Journalist

Lee Hyo jung
  • Lotte Biologics to Present SoluFlex Link ADC Platform Data at AACR 2026
    Lotte Biologics to Present SoluFlex Link ADC Platform Data at AACR 2026 Lotte Biologics said Tuesday it will present research results on its antibody-drug conjugate, or ADC, platform technology, SoluFlex Link, at the American Association for Cancer Research meeting, AACR 2026, to be held April 17-22 in San Diego. At the conference, the company will disclose results from an evaluation of the structural stability of an ADC using SoluFlex Link technology co-developed with Kanaph Therapeutics. According to Lotte Biologics, an analysis of aggregate changes over time found that a control group without the SoluFlex linker showed increasing aggregation as time passed, while the group using the SoluFlex linker showed markedly suppressed aggregation and maintained high stability. The company said the technology could help keep product quality stable during distribution and storage. In cell tests targeting multiple markers, including epidermal growth factor receptor (EGFR) and trophoblast cell surface antigen 2 (TROP-2), the SoluFlex Link group showed stronger anticancer effects at lower concentrations than the non-applied group, the company said. It also showed strong efficacy in triple-negative breast cancer cells. Lotte Biologics said animal studies showed improved in vivo pharmacokinetics, or PK, based on high stability. The company said the findings support SoluFlex Link as a platform technology not limited to a specific antibody, with potential to improve anticancer efficacy and pharmacokinetic properties. A Lotte Biologics official said SoluFlex Link is a differentiated platform that goes beyond the limits of existing technologies, adding that the company will provide solutions to help partners and customers develop next-generation ADCs. AACR is considered one of the world’s three major cancer meetings, along with the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO). It brings together cancer researchers and industry representatives to discuss cancer treatments and new drug development. * This article has been translated by AI. 2026-04-15 10:45:00
  • Korean Drugmakers Reshape R&D as Price Cuts and Commercial Law Changes Loom
    Korean Drugmakers Reshape R&D as Price Cuts and Commercial Law Changes Loom Korean drugmakers are reorganizing research and development around their headquarters and speeding up outside hiring and internal reshuffles as policy changes such as drug price cuts and revisions to the Commercial Act take shape. The moves are aimed at concentrating new-drug development and commercialization capabilities as profitability is expected to come under pressure. According to the industry on the 14th, Ildong Pharmaceutical decided the previous day to merge its R&D subsidiary Unovia into the parent company. Ildong cited a changing business environment and rising uncertainty, the need to strengthen competitiveness and the goal of operational stability. The company said it will integrate R&D functions into headquarters to improve management efficiency in line with institutional changes, including implementation of a revamped drug-pricing system. Unovia has led development of Ildong Pharmaceutical’s key pipeline. It has secured Phase 1 topline data for a GLP-1RA obesity drug candidate, and its P-CAB peptic ulcer treatment fadoprazan is in Phase 3 trials. Ildong said the reintegration will help speed technology licensing deals and commercialization. Industry officials view the decision as more than routine restructuring, describing it as a strategic response to pricing pressure and a broader push to overhaul corporate governance. The government is pursuing a plan to lower the pricing formula for generic drugs from 53.55% to about 45%, increasing downside pressure on earnings. At the same time, revisions to the Commercial Act are expected to add burdens related to treasury shares and governance responses. Across the pharmaceutical and biotech sector, companies are moving quickly on steps such as disposing of treasury shares, revising articles of incorporation and expanding independent directors. The revised Commercial Act includes a principle of mandatory cancellation of treasury shares, stronger board independence and changes to the structure for appointing audit committee members, affecting management strategies across the industry. Recruitment of outside specialists is also increasing. Ildong Pharmaceutical this month appointed Dr. Park Jae-hong as its new head of the R&D division. The company said Park will oversee Ildong’s overall R&D, including new-drug research and development, and that the hire will strengthen pipeline competitiveness and further raise R&D capabilities. SK Bioscience also hired Ma Sang-ho, a vice president and an infectious-disease research project management specialist, as head of the Research Support Office within its Bio Research Division. The company said it plans to strengthen R&D project management and open innovation, and to build a support system covering the full cycle from research planning to regulatory responses and operation of nonclinical and clinical sample analysis (GCLP). Yuyu Pharma hired Ryu Hyun-gi as head of its Development Division. Ryu has experience in development planning and business development after working at Kwangdong Pharmaceutical, Kyungnam Pharmaceutical, Korea Pharmbio and Hanwha Pharmaceutical. Yuyu said it aims to accelerate development of next-generation improved drugs and specialized formulations through the hire. The market expects the trend to continue for the time being. “Reorganizations centered on talent that understands clinical trials, regulatory approvals and business development are now in full swing,” a pharmaceutical company official said. “For companies seeking a breakthrough through R&D investment and securing specialized talent, it could instead become an opportunity to reset strategy.” Meanwhile, R&D spending in South Korea’s biohealth industry has continued to rise. According to the Korea Health Industry Development Institute’s “2025 Biohealth Industry Statistical Yearbook,” corporate R&D spending in the domestic biohealth industry increased from 3.4293 trillion won in 2020 to 4.4743 trillion won in 2024. * This article has been translated by AI. 2026-04-14 19:03:00
  • Centrum Cites Long-Term Research on Brain Health and Healthy Aging, Expands Korea Strategy
    Centrum Cites Long-Term Research on Brain Health and Healthy Aging, Expands Korea Strategy “Multivitamins have been shown to have positive effects beyond addressing nutrient gaps, including supporting brain health and slowing aging,” Haleon’s multivitamin brand Centrum said as it shared research accumulated over the past 35 years and outlined plans to expand Korea-specific strategies. Park Min-seok, head of medical and academic affairs at Haleon Korea, said at the “Centrum Day” event held April 14 in Seoul’s Myeong-dong that multivitamin research is moving beyond deficiency prevention toward improving quality of life and extending healthy life expectancy. “Multivitamin research is evolving from simply correcting deficiencies to improving quality of life and extending healthy life expectancy,” Park said. “Based on our global research capabilities, we will continue to expand optimal nutrition solutions for Koreans.” Organizers said Centrum, described as one of the world’s most-studied multivitamin brands, has scientific evidence supported by large-scale human studies and long-term follow-up data. Centrum said its research dates to 1985, beginning with studies of micronutrient deficiencies in China’s Linxian region, and includes long-term tracking of cancer incidence among U.S. male physicians in collaboration with the U.S. National Institutes of Health. Park said the field is also expanding to broader social value, including improved energy levels, better quality of life and reduced social costs. He added that recent work is increasingly focused on “precision nutrition” and “healthy life expectancy,” incorporating indicators such as brain health, aging biomarkers and individual lifestyle factors. Centrum also highlighted recent international findings. In an observational study of 614 adults in India last year, participants reported about a 44% improvement in energy levels after taking multivitamins, and the frequency of sick days fell by about 50%. In a health-economics model study involving older adults in Taiwan, researchers suggested that if multivitamin use slows cognitive decline, dementia cases could fall over the next 10 years, with potential social cost savings of about 65 trillion won. A Singapore study released early this year analyzed blood plasma from 662 middle-aged women and found low folate levels were linked to higher perceived stress, while B vitamins and vitamin D levels were associated with metabolic regulation. In South Korea, the company said it will strengthen a tailored approach reflecting Koreans’ dietary patterns and nutritional status. Centrum said it has continued developing localized products through research aligned with Korean eating habits and dietary reference intakes, and that this research helped lead to products such as “Centrum One Day Pack.” A Centrum official said the company will continue expanding Korea-specific data and solutions based on its global research capabilities. 2026-04-14 15:48:00
  • China’s Biotech Pipeline Nears U.S. Share, Driving Big Pharma and Korean Partnerships
    China’s Biotech Pipeline Nears U.S. Share, Driving Big Pharma and Korean Partnerships China’s biotech sector is rapidly closing the gap with the United States, reshaping global collaboration in drug discovery, licensing and co-development. As China’s share of new drug candidates rises, global pharmaceutical giants such as AstraZeneca and Pfizer — along with major South Korean drugmakers — are stepping up partnerships with Chinese companies. McKinsey & Company said on the 13th that last year’s global share of new drug candidates was led by the United States at 33%, followed by China at 30.5% and South Korea at 6%. The gap between the United States and China narrowed to 2.5 percentage points in just one year. McKinsey also said Asia, as of 2024, was driving the global pipeline for innovative drugs, highlighting China’s surge. In 2023, China’s share was 23% versus 36% for the United States, a 13-point gap. At the current pace, some forecasts say China could overtake the United States in global share of new drug candidates as early as next year. AstraZeneca last March signed a strategic collaboration with Beijing-based Sineron Bio, an artificial intelligence-driven peptide drug startup, to develop a first-in-class macrocyclic peptide for chronic disease treatment. Under the deal, AstraZeneca gained access to Sineron Bio’s Synova platform. The platform is designed as an intelligent, high-throughput, large-scale macrocyclic peptide R&D system to support research programs exploring future treatment options for chronic diseases, including rare diseases, autoimmune disorders and metabolic diseases. Pfizer is also using an AI model from China’s CrystalPi to advance small-molecule drug research. The deals underscore that China’s biotech industry is emerging not only as a manufacturing base but also as a source of early-stage discovery and platform technologies. Market observers describe the partnerships as evidence that global drugmakers are increasingly recognizing Chinese firms’ technical capabilities. Some also say the rise in global dealmaking involving China’s AI-biotech sector reflects growing technological maturity. South Korean companies are also bringing in promising Chinese candidates and expanding development ties. JW Pharmaceutical on April 8 signed an exclusive license-in deal with China’s Gan & Lee Pharmaceuticals for the GLP-1 receptor agonist candidate “bofanglutide” in South Korea. JW Pharmaceutical secured exclusive rights for development, regulatory approval, marketing and commercialization in the country. Gan & Lee agreed to provide regulatory data needed for clinical trial plan approval and product authorization in South Korea. HK inno.N last year acquired South Korean development and commercialization rights from China’s Sciwind Biosciences for the GLP-1 analog “ecnoglutide.” The candidate is in Phase 3 clinical trials in China for type 2 diabetes and obesity. HK inno.N is pursuing development in South Korea for obesity and diabetes treatments. Samsung Bioepis also signed a joint research partnership with Chinese biotech Frontline Biopharma to develop, manufacture and commercialize candidates in the antibody-drug conjugate, or ADC, field. A biotech industry official said South Korea’s industry long focused on catching up with U.S. and European technologies, but is now moving to secure next-generation modalities through co-development with China. The official said China’s biotech sector is growing quickly, supported by its large population and active government policies.* This article has been translated by AI. 2026-04-14 08:30:00
  • Celltrion Expands Omliclo Prescriptions Across Europe, Wins Key Tenders
    Celltrion Expands Omliclo Prescriptions Across Europe, Wins Key Tenders Celltrion expands Omliclo prescriptions across Europe Celltrion said April 13 that Omliclo (omalizumab), used to treat chronic idiopathic urticaria and allergic asthma, is gaining prescriptions across Europe and posting tender wins. In Italy, Celltrion’s local unit won bids from 10 regional governments. Supply has begun in some areas, including Umbria, Trentino-Alto Adige and Tuscany, the company said. In the United Kingdom, Celltrion said it won National Health Service tenders in all four administrative areas, including England, the largest omalizumab market. As of January, before the official tenders opened, Omliclo had already reached a double-digit market share, it said. In Germany, Celltrion said Omliclo, launched in September last year, reached a double-digit share within one month and continues to grow. The German unit completed listing agreements with all public health insurers shortly after launch, it said. In Northern Europe, Celltrion said results are becoming clearer. In Denmark, after winning a national tender, the company moved the launch up by four months through talks with the tendering body and secured exclusive supply status through September. Omliclo held a 98% share in Denmark as of January, based on IQVIA and market data, it said. In Finland, it posted a 73% share as of February, as switching from the original product accelerates in key Nordic markets. In Spain, Celltrion said it was selected as the top-ranked supplier in tenders to supply all public medical institutions in Catalonia and the Basque Country. Ha Tae-hoon, head of Celltrion’s Europe headquarters, said, “We will continue expanding our sales coverage so the results achieved in launch countries can spread across Europe.” Daewoong Bio launches 5 mg Glivixa, completing full lineup Daewoong Bio said April 13 it will launch a 5 mg low-dose version of Glivixa (memantine hydrochloride), a treatment for Alzheimer’s-type dementia. The addition completes the product’s dose lineup alongside 10 mg and 20 mg tablets. The company said Glivixa posted a compound annual growth rate of 18% from 2021 to 2025. It ranks No. 2 among prescription memantine products by outpatient prescription sales, and No. 1 in the generic market excluding the original product, it said. Daewoong Bio said it plans to accelerate prescribing based on the full lineup and to maximize synergy with its central nervous system portfolio, including Gliatamin, Cerebrain and Beacept. Memantine hydrochloride works by regulating excessive activity of glutamate, a neurotransmitter linked to Alzheimer’s-type dementia, helping prevent brain-cell damage and improve cognitive function, the company said. It added that early treatment can cause side effects such as dizziness, headache and drowsiness, requiring careful dose adjustment. Memantine therapy typically starts at 5 mg and is increased gradually over three weeks to reduce the risk of adverse reactions, it said. Patients with moderate or worse renal impairment must reduce the dose to 10 mg per day, which has driven steady demand for low-dose products. A Daewoong Bio official said the 5 mg product is expected to provide a safer option for patients starting treatment or those with moderate renal impairment, improving tolerability. Yuyu Pharma pushes AI-based work innovation toward a smart factory Yuyu Pharma said April 13 it is expanding AI-based work innovation beyond its factory, sharing use cases with staff in sales and marketing, research and development, and management support, and rolling out the enterprise AI solution WorksAI companywide. The company said it formed a production AI task force in the second half of last year to support smart-factory operations, including process optimization. The team identified six improvement areas, including manual Excel work, document review and the risk of human error. It compared five paid AI tools, including ChatGPT and Claude, and began applying selected tools tailored to each factory team’s work, it said. Yuyu Pharma said the effort produced practical tools, including production and quality data dashboards, precise comparisons of labeling materials and design drafts, searches and interpretation for GMP and regulatory documents, and equipment manual troubleshooting. The company said frontline staff in production management, quality management and product technology built the tools using AI despite limited IT expertise, with the IT department stepping in only where technical support was needed, such as real-time connections to internal servers. Yuyu Pharma said the tools are now being used to optimize processes, reduce bottlenecks by shifting repetitive tasks to AI, and lower risk factors by detecting structural errors, improving confidence in quality and safety. CEO Park No-yong said the company will deepen and expand AI use in production, including automating labor-hour analysis through data integration and conducting industrial safety risk assessments, while continuing to identify AI models suited to factory needs. CHA Women’s Medical Center signs agreements with Jeju providers to build infertility-care network CHA Women’s Medical Center Seoul Station said April 13 it has signed a series of agreements with four major medical providers in Jeju to build an infertility-care network: Hanmaeum Hospital, Seogwipo Medical Center, Hyundai Obstetrics and Gynecology Clinic, and L Obstetrics and Gynecology Clinic. Under the agreements, the organizations will work on referrals and return referrals based on patient symptoms, share clinical information to ensure continuity of care, and operate a cooperative system aimed at improving public health, the center said. A key goal is to help patients in Jeju receive follow-up care near home after undergoing advanced infertility procedures at the Seoul Station center, it said. The center said the network is expected to help patients focus on preparing for pregnancy and prenatal care without gaps caused by long-distance travel. Director Yoon Tae-gi said, “Through a close referral and clinical cooperation system, we will do our best to provide patients with the greatest convenience and, together with regional hub hospitals, contribute to the task of addressing the low birthrate.”* This article has been translated by AI. 2026-04-13 16:39:25
  • South Korea Food Safety Agency Cites 21 Firms for Misleading Albumin Food Ads
    South Korea Food Safety Agency Cites 21 Firms for Misleading Albumin Food Ads South Korea’s Ministry of Food and Drug Safety said Monday it cited 21 businesses after inspecting sellers of albumin-labeled foods from March 20 to April 3. The ministry said nine companies violated labeling and advertising rules, and 12 violated the Food Sanitation Act and the Health Functional Foods Act. At a briefing at the Seoul Regional MFDS office, the agency’s Emergency Response Team for Unfair Food Practices said it found nine firms that sold about 1.8 billion won worth of products by running online ads that could lead consumers to mistake albumin foods for health functional foods. The ministry said seven firms used phrases such as “fatigue relief,” “helps maintain liver function,” “albumin supplement” and “amino acid supplement,” which could mislead consumers into thinking the products had approved health claims. It also said two firms promoted ingredient-related effects as if they were proven benefits of the foods, including claims that “albumin helps maintain osmotic pressure in blood vessels” and that low albumin levels “can cause dizziness, edema and ascites.” The ministry urged consumers not to equate egg-white albumin used as a food ingredient with serum albumin, a medicine. Serum albumin is a protein that performs specific physiological functions in the blood and is a prescription drug injected, under a doctor’s order, into patients such as those with liver cirrhosis. Egg-white albumin, by contrast, is a food protein derived from egg whites and serves only as a source of nutrients when consumed. Baek Nam-i, head of the Emergency Response Team for Unfair Food Practices, said the ministry would continue to quickly block the creation and spread of illegal or misleading ads and respond strictly to violations.* This article has been translated by AI. 2026-04-13 15:03:00
  • ST Pharm Secures Japan Patent for Key mRNA-LNP Ionizable Lipid
    ST Pharm Secures Japan Patent for Key mRNA-LNP Ionizable Lipid ST Pharm said on the 13th it has completed patent registration in Japan for its ionizable lipid STP1244, a key raw material for its mRNA-LNP (messenger RNA-lipid nanoparticle) platform, STLNP, as well as an LNP formulation applying the lipid (STL1244). The company said the registration is the first granted patent tied to its STLNP platform. It said the patent is significant because it covers not only formulation technology but also a core ingredient that determines LNP performance, adding that the approval formally recognizes the technology’s originality and completeness. LNPs are essential carriers that deliver mRNA into cells, and ionizable lipids play a central role in delivery efficiency and endosomal escape. ST Pharm said STP1244, which it designed and developed in-house, helps improve intracellular delivery efficiency and supports delivery stability. With the patent, ST Pharm said it has built a technology portfolio spanning from key raw materials to finished formulations, strengthening its technical base as a CDMO in the fast-growing mRNA vaccine and therapeutics market. The company said it is pursuing patent examinations for the same technology in nine countries, starting with Japan and including South Korea, the United States, Europe and China, and plans to expand global rights. A company official said that, following last year’s Japanese patent registration for SmartCap, securing STLNP means ST Pharm now holds both core platform technologies for mRNA drug development. The official said the company will play a “pivotal role” in developing mRNA cancer vaccines and in-vivo CAR-T therapies.* This article has been translated by AI. 2026-04-13 14:36:00
  • Yuhan Wins FDA Orphan Drug Designation for Gaucher Disease Candidate YH35995
    Yuhan Wins FDA Orphan Drug Designation for Gaucher Disease Candidate YH35995 Yuhan said on the 13th that its new drug candidate YH35995, being developed to treat Gaucher disease, has received Orphan Drug Designation from the U.S. Food and Drug Administration for the Gaucher disease indication. The FDA program is intended to encourage development of treatments for diseases that affect small patient populations and have limited options. Designated products may qualify for incentives including clinical trial tax credits, waiver of certain review fees and up to seven years of market exclusivity after approval. Gaucher disease is a lysosomal storage disease caused by an enzyme deficiency that disrupts metabolism. It is an inherited rare disorder that can cause a range of symptoms throughout the body, including enlarged liver and spleen, anemia, low platelet counts and skeletal problems. Type 3 Gaucher disease includes neurologic symptoms, and there is no approved treatment for those symptoms, the company said. YH35995 is an oral small-molecule glucosylceramide synthase inhibitor designed to reduce production of glucosylceramide (GL1), a form of substrate reduction therapy. In preclinical studies, the compound showed a tendency to maintain strong and sustained inhibition of GL1 in the brain based on its ability to cross the blood-brain barrier. Yuhan said it expects the drug could provide clinical benefit for Type 3 patients, who have limited treatment options for neurologic symptoms. Yuhan said it plans to use the orphan designation to organize its global clinical development and regulatory strategy and focus on follow-up development aimed at improving patient access. The company previously received approval from South Korea’s Ministry of Food and Drug Safety for an investigational new drug application for a Phase 1 trial and is conducting a first-in-human study in healthy volunteers to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics. “This FDA orphan drug designation is a meaningful achievement that externally confirms both the need to develop a new treatment option for Type 3 Gaucher disease patients and the potential of YH35995,” said Kim Yeol-hong, head of R&D at Yuhan. “Based on discussions with global regulators, we will do our best to accelerate clinical development and provide a practical treatment alternative for patients with rare diseases.”* This article has been translated by AI. 2026-04-13 11:00:37
  • Korea’s Biopharma CDMO Exports Hit Record Q1 High Despite Mideast Risks
    Korea’s Biopharma CDMO Exports Hit Record Q1 High Despite Mideast Risks South Korea’s biopharmaceutical exports posted a record first-quarter total despite prolonged Middle East risks, led by contract development and manufacturing (CDMO) firms, regulators said. At the same time, domestically focused drugmakers are moving to emergency measures as uncertainty grows over supplies of packaging-related materials. The Ministry of Food and Drug Safety said April 12 that biopharmaceutical exports in the first quarter totaled $2.0 billion (about 2.96 trillion won), up 11.1% from a year earlier. Biopharma accounted for 71% of Korea’s total pharmaceutical exports of $2.8 billion. The quarterly total extended a three-year rise from $1.5 billion in 2024 to $1.8 billion last year and $2.0 billion this year, underscoring the competitiveness of Korea’s CDMO industry. Monthly exports were steady: $660 million in January, up 11.9% year over year; $690 million in February, up 25.4%; and $650 million in March, up 2%. By destination, Switzerland took 17%, the United States 16.5%, Hungary 15%, Germany 10% and the Netherlands 9.5%. The top five markets accounted for 68.4% of the total. Industry officials attributed the expansion in Europe to a combination of co-development with global drugmakers, technology exports and favorable perceptions of biosimilars. “As CDMO competitiveness and production infrastructure reach global standards, companies are actively building direct production and supply systems for Europe,” an industry official said. Samsung Biologics and Celltrion, among large companies with in-house production and CDMO capabilities, have helped drive the boom. Lotte Biologics, a late entrant to the CDMO market, is expanding the business with more than 1 trillion won in group-level investment. The government is also stepping up support for global expansion. A special law enacted last year to provide regulatory support for biopharmaceutical CDMO companies is set to take effect in December. Key provisions include streamlining production licensing and cutting the number of documents required for GMP evaluation submissions to four from 11. The law is intended to provide a framework allowing export-oriented CDMO companies to enter overseas markets without obtaining a separate manufacturing license. The ministry is also running a pilot program to certify manufacturing sites for raw materials and providing global regulatory information, while supporting the industry’s push to build a “fast-track review system.” While exports remain strong, Middle East-related risks are weighing on the broader domestic medicine supply chain. As fighting between the United States and Iran drags on, the Strait of Hormuz has remained blocked, and international oil prices at one point topped $100 a barrel. With crude supply uncertainty spreading to refiners, naphtha prices have recently jumped by 20% to 30%. Naphtha is a key feedstock for medical plastics such as IV fluid bags and packaging containers. That has heightened concerns among suppliers of IV solutions, including JW Pharmaceutical and HK inno.N. The pharmaceutical industry is also working to prevent stockpiling by hospitals, clinics and pharmacies. Yuhan Corp. has tightened inventory management for its acetaminophen in IV-bag form. HK inno.N, an IV-solution supplier, has adjusted some excessive orders to block stockpiling in advance. The ministry recently held an emergency meeting with major drugmakers to discuss short-term steps including using alternative materials, adjusting shipments and freezing inventories. Major companies are expanding stockpiles and diversifying suppliers amid concerns over shortages of key inputs such as naphtha, while the government is strengthening supply-chain monitoring and seeking joint measures with the industry. * This article has been translated by AI. 2026-04-12 17:30:00
  • South Korea Medical AI Approvals Jump 2.5-Fold in Three Years, Reaching 157 in 2025
    South Korea Medical AI Approvals Jump 2.5-Fold in Three Years, Reaching 157 in 2025 South Korea’s medical artificial intelligence market is expanding rapidly, with government approvals rising more than 2.5 times over the past three years, according to the Ministry of Food and Drug Safety. The technology is also evolving beyond diagnostic support to systems that can generate preliminary findings for imaging readers, industry officials say. The ministry said approvals, certifications and filings for AI-based software medical devices climbed from 62 cases in 2023 to 108 in 2024 and 157 in 2025. Another 55 cases were added in the first quarter of this year, it said. That compares with 4 cases in 2018, 13 in 2019 and 50 in 2020, underscoring how quickly the market has grown in less than a decade. The industry attributes the broader uptake to results from early leaders such as Lunit and VUNO, along with progress by newer entrants. Lunit said it received domestic approval last year for its 3D breast tomosynthesis AI image analysis solution, “Lunit INSIGHT DBT.” The product received U.S. Food and Drug Administration premarket approval in November 2023 and is being supplied through major U.S. imaging centers including SimonMed Imaging and Resolute, the company said. Lunit reported consolidated revenue of 83.1 billion won last year, up 53% from 54.2 billion won a year earlier, its highest annual total. Overseas revenue was 76.8 billion won, or 92% of the total, up 61% from 47.8 billion won. Fourth-quarter revenue rose 32% to 26.5 billion won from 20.0 billion won a year earlier. VUNO said it expanded its lineup after receiving ministry approval for “VUNO Med-DeepECG Kidney,” an AI-based electrocardiogram analysis software designed to screen for declining kidney function. The company said the deep-learning algorithm analyzes 12-lead ECG data to provide noninvasive, rapid and accurate screening. VUNO posted revenue of 34.8 billion won last year, up 34.4% from the previous year, a record. Sales of its flagship AI-based cardiac arrest prediction device, “VUNO Med-DeepCARS,” rose 18% to 25.7 billion won. Revenue from its AI-based ECG measurement device “Hativ” also increased to 1.9 billion won, the company said. Other companies, including Noeul and 3billion, are also contributing to market growth by targeting areas not dominated by the leading firms, such as AI-based blood and cancer diagnostics and AI-based rare disease diagnosis, the report said. In contrast, the number of approvals for medical AI clinical trial plans has declined, the ministry said, falling from 59 in 2023 to 56 in 2024 and 38 in 2025. Seven plans were approved in the first quarter of this year. A ministry official said the drop reflects the Digital Medical Products Act, under which data-based clinical trials are exempt from plan approval. “Because AI software often relies on data-based clinical studies, there are likely many trials conducted without ministry approval,” the official said. 2026-04-12 14:27:00