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- 2026-04-24 02:52:24
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- Diabetes drug 'Ozempic' prescriptions available at general hospitals
- by Eo, Yun-Ho Mar 23, 2026 08:42am
- 'Ozempic,' a diabetes treatment version of the obesity drug Wegovy, is entering the general hospital prescription areas.According to industry sources, Novo Nordisk Korea's GLP-1 receptor agonist (GLP-1 RA) Ozempic has passed the drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital.Since it was added to the insurance reimbursement list in February, Ozempic has continued to expand prescription areas.Ozempic can be prescribed as part of a triple therapy including metformin and sulfonylurea (SU), or in combination with insulin. However, unlike existing GLP-1 analogs, the reimbursement criteria have been restricted to 'Type 2 diabetes patients whose glycated hemoglobin (HbA1C) levels remain at 7% or higher despite at least 2 to 4 months of combination drug therapy.'While analysis suggests that this is Ministry of Health and Welfare's measure to prevent misuse or abuse of Ozempic, some critics argue it limits patient access. It remains to be seen how Ozempic, with many limitations, will perform in the diabetes treatment market.Jang Won Son, a professor of the Department of Internal Medicine at Bucheon St. Mary's Hospital, stated, "Since Ozempic's domestic reimbursement criteria have some partial limitations, compared with the current guidelines, proactive discussions regarding flexible application that comprehensively consider potential complications are needed. Whether an initial measure that excessively considers misuses can be reassessed later is important."Meanwhile, Ozempic demonstrated superior blood sugar-lowering and weight loss effects compared to various diabetes medications, including DPP-4 inhibitor Januvia (sitagliptin), the exendin-4-based GLP-1 RA Byetta (exenatide), and the GLP-1 RA Trulicity (dulaglutide), through six Phase 3 studies (SUSTAIN 1–5 and 7). Notably, Ozempic showed superior blood sugar-lowering effects compared to insulin while maintaining a lower risk of hypoglycemia.The 'SUSTAIN 9' study confirmed additional blood sugar and weight reduction effects in Type 2 diabetes patients who did not achieve sufficient control following treatment with SGLT-2 inhibitors, a leading class of oral diabetes medications. In the 'SUSTAIN 6' Phase 3 trial, the drug reduced the risk of major adverse cardiovascular events (MACE) by 26% in adult patients with Type 2 diabetes and high cardiovascular risk.
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- En masse designation of quasi-innovative pharmas?
- by Kim, Jin-Gu Mar 20, 2026 08:55am
- The government is reviewing a pricing incentive scheme for companies deemed equivalent to innovative pharmaceutical firms (“quasi-innovative” companies). Although more than 30 companies are expected to meet the criteria, the actual level of preferential treatment granted to the companies appears limited, leading to criticism that the policy is merely a publicity stunt.According to industry sources on the 19th, the government is considering establishing a new preferential pricing track for “companies equivalent to innovative pharmaceutical firms (quasi-innovative firms).”The government’s policy is to review price preferences to enable solid pharmaceutical companies with potential to advance to the level of innovative pharmaceutical firms at an early stage. These details were revealed during the Health Insurance Policy Deliberation Committee subcommittee meeting on the 11th.The government has proposed R&D investment ratios relative to revenue as the key criterion. Companies with revenue above KRW 100 billion must have an R&D ratio of at least 5%, and companies below KRW 100 billion must have at least 7%. Companies that have received administrative sanctions within the past 5 years under the Pharmaceutical Affairs Act, Fair Trade Act, or Pharmaceutical Industry Act due to rebate-related issues will be excluded.Companies that meet these requirements will receive preferential drug pricing. Preferential pricing will be applied to newly listed generics, and the duration of this preferential treatment is currently under review to be similar to that for innovative pharmaceutical companies. The government also plans to grant temporary special exemptions when adjusting the prices of already listed drugs.This plan is interpreted as a response to the pharmaceutical industry’s backlash against the drug pricing system reform draft released last November. At that time, the government proposed applying price discounts of 68%, 60%, and 55% to innovative pharmaceutical companies based on their R&D ratios. However, criticism arose that the benefits would be concentrated among a select few top companies, while most companies would find it difficult to avoid price reductions.Applying the new criteria would significantly increase the number of companies eligible for preferential pricing.An analysis of 98 listed pharmaceutical companies classified as pharmaceutical firms on the KOSPI and KOSDAQ that will be affected by price cuts found that 32 companies would newly qualify. This excludes holding companies, R&D-focused biotech ventures, and medical device firms that are not affected by price cuts.Conversely, 45 companies failed to meet the criteria. The remaining 21 are companies that had previously been designated as innovative pharmaceutical companies.Among companies with revenue above KRW 100 billion, those meeting the ≥5% R&D ratio include firms such as ▲CMG Pharmaceutical, J▲W Pharmaceutical, ▲SK Bioscience, ▲SK Biopharmaceuticals, ▲Kyungdong Pharm, ▲Kyungbo Pharm, ▲Daehan New Pharm, ▲Dong-A ST, ▲Myung-In Pharm, ▲Samjin Pharm, ▲Sam Chung Dang Pharm, ▲Ahn-Gook Pharmaceutical, ▲Withus Pharmaceutical, ▲Korea United Pharm, ▲Il-Yang Pharm, ▲Jeil Pharmaceuticval, ▲Chong Kun Dang, ▲Kolon Life Science, ▲Hana Pharm, ▲ Hanall Biopharma, ▲Whanin Pharm, ▲Humedix, and ▲Huons. These companies will likely be included as quasi-innovative pharmaceutical companies.On the other hand, companies such as ▲HLB Pharma, ▲Kwang Dong Pharmaceutical, ▲Kukjeon Pharmaceutical, ▲Kukje Pharm, ▲Dai Han Pharm, ▲Dongkook Life Science, ▲Myungmoon Pharm, ▲Binex, ▲Samsung Biologics, ▲Samil Pharm, ▲Celltrion Pharm, ▲Sinsin Pharmaceutical, ▲CTC Bio, ▲Arlico Pharm, ▲RP Bio, ▲Yungjin Pharm, ▲Yuyu Pharma, ▲Reyon Pharmacuetical, ▲ Jinyang Pharm, ▲Kips Pharma, ▲Theragen Etex, ▲Pharmgen Science, ▲Hawil Pharm, ▲Hugel have R&D rations belos 5% as of the end of last year or Q3 last year, and fail to meet the threshold. It will be unlikely for these companies to receive preferential treatment during price cuts.Among companies with revenue below KRW 100 billion, relatively few meet the ≥7% R&D threshold, with only a handful such as ▲Samsung Pharmaceutical, ▲Sam-A Pharmaceutical, ▲Samyang Biopharm, ▲Cellbion, ▲Onconic Therapeutics, ▲ENCell, ▲GL PharmTech, and ▲Prestige Biologics.In fact, within the same revenue bracket, many companies do not meet the criteria for quasi-innovative pharmaceutical firms. These include ▲JW Shinyak, ▲Kyungnam Pharm, ▲Korean Drug Pharm, ▲Dongsung Pharmaceutical, ▲DuChemBio, ▲Vaskan Bio Pharm, ▲Vivozon Pharmaceutical, ▲Samik Pharmaceutical, ▲Seoul Pharma, ▲Sinil Pharmacuetical, ▲Icure, ▲Aprogen Biologics, ▲L&C Bio, ▲Optus Pharmacuetical, ▲Ilsung IS, ▲Cho-A Pharm, ▲Telcon TF Pharmaceutical, ▲TDS Pharm, ▲BNC Korea, ▲ Union Korea Pharm, ▲ Korea Pharma, among others, which have R&D ratios below 7%, making it highly likely they will not receive preferential treatment in the event of drug price reductions.Industry observers emphasize that the actual level of pricing incentives matters more than the number of eligible companies. Even if many firms qualify, limited incentives could render the policy merely symbolic.In the revised reform plan, the government proposed a 60% pricing premium for innovative pharmaceutical companies when listing new generics, with the preferential period extended to up to 4 years. For quasi-innovative companies, a lower level of benefit is expected.It is reported that the government is considering a preferential level of around 50% for quasi-innovative companies. Given that generic prices are currently set at around 58.55%, this implies that price reductions would still be unavoidable even with preferential treatment. The relatively short preferential period of 1+3 years is also criticized as insufficient to provide meaningful incentives.An industry official commented, “The introduction of criteria for quasi-innovative pharmaceutical companies and pricing incentives is positive in itself. However, in reality, it is more of a structure that reduces the extent of price cuts and is far from being a true incentive. It is a scheme designed to include a large number of companies for the sake of appearances, while in reality, it forces them to lower drug prices.”
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- Medical device companies gather for KIMES2026
- by Hwang, byoung woo Mar 20, 2026 08:55am
- A four-day Korea International Medical & Hospital Equipment Show (KIMES) 2026 takes off on March 19At the medical device exhibition, the primary topic has emerged from the 'whether to adopt Artificial Intelligence (AI)' to the question of 'how to implement it.'At 'KIMES 2026,' which opened on the 19th, a clear shift in hospital views toward AI acceptance was observed, signaling a rapid migration of the industry's competitive axis.KIMES, celebrating its 41st anniversary, is South Korea's largest medical device exhibition, reflecting global healthcare trends and encompassing the entire industrial ecosystem. This year's event featured 1,490 manufacturers from 41 countries, including 846 domestic and 644 international companies.In this exhibition, major players in ultrasound, diagnostic imaging, endoscopy, and patient monitoring moved beyond standalone hardware to showcase integrated solutions linking diagnosis, treatment, and management. Notably, a 'platform war' is intensifying, with AI serving as the nexus connecting medical data and clinical workflows.Beyond hardware to 'platform' competition…AI-Driven industrial restructuringFirst, global medical device companies presented 'Life-cycle Patient Management' as their core strategy this year.GE HealthCare Korea emphasized a structural continuum from diagnosis to treatment and monitoring by unveiling integrated solutions that combine ultrasound, MRI, and patient monitoring technologies. By presenting ultrasound for quantitative fatty liver analysis, AI-based MRI image reconstruction, and pain-response monitoring during surgery, the company showcased its direction toward data-driven precision medicine.Samsung Medison also placed its platform strategy at the forefront by revealing its next-generation ultrasound brand, 'One Platform.' This structure ensures consistency across the entire examination process through a unified User Interface (UI) and automated features through AI to enhance diagnostic efficiency.These industry leaders are moving past performance competition of individual devices to engage in a full-scale platform battle, one that connects diverse medical data points to facilitate clinical decision-making.The direction of change was also distinct in the diagnostic imaging sector. While the transition from film-based X-rays to digital detectors is complete, advanced equipment such as CT and CBCT (Cone Beam Computed Tomography) is now becoming the standard for medical institutions.Specifically in dentistry, CBCT has effectively become the standard, making 3D-based diagnostics a common practice.Furthermore, the utility of portable X-rays and C-arm systems is expanding into operating rooms and emergency sites, evolving from simple diagnostic tools into procedural support equipment.The most notable change is the improvement in diagnostic efficiency enabled by AI.In the MRI field, there is a clear trend of using AI-based image reconstruction technology to shorten scan times. This is considered a critical factor that not only reduces patient wait times but also increases the number of scans, thereby directly impacting hospital operational efficiency and profitability.An official from SG HealthCare stated, "Reducing MRI scan times is more than just a convenience. It is directly linked to hospital operational efficiency," and "With the introduction of AI, demand for simultaneously improving scan speed and quality is rising rapidly."(Clockwise from top left) Booths of GE HealthCare, Samsung Medison, SG HealthCare, and Waycen"The necessity of AI adoption has grown"…a shift in fieldThe most significant change from this exhibition is the shift in how hospitals perceive medical AI. Industry representatives on-site unanimously noted that the nature of visitor inquiries has changed.In the past, questions primarily focused on hardware specifications or pricing. This year, however, there was a surge in inquiries regarding "whether AI features are applied," "where they are used in practice," and "what effects are observed."Analysis suggests that interest in AI has moved beyond the exploratory phase to the actual implementation review stage. A consensus on the necessity of AI adoption is spreading quickly, particularly among large-scale tertiary hospitals.Questions were raised regarding actual use cases and efficacy in various fields, including AI endoscopy, patient monitoring, and clinical support software, shifting the focus from technical validation to 'practical utility.'However, the market is still in its early stages, with variations in adoption rates among institutions. While some hospitals show aggressive intent to adopt, many others maintain a cautious approach, weighing costs against clinical utility.An official from an AI firm at the site commented, "The necessity for AI is becoming clear, starting with large hospitals. Once this trend solidifies, it is highly likely to influence small and medium-sized hospitals."Numerous technologies that incorporate AI, the current industry mainstay, were on display at medical device booths.Platform competition intensifies…reshaping hospital operationsKIMES 2026 demonstrated that the medical device industry is transitioning from a hardware-centric industry to a 'data-driven platform industry.'While performance and price were the core competitive factors in the past, ▲the new competitive axes include AI-based automation ▲data integration, workflow optimization ▲ensuring continuity of patient care.InBody showed a trend of expanding into primary points of contact, such as pharmacies, by combining digital technology with its body composition analysis solutions. They introduced cases in which measurement data is analyzed in real time and results are presented through visualization, a structure that connects simple measurement to consultation and health management.A view of the InBody booth.This is evaluated as an example of medical devices evolving beyond diagnostic tools into 'data-driven health management platforms.'In particular, AI technology has become a key factor influencing not only diagnostic assistance but also the operational efficiency and revenue structures of hospitals and pharmacies.The industry anticipates that future competition in the medical device market will likely be reorganized around 'platform units' rather than individual equipment.An industry insider stated, "AI is not just a technology. It is an element that changes how hospitals operate," and concluded, "Corporate competitiveness will be determined by how effectively a company can connect and utilize data."
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- MedTech–Pharma alliances intensify as remote monitoring turns profitable
- by Hwang, byoung woo Mar 19, 2026 12:39pm
- As the remote patient monitoring (RPM) market enters a profit-generating phase, competition in the form of alliances between medical device companies and pharmaceutical firms is intensifying.Currently, the domestic RPM market is developing within a framework of alliances between medical device companies and pharmaceutical firms. Seers Technology is partnering with Daewoong Pharmaceutical, Mezoo with Dong-A ST, Huinno with Yuhan Corp, and Wellysis with Samjin Pharmaceutical, forming a competitive landscape among these alliances.Seers Technology is rapidly building references by targeting hospitals with its ward monitoring platform thynC. Mezzue, which is set to list on KOSDAQ in March, is targeting the ward monitoring market with its mobile patient monitoring platform, HiCardi. Wellysis is expanding through wearable ECG devices, while Huinno is growing its business around ECG-based digital healthcare solutions.This surge in collaboration is interpreted as a sign that the RPM market has entered a phase where it is generating revenue. Pharmaceutical companies can expand patient management services based on therapeutic expertise and sales networks, while digital healthcare firms can strengthen data acquisition and platform competitiveness. These aligned interests are accelerating collaboration.RPM market expands beyond ECG to patient management platformsRPM is a digital healthcare technology that continuously measures and manages patients’ vital signs outside hospitals or within general wards.While the initial market was centered on wearable ECG-based arrhythmia detection technology, it has recently been rapidly evolving into a platform format that simultaneously analyzes various vital signs such as heart rate, respiration, body temperature, and physical activity levels.According to market research firm Markets and Markets, the global RPM market is expected to grow from USD 27.7 billion (KRW 41 trillion) in 2024 to USD 56.9 billion (KRW 85 trillion) by 2030, with an estimated annual growth rate of approximately 12–13%.RPM market prospect: Rise from USD 27.7 billion (2024) to USD 56.9 billion (2030) In fact, as hospitals increasingly adopt ward-based monitoring systems, related companies are seeing rapid revenue growth.Industry observers assess that the RPM market is now transitioning from the technology validation phase to the actual commercialization phase.An industry source stated, “Pharmaceutical companies are expanding the market by applying specialized strategies aligned with their therapeutic areas and sales environments. Even those not currently collaborating with medical device companies are closely watching as successful cases emerge.”Hospitals adopt multiple platforms …market expansion phaseHowever, many in the industry view the competition in the RPM market as being closer to a phase of market expansion rather than a zero-sum game for the time being.In fact, some hospitals are adopting multiple RPM platforms simultaneously.An industry insider noted, “While some hospitals adopt only a single solution, others adopt two platforms simultaneously after proof of concept (PoC) has been validated. Since the RPM market is still in its early stages, the structure allows multiple companies to grow together.”Similar to how markets expand when new mechanisms of action enter therapeutic areas, insiders believe the key factor for the RPM market is in increasing the number of hospital beds adopting the technology.As a result, analysts expect the RPM market to grow rapidly over the next 3–5 years, with multiple players expanding simultaneously.Competition in the RPM market is expected to intensify further following upcoming initial public offerings (IPOs) and global expansion.For example, Daewoong Pharmaceutical is pursuing a platform expansion strategy involving multiple partners in addition to Seers Technology, such as Skylabs, iKooB, and Puzzle AI, suggesting that competition may evolve beyond simple partnerships between medical device companies and pharmaceutical firms, into broader digital health alliances.Ultimately, the RPM market may evolve beyond mere collaboration between medical device companies and pharmaceutical firms into a data-driven patient management platform industry.An industry insider stated, “The RPM market is now moving beyond technological competition into a phase of platform competition. How companies build service models based on patient data will determine their future competitiveness.”
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- Se Eun Hwang appointed as the new general manager of CSL Korea.
- by Son, Hyung Min Mar 19, 2026 12:39pm
- Se Eun Hwang, new General Manager of CSL KoreaCSL announced the appointment of Se Eun Hwang, former general manager of Biogen Korea, as the new General Manager of its Korean subsidiary.Effective the 17th, Hwang will oversee overall operations of CSL Korea, leading domestic business strategy, strengthening organizational capabilities, and driving patient-centric corporate operations.Hwang has extensive leadership experience across Korea’s pharmaceutical and biotech industry, covering commercial strategy, market access, and medical affairs.She has successfully driven business growth by building competitive organizations and successfully launching products in Korea’s complex regulatory environment.Before joining CSL, Hwang served as general manager of Biogen Korea, where she established the local organization and led its expansion. During her tenure, she successfully developed reimbursement strategies and achieved market entry for rare disease therapies.Previously, she served as Head of a Rare Disease Franchise at Handok and as Head of Marketing at Abbott Korea, and she also held key positions at JW Pharmaceutical and Hanil Pharmaceutical, gaining experience across the entire pharmaceutical industry. Hwang is a pharmacist by training. She earned an MBA from Sogang University and subsequently obtained a Ph.D. in Clinical Pharmacy from Chung-Ang University, specializing in Social and Health Pharmacy.The newly appointed general manager said, “I am both delighted and feel a strong sense of responsibility taking on this important role, which will allow me to contribute to the lives of patients with rare and severe diseases in Korea through CSL’s innovative portfolio. We will prioritize patient-centric values, maximize organizational capabilities, and work closely with partners to drive new growth at CSL Korea.”Through the leadership appointment, CSL plans to further strengthen its business foundation in Korea and continue efforts to improve the quality of life for patients with rare and severe diseases.
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- Dayvigo targets Zolpidem dominance…Korean commercial launch imminent
- by Eo, Yun-Ho Mar 19, 2026 12:39pm
- An insomnia treatment with a new mechanism of action, ‘Dayvigo,’ is soon to be commercialized in Korea.According to industry sources, Eisai Korea is currently undergoing the approval process with the Ministry of Food and Drug Safety (MFDS) for Dayvigo (lemborexant), a dual orexin receptor antagonist (DORA). Formal approval is anticipated around mid-year.Mechanistically, Dayvigo is classified as an orexin/hypocretin receptor antagonist. It works by inhibiting orexin, which promotes sleep. It is important to note that orexin itself is a neuropeptide in the brain that promotes wakefulness.The drug demonstrated efficacy through two Phase III clinical trials, including the SUNRISE I study.The trials involved 1,006 adult patients from 67 medical institutions in the U.S. and Europe, who were divided into 4 treatment groups. These included 266 patients in the Davigo 5 mg treatment group, 269 in the Davigo 10 mg treatment group, 263 in the zolpidem CR Tab (6.25 mg) treatment group, and 208 in the placebo group. The average age of the patients participating in the study was 63, and 86% were female.Key results showed that most patients in the Dayvigo groups fell asleep within 20 minutes, demonstrating improved sleep onset. In addition, nighttime sleep maintenance time increased by more than 60 minutes compared to baseline.Furthermore, both the low-dose and high-dose groups demonstrated superiority over the placebo group in terms of sleep onset and sleep maintenance. These improvements were particularly pronounced in the Dayvigo 10mg treatment group.Dayvigo received FDA approval in 2019 and is currently prescribed in markets including Europe and Japan.
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- Jeil's subsidiary, Onconic licensing transactions total KRW 10B
- by Chon, Seung-Hyun Mar 19, 2026 12:39pm
- Jeil Pharmaceutical has reached the cumulative technology licensing fees revenue of KRW 10 billion from its R&D subsidiary, Onconic Therapeutics. This steady influx of technology licensing fee stems from the completion of domestic clinical trials, the approval of the new drug Jaqbo, and its successful entry into the Chinese market. Additionally, Jeil Pharmaceutical's revenue surged to KRW 67.1 billion last year as it ramped up sales of Jaqbo.According to the Financial Supervisory Service (FSS) on the 18th, Jeil Pharmaceutical received a total of KRW 1.8 billion in technology licensing fees from Onconic Therapeutics last year. Specifically, the company received KRW 600 million in February, followed by KRW 300 million and KRW 900 million in May and October, respectively.Yearly Cumulative Technology Licensing Fees of Jeil Pharmaceutical's subsidiary Onconic Therapeutics (unit: KRW 1 million, source: Financial Supervisory Service)These payments stem from the settlement of technology export milestones for Jaqbo, which Jeil Pharmaceutical originally out-licensed to Onconic Therapeutics. In March 2023, Onconic Therapeutics signed a technology export deal with the Chinese firm Livzon Pharmaceutical Group for Jaqbo, valued at up to $127.5 million. Under the terms, Onconic received a non-refundable upfront payment of $150 million and is expected to receive up to $112.5 million in milestone payments based on development, regulatory approval, and commercialization stages.In January of last year, Onconic Therapeutics received a $3 million milestone from Livzon following the first patient dosing in China's Phase 3 clinical trial. In March, it billed an additional $1.5 million after completing the transfer of production technology to Livzon.By August, Onconic billed and received a $5 million development milestone within 30 business days. This was achieved by the successful conclusion of Phase 3 trials in China and the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA). A portion of these fees received from Livzon is redistributed to Jeil Pharmaceutical as milestones.Jaqbo is a P-CAB (Potassium-Competitive Acid Blocker) drug, approved in April 2024 as the 37th Korea-developed new drug. P-CAB anti-ulcer agents work by competitively binding with potassium ions to the proton pump, the final stage of acid secretion in gastric parietal cells, thereby inhibiting gastric acid secretion.Jeil Pharmaceutical's revenue history from Jaqbo includes two non-refundable payments of KRW 150 million each in December 2020 and May 2021. In 2022, it received KRW 1 billion in February and another KRW 1 billion in December as Phase 3 clinical milestones. In April 2023, the company received KRW 2.7 billion as a settlement from Onconic’s upfront payment from Livzon (representing 13.5% of the $15 million). In 2024, an additional KRW 600 million was paid over four installments. As of last year, Jeil's cumulative technology licensing fees for Jaqbo totaled KRW 7.58 billion.Jeil Pharmaceutical has also consistently generated revenue from an oncology drug out-licensed to Onconic. For the dual-target anticancer agent JPI-547, the company has secured a total of KRW 2.5 billion. This includes upfront payments of KRW 750 million each in December 2020 and May 2021, plus a KRW 1 billion development milestone received in December 2022. The total amount Jeil Pharmaceutical has collected from Onconic Therapeutics for both Jaqbo and JPI-547 amounted to KRW 10.08 billion.Through Jaqbo domestic sales, Jeil Pharmaceutical achieved expanded sales effects. Jaqbo entered the prescription market in last October after receiving National Health Insurance coverage. Jeil Pharmaceutical and Dong-A ST collaborate on leading marketing and sales. Jaqbo's revenue for Jeil expanded from KRW 8.3 billion in 2024 to KRW 67.1 billion last year.
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- Multi-indication anti-cancer drugs, 'Tevimbra' offers alternative
- by Eo, Yun-Ho Mar 18, 2026 09:12am
- Product photo of 'Tevimbra (tislelizumab)' As advanced oncology treatments surge, discussions are in full swing to bridge the gap between the financial burden and improved patient access.The government recently presented the enhancement of coverage for rare cancers as a core task through the 5th Comprehensive Cancer Control Plan (2026–2030), and the need to re-examine the overall financial structure of oncology reimbursement is gaining attention.Related to this, the Korean Society of Medical Oncology has also emphasized the need to expand the scope of reimbursement for rare cancer treatments, calling for a balance between coverage expansion and fiscal sustainability.The background to these policy discussions is the rapid expansion of approved uses for multi-indication oncology drugs, such as immune checkpoint inhibitors, antibody-drug conjugates, and bispecific antibodies, which could accelerate the pace of expenditure growth.The recent regulatory and expanded reimbursement of the immunotherapy 'Tevimbra (tislelizumab)' is garnering significant attention. It is being interpreted as a case study demonstrating how realistic alternatives can be implemented amidst spending on multi-indication oncology drugs is skyrocketing.Tevimbra entered the Korean market in April last year, becoming the first immunotherapy to successfully secure reimbursement for the first-line treatment of esophageal cancer in combination with chemotherapy. Within just two months, it expanded its approved indications to a total of five, including esophageal cancer, gastric cancer, and first- and second-line treatment of non-small cell lung cancer.In December of the same year, an unusual record for Tevimbra was set when all five of these indications passed the Cancer Drug Review Committee in a single session. After that, it secured additional indications in perioperative adjuvant therapy for non-small cell lung cancer, extensive-stage small-cell lung cancer, and nasopharyngeal cancer. This drug's scope was expanded from major to rare cancers with limited existing treatment options in a short period. However, the expanded reimbursement for major indications remains ongoing.Despite concerns in the medical community that regulatory and reimbursement hurdles are rising, Tevimbra's rapid achievement is raising expectations, largely due to a strategy that combines proven clinical equivalence with a rational pricing model. By demonstrating clinical utility equivalent to first-in-class agents while offering a pricing structure that reduces the financial burden relative to competitors, the drug has navigated the approval and reimbursement processes swiftly. Experts evaluate Tevimbra as a symbolic case that tests the consistency of the reimbursement review process.Both clinicians and National Health Insurance subscribers are also welcoming Tevimbra as an expansion of treatment options. Clinicians appreciate the increased choices within the same efficacy profile, allowing for prescriptions tailored to patient characteristics. At the same time, payers view the situation positively as price competition between drugs with equivalent clinical effects can lead to significant cost savings.Providing options for rare cancers like nasopharyngeal cancer, or for areas like perioperative non-small cell lung cancer and esophageal cancer where reimbursed treatment options were previously lacking, aligns with the government's goal of expanding reimbursement coverage.In a situation where the reimbursement system is becoming restricted due to spending being concentrated on specific immunotherapies, a drug that successfully enters the reimbursement list by presenting a new price structure based on clinical similarity is expected to set a favorable precedent.Professor Ji-Youn Han of the Hematology-Oncology Department at the National Cancer Center said, "Tevimbra demonstrated an efficacy and safety profile equivalent to that of existing immunotherapies across various studies. In certain patient subgroups, it has shown clear relative advantages." Professor Han added, "As clinical evidence for Tevimbra grows, it is an option that can broaden the scope of treatment selection and improve clinical benefits and access. We hope for rapid reimbursement expansion so that patients can receive benefits."
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- 'Nubeqa' reimb progress…changes to prostate cancer trt strategies
- by Son, Hyung Min Mar 18, 2026 09:11am
- Prostate cancer treatment 'Nubeqa' The prostate cancer treatment 'Nubeqa' is under reviews for final insurance reimbursement hurdle.As the competing drug 'Erleada' faced setbacks in price negotiations and the patent expiration of Xtandi approaches, a total shift in the competitive landscape among Androgen Receptor Pathway Inhibitors (ARPI) is expected.According to industry sources, Bayer Korea is set to enter price negotiations with the National Health Insurance Service for Nubeqa (darolutamide). Nubeqa passed the Drug Benefit Evaluation Committee earlier this month, advancing to the final stage of coverage.The indications that passed the reimbursement evaluation include ▲high-risk non-metastatic castration-resistant prostate cancer ▲hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) ▲mHSPC in combination with docetaxel and ADT.Among these, the hormone-sensitive combination therapies were approved as suitable for reimbursement on the condition that a price below the evaluated amount be accepted.Once reimbursement discussions are finalized, Nubeqa will be available for practical clinical use in both triplet and doublet therapies. The strength of this drug lies in its differentiated treatment strategies, depending on whether docetaxel is co-administered, allowing for customized treatment tailored to the patient's condition.Doctors evaluate that this will expand treatment options, as triplet therapy (Nubeqa+ADT+docetaxel) can be used for patients who require aggressive early treatment. In contrast, doublet therapy (Nubeqa+ADT) can be considered for elderly patients or those with high chemotherapy burdens due to comorbidities.Clinical evidence for Nubeqa continues to accumulate, with the ARANOTE study targeting mHSPC patients showing that the Nubeqa + ADT doublet therapy significantly improved outcomes, reducing the risk of radiological progression or death by 46% compared to placebo.It also delayed the time to progression and PSA progression, showing consistent results across secondary endpoints. A post-monitoring analysis confirmed delay in time to deterioration of quality-of-life and pain progression.Furthermore, the ARASENS study showed that the triplet combination of Nubeqa + ADT + docetaxel significantly improved overall survival, reducing the risk of death by 32.5%.Competition among ARPIs intensifies…the market is closely watching variables such as reimbursement and patentsCurrently, the prostate cancer treatment landscape is centered on androgen receptor inhibitors.Major treatment options include Janssen's 'Zytiga (abiraterone),' 'Erleada (apalutamide),' and 'Xtandi (enzalutamide)' serving as major options alongside Nubeqa.However, several variables surround the market environment. Competing drug Erleada reportedly failed to reach an agreement during recent price negotiations with the National Health Insurance Service on expanding reimbursement for its high-risk non-metastatic indication.Prostate cancer treatment 'Xtandi'Analysis suggests that the adjustment of the Risk-Sharing Agreements (RSA) rate following the expansion of the target population is a key point of contention.Furthermore, the patent for Xtandi, which has led the market, is set to expire in major countries, starting with the U.S., in 2027. As Xtandi is a blockbuster with annual sales of approximately $6 billion, the possibility of structural market changes due to generic entry is being discussed in the mid- to long-term.Ultimately, Nubeqa's reimbursement progress, beyond a new listing, is evaluated as a variable that will influence the overall competitive landscape.As treatment options with clinical use as both doublet and triplet combination strategies are made available, depending on reimbursement status, the paradigm of prostate cancer treatment in Korea is increasingly likely to be restructured toward more patient-centered care.
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- Adjuvant immunotherapies shift gastric cancer trt paradigm
- by Son, Hyung Min Mar 17, 2026 09:22am
- Cancer immunotherapy 'Imfinzi'Major immune checkpoint inhibitors have demonstrated effects in pre- and post-operative adjuvant therapy. A paradigm shift in the treatment of gastric cancer is expected.According to industry sources on the 17th, the addition of an indication for the immunotherapy 'Imfinzi (durvalumab)' in advanced gastric cancer is imminent. AstraZeneca Korea anticipates approval within this month.While East Asia is notable for excellent early diagnosis and surgical outcomes, the risk of recurrence due to residual micrometastases remains high for patients with Stage 2–3 locally advanced disease. A perioperative treatment strategy, administering anticancer drugs both before and after surgery, has emerged as a solution to improve clinical outcomes.According to the final analysis of the Phase 3 MATTERHORN trial presented at the European Society for Medical Oncology (ESMO 2025) in Berlin last October, Imfinzi's perioperative adjuvant therapy significantly improved overall survival (OS) with statistical significance. Furthermore, clinical results for Asian patients, including South Koreans, were introduced at ESMO ASIA 2025.A total of 180 Asian patients participated in this analysis. The Asian cohort had a higher proportion of high-risk patients, with a greater frequency of T4 staging and lymph node positivity compared to the overall study population.Despite this, the Imfinzi combination therapy showed positive results, reducing the risk of disease progression by 26% in the event-free survival (EFS) endpoint compared with the placebo combination group. The 24-month EFS rate was 72.1% for the Imfinzi group, higher than the 64.2% in the placebo group. As the median EFS has not yet been reached in either group, the treatment benefit may become even more pronounced during long-term follow-up. The OS benefits were also consistent with the previous global clinical data.A particularly striking result was the pathological complete response (pCR). In the Asian cohort, the Imfinzi combination increased the proportion of patients whose tumors completely disappeared at the time of surgery to 18.9%, more than triple the 5.6% recorded in the placebo group. This level is similar to the overall analysis results, demonstrating that Imfinzi can significantly enhance tumor shrinkage effects during the preoperative phase.Safety was also confirmed to be at a manageable level, with no specific increase in toxicity compared to the standard FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) regimen. There was no significant difference in Grade 3 or higher adverse events between the two groups, and treatment discontinuation rates were similar, indicating no new safety concerns arising from the addition of Imfinzi. Given that FLOT itself is an intensive regimen, this is interpreted as an important finding.Based on these clinical results, the U.S. Food and Drug Administration (FDA) last month approved Imfinzi monotherapy as maintenance treatment following FLOT combination therapy in adult patients with resectable gastric and gastroesophageal junction adenocarcinoma.While surgery remains the cornerstone of curative treatment for gastric cancer, there is a growing global consensus, including in Asia, that surgery alone is often insufficient for a full cure. The MATTERHORN study has shown that administering immunotherapy in combination with FLOT before surgery, followed by radical resection and subsequent treatment, can meaningfully improve long-term outcomes.Clinical trials of major immunotherapies in perioperative adjuvant therapyCancer immunotherapy 'Keytruda'The attempt to integrate immunotherapy into perioperative care is not limited to Imfinzi. Various studies combining different immunotherapies with chemotherapy are confirming the potential for expanding gastric cancer treatment strategies.For example, improvements in preoperative pathological response rates have been reported in several studies, including studies involving avelumab + FLOT (MONEO), sintilimab + FLOT, toripalimab + SOX, and tislelizumab + SOX. Some studies are also exploring strategies that combine immunotherapy with anti-angiogenic agents or radiation therapy.Recently, the potential to improve tumor response rates has also been identified in preoperative adjuvant strategies involving the PD-1 inhibitor Tevimbra (tislelizumab), further raising the possibility of expanding preoperative immunotherapy.However, not all immunotherapies have achieved the same level of success.MSD's Keytruda (pembrolizumab) demonstrated improved pCR in the Phase 3 KEYNOTE-585 study evaluating a perioperative adjuvant strategy but failed to improve EFS, thus failing to meet its primary endpoints.
