with national health insurance coverage beginning in May, patient access has improved, and market conditions are changing.In particular, because the reimbursement applies not to a specific company’s product but to the ‘PFA procedure’ itself, Boston Scientific, Johnson & Johnson (J&J), and Medtronic are all expected to compete under the same regulatory framework.Reimbursement marks a turning point in the market... Will PFA adoption accelerate?PFA is an ablation procedure that uses high-voltage electric fields to selectively damage myocardial cells. Unlike conventional radiofrequency ablation or cryoablation, which rely on heat, PFA is considered a next-generation atrial fibrillation treatment because it can reduce damage to surrounding tissues.In particular, its ability to reduce the risk of complications, such as esophageal injury, phrenic nerve injury, and pulmonary vein stenosis, which were concerns with traditional thermal ablation, is cited as a key strength. Combined with the potential for shorter procedure times, the shift to PFA is already progressing rapidly in the global market.According to a report by the Korea Health Industry Development Institute, Korea’s PFA market is expected to grow from approximately USD 31 million in 2024 to around USD 53 million by 2029, representing a compound annual growth rate of 11.1%.The global PFA market is projected to expand from approximately USD 1.53 billion in 2024 to about USD 9.25 billion by 2029.In practice, even during the non-reimbursed stage, some major tertiary hospitals had already accumulated experience using PFA. According to the report, Severance Hospital introduced PFA at the end of 2024 and has been actively using it since 2025.Out of roughly 1,000 total atrial fibrillation ablation procedures currently performed, about 350 are now conducted using PFA, and the hospital expects more than 70% of all procedures to eventually transition to PFA.Ultimately, while PFA was previously used only on a limited basis depending on whether patients had out-of-pocket insurance coverage, its reimbursement coverage is expected to reduce cost barriers and position PFA as a major treatment option for atrial fibrillation ablation.Market Size and Growth of Korea's PFA Market (Reconstructed AI image of Korea Health Industry Development Institute's report)Boston Scientific’s early approval advantage…J&J focuses on integration, Medtronic on expandabilityAccording to the medical device industry, Boston Scientific currently holds the leading position in the early competitive landscape.Boston Scientific’s Farapulse PFA platform became the first medical device approved in Korea for PFA when it received Ministry of Food and Drug Safety approval in September 2024.Boston Scientific emphasizes that, in connection with the new reimbursement coverage, it possesses both the “Farawave PFA Catheter,” capable of two-dimensional visualization, and the “Farawave NAV PFA Catheter,” which enables three-dimensional visualization of treatment sites.Farapulse’s strengths lie in its early approval and accumulated clinical evidence. According to the company, Farapulse has built up safety and efficacy data through studies such as the ADVENT trial, which directly compared it with thermal ablation, and the MANIFEST-17K registry, which analyzed real-world clinical outcomes in more than 17,000 patients.Its competitor, Johnson & Johnson, is promoting a different type of competitiveness through Varipulse. The Varipulse system is a three-dimensional PFA treatment solution consisting of the Varipulse catheter, TruPulse generator, Carto3 3D mapping system, and Vizigo Steerable Sheath.Its key advantage is integration. Varipulse is designed to integrate with J&J’s electroanatomical mapping system, Carto 3. Because confirming catheter position, visualizing cardiac structures, and identifying lesion locations are increasingly important during PFA procedures, integration with mapping systems may become an important factor in hospital purchasing decisions.Being somewhat of a late entrant in Korea, Medtronic is establishing a competitive presence in terms of expandability.Medtronic’s PulseSelect PFA system received U.S. FDA approval in December 2023 for the treatment of paroxysmal and persistent atrial fibrillation. The company is expected to leverage the fact that PulseSelect was the first PFA system approved by the FDA, along with its global clinical usage experience.Another differentiating point for Medtronic is its future product lineup. Through products such as the dual-energy Affera Mapping and Ablation System, which combines pulsed field and radiofrequency energy, and the Sphere-9 Catheter, the company is pursuing a strategy of expanding treatment areas beyond atrial fibrillation into atrial flutter and ventricular tachycardia.KHIDI Report (AI image reconstruction)Competition lies in hospital workflows rather than productsFollowing reimbursement listing for PFA, market competition is likely to unfold not as a one-sided dominance by a specific company, but rather as a diversification of selection criteria among individual hospitals.Atrial fibrillation ablation procedures are not determined by a catheter alone. Mapping systems, imaging equipment, physician expertise, existing hospital equipment infrastructure, training support, long-term clinical data, and cost structures all play important roles. As a result, preferred platforms may vary from hospital to hospital.For example, hospitals prioritizing early adoption experience and accumulated clinical evidence may favor Boston Scientific’s Farapulse, while hospitals already operating electrophysiology workflows centered on the Carto3 system may choose J&J’s integrated Varipulse solution.Hospitals focusing on future technologies and expandability of indications may instead see Medtronic’s long-term product lineup as more competitive.Nevertheless, the general consensus is that as PFA becomes mainstream, the atrial fibrillation ablation market has entered a full-fledged transition phase.Whereas the technology was previously used mainly by select patients and leading hospitals, patient accessibility and hospital adoption potential are now expanding simultaneously.As a result, while domestic approval and early adoption were previously the key competitive factors, post-reimbursement competition is expected to depend increasingly on real-world experience, interoperability with existing hospital equipment, procedural training, data accumulation, and the speed of follow-up product introductions.A medical device industry official said, “In overseas markets such as the United States, PFA is already rapidly establishing itself as the standard of care. With reimbursement now improving patient access in Korea as well, the transition toward PFA driven by procedural efficiency and safety is expected to accelerate further.”
- Company
- Varying performance levels of medical imaging AI companies
- by Hwang, byoung woo May 26, 2026 03:21pm
- AI-generated imageDomestic medical imaging artificial intelligence (AI) companies reported varying performance in their first-quarter results, even as they posted losses.While attention was previously focused on whether these companies could generate any sales during the initial stages of commercialization, the market is now asking "How do these companies make money?"Consequently, the attention is on the Q1 2026 performance is not top-line sales rankings, but rather the specific channels through which sales is generated. Performance divergence among medical imaging AI companies is accelerating, depending on factors such as overseas commercialization channels, integration into domestic institutional healthcare frameworks, and volume-based recurring revenue streams.Positive indicators in overseas·recurring revenue…Lunit·Coreline Soft differentiating factorsLunit recorded revenue of KRW 24.0 billion for the first quarter of 2026, a 25% increase compared to the KRW 19.2 billion recorded in the same period last year. Concurrently, its operating loss narrowed from KRW 20.8 billion to KRW 13.6 billion, demonstrating increased revenue alongside a reduction in losses.The most critical indicator in Lunit’s performance is its overseas revenue. According to the company's Q1 financial data, international sales reached KRW 23.2 billion, a 29% increase from KRW 17.9 billion in the prior-year period, accounting for a 97% of total revenue.Domestic medical AI markets are highly susceptible to institutional and regulatory factors, such as New Medical Technology Assessments, non-reimbursement status, and reimbursement rates. Conversely, Lunit has successfully established a structure in which the vast majority of its quarterly revenue is secured through global distribution channels.By business segment, cancer screening remains the primary growth driver. Software revenue from Lunit's cancer screening segment totaled KRW 21.3 billion in Q1, accounting for approximately 89% of total revenue.Although its cancer treatment decision-support segment, which includes Lunit SCOPE, is emerging as a new growth vector, the core revenue generator as of Q1 2026 remains the cancer screening business, which includes diagnostic imaging assistance and breast cancer screening software.However, challenges persist on the bottom line. While its operating loss narrowed, the company still posted a KRW 13.6 billion deficit in the first quarter. Although an improving trend in profitability has been confirmed, further revenue expansion and disciplined cost management are required to achieve a turnaround to operating profitability.Comparison of 2025-2026 first quarter revenue of major medical imaging artificial intelligence (AI) companies (unit: KRW 100 million/source: quarterly reports). Lunit, Vuno, Deepnoid, Coreline Soft, and JLK.Coreline Soft, while not yet achieving Lunit's massive exterior performance, showed other positive indicators in its revenue structure.Coreline Soft recorded consolidated revenue of KRW 1.3 billion in the first quarter of this year, representing an approximate 44% increase year-over-year.Out of this total, overseas revenue amounted to approximately KRW 800 million, representing 62.4% of its overall business. This was the first time the company's international revenue share has exceeded 50%.The expansion of its recurring revenue stream is also noteworthy. The company announced that the share of recurring revenue derived from volume-based utilization, term licenses, and software maintenance agreements reached 49.1% in Q1, climbing roughly 10 percentage points from 38.9% in the prior-year period.Specifically, volume-based pay-per-use revenue surged by 319.7% year-over-year. This indicates that the business model of medical AI companies is successfully pivoting from one-off, on-premise deployments and perpetual license sales toward a framework dynamically tied to actual utilization rates and diagnostic screening traffic.This structural shift is closely aligned with international national screening initiatives. According to Coreline Soft's documents, the company secured 11 new hospital contracts in Germany during Q1 alone, surpassing its entire annual total of 10 new contracts in Germany for the previous year within a single quarter.Coinciding with Germany’s statutory health insurance reimbursement coverage for low-dose CT (LDCT) lung cancer screening, demand for AI-driven diagnostic reading, quality control, and longitudinal tracking systems is poised for further expansion.Ultimately, Lunit leveraged international revenue to establish a quarterly baseline of over KRW 20 billion, while Coreline Soft signaled a clear structural pivot toward recurring revenue streams despite its smaller absolute volume. The former differentiated itself through scale, and the latter through its business model structure.Vuno shows high reliance on DeepCARS…performance staggers due to regulatory variablesIn the case of Vuno, the company had previously achieved record-high consolidated annual revenue of KRW 34.8 billion last year, growing 35% year-over-year, and successfully narrowed its operating loss by 60% down to KRW 4.9 billion through aggressive cost-optimization initiatives.Performance was led by its flagship product, DeepCARS, an AI-driven cardiac arrest prediction medical device, which generated KRW 25.7 billion in revenue, representing an approximate 18% year-over-year increase.However, its momentum slowed in the first quarter of 2026, with revenue dipping 16% quarter over quarter to KRW 6.0 billion.The company explained that this temporary revenue fluctuation occurred as DeepCARS navigated the New Medical Technology Assessment process, coinciding with the expiration of its assessment deferral window.Vuno’s challenge lies in the high concentration of its core revenue stream in domestic DeepCARS sales.Although Vuno has designated the US commercial launch of DeepCARS as its top strategic priority, a fully realized revenue stream backed by US regulatory clearance and insurance reimbursement has not yet materialized. Consequently, Vuno's Q1 financial performance remained dependent on domestic DeepCARS sales and the progress of the domestic New Medical Technology Assessment procedures.While market expansion is anticipated once the regulatory assessment process is finalized, establishing and diversifying commercial pipelines in global markets remains an urgent, ultimate objective.AI-generated imageDeepnoid·JLK, In a transitional phase prior to scaling revenue volumeDeepnoid generated only KRW 7.5 billion in annual revenue, falling significantly short of its previously guided revenue forecasts.Deepnoid attributed this discrepancy to slower-than-expected expansion in medical AI adoption, delays in securing health insurance reimbursement pricing and international regulatory clearances, and intensifying competition from incumbent PACS (Picture Archiving and Communication System) vendors.Furthermore, Deepnoid disclosed that it halted the standalone commercialization of DEEP:PHI, citing diminished differentiation for platform-type business models following the advent of generative AI.Its revenue for the first quarter of 2026 amounted to approximately KRW 400 million. Even within this figure, the company relied heavily on its industrial AI division (roughly KRW 300 million) rather than its core medical AI segment (which brought in just KRW 57.75 million).As operating deficits widened due to increased fixed costs associated with R&D scaling and expert talent acquisition, the company’s top priority has shifted to proving the self-sustainability of its medical division. This hinges on successfully anchoring its cerebral aneurysm solution, "DEEP:NEURO," within the domestic non-reimbursement market.JLK is actively driving market entry into the non-reimbursement sector for its pipeline expansion, including its large vessel occlusion (LVO) detection solution, "JLK-LVO", starting with the current non-reimbursement prescriptions of its ischemic stroke solution, "JLK-DWI."However, to overcome the limitations of a constrained domestic market, the company is committing substantial capital to establishing international commercial networks via its wholly owned subsidiaries in the United States (JLK USA INC.) and Japan (JLK Japan, Inc.).Both JLK USA and JLK Japan reported zero revenue in the first quarter, posting net losses of approximately KRW 100 million each. Because these international subsidiaries have yet to generate meaningful top-line contributions, the company is currently in a wait-and-see window to determine whether these infrastructure investments will successfully translate into global financial performance.A medical device industry employee stated, "With digital health companies that have secured insurance reimbursement pricing recently reporting robust financial metrics, pressure to perform is intensifying for medical imaging AI firms as well. We have entered a stage where regulatory clearance or initial hospital adoption alone no longer satisfies market evaluation. The core mandate now is establishing a commercial architecture that translates into sustainable, predictable revenue."
- Company
- Will reimbursement of CDK4/6 inhibitors finally be expanded?
- by Eo, Yun-Ho May 26, 2026 03:21pm
- The decisive moment for expanding reimbursement coverage of CDK4/6 inhibitors in early breast cancer is approaching.According to industry sources, Eli Lilly Korea’s Verzenio (abemaciclib) and Novartis Korea’s Kisqali (ribociclib) are expected to be submitted this week to the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.The specific indication under consideration for reimbursement expansion is “adjuvant therapy for patients with HR-positive (hormone receptor-positive)/HER2-negative stage II and III early breast cancer at high risk of recurrence.”Although the two drugs share the same mechanism of action, their situations differ somewhat. Verzenio is making its fourth attempt before the reimbursement committee, while Kisqali is being reviewed for the first time. The reimbursement expansion application for Kisqali was filed by the pharmaceutical company itself, whereas the application for Verzenio was submitted by the Breast Cancer Subcommittee of the Korean Society of Medical Oncology.Verzenio faced difficulties in being reviewed by CDDC from its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDDC 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 and July last year, it was submitted to CDDC for review, resulting in the same outcomes.The overall survival (OS) data was cited as the primary reason for Verzenio’s failure to secure expanded coverage. However, with Verzenio now securing OS data, expectations are rising for this CDDC review.In contrast, Kisqali, which is making its first attempt, has not yet secured OS data. While an improvement in OS is foreseeable, there is no direct supporting data available yet.Invasive disease-free survival (iDFS) is regarded as a clinically meaningful surrogate endpoint strongly correlated with OS in early breast cancer due to the disease characteristics, and Kisqali demonstrated encouraging results in the NATALEE study.Although the two drugs share the same mechanism, their differing circumstances make it noteworthy to see what outcomes the two drugs will yield at the CDDC review.
- Policy
- CSO 규제 향방은…복지부, 재위탁·수수료율 손질 가능성
- by Lee, Jeong-Hwan May 26, 2026 03:21pm
- [데일리팜=이정환 기자] 보건복지부가 의약품 판촉영업 대행사(CSO) 추가 규제를 통한 의약품 유통 구조 투명성 강화 필요성을에 공감하면서 이어질 정책 방향에 시선이 모인다.제약업계에서 회자되고 있는 규제는 CSO가 다른 CSO에게 의약품 영업판촉 업무를 재위탁하는 행위를 금지하거나 관련 규제 수위를 지금보다 높이는 방식이다.이와 함께 CSO가 제약사에게 요구하는 수수료율의 상한선을 규정하는 등 CSO 수수료에 대한 행정적·법적 제한을 신설하는 규제도 거론되고 있다.25일 제약업계는 복지부가 한국제약바이오협회와 함께 CSO 실태조사에 착수한 만큼 연내 구체적인 규제 방향성을 수립할 것으로 전망중이다.현재 CSO 업계는 제약바이오산업 육성을 위해 CSO도 산업으로 육성할 필요성을 강조하며 복지부를 향해 한국CSO협회의 사단법인 인가를 촉구하는 실정이다.반면 복지부와 국내외 제약사들은 CSO의 사단법인 인가는 아직 시기상조라는 입장이다. CSO 업계가 CSO협회를 조직해 자체적으로 산업 선진화 등 노력을 기울이고 있지만, 여전히 CSO를 활용한 불법이 정화되지 않는 등 사단법인으로서 지위를 인정해주기엔 역부족이라는 평가다.이에 복지부와 제약협회 실태조사 이후 추가 규제가 이뤄져야 논의 가능성이 향상할 것으로 보인다.일단 CSO를 악용한 불법 리베이트의 가장 실질적인 원인으로 꼽히는 '무제한 재위탁'이 규제 사정권으로 분류된다.제약사가 CSO에게 의약품 판촉영업 대행 위수탁 계약을 체결한 이후, 해당 CSO가 다른 CSO와 또 위수탁 계약을 체결하면서 불법 리베이트 진원지를 찾을 수 없는 문제를 해결할 필요가 있다는 게 복지부와 제약업계, 국회의 공감대다. CSO 위탁 계약 원천 금지 규제 가능성이 거론되는 이유다.다음으로는 제약사가 CSO에 지급하는 의약품 판촉영업 수수료 비중을 제한하는 수수료 상한제다. 높은 CSO 수수료는 결국 불법 의약품 리베이트 재원으로 쓰이게 된다는 비판을 법으로 규제하는 차원이다.다만 CSO 수수료 규제는 헌법에 위배될 소지가 있어 복지부와 정치권은 입법에 고심하는 표정이다. 그럼에도 CSO 수수료 제한이 실질적인 리베이트 근절과 투명한 의약품 유통질서 강화 효과가 기대될 경우 간접적으로 CSO 수수료 구조를 투명화하는 행정 규제와 입법이 추진될 공산이 크다.복지부는 일단 이번 실태조사에서 제약사와 CSO, CSO와 CSO 간 위수탁 계약, 재위탁 계약 현황 분석으로 규제 방향성을 수립한다는 방침이다.특히 복지부는 CSO 산업을 육성하는 게 복지부의 주된 업무가 아니라는 입장으로, 공정하고 투명한 의약품 유통질서 확립 즉, CSO 리베이트 근절을 위한 규제 신설을 고민할 것으로 보인다.제약업계 관계자는 "복지부는 CSO 수수료율 규제를 정부가 나서서 추진하는 것에 일부 부담감을 느끼는 동시에 위헌 가능성에 집중하는 분위기"라며 "법으로 CSO 수수료율을 옭아매는 게 무조건 좋은 방법인지 여부에 대한 판단도 안 선 것 같다. 다만 재위탁 문제가 심각해 불법 리베이트 규제 공백을 키우고 있는데 대한 문제의식엔 공감하는 것으로 안다"고 귀띔했다.그러면서 "CSO 수수료 상한제는 제약사들로서는 가장 직접적이고 효율적인 규제 방향일 수 있다. 하지만 법으로 당장 제한하기 어려울 수 있어 간접적으로 CSO가 과도한 수수료를 제약사에 요구하고 정당한 판촉이 아닌 리베이트 영업으로 품목 처방 매출을 유지하는 문제를 막는 방법을 고민할 필요가 있다"며 "CSO 업계 자체도 일단 자정 필요성에 공감은 하고 있는 것으로 안다. 문제는 너무 점 조직으로 구성돼 CSO 업계에 대한 일괄적 규제나 의견 수렴, 통합이 어렵다는 게 문제"라고 말했다.이어 "일단 불법 리베이트 근절에 앞장서고 있는 다수 제약사는 CSO 신고제 시행 2년차를 맞은 지금, 신고제를 넘어선 추가 규제가 필요하다는 의견"이라며 "복지부의 제네릭 약가인하 정책이 예고된 시점과 맞물려 추가 행정이 시급하다"고 덧붙였다.
- Opinion
- "The expected probability of a clinical cure for TNBC"…Keytruda
- by Son, Hyung Min May 22, 2026 10:25am
- Although triple-negative breast cancer (TNBC) accounts for approximately 15 to 20% of all breast cancer cases, it is recognized as a highly aggressive subtype with a significant risk of recurrence.Due to the lack of hormone receptors (HR) or HER2 expression, targeted therapies cannot be used, leaving patients with relatively limited treatment options. It has been classified as a high-risk breast cancer, particularly due to the high risk of recurrence and mortality within five years of diagnosis.TNBC carries a high risk of recurrence even in relatively early stages (Stages I and II), and recurrence is highly likely to manifest as distant metastasis. Notably, the T2N0 patient population, characterized by a tumor size of 2 to 5 cm and node-negative status, has recently regarded as a high-risk subgroup requiring aggressive therapeutic intervention.Amid this therapeutic landscape, analysis suggests that a perioperative treatment strategy based on the cancer immunotherapy 'Keytruda (pembrolizumab)' is leading a paradigm shift in the management of early-stage TNBC.Professor Hee Kyung Ahn, Department of Hematology-Oncology, Samsung Medical CenterKeytruda received regulatory approval from the Ministry of Food and Drug Safety (MFDS) in July 2022 for the perioperative treatment of high-risk early-stage TNBC.Based on the KEYNOTE-522 clinical study, Keytruda demonstrated significant improvements not only in pathological complete response (pCR) but also in event-free survival (EFS) and overall survival (OS). Consequently, it is drawing attention as a therapeutic strategy aimed at increasing the probability of a clinical cure rather than merely delaying disease recurrence.As a result, an integrated therapeutic approach encompassing neoadjuvant chemotherapy, definitive surgery, and subsequent adjuvant therapy is increasingly well established in real-world clinical practice.DailyPharm met with Professor Hee Kyung Ahn of the Department of Hematology-Oncology at Samsung Medical Center to discuss the shifting treatment paradigms in early-stage TNBC and the clinical implications of Keytruda-based perioperative therapy.Q. What are the changes in clinical practices since Keytruda was approved for early-stage TNBC?The therapeutic landscape has transformed significantly over the past few years, and Keytruda is now widely used in clinical settings.Today, we no longer proceed to surgery first, even for node-negative Stage IIA patients. Instead, neoadjuvant therapy with Keytruda is used, followed by a risk-based adjuvant regimen regardless of whether the patient achieves pCR post-surgery. Because robust clinical trial data have demonstrated survival benefits with this strategy, proactive clinical interest and adoption have risen substantially.Based on the KEYNOTE-522 clinical data, the pCR rate was 64.8% in the Keytruda arm compared to 51.2% in the control arm, representing an absolute improvement of approximately 13.6 percentage points. Furthermore, EFS improved by roughly 8 percentage points, and the overall survival rate improved by about 5 percentage points. Demonstrating these absolute benefit margins underscores a major breakthrough in therapeutic outcomes, making it a highly clinically meaningful finding.Q. Why is the T2N0 patient cohort frequently highlighted in discussions regarding TNBC?T2N0 defines a case where the tumor size spans 2 to 5 cm with node-negative status. Patients often feel reassured because it is classified as Stage IIA, a relatively early stage. However, even within the same clinical stage, TNBC carries a profoundly higher risk of recurrence compared to other subtypes, such as hormone receptor-positive breast cancer.While the stage of the cancer is important, TNBC carries the risk of a poor prognosis and aggressive biological phenotype that even Stage IIA patients are classified into a high-risk group with an elevated risk of recurrence. Consequently, formulating an aggressive treatment strategy is essentialQ. How do you evaluate the clinical significance of Keytruda demonstrating an OS benefit?Demonstrating an OS benefit in early-stage curative settings is incredibly difficult. It requires proving that a therapy extends actual patient survival, rather than merely delaying disease recurrence.Certain therapies may successfully prolong the time to recurrence, but once the disease recurs, the biological characteristics of the tumor can shift aggressively, preventing extended patient survival. In those situations, an OS benefit is absent.In contrast, the validation of an OS benefit implies that early-intervention treatment successfully translates into a potential cure for a substantial proportion of patients, or at the very least, prolongs overall life expectancy even if the disease eventually recurs.Because cancer directly threatens life, the absolute benchmark and ultimate objective of all oncology treatments is to extend survival as much as possible. Thus, improving overall survival holds significance, demonstrating that the therapy has successfully achieved the gold standard goal of oncological intervention.Q. What do you consider to be the most noteworthy findings from the subgroup analysis?The fact that consistent outcomes were demonstrated across nearly all subgroups is highly meaningful. An especially intriguing aspect is the divergence between metastatic TNBC and early-stage TNBC data.In the metastatic setting, Keytruda's efficacy was confirmed exclusively in PD-L1-positive patients. However, in early-stage TNBC, pCR and EFS improvements were achieved regardless of PD-L1 expression status.This means that early-stage TNBC may possess distinct immunological profiles compared to the metastatic stage, suggesting that Keytruda-based regimens function more effectively when deployed early in the disease stage.Q. Why is the integrated therapeutic approach of continuing perioperative adjuvant therapy so crucial in early-stage TNBC?Previously, if a patient achieved pCR following neoadjuvant chemotherapy, further post-operative systemic treatment was frequently omitted. However, the KEYNOTE-522 study design mandated that even patients achieving pCR continue receiving adjuvant Keytruda post-surgery. Driven by these data, current guidelines recommend maintaining therapy unless precluded by significant adverse events.Notably, highly meaningful outcomes were confirmed in the non-pCR cohort. While this subpopulation historically carries a dismal prognosis, the inclusion of Keytruda demonstrated a trend toward improved survival outcomes. This strongly suggests that maintaining adjuvant therapy plays a critical role in managing residual disease burdens and mitigating the risk of recurrence.Keytruda's ability to fundamentally transform treatment outcomes across the entire TNBC continuum (from early-stage to metastatic disease) is significant. The observable decline in recurring patients compared to the past directly translates to lives saved, which is why its clinical value is so deeply felt on the ground.Q. How do you view the current reimbursement landscape and the challenges ahead?Currently, Keytruda is not reimbursed for this indication; partial reimbursement is restricted only to the backbone cytotoxic chemotherapies used in the combination regimen. While this alleviates a fraction of the cost, the out-of-pocket financial burden on patients remains substantial.The crucial factor we must not overlook is the societal and economic value of a clinical cure. Achieving a cure goes beyond the mere eradication of cancer cells; it represents returning a patient fully to society. When a patient is cured, it eliminates the massive future medical expenditures and drug costs associated with recurrence, while preserving the economic and social productivity that would otherwise be lost.In South Korea, a stringent threshold demand high standard for OS data for early-stage indications due to fiscal constraints. However, capturing definitive OS data requires an extended timeline, and while waiting for those results, a significant number of patients miss their critical window for a cure.While managing metastatic disease is vital, I personally believe that curative-intent treatment in the early-stage setting should take precedence. This is particularly justifiable because therapies deployed in the neoadjuvant setting have a fixed number of treatment cycles, allowing total healthcare expenditures to be capped and predicted in advance.Therefore, as a realistic alternative, if budget impact is the primary hurdle delaying full reimbursement, health authorities should actively explore mechanisms to enhance patient access, such as implementing partial reimbursement structure or adjusting patient co-payment tiers to a realistically affordable level.Allowing regulatory and institutional flexibility by taking into account the manageable financial thresholds for individuals confronting critical illnesses will serve as a practical solution to improve market access and patient drug availability for cancer patients.
- Company
- 10th year of Boksan-Suzuken partnership…"Establishing a platform for mutual growth"
- by Kim, Jin-Gu May 22, 2026 10:25am
- Commemorating the 10th anniversary of their strategic partnership, Boksan Nice and Japan's Suzuken presented the 'redefinition of roles between pharmaceutical companies-wholesalers' and the 'transition to digital distribution platforms' as key strategies to overcome the crisis facing the pharmaceutical industry, which is currently pressured by drug price cuts and market restructuring.On the 21st, Boksan Nice and Suzuken hosted the 'Boksan Nice-Suzuken Partnership 10th Anniversary Seminar' at the Orchid Room of the Westin Josun Seoul. The event brought together executives from both companies and around 80 stakeholders from the pharmaceutical distribution industry.The event was organized to reflect on the decade-long partnership between the two companies and to outline specific future collaboration pathways for pharmaceutical companies and the wholesale sector to achieve mutual growth amid ongoing large-scale drug price reductions and structural inefficiencies in distribution in South Korea. The two companies established their relationship in 2016 when Suzuken made a KRW 52 billion investment in Boksan Nice.In his opening remarks, Boksan Nice Chairman Eom Tae-ung emphasized, "This seminar goes beyond a simple 10th-anniversary celebration; it is a venue to collectively address the rapid changes and future direction facing the pharmaceutical industry and distribution sector today." and added, "As the global weight of marketing and distribution continues to grow, Boksan Nice’s clear direction in this era of selection and concentration is to become a healthy and competitive partner for domestic pharmaceutical companies."Suzuken Chairman Hiromi Miyata introduced the background behind the long-standing trust between the two companies over the past decade. Chairman Miyata stated, "When we entered the Korean market 10 years ago, we conducted interviews and surveys targeting pharmaceutical companies, healthcare institutions, and pharmacies, and Boksan Nice's reputation and credibility were overwhelmingly high," and added, "This deep trust became the decisive factor for our collaboration. Over the last 10 years, we have built a foundation for growth through continuous joint projects and close talent exchange. We will continue to support the growth of Boksan Nice."Boksan Nice Chairman Eom Tae-ung (left) and Suzuken Chairman Hiromi Miyata.Boksan Nice and Suzuken jointly assessed that the pharma-biotech markets and pharmaceutical distribution environments in both Korea and Japan are undergoing profound shifts. In Korea's case, a heightened sense of crisis is escalating due to large-scale drug pricing restructuring.In response to this crisis, Japan's Suzuken proposed a "digital platform" strategy as an alternative solution. Shigeru Asano, Director and Chairman of Suzuken, shared collaboration case studies from the Japanese market, noting, "Amid changing market environments, wholesalers as well as pharmaceutical companies must move beyond simple logistics fulfillment to deliver new value-added functionalities."Chairman Asano identified "Visualization, Connection, and Change" as the core strategies of the Suzuken Group, explaining, "We are currently building a digital-based 'healthcare data platform' that organically links data from medical institutions, healthcare professionals, and the supply chain," and added, "Through this, we will perform an advanced role by supporting the digital marketing efforts of pharmaceutical companies while, in turn, providing a stable infrastructure for pharmaceutical supply."Chairman Eom Seung-wook of Boksan Nice identified fundamental inefficiencies in the domestic pharmaceutical distribution structure and proposed streamlining distribution channels as a solution.Eom diagnosed, "Currently, there are around 4,000 wholesalers in Korea, and the collective market share of the top 10 companies does not exceed 40%," and added, "Consequently, Korean wholesalers have remained in the role of simple delivery vendors until now, and under the pressure of large-scale drug price cuts, the legacy approach is unsustainable for both pharmaceutical companies and wholesalers."Eom proposed a structural division of business as a concrete model for collaboration. He emphasized, "Simplifying distribution channels is no longer an option but an absolute necessity. Roles must be redefined so that pharmaceutical companies can focus entirely on their core operations, such as R&D and manufacturing. At the same time, wholesalers solely handle distribution and operational efficiency," and concluded, "Boksan Nice will become a core partner that substantially contributes to improving the profitability of pharmaceutical companies hit by drug price cuts by eliminating unnecessary costs, expanding market accessibility, and simplifying workflows."
- Company
- HPV prevention expanded to male adolescents
- by Son, Hyung Min May 22, 2026 10:25am
- With the National Immunization Program (NIP) expanding to include male adolescents, Korea’s HPV (human papillomavirus) prevention strategy is shifting from a male-centered approach to a system that prevents HPV in both male and female individuals.Analysts emphasize the significance of this move, noting that while major countries abroad have been implementing simultaneous vaccination for both genders for several years as part of their strategies to reduce HPV-related cancers, Korea has finally established a foundation for vaccinating male adolescents, albeit belatedly.On the 20th, MSD Korea held a media session at Seongam Art Hall in Seoul under the theme “A New Standard for HPV National Immunization: Vaccination for Both Genders.”Starting this month, the Korea Disease Control and Prevention Agency (KDCA) has included 12-year-old male adolescents (born in 2014) in the National HPV Immunization Program. Previously, the program only covered female adolescents aged 12 to 17 and low-income women.This expansion is considered significant because it extends free HPV vaccination, which had been limited to females for the past decade, to include male adolescents. According to the presented materials, the first-dose HPV vaccination rate among male adolescents in Korea stood at just 0.2%. In contrast, rates were 77.7% in Australia, 71.2% in the UK, and 59.0% in the US.HPV is known to be a virus that can infect both men and women. According to the International Papillomavirus Society (IPVS), approximately 5% of all cancer cases worldwide are reported to be related to HPV. While most infections clear up naturally, persistent infection can lead to cervical cancer, vaginal cancer, anal cancer, vulvar cancer, and genital warts.Dong-hyun Kim, Professor of Pediatrics at Inha University HospitalDong-hyun Kim, a professor of pediatrics at Inha University Hospital, stated, “HPV is not just a cervical cancer issue. It is a virus that can also cause anal cancer and genital warts in men. Since it is an infectious disease that affects and spreads among both men and women, it is difficult to approach it with prevention strategies targeting only a specific gender.”According to data from the Korea Disease Control and Prevention Agency, reported HPV cases in Korea increased from 10,945 in 2020 to 14,534 in 2024. In particular, reported cases among men rose 82.9% during the same period, from 117 to 214 cases. A domestic study of men found that approximately 59% tested positive for HPV DNA.Professor Kim cited high reinfection risk and low natural clearance rates as characteristics of HPV infection in men.“HPV is a virus that can infect both men and women, and it is not an issue limited to a specific gender. We need to approach prevention strategies from the perspective of infectious disease, rather than gender.”He continued, “Men often carry the virus asymptomatically, and the rate of natural clearance is known to be slower than in women. This means transmission may continue repeatedly without the person even being aware of it.“Experts recommend 11–12 years of age as the optimal age for HPV vaccination. This is because vaccination before sexual debut ensures high immunogenicity, and the 9–14 age group can expect a sufficient immune response with fewer doses than adults.Professor Kim emphasized that HPV vaccination is not a gender-specific issue, but an infectious disease prevention strategy for both men and women.The quadrivalent HPV vaccine available through the HPV national immunization program is administered in two doses for those aged 9 to 13 (6–12 months apart)In particular, study results showed that two doses administered at ages 9 to 13, when immune responses are active, demonstrated non-inferior immunogenicity (geometric mean antibody titers, GMT) against HPV types 16 and 18 compared with three doses in women aged 16 to 26. This highlights the need to secure preventive effects through early vaccination.Professor Kim said, “When vaccinated before age 15, two doses alone show high immunogenicity compared with three doses in older age groups. It is also meaningful in terms of vaccination convenience because it can be administered at the same time with other vaccines included in the national immunization schedule, such as Tdap and Japanese encephalitis vaccines.”He continued, “Overseas, countries have already set the eradication of cervical cancer as a national goal based on simultaneous vaccination of both men and women. Korea also needs to begin serious discussions on shifting its HPV prevention strategy, starting with this expansion of the NIP to male adolescents.”
- InterView
- [Reporter’s View] Beyond Korea's drug pricing reform
- by Lee, Jeong-Hwan May 22, 2026 10:25am
- The government has finalized implementation of a drug pricing system reform plan centered on applying a 45% pricing rate for generics and granting pricing incentives to innovative pharmaceutical companies, quasi-innovative pharmaceutical companies, and companies contributing to the stable supply of essential medicines. However, the tasks needed to maximize the effects of the reform and minimize side effects remain unfinished.Fortunately, the ruling party and the government appear to have immediately begun work on preparing the “next-level” administrative and legislative specifics needed to create synergy with the drug pricing reform.The direction is clear: Korea must break away from and reform the abnormal multi-product generic structure in which hundreds of products are approved for a single ingredient, leading the market to be mired in distorted promotional competition—specifically, illegal rebate competition—rather than competition based on product quality.The specific policy goal of the ruling party and the government is to broadly gather opinions from the pharmaceutical industry, professional organizations, and academia to reduce or abolish the currently permitted 1+3 contract-based joint bioequivalence system for generics, while also overhauling the pharmaceutical industry structure that abuses contract sales organizations (CSOs) to distribute illegal rebates.This is a necessary policy shift for Korea’s pharmaceutical industry to move beyond domestic generic drug sales competition and evolve into a nation capable of developing blockbuster new drugs that dominate the global market.Jae-hyun Lee, head of the Korea Regulatory Affairs Professional Society and an expert in drug approval regulations and health policy, criticized the 1+3 joint bioequivalence system as “a deformed system that cannot be found anywhere else in the world and the main culprit behind the proliferation of generics in Korea,” calling on the government to seriously reflect and change course.Lee said, “The domestic regulatory system itself, which grants product approval through joint bioequivalence, makes no sense. Even a 1+1 system, which would allow one contract manufacturer to grant approval rights to only one consignment company, is unreasonable. Korea needs to shift to a single-generic per product policy by abolishing consignment bioequivalence testing and eliminating identical generics.”Won-jun Cho, Senior Policy Advisor for Health and Medical Policy for the Democratic Party of Korea and the Director of the Party’s Policy Committee, also assessed that the Ministry of Health and Welfare’s planned drug pricing reform can land smoothly without distortion only if if the government actively considers abolishing consignment bioequivalence testing and simultaneously imposes strict regulations on CSOs, which are used as a means for illegal rebates.Cho said, “To maximize the effects of the drug pricing reform for real pharmaceutical companies leading innovation, quasi-innovation, and stable supply, we must eliminate ‘free-riding’ pharmaceutical companies and paper companies that contribute little to the pharmaceutical industry or national development and are solely focused on rebate-driven promotion and sales from generics approved via consignment bioequivalence studies. Together with the government, we will also pursue regulations against pharmaceutical companies and problematic CSOs that damage the sound distribution order of medicines by colluding with certain medical institutions to provide indirect rebates through CSOs, as well as substandard CSOs.”In other words, academia, the government, and the ruling party share the view that unresolved issues long left unattended must now be actively addressed following the implementation of the drug pricing reform.Accordingly, the government (Ministry of Health and Welfare and the Ministry of Food and Drug Safety), academia, and the National Assembly led by the ruling party are expected to take immediate legislative and administrative measures regarding the drug approval system and CSO regulations in the near future.The reason Korea needs to review the reduction or abolition of the 1+3 joint bioequivalence system from multiple angles is that it directly conflicts with the philosophy of the newly revised drug pricing system. It is difficult to establish a logical basis for guaranteeing the same drug price to consignment generic companies that have no production infrastructure or research personnel and simply resell drugs made by others under a different brand name, using only sales networks. After multiple rounds of gathering opinions from the pharmaceutical industry, the government needs to assess the utility and limitations of the consignment bioequivalence system and make a reasonable administrative decision.Furthermore, the success of the drug pricing reform plan also requires eliminating the illegal CSO rebate structure, which serves as a distorted business practice for some generic drug companies. In a situation where the products themselves have virtually no competitive edge, some generic drug companies currently rely on distributing rebates to doctors to induce prescriptions, and this must be stopped. Regulatory standards must be tightened to ensure that CSOs are no longer used as scapegoats.It is time to consider introducing a dual-penalty system that clearly links illegal rebate liability between pharmaceutical companies and CSOs, while also strengthening penalties for doctors who receive rebates to a level sufficient to restore market order. This is because drug price cuts alone cannot completely block the flow of illicit funds into illegal business practices.The Ministry of Health and Welfare’s drug pricing reform is the first step toward innovation in the pharmaceutical industry. Unless the National Assembly enacts legislation to eliminate unreasonable systems and health authorities follow up with aggressive measures, there is a risk that this reform plan will remain just another unfinished policy. To ensure that the principles of “removing free riders” and “rewarding innovation” become firmly rooted in the market, the 22nd National Assembly and the government must act without delay.
- Company
- Reimbursement listing discussions for Vyloy in slow progress
- by Eo, Yun-Ho May 22, 2026 10:25am
- Reimbursement discussions for the gastric cancer-targeted anticancer therapy Vyloy remain sluggish. Therefore, attention is now on whether progress can be made within the first half of the year.According to Dailypharm coverage, Astellas Pharma Korea’s Claudin 18.2-positive gastric cancer targeted therapy Vyloy (zolbetuximab) is expected to be presented to the Pharmacoeconomic Evaluation Subcommittee of the Health Insurance Review and Assessment Service today, on the 21st.Vyloy passed the Cancer Drug Review Committee last October. This means more than 6 months have passed before its submission to the Pharmacoeconomic Evaluation Subcommittee.Vyloy, which was approved in Korea in September 2024, failed to pass the Cancer Drug Review Committee on its first attempt in February last year. However, the company immediately resubmitted the application and succeeded in obtaining a positive result. However, as subsequent procedures are proceeding slowly, it is expected to take even longer to reach a final listing decision.Vyloy is the world’s first approved Claudin 18.2–targeted therapy. It is a monoclonal immunoglobulin antibody that binds to Claudin 18.2, a protein expressed and exposed on gastric cells.According to the Phase III SPOTLIGHT study, which formed the basis for Vyloy's approval, the median progression-free survival (mPFS) for Vyloy combined with mFOLFOX6 (oxaliplatin, leucovorin, fluorouracil) was 10.61 months, exceeding the placebo group’s 8.67 months. Median overall survival (mOS) was also longer at 18.23 months versus 15.54 months.In the GLOW study, the Vyloy plus CAPOX (capecitabine and oxaliplatin) combination group achieved a median progression-free survival of 8.21 months, reducing the risk of disease progression or death by approximately 31%.Professor Sun Young Rha of Yonsei Cancer Center stated, “About 90% of patients with metastatic gastric cancer are HER2-negative, underscoring the urgent need for therapies targeting new biomarkers. Given that about 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the emergence of Vyloy, which selectively binds to Claudin 18.2, presents a new therapeutic option for these patients.”Meanwhile, the Korean Gastric Cancer Association revised its treatment guidelines on January 6, 2025, in the Journal of Gastric Cancer (JGC), granting Vyloy the ‘highest-level’ recommendation as first-line therapy for patients who are HER2-negative and Claudin 18.2-positive.Vyloy has also been listed as a standard treatment option in Japan’s gastric cancer guidelines and the European Society for Medical Oncology (ESMO) clinical practice guidelines. It is included as a preferred regimen in the U.S. NCCN guidelines, rapidly establishing itself as a global standard of care for gastric cancer.
