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- 2026-04-24 03:18:51
- Company
- Roche Diagnostics bets on mass spectrometry for lab automation
- by Hwang, byoung woo Feb 09, 2026 07:32am
- Roche Diagnostics Korea has positioned its ‘automated mass spectrometry solution’ as the final piece of the laboratory automation puzzle.The vision is to extend the laboratory efficiency gained through existing core lab automation to mass spectrometry, delivering the most accurate results precisely when patients need them.The company particularly emphasized a strategy to organically connect automated and digital platforms within the clinical setting, which is in line with Korea’s trend of seeking infrastructure expansion.On February 6, Roche Diagnostics Korea hosted a media session titled “Beyond Data, To Certainty,” where it shared its vision for next-generation automated mass spectrometry solutions designed to maximize laboratory efficiency, alongside AI-driven digital insights.(from the left) Sungho Cho, Head of Core Lab & POC at Roche Diagnostics Korea; Muhwan Yoon, Head of Digital Insights at Roche Diagnostics KoreaFrom ‘isolated islands’ to automated tracks... the evolution of mass spectrometryAccording to Roche, mass spectrometry has traditionally functioned as an “isolated island” within diagnostic laboratories. While recognized as the gold standard for analytes requiring precise quantification, such as hormones and vitamin D metabolites, its complex process has necessitated highly skilled personnel performing manual processes in dedicated spaces.Sungho Cho, Head of Core Lab & POC at Roche Diagnostics Korea, who led the presentation at the event, said, “Until now, mass spectrometry testing was inevitably conducted in batch mode. Samples were collected and analyzed only on specific days or outsourced to external laboratories, which meant patients sometimes had to wait a full week for results.”Roche’s proposed solution is to integrate this ‘island’ into the automated laboratory track. From sample receipt and pre-analytical processing to analysis and result reporting, all steps are unified into a single automated workflow, seamlessly connecting mass spectrometry to core lab automation.At the forefront of this strategy is the company's newly introduced ‘cobas pro i 601 analyzer’. Its core feature is the direct connection of the mass spectrometry equipment to the same track as standard automated immunoassay/biochemistry analyzers, integrating the entire process from sample loading to result generation.Cho emphasized, “The era has arrived where random access (Anytime Testing) is possible for even mass spectrometry, allowing results to be confirmed on the day of testing and immediately reflected in treatment. This is the realization of Roche’s vision for a seamless, uninterrupted patient journey.”NAVIFY's smart lab vision… adding ‘certainty’ to dataWhile mass spectrometry completes the hardware connection, Roche’s digital insights brand, ‘NAVIFY’ aims to create clinical value by analyzing the data flowing across the infrastructure.Muhwan Yoon, Head of Digital Insights at Roche Diagnostics Korea, described NAVIFY as a comprehensive digital ecosystem encompassing diagnostics, clinical care, pathology, and molecular diagnostics. Roche’s digital strategy centers on AI-driven 3P principles: Prediction, Performance, and Personalization.Specifically, AI algorithms identify patients' chronic disease risks early and provide recommendations to clinicians, while predicting laboratory workload to optimize staffing and reagent allocation. The core objective is to connect this to deriving personalized treatment options tailored to each individual patient.NAVIFY-based solutions initially focused on clinical laboratories but have since expanded to include clinicians, pathology, and molecular diagnostics.Yoon emphasized, “NAVIFY integrates not only diagnostic testing but also clinical, pathology, and molecular diagnostic data into a single ecosystem. It will become the tool for delivering a ‘true smart lab,’ which reduces the time medical staff spend on administrative tasks and allows them to focus solely on patient care.”Cost and regulation remain challenges…but automation is inevitableLooking ahead, cost and regulatory barriers remain key challenges for the adoption of innovative technologies in real-world clinical settings.On this, Cho said, “Traditional manual workflows involve hidden costs such as high labor expenses for specialized personnel and management costs associated with human error. Roche’s automation systems reduce reliance on manual labor, significantly improving operational efficiency. In the long term, this represents a strategic investment that enhances both hospital profitability and diagnostic accuracy.”Kit Tang, General Manager of Roche Diagnostics KoreaYoon also stated, “We are lowering entry barriers by offering various options tailored to hospital situations, such as subscription models.”He added that the company is actively engaging with regulators to address challenges arising from the intersection of digital technologies and traditional medical device approval frameworks. There is a growing consensus in the field that digitalization is a matter of survival.In closing, Kit Tang, General Manager of Roche Diagnostics Korea, emphasized, “Roche’s mission is ‘Doing now what patients need next.’ Automating mass spectrometry and digitally connecting diagnostics are not merely for product launches. They represent our commitment to eliminating diagnostic uncertainty and providing confidence to patients.”He added, “True patient-centered care is achieved not by introducing individual technologies, but by ensuring those technologies are organically connected in the clinical setting and translated into tangible benefits for patients.”
- Company
- Biologics for atopic dermatitis, 'four-way race'
- by Son, Hyung Min Feb 06, 2026 06:43am
- The biologic market for atopic dermatitis is experiencing a new shift. Competition among interleukin (IL)-13 inhibitors has been previously centered around 'Dupixent.' As treatments with new mechanisms enter the race, multi-layer competition is intensifying, with drugs that differ in their immune pathways. (clockwise from left) Nemluvio, Dupixent, Adtralza, EbglyssAccording to industry sources on the 4th, Galderma Korea has recently received domestic approval for its biologic agent 'Nemluvio (nemolizumab).' The indication is for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis (PN). With the addition of Nemluvio to the previously approved treatments, including Sanofi and Regeneron's Dupixent (dupilumab), LEO Pharma's Adtralza (tralokinumab), and Eli Lilly's Ebglyss (lebrikizumab)—the therapeutic options in the Korean atopic dermatitis market have expanded to four.Nemluvio is the only IL-31 receptor inhibitor among the drugs approved in Korea, targeting a distinctly different immune axis compared to existing treatments that inhibit the Th2 axis related to IL-13.IL-31 is a neuro-immune cytokine that induces itch signals, sitting at the center of a vicious cycle in which it directly stimulates sensory nerves, exacerbating scratching behavior.Unlike existing drugs like Dupixent (IL-4/13) and Adtralza or Ebglyss (IL-13), which focus on inflammation control, Nemluvio's mechanistic differentiation lies in its direct blockage of itching, the core symptom of the disease burden.In clinical trials, Nemluvio, when combined with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI), met all endpoints compared with placebo.Notably, the speed of itch improvement is rapid. In the global Phase 3 ARCADIA study, Nemluvio showed a statistically significant reduction in itching compared to placebo starting from 48 hours after administration, and at the 4-week and 16-week marks, more than twice as many patients compared to the placebo group experienced a clinically meaningful level of itch relief (PP-NRS improvement of 4 points or more).Regarding inflammation and lesion improvement, the Eczema Area and Severity Index 75% improvement (EASI-75) was 43.5% and 42.1% in ARCADIA-1 and ARCADIA-2, respectively, indicating a level of inflammation suppression similar to that of existing Th2 inhibitors.Administration convenience is also a strength. For atopic dermatitis, Nemluvio is administered at an initial dose of 60mg followed by 4-week intervals up to 16 weeks, and it is the only drug in Korea that can be switched to an 8-week dosing interval once a clinical response is confirmed.Considering that Dupixent and Ebglyss are both administered every 2 weeks, and Adtralza is administered every 2 or 4 weeks, Nemluvio is the first drug to provide a dosing interval optimization model based on clinical response.Analysis suggests that, given the essential role of long-term treatment for moderate-to-severe patients, this can significantly enhance market competitiveness by improving patient convenience and compliance.Clinical safety also showed no significant difference compared to existing treatments. Adverse events reported relatively frequently with existing biologics, such as conjunctivitis and herpes, showed no significant difference between the Nemluvio and placebo groups, and most adverse events were manageable at mild to moderate levels.New target competition intensifies… IL-22·IL-18 inhibitors are being developedAs atopic dermatitis is recognized as a multi-immune network disease that is difficult to explain by the inhibition of a single cytokine, new drug development is rapidly shifting from a Th2-centric approach to a multi-mechanism competition targeting various immune axes, such as IL-31, IL-22, and IL-18.Among these, the IL-22 inhibitor 'temtokibart,' being developed by LEO Pharma, is considered one of the most notable next-generation candidates.IL-22 is a key cytokine that induces epidermal proliferation, decreased barrier function, and chronic inflammation. IL-22 inhibition offers a distinct approach to existing Th2 inhibitors by simultaneously promoting skin barrier recovery and relieving inflammation.Temtokibart binds to IL-22RA1 (IL-22 receptor α1) to block IL-22 signaling and has the potential to inhibit the IL-20 and IL-24 pathways that share the same receptor. Thus, its strength lies in its upstream signal-inhibition mechanism, which regulates the entire epidermal barrier function and inflammatory pathways rather than blocking a single cytokine.In a Phase 2a study, temtokibart achieved EASI-90 in 30.8% of patients and EASI-100 in 20.9%, with broad reductions in systemic inflammatory proteins.Additionally, temtokibart was evaluated as the first mechanistic candidate to directly regulate epidermis-immune interactions, as it was shown to simultaneously inhibit the Th17/22, Th2, and Th1 axes and restore the expression of barrier genes such as KRT and CLDN.Another new drug candidate, camoteskimab from the U.S. biotech company Apollo Therapeutics, showed an 80% improvement in EASI scores in Phase 2a and maintained clinical responses even in the patient group that failed Dupixent.Since IL-18 is known as an upstream regulator of Th1, Th2, Th17, and Th22, it is expected to be a meaningful alternative for patients who did not respond to existing treatments. Korean company AprilBio and the U.S. drug development company Evommune have also entered Phase 2 clinical trials with this same mechanism.
- Policy
- HIRA to reinforce staff for post-listing evaluation
- by Jung, Heung-Jun Feb 06, 2026 06:43am
- The Health Insurance Review and Assessment Service (HIRA) has begun reinforcing post-listing evaluation by expanding personnel and restructuring its organization in preparation for shortened listing timelines for rare disease drugs.The existing Pharmaceutical Performance Assessment Department has been reorganized into the Rare & Severe Disease Pharmaceutical Performance Assessment Department within the Health Insurance Innovation Center, accompanied by staffing reinforcements.As evaluation procedures must be streamlined to shorten listing periods, post-listing assessment of clinical outcomes will be intensified.On the afternoon of the 4th, HIRA President Jung-gu Kang explained the plan to shorten the listing period for rare disease treatments, included in the proposed drug pricing reform plan, during a briefing with press corps reporters.The drug pricing reform plan reported to the Health Insurance Policy Deliberation Committee (HIPDC) in January includes a policy to enable fast-track reimbursement listing of rare disease drugs within 100 days.Kang stated, “We will simplify reimbursement appropriateness evaluation and negotiation procedures to shorten listing timelines and improve patient access. Conversely, to strengthen post-listing evaluation and ensure internal scalability, we have reorganized the existing Pharmaceutical Performance Assessment Department into the Rare & Severe Disease Pharmaceutical Performance Assessment Department within the Health Insurance Innovation Center and increased staffing.”In the first half of this year, HIRA also plans to commission research projects aimed at establishing cost-effectiveness evaluation criteria for new drugs.Kang said, “Through these research projects, we will develop an ICER threshold and adjustment framework suited to the Korean context, thereby building a rational and sustainable cost-effectiveness evaluation system.”Furthermore, to strengthen post-market evaluation for new drugs with unclear clinical evidence, plans are underway to utilize Real-World Data (RWD) and Real-World Evidence (RWE).Guidelines were developed based on the results of a research project conducted from March to November last year. Currently, registries for 12 drugs are being established to conduct performance assessments.The drugs under evaluation include Kymriah, Zolgensma, Spinraza, Evrysdi dry syrup, Luxturna, Qarziba, Bylvay capsules, Livmarli oral solution, Ilaris, Pemazyre, Zepzelca, and Isturisa film-coated tablets.Kang stated, “We revised detailed evaluation criteria to establish a solid foundation that enables outcome assessment using RWD. We will enhance the utilization of RWE generation guidelines, systematically manage registry quality to continuously verify clinical value, and strive to ensure patient safety.”Advancing health insurance payment reform… reviewing introducing a parallel fee scheduleBeyond drug-related issues, HIRA also outlined plans to develop a roadmap for reforming the national health insurance payment system. HIRA is reviewing a parallel payment model that combines fee-for-service and diagnosis-related group (DRG) payment system.For example, fee-for-service reimbursement would be maintained for physicians’ specialized surgical procedures and interventions, while hospital system usage fees, such as hospitalization charges or examination fees, would be compensated under a bundled payment system by DRG.HIRA also plans to further refine the Clinical Practice Evaluation Panel (CPEP) system, which precisely measures physician effort and equipment costs associated with individual medical services. The goal is to reassess and appropriately revalue services that have been historically undervalued.Kang explained, “Based on research recommendations, we are reviewing relative value payment reforms, including further refinement of CPEP to reform the current fee-for-service system. We are also considering the introduction of parallel payment models in relation to bundled payments.”He added, “We will shorten the cycle of the relative value score adjustment structure, which is a national policy task, and ultimately transition to a continuous adjustment system. This will help break away from the structure where profits increase only by performing many tests, and instead support a more realistic and sustainable reimbursement system.”
- Policy
- HK Inno.N enters Prolia biosimilar market
- by Lee, Tak-Sun Feb 06, 2026 06:43am
- HK Inno.N has joined the biosimilar market for the osteoporosis treatment Prolia (denosumab).It is the third company to obtain regulatory approval for a Prolia biosimilar, following Celltrion and Samsung Bioepis. Competition in the approximately KRW 170 billion market is expected to intensify.Korea’s Ministry of Food and Drug Safety approved HK Inno.N’s Izambia Prefilled Syringe (denosumab) on the 4th.Izambia is a biosimilar with the same efficacy and effects as the original drug, Prolia Prefilled Syringe, which contains the same active ingredient. It is indicated for: ▲ Treatment of osteoporosis in postmenopausal women ▲ Treatment to increase bone mineral density in men with osteoporosis ▲ Treatment of glucocorticoid-induced osteoporosis ▲ Treatment of bone loss in non-metastatic prostate cancer patients receiving androgen deprivation therapy ▲ Treatment of bone loss in female breast cancer patients receiving adjuvant aromatase inhibitor therapy.Izambia was licensed from Spain’s mAbxience. In January 2023, HK inno.N signed an exclusive domestic licensing agreement with mAbxience for denosumab biosimilars. Under the agreement, HK inno.N secured exclusive supply rights for two denosumab biosimilars, as well as domestic regulatory approval and commercialization rights.Denosumab is an antibody therapy that targets the ‘RANKL’ protein, which is critical for the survival and function of osteoclasts, thereby exerting potent inhibition of bone resorption. The original drugs are Amgen's osteoporosis treatment ‘Prolia’ and ‘Xgeva’, used for preventing skeletal-related events in patients with bone metastases and treating giant cell tumor of bone. Both products were launched in 2016.On the same day, HK inno.N also received approval for Denbrayce Inj, a biosimilar to Xgeva.Amgen’s ProliaProlia, which recorded annual sales of approximately KRW 174.9 billion in 2024 (IQVIA data), began facing biosimilar competition after its substance patent expired in March last year. Celltrion’s Stoboclo was the first biosimilar to launch, followed by Samsung Bioepis’ Obodence last year.Stoboclo is co-marketed by Daewoong Pharmaceutical, while Obodence is co-marketed by Hanmi Pharmaceutical. Given that the original Prolia is co-marketed in Korea by Chong Kun Dang and Amgen, the denosumab market has effectively become a battleground for major domestic pharmaceutical companies.With HK inno.N now entering the market, competition is expected to further intensify. The newly approved denosumab biosimilars from HK inno.N are expected to be launched within the first half of the year, following completion of reimbursement pricing procedures.
- Company
- Imdelltra can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Feb 06, 2026 06:43am
- The bispecific antibody anticancer drug Imdelltra is entering major hospital prescription lists in Korea.According to industry sources, Amgen Korea's Imdelltra (talatamab), a treatment for relapsed or refractory extensive-stage small cell lung cancer (SCLC), has passed the Drug Committee (DC) reviews at leading general hospitals, including Samsung Medical Center, Asan Medical Center, and Severance Hospital.However, Imdelltra has not yet been listed for reimbursement. In January, during the Health Insurance Review and Assessment Service’s first Cancer Drug Review Committee meeting of the year, the drug received a decision of “reimbursement criteria not established.”Therefore, it remains to be seen whether Imdelltra will secure reimbursement status and emerge as a treatment option in the underserved small-cell lung cancer field.Approved in Korea in May last year, Imdelltra is a bispecific antibody targeting delta-like ligand 3 (DLL3), which is expressed in approximately 85–96% of patients with small cell lung cancer. DLL3 is typically localized intracellularly in normal cells but is aberrantly expressed on the surface of tumor cells in SCLC and other neuroendocrine cancers.Imdelltra binds to both the DLL3 antigen on cancer cells and the CD3 antigen on T cells, redirecting T cells to induce tumor cell death. Crucially, it acts directly on the antigens of T cells and cancer cells, independent of Major Histocompatibility Complex Class I (MHC-1) expression, one of the key pathways cancer cells use to evade the immune system, making it effective even against immune-evading cancer cells.The efficacy of Imdelltra was demonstrated in the DeLLphi-301 clinical trial, a phase 2 study conducted in adult patients with extensive-stage SCLC whose disease had progressed after at least two prior lines of therapy, including platinum-based chemotherapy.In the study, Imdelltra showed a clinically meaningful objective response rate (ORR). Among 100 patients treated with Imdelltra 10 mg, the ORR was 40%, and 58% of responders (n=23/40) maintained their response for six months or longer.Furthermore, the median overall survival (OS) in the Imdelltra 10mg group was 14.3 months, and the median progression-free survival (PFS) was 4.9 months. Treatment-related adverse events in the Imdelltra 10mg group were mostly low grade, with grade 3 or higher adverse events occurring in 29% of patients in the clinical Parts 1-2 and 15% of patients in Part 3.Based on these results, the National Comprehensive Cancer Network (NCCN) recommends Imdelltra monotherapy as a preferred regimen for platinum-resistant patients and as another recommended regimen for platinum-sensitive patients. In addition, the American Society of Clinical Oncology (ASCO) has issued a strong recommendation for Imdelltra monotherapy in patients with recurrent disease after chemotherapy.Small cell lung cancer (SCLC) accounts for approximately 10-15% of all lung cancer patients and is characterized by rapid cancer cell proliferation, leading to widespread metastasis within a short period. It is known that 6 to 7 out of 10 patients are diagnosed at the extensive stage, where cancer cells have metastasized to the contralateral lung or distant organs.Current treatment options for extensive-stage SCLC are limited, primarily consisting of chemotherapy and immunotherapy. Therapeutic choices become even more restricted beyond third-line treatment. Although initial response rates to chemotherapy are relatively high, responses are often short-lived, with rapid disease progression. Particularly in refractory or resistant patients whose disease progressed within 6 months after the last chemotherapy treatment, the response rate to conventional chemotherapy drops below 10%, underscoring the substantial unmet need for new treatment options.
- Company
- 'Fintepla' reduces seizure freq…treating Dravet syndrome"
- by Son, Hyung Min Feb 06, 2026 06:43am
- Changes are emerging in the treatment landscape for Dravet syndrome, an ultra-rare pediatric refractory disease. With the domestic approval of a serotonin-based novel drug that has demonstrated efficacy in reducing seizure frequency, expectations are high for a shift in the treatment paradigm for an area with significant unmet medical needs.On the 4th, UCB Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul, to celebrate the approval of 'Fintepla (fenfluramine),' a treatment for Dravet syndrome, in Korea.Professor Hunmin Kim of Seoul National University Bundang Hospital Fintepla was designated as a drug for the second pilot project of the 'Approval-Evaluation-Negotiation Linkage System' in December 2024. This drug was officially approved in Korea last December, one year after its designation.The specific indication is an add-on therapy for the treatment of seizures in patients with Dravet syndrome aged 2 years and older. Given the nature of pediatric patients who may have difficulty swallowing pills, Fintepla is formulated as a syrup.Fintepla is a treatment that reduces seizures by stimulating multiple 5-HT receptor subtypes through serotonin release. It can decrease a patient's seizures through a dual mechanism that simultaneously activates serotonin receptors and sigma-1 receptors.Fintepla's clinical value was demonstrated in three randomized Phase 3 trials (STUDY 1–3).The analysis results of STUDY 1, which initially enrolled 119 patients, and STUDY 3, which included subsequently recruited patients, showed that the monthly average convulsive seizure frequency (MCSF) in the Fintepla-treated groups decreased by 62.3% and 64.8%, respectively. Notably, near-complete seizure freedom was confirmed only in the Fintepla-treated group.In STUDY 2, which consisted of a 6-week baseline, 3-week titration, and 12-week maintenance period for a total of 15 weeks, patients were randomly assigned 1:1 to either Fintepla or a placebo as an add-on to the existing standard of care, stiripentol (+ clobazam and/or valproate).In that study, the proportion of patients who showed a 50% or greater reduction in MCSF from baseline was 53.5% in the Fintepla combination group, compared with only 2% in the placebo group.In a 3-year open-label extension study, the reduction in seizure frequency with Fintepla was maintained. 64.2% of all patients showed a 50% or greater decrease in MCSF from baseline.In terms of safety, 216 patients with Dravet syndrome who received Fintepla showed a similar adverse event profile. The most commonly reported adverse events were decreased appetite (34.7%), diarrhea (19.9%), fatigue (19.0%), fever (18.7%), reduced blood glucose (14.4%), and somnolence (13.9%).Professor Hunmin Kim of Seoul National University Bundang Hospital explained, "Fintepla is a treatment that has consistently proven its seizure control effect and therapeutic value in multiple clinical trials, despite the difficult environment for patient recruitment due to the nature of ultra-rare pediatric severe refractory diseases."Professor Kim added, "Not only the mortality rate due to sudden death but also the all-cause mortality rate appeared lower in the Fintepla-treated group compared to values reported in existing literature."Limited treatment environment for Dravet Syndrome... Expectations↑ with new treatment optionProfessor Hoon-Chul Kang of the Department of Pediatric Neurology at Severance Children's HospitalDravet syndrome is a type of pediatric epilepsy that occurs in infancy. According to experts, the majority (80%) of this disease is caused by a mutation in the SCN1A gene.The disease develops around 12 months of age, and up to 15% of patients die during early childhood or adolescence. Dravet syndrome patients are at high risk for physical and mental comorbidities, such as physical stiffness, language development disorders, autism, intellectual disability, and ADHD.Caregivers also endure high caregiving stress and low quality of life due to 24-hour care burdens, career interruptions, and loss of income.Frequent long-term seizures in Dravet syndrome patients not only lower the quality of life for both patients and caregivers but also carry a risk of Sudden Unexpected Death in Epilepsy (SUDEP). Therefore, the primary goal of treatment is to reduce or stop seizures.However, existing anti-epileptic drugs have limitations in controlling seizures, and some medications can even worsen them, leaving a significant unmet need in the domestic treatment environment.Professor Hoon-Chul Kang of the Department of Pediatric Neurology at Severance Children's Hospital stated, "Treatment for Dravet syndrome should aim beyond reducing seizure frequency to managing non-seizure comorbidities and minimizing drug side effects, but this has been difficult to achieve in the current treatment environment."Professor Kang emphasized, "There is an unmet need for treatment options that can more effectively control seizures, reduce cognitive decline and long-term disability, and improve the quality of life for patients and caregivers. Fintepla functions to prevent seizures. Seizure-freedom effects can also be expected. As it works differently from existing drugs, expectations are high."
- Product
- Pharmacies express discontent over Xigduo distribution
- by Kang, Hye-Kyung Feb 05, 2026 07:48am
- ChatGPT-generated image.As the distribution of a widely prescribed pharmaceutical product has shifted from a manufacturer-led model to a wholesaler-led model, supply blind spots have emerged, leaving pharmacies that do not have a direct contract with the wholesaler unable to secure the drug.Pharmacies claim they are effectively forced to enter direct trading agreements with the specific distributors to receive products, facing unprecedented inconvenience.The product in question is AstraZeneca's diabetes drug, Xigduo XR (metformin hydrochloride, dapagliflozin propanediol monohydrate).Until last year, HK Inno.N was in charge of its sales and supply. However, as of January 1 this year, sales and supply were transferred to AstraZeneca Korea. In the process, a large domestic wholesaler (Wholesaler A) secured exclusive pharmacy distribution rights for the product.The problem is that since Company A secured the pharmacy distribution rights, supply to other wholesalers became impossible. In other words, pharmacies can only receive the drug if they have a direct trading relationship with Wholesaler A.One pharmacist said, “None of our four primary wholesalers can source the product from Wholesaler A, and it shows as out of stock across online wholesale platforms. For pharmacies like ours that do not have a direct trading relationship with Wholesaler A, securing inventory is impossible. It is unfair for a single wholesaler to effectively monopolize the sale and supply of a prescription drug.The pharmacist added that the product should at least be made available to other wholesalers through secondary wholesale channels.Another pharmacist noted, “When we checked why Xigduo XR was unavailable, we found that it could only be purchased through Wholesaler A. According to the sales representative, distribution to other wholesalers will only take place after distribution rights and inventory are fully reorganized.”In response, Wholesaler A stated that the policy is unavoidable given current supply conditions, citing limited inventory as a key constraint.A representative from Company A stated, “Due to limited market inventory, we are prioritizing supply to our contracted pharmacies. Secondary wholesale distribution is physically not feasible at this time.”The official added, “We currently have trading relationships with approximately 80% of pharmacies nationwide. Pharmacies with direct trade agreements can secure inventory as long as they meet the minimum order requirement.”However, this leaves around 20% of pharmacies facing significant hurdles, as initiating a new trading relationship requires meeting an initial minimum order threshold.Critics point out that pharmacies with low order volumes or long-standing relationships with other primary wholesalers are unlikely to open a new account solely to secure Xigduo XR—particularly when doing so may require purchasing several million wons worth of products upfront to meet initial order requirements.
- Company
- Kwangdong and MSD form pneumococcal vaccine alliance
- by Hwang, byoung woo Feb 05, 2026 07:48am
- The vaccine alliance between Kwangdong Pharmaceutical and MSD Korea is expanding into the adult pneumococcal market. Beyond their HPV vaccine collaboration, the partnership now includes the adult-specific 21-valent pneumococcal vaccine, marking an evolution in the companies' preventive portfolio partnership.Kwangdong Pharmaceutical is shifting its business focus toward prescription pharmaceuticals and vaccines by extending its existing vaccine sales infrastructure into the adult preventive care domain.On the 4th, Kwangdong Pharmaceutical announced that it had entered into a domestic co-promotion agreement with MSD Korea for Capvaxive, an adult-only 21-valent pneumococcal protein-conjugated vaccine. The two companies will jointly handle domestic marketing and distribution of Capvaxive starting from its launch in the first quarter of 2026.This collaboration builds on the partnership established through the co-promotion of the HPV vaccines Gardasil and Gardasil 9, which the two companies have jointly marketed and distributed in Korea since 2024.Given their existing cooperative relationship, the combination of Kwangdong’s sales infrastructure and MSD’s global vaccine portfolio is expected to generate significant synergies in the adult prevention market.Adult-only 21-valent design… broader serotype coverage expands protectionCapvaxive is a newly designed vaccine aimed at preventing invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults. It reflects the latest epidemiological characteristics of adult pneumococcal disease to address unmet needs.It prominently features the addition of eight unique serotypes—15A, 15C (deOAc15B), 16F, 23A, 23B, 24F, 31, and 35B—providing the broadest serotype coverage among currently approved pneumococcal protein-conjugated vaccines in Korea.According to the Ministry of Food and Drug Safety (MFDS) approval, Capvaxive is indicated for the prevention of invasive disease and pneumococcal pneumonia caused by pneumococcal serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) in adults aged 18 years and older.Having accumulated over 25 years of experience supplying pneumococcal vaccines to adults in Korea, MSD Korea plans to fully implement adult-tailored prevention strategies through this partnership.The company stated that it will work with Kwangdong Pharmaceutical to ensure that more adults benefit from expanded serotype-based protection.The current direct competitor is Pfizer's 20-valent pneumococcal protein-conjugated vaccine, Prevnar 20.With Chong Kun Dang handling domestic sales for Prevnar 20 for adults, marketing competition between the co-promotion partners is expected to intensify.For Kwangdong Pharmaceutical, the agreement represents more than a simple product addition, as it represents part of its broader effort to build experience in the vaccine business.Having already established preventive vaccine sales and marketing systems through the co-promotion of Gardasil and Gardasil 9, the company is now positioned to extend that infrastructure to adult pneumococcal vaccines.Sung-won Choi, CEO of Kwangdong Pharmaceutical, said, “This collaboration will further strengthen our vaccine portfolio and establish a foundation to address broader preventive healthcare needs. Leveraging our differentiated sales infrastructure and expertise, we will support the successful market entry of Capvaxive and continue to enhance our competitiveness in the domestic vaccine market.”Industry observers view this collaboration as an extension of Kwangdong Pharmaceutical’s ongoing strategic shift.While maintaining stable cash flows from its beverage and OTC businesses, the company is increasingly expanding its portfolio into high-value-added areas such as prescription drugs and vaccines.According to the recently disclosed quarterly report (cumulative for Q3 2025), Kwang Dong Pharmaceutical's sales structure is gradually shifting toward a pharmaceutical-centric portfolio.Reviewing sales and order status, the combined sales of prescription drugs (ETC) and vaccines reached KRW 140.5 billion. This represents approximately 18.3% of the company’s total revenue (KRW 768.5 billion).
- InterView
- [Reporter's View] Medical AI must read 'NULL' values
- by Hwang, byoung woo Feb 05, 2026 07:48am
- When we discuss medical AI, we often think of lines of data, more detailed records, and more meticulous numbers. It is widely believed that a data set with complete electronic medical records and no missing values is a shortcut to improving performance.However, the medical field is different. In medical data, 'NULL' values are not simply omitted during data processing. It is rather an outcome of a clinical decision made by doctors who observe patients and then state 'the testing is no longer needed.When a patient is stable, it is common practice in the field to avoid frequent blood draws and imaging. In other words, unrecorded silence itself is the most powerful data proving the patient's stable condition.It means that the data's nature is not limited to recorded values but also includes unrecorded contexts.An issue often arises when a NULL space is mechanically filled. AI loses context when it adjusts a NULL value to man-made numbers to improve data analysis efficiency.It falls into the trap of Domain Shift, a phenomenon where the distribution of the training environment and the actual clinical field diverges. While it is a technical choice to create a clean table, the context of medical data is compromised in the process.In fact, research results showing that AI's prediction accuracy drops by nearly 10% when data is forcibly adjusted while ignoring clinical prescription patterns are highly suggestive.This is because the AI model experiences a form of "cognitive dissonance" when encountering numbers forcibly inserted where NULL should be. Ultimately, this results in erasing the subtle signals sent by medical staff to save patients.At this point, the perspective on Medical AI must change as well. A good Medical AI is not a model that uses complex algorithms, but one that reflects the field's decision-making structure without distortion. The sense of understanding the flow of the medical system is becoming more important than the technology of matching numbers.Now, as the government discusses the early introduction and expansion of Medical AI, the question of "what philosophy governs the data?" becomes as important as "how much data was collected?" Filling in NULL is not absolute. Sometimes, respecting the blank itself is the way to preserve the performance of Medical AI.It is now time to consider whether we are erasing the silence left by medical staff to save patients in the name of data refinement. What Medical AI needs now is not the technology to fill in numbers, but the insight to hear the voices of medical staff contained within those NULL values.
- Company
- Sears turns profit, seeks expansion from Middle East
- by Hwang, byoung woo Feb 05, 2026 07:47am
- Seers Technology, having solved the long-standing profitability challenge in Korea’s medical AI industry, has now proposed building ‘global smart wards’ as its next step.Leveraging its integrated healthcare model that starts from inpatient monitoring and extends to outpatient and home care, Seers plans to accelerate its global market expansion from the Middle East.At an investor relations (IR) event held in Yeouido on the 4th, Seers unveiled its achievement of turning an annual profit in 2025 and its blueprint for a quantum leap as a healthcare platform company.“Workflow improvements felt by HCPs, the key to profitability”Young-shin Lee, Founder & CEO of Seers TechnologyAt the event, CEO Young-shin Lee cited “hospital workflow optimization” as the core driver behind the company’s return to profitability.Lee said, “Hospitals are not just places for treatment, but spaces where patients are continuously monitored and managed. To extend real-time monitoring beyond intensive care units to general wards, we focused on workflow improvements that reduce medical staff's workload.”Seers’ inpatient monitoring platform, thynC, continuously collects and analyzes vital signs from all patients across the entire hospital wards.Once installed at the bedside, the platform is combined with a subscription-based service, which the company believes will create a virtuous cycle of recurring revenue from existing beds.Lee explained, “thynC is not a one-time installation; its structure builds recurring revenue over time from existing beds. From 2028, new deployments and renewals will overlap, driving full-scale profit leverage.”Seers reported 2025 revenue of KRW 48.2 billion, a 595% increase from KRW 8.1 billion in 2024. Operating profit also turned positive, swinging from a KRW 8.7 billion loss to a KRW 16.3 billion profit.By 2028, which is when Lee believes the profit leverage is expected to fully materialize, the company projects the number of hospitals using its platform to nearly double to around 400.The company views this structure as closer to an operational platform than simple equipment sales. It is a model that enhances hospital operational efficiency itself by linking patient biometric data with nursing records, electronic medical records (EMRs), and ward workflows.Middle East as a “model transplantation hub,” not just a sales market… medical fees 3–5 times higherA major focus of the briefing was Seers’ overseas strategy, particularly in the Middle East and North Africa(MENA).Seers has positioned the UAE as a strategic foothold for its global expansion and is collaborating with PureHealth, the largest state-owned healthcare group in the Middle East.Lee noted, “If the reimbursement for a one-day arrhythmia test in Korea is around KRW 60,000, in the Middle East it is three to five times higher. The scale of inpatient beds in the MENA region is also larger than in Korea, and the number of chronic disease patients is significantly higher, resulting in a fundamentally different revenue structure.”Seers’ approach is not simply product supply. The company plans to leverage PureHealth’s hospital network, insurance, and distribution infrastructure to deploy an integrated wearable AI healthcare model within local systems. This model encompasses ▲arrhythmia screening based on mobiCARE, ▲inpatient monitoring via thynC, and ▲remote patient monitoring (RPM) for home care. Proof-of-concept (PoC) programs for the full product portfolio are currently underway in stages.Lee emphasized, “Selling a few pieces of equipment overseas is unlikely to yield meaningful results. Our goal is to replicate the ‘hospital-outpatient-home care integrated model that has been validated in Korea.The company has set a target to raise the proportion of overseas sales to around 50% by around 2029 through this phased expansion strategy.Lee particularly conveyed the company's determination to penetrate the market based on technological specialization, noting that global giants like Philips and GE Healthcare already dominate the international arena.He stressed, “The Middle East market is a battleground where all global leaders compete. Seers distinguishes itself by internalizing the entire process—from materials to sensors and AI algorithms. We will secure references by winning against them to enter the US and European markets.”Additionally, Seers is pursuing a collaborative model linking real-time patient data accumulated via wearable devices to the pharmaceutical industry. The vision is to combine medication information with biometric data to expand into the realm of clinical and real-world data (RWD) applications.Lee concluded, “By achieving a 50% overseas revenue share by 2029, we aim to become a global wearable AI healthcare platform company. Our first-ever profitability milestone is only the starting line. We will continue to build a sustainable revenue structure while completing our global expansion.”
