Journalist

Lee Hugh
  • South Korea’s Fast-Track Rule Opens Door for AI Medical Devices, Raising Oversight Questions
    South Korea’s Fast-Track Rule Opens Door for AI Medical Devices, Raising Oversight Questions A new system allowing certain “immediate market entry” medical technologies to be used in clinics without a separate new health technology assessment is reshaping South Korea’s artificial intelligence medical device sector. The lower barrier is expected to expand the size and competitiveness of K-AI medical devices, but debate remains over safety verification and accountability. Industry officials said 113 of the 199 device items covered by the immediate-entry system are digital medical devices that include AI-based standalone software. Companies have welcomed what they call an opening of the AI medical device market, expecting faster commercialization to spur research and development and attract outside investment. Park Chang Min, president of the Korean Society of Medical Artificial Intelligence and a radiology professor at Seoul National University Hospital, said the move reflects urgency as competitors such as the United States and China move quickly. “It can improve access to innovative technology for patients and clinicians, and give breathing room to domestic medical AI companies facing financial strain,” he said. A medical device industry official said it was “clearly positive” that shortened procedures improve conditions for new entrants. Another industry official said companies may face higher expectations: “As the review period shrinks, the standards regulators demand will rise. The change is both an opportunity and pressure.” Clinicians and patient-safety advocates raised broader concerns. Jeon Jin Han, policy director at the Association of Doctors for Humanism, said AI has already been a major beneficiary of early-entry policies such as deferrals of new health technology assessments. “The key issue is that medical technologies that have not gone through the new health technology assessment are hard to view as sufficiently verified for safety and effectiveness,” he said, adding that approval by the Ministry of Food and Drug Safety does not itself mean clinical effectiveness has been proven. The system is intended to introduce and use strong medical technologies earlier. Critics warn that skipping the new health technology assessment — which can take up to 250 days — and allowing market entry based only on ministry approval could lead to adverse outcomes such as misdiagnosis. Some experts also called for separate standards for generative AI-based medical devices. In a report, the Korea Health Industry Development Institute said generative AI medical devices need new evaluation criteria that consider potential indications, and that a management system is essential to monitor adverse events in real time and update products continuously. The government said it is putting procedural safeguards in place. Seong Hong Mo, director of the medical device policy division at the Ministry of Food and Drug Safety, said AI medical devices already undergo strict review of safety and effectiveness at the approval stage, and that companies and medical institutions are required to report adverse events. Seong said a separate oversight system is also in place for AI model updates. Under the Digital Medical Products Act that took effect last year, he said, companies must seek approval again if key performance or intended use changes significantly. Experts said the policy’s success will depend on tighter post-market controls. Park said a clear mechanism must work to remove technologies from the market if they fail to prove effectiveness in clinical use or if misuse or side effects are confirmed. “Speed and safety are separate issues,” he said, adding that lower entry barriers must be paired with strong post-market monitoring and a clear exit structure.* This article has been translated by AI. 2026-02-08 18:33:00
  • More South Korean firms to offer five-day Lunar New Year break as outlook brightens
    More South Korean firms to offer five-day Lunar New Year break as outlook brightens SEOUL, February 08 (AJP) - A new survey shows that more than six out of ten South Korean businesses plan to observe a five-day holiday for the upcoming Lunar New Year. The findings also indicate that the number of companies reporting a decline in economic conditions has dropped significantly compared to last year, suggesting a recovery in business confidence. The Korea Enterprises Federation (KEF) released the results of its Lunar New Year Holiday Survey on February 8, after polling 447 companies nationwide with five or more employees. The data shows that 64.8 percent of these firms will close for five days. This year's holiday period stretches from the weekend of February 14 and 15 through the official public holidays of February 16 to 18. Among the respondents, 26.1 percent plan to offer four days or fewer, while 9.2 percent will provide six days or more. For the companies offering these extended breaks, 59.4 percent stated they were following mandatory requirements set by collective bargaining agreements or internal employment rules. Larger firms with 300 or more employees were notably more likely to offer longer breaks, with 22.7 percent providing at least six days off, compared to just 7.6 percent of smaller businesses. Regarding holiday pay, 58.7 percent of companies said they will provide a Lunar New Year bonus, a slight decrease from 61.5 percent last year. Among those paying out, 66.3 percent will issue them as regular bonuses, 28.6 percent as separate discretionary bonuses, and 5.2 percent will provide both. For the businesses opting for discretionary bonuses, 85.7 percent intend to keep the amounts consistent with last year's levels. The survey highlights a shift in how businesses view the current economic climate. While 55.6 percent of respondents described the situation as "similar to the previous year," the proportion of companies stating the economy had "worsened" fell to 39.5 percent. This is a sharp decline from the 60.5 percent who reported a worsening economy during the same period last year. The KEF also gathered projections for the current fiscal year. Roughly 50.9 percent of the surveyed firms expect their operating profits to increase compared to last year, while 36.0 percent anticipate a decrease. The data reflects the prevailing mood in the field as companies prepare for one of South Korea's most significant traditional holidays. Local businesses appear to be leaning toward a more stable outlook even as they manage holiday bonus distributions. 2026-02-08 18:28:55
  • Seoul Metro Railcar Bid for Lines 6 and 7 Renews Debate Over Lowest-Price Contracting
    Seoul Metro Railcar Bid for Lines 6 and 7 Renews Debate Over Lowest-Price Contracting Dawonsys’ delivery delays are fueling renewed debate over how Seoul subway railcars are procured. With Seoul Metro expected to keep a lowest-price structure for its Lines 6 and 7 railcar purchase, critics are calling for a broader review of the bidding system. According to the rail industry on Saturday, Seoul Metro will hold a project briefing on Feb. 11 in Seongdong-gu, Seoul, for a plan to buy 376 railcars for Lines 6 and 7. The project would replace some aging trains, with an order value of about 950 billion won. Seoul Metro is expected to disclose details such as the bidding method and evaluation criteria at the briefing. The leading option under review is the existing lowest-price bidding approach. Seoul Metro is reported to have posted a notice last month indicating it would pursue the project through lowest-price bidding. Under the system, bidders are screened in a first stage based on factors such as quality, capacity and delivery track record, then the contract is awarded in a second stage to the company offering the lowest price. Buyers favor the method because it can reduce upfront costs. But the lowest-price focus has long been blamed for delivery delays. Industry officials say aggressive price competition can lead to the use of low-cost Chinese parts, more breakdowns and service disruptions. The Public Procurement Service is reported to have sent an official letter to the Seoul city government asking it to consider switching to a “contract by negotiation” model. Dawonsys delivered Line 4 railcars 597 days late, completing delivery last year after originally agreeing to deliver by May 2024. A separate order for 298 railcars for Lines 5 and 8 is past its deadline and has not yet been delivered. Industry officials warn similar problems could recur if the lowest-price structure remains, arguing it does not adequately reflect long-term maintenance costs even if it lowers the initial purchase price. “Railcars are long-term equipment with a service life of up to 30 years,” a rail industry official said. “Maintenance costs are far larger than the initial purchase cost, but lowest-price bidding is structured to judge only the vehicle price.” Competition is expected between Woojin Industrial Systems, which has recently won a series of urban railcar projects, and Hyundai Rotem, which is seeking to expand its domestic railcar business. Some in the industry say a lowest-price format could disadvantage Hyundai Rotem because it has a higher share of domestic production. In the National Assembly, discussions on reforming the procurement market are continuing, including the introduction of a set of bills aimed at preventing repeat delivery delays, dubbed the “Dawonsys ban law.” The proposed revisions would generally cap advance payments for construction, manufacturing and service contracts above a certain amount at 20%, allowing up to 50% only when unavoidable. They would also designate companies with habitual delivery delays or misuse of advance payments as “unfair contractors,” restricting them from public bids. 2026-02-08 18:03:00
  • South Korean Drugmakers Step Up FDA Filings to Enter U.S. Market
    South Korean Drugmakers Step Up FDA Filings to Enter U.S. Market South Korean pharmaceutical and biotech companies seeking entry to the world’s largest drug market, the United States, are increasingly filing for U.S. approvals. According to the industry on Feb. 8, HK inno.N said it filed a new drug application, or NDA, with the Food and Drug Administration last month for K-CAB, South Korea’s 30th domestically developed new drug. K-CAB treats gastroesophageal reflux disease. In a global Phase 3 trial, it showed clinical superiority over proton pump inhibitors, or PPIs, an existing class of treatments. HLB has again approached the FDA with a liver cancer drug, its third attempt. In mid-January, HLB’s U.S. subsidiary Elevar Therapeutics and partner Hengrui Pharmaceuticals filed an NDA for rivoceranib and a biologics license application, or BLA, for camrelizumab, respectively. In the same month, the company also requested an NDA for lirafugratinib as a second-line treatment for bile duct cancer. Companies are also moving through earlier steps, including submitting and winning approval of investigational new drug applications, or INDs. ABL Bio said it submitted an IND to the FDA in late January to begin a Phase 1 trial of ABL209, a bispecific antibody-drug conjugate, or ADC, candidate. The company plans to start Phase 1 trials of ABL209 and another bispecific ADC candidate, ABL206, at the same time around midyear and release early data next year. ABL206 received FDA IND clearance in January. SK Biopharmaceuticals, which is expanding its radiopharmaceutical therapy, or RPT, business, said it received Phase 1 approval in January for RPT candidate SKL35501 and imaging agent SKL35502. PharmaResearch said its nano cancer drug PRD-101 received Phase 1 approval last week. The company, known for strength in aesthetics, plans to expand into cancer treatment based on PRD-101. Vivozon said it received clinical approval for VVZ-2471, a non-opioid oral painkiller candidate. The company plans to develop it in South Korea as a treatment for neuropathic pain and in the United States as a treatment for opioid addiction. With companies accelerating FDA work, the industry expects more South Korean new drugs to reach the U.S. market this year. The Korea Biotechnology Industry Organization said the FDA approved 46 new drugs last year. The list included drugs developed by Chinese and Japanese companies, but none from South Korea.* This article has been translated by AI. 2026-02-08 17:18:00
  • POSCO Cuts Output at Pohang No. 2 Wire Rod Mill, Reassigns Half of Shifts
    POSCO Cuts Output at Pohang No. 2 Wire Rod Mill, Reassigns Half of Shifts China-driven oversupply and a prolonged slowdown in global steel demand are pushing POSCO to idle key facilities at its Pohang Works. After shutting its No. 1 wire rod mill in 2024, the company is now moving to sharply cut output at the No. 2 wire rod mill, deepening a restructuring of production.  According to Ajunews reporting on Saturday, POSCO has recently been reassigning workers from the No. 2 wire rod mill to other departments. The mill has operated with four shift teams, and two teams have already completed transfers, the report said. Industry officials expect operations at the mill could be suspended once the remaining reassignments are finished. The No. 2 wire rod mill began operating in 1984 and has produced high-grade wire rod products. Wire rod is made by rolling semi-finished steel into coils and is used as an intermediate material for products such as steel wire, wire rope and welding rods.  Pohang Works once ran four wire rod mills. It started operating the No. 1 mill in 1979 and completed the No. 2 mill in 1984 to begin producing high-grade wire rod. As demand rose, it later built the No. 3 and No. 4 mills. Annual capacity is about 750,000 tons for No. 1, 547,000 tons for No. 2, 850,000 tons for No. 3 and 700,000 tons for No. 4. The No. 1 mill was already closed in 2024 amid persistent oversupply in the global steel market. The latest move involving the No. 2 mill is being viewed in the same context, as structural oversupply in China has intensified price competition for commodity wire rod and demand has recovered more slowly than expected, squeezing profitability. Domestic demand for wire rod has stayed below 3 million tons a year over the past three years, marking the lowest level since 2025. The Korea Iron & Steel Association said last year’s domestic wire rod production, exports and domestic sales were 2,136,615 tons, 613,020 tons and 1,467,031 tons, respectively, all down by as much as nearly 18% from a year earlier. Over the same period, total domestic wire rod sales fell 16.7% to 2,080,051 tons, and domestic demand slipped 7.3% to 2,607,605 tons. Meanwhile, the market share of imported Chinese products rose to a record 34.3%. The cutbacks at Pohang Works are not limited to wire rod. POSCO is also said to be reviewing a plan to remove a continuous caster at the No. 2 continuous casting plant. A continuous caster is a core steelmaking facility that continuously casts molten steel into semi-finished products such as slabs or billets.  Because most rolling processes — including wire rod, heavy plate and hot-rolled products — rely on output from continuous casters, reducing that equipment is seen as part of a broader effort to streamline the steel production system alongside wire rod cutbacks. A POSCO official said the No. 2 wire rod mill has reduced its operating scale after reassigning workers from two of its four shift teams to other departments. But the official added that the company is lowering utilization and “does not have a plan to completely shut the plant for now.”  2026-02-08 17:03:00
  • Renault Korea to Offer Free Vehicle Safety Checks Ahead of Lunar New Year Holiday
    Renault Korea to Offer Free Vehicle Safety Checks Ahead of Lunar New Year Holiday Renault Korea said Sunday it will offer free vehicle inspections nationwide to support safe driving during the Lunar New Year holiday, when many drivers travel long distances. The company will also run a giveaway for customers who pay for repairs during the period. The free-check program will run Feb. 9-13, longer than the joint schedule set by the Korea Automobile Mobility Industry Association. Customers can visit any of Renault Korea’s seven company-run service centers or 364 service-network locations for the inspection. Inspection items include lamps; key fluids such as power-steering oil, engine oil, brake oil, washer fluid, coolant and automatic transmission oil; wiper operation; front and rear brake pads; tire condition and wear; and winter-safety essentials including the battery and terminals and belt cracking. Renault Korea said it will also hold an event for customers who need repairs based on the inspection results. Among customers who receive at least 50,000 won in paid repairs at service-network locations during the free-check period, the company will draw 100 winners a day, for a total of 500, and provide each a mobile fuel voucher worth 20,000 won.* This article has been translated by AI. 2026-02-08 16:36:00
  • Ilia Malinin Lands Backflip at 2026 Milan Olympics After Ban Lifted
    Ilia Malinin Lands Backflip at 2026 Milan Olympics After Ban Lifted A figure skating backflip, long treated as taboo on the Olympic stage, returned after nearly 50 years when American Ilia Malinin landed one without penalty, drawing a loud reaction from the crowd. Malinin completed the backflip late in his program in the men’s singles short program of the figure skating team event at the 2026 Milan-Cortina d’Ampezzo Winter Olympics at the Milan Ice Skating Arena in Italy, according to the report. The backflip had been effectively barred for decades. After American Terry Kubicka first attempted it at the 1976 Innsbruck Winter Olympics, the International Skating Union banned the move starting the following year, citing athlete safety and injury risk. After that, skaters were assessed a two-point deduction whether or not they landed it. At the 1998 Nagano Winter Olympics, France’s Surya Bonaly drew attention by attempting a backflip while accepting the deduction as a protest over judging. The report said Bonaly, then among the world’s top skaters, alleged discriminatory judging and left the Olympic stage after that performance. With the sport placing more emphasis on expression and spectacle, the ISU lifted the backflip ban in 2024. Malinin became the first skater to land a backflip at the Olympics without a deduction since the rule change. Malinin scored 98.00 points, combining technical and program components, to place second behind Japan’s Yuma Kagiyama, who scored 108.67. The backflip itself did not earn a separate bonus. Afterward, Malinin said, “The crowd cheered so loudly it was uncontrollable,” adding, “It was a moment when I felt the weight of the Olympic stage and gratitude.”* This article has been translated by AI. 2026-02-08 16:27:00
  • South Korea’s Big 4 Banks Post Record Profit, but Bad Loans Surge More Than 50%
    South Korea’s Big 4 Banks Post Record Profit, but Bad Loans Surge More Than 50% South Korea’s four biggest commercial banks — KB Kookmin, Shinhan, Hana and Woori — posted record net profit last year, but key asset-quality indicators worsened as troubled loans climbed sharply. With more borrowers struggling to repay since the COVID-19 period, the combined volume of bad loans has jumped by more than 50% in four years, raising concerns that hidden stress could surface as rate-cut expectations fade and market rates rise. According to the financial sector on Feb. 8, the four banks’ combined net profit for last year totaled 13.9919 trillion won, up 4.9% from 13.3435 trillion won a year earlier and the highest on record. The Bank of Korea cut its benchmark interest rate twice last year, in February and May. Even so, interest income kept rising as loan assets expanded. Typically, falling benchmark rates squeeze banks’ net interest margins, but last year loan growth was enough to offset the margin decline and lift interest earnings. At the same time, troubled loans grew quickly. As of the end of December last year, the four banks’ combined bad loans totaled 12.4780 trillion won. The figure includes “precautionary” loans that are one to three months overdue and nonperforming loans (NPLs) that are more than three months overdue. It was up about 52.6% from 2021. By year-end totals, bad loans were 8.1736 trillion won in 2021, 8.7892 trillion won in 2022, 9.6781 trillion won in 2023 and 11.0639 trillion won in 2024. The share of total loans that were more than three months overdue rose to 0.30% last year, the highest level in five years. Both precautionary loans and NPL balances were the highest since 2021. NPLs rose to 4.5489 trillion won at the end of last year from 2.8643 trillion won at the end of 2021, an increase of 59%. That means more than 1.6 trillion won in unpaid debt accumulated over four years. Precautionary loans reached 7.9291 trillion won at the end of last year, up about 49% from 2021. As bad loans increased, banks’ ability to absorb losses also weakened. The NPL coverage ratio, a measure of reserves relative to bad loans, fell to 171.7% last year, dropping below 200% again for the first time in four years. Banks set aside large provisions each year, but the pace of bad-loan growth has outstripped those buffers. With the Bank of Korea signaling an end to rate cuts and market rates rebounding, concerns are growing that more bad debt could emerge. Domestic demand has weakened, and rising rates have pushed small and midsize businesses and self-employed owners closer to their repayment limits, according to the report. A financial industry official said, “Since COVID-19, the pace of deterioration has been accelerating again along with the economic slowdown,” adding, “The larger the volume of bad loans, the more provisions banks must build, which will further hurt profitability.”* This article has been translated by AI. 2026-02-08 16:03:00
  • Samsung Biologics Gets Third-Party Verification for Product Carbon Footprint System
    Samsung Biologics Gets Third-Party Verification for Product Carbon Footprint System Samsung Biologics said Saturday that its product carbon footprint (PCF) system has completed third-party verification. The company recently received a third-party verification certificate for the system from DNV, a global certification body headquartered in Norway. PCF refers to greenhouse gas emissions generated across a product’s full life cycle, from production to disposal. DNV provides verification and certification services related to quality, environment and safety based on international standards. The verification covered biopharmaceutical manufacturing processes at the company’s first Bio Campus in Songdo, Incheon. The review found that Samsung Biologics’ in-house PCF system accurately calculates greenhouse gas emissions tied to energy and raw-material use across drug production, as well as emissions from waste and wastewater output. The company said the result formally recognizes the system’s objectivity and reliability and shows it is carrying out activities aligned with environmental strategies sought by global customers under environmental, social and governance, or ESG, requirements. CEO John Rim said, “This verification provides an opportunity to meet global customers’ requirements and further strengthen trust,” adding that the company will continue working to achieve its carbon-neutrality goals as an ESG leader in the pharmaceutical and biotech industry.* This article has been translated by AI. 2026-02-08 15:45:00
  • Samsung Elec on track roll out HBM4 chips this month
    Samsung Elec on track roll out HBM4 chips this month SEOUL, February 08 (AJP) - Samsung Electronics is set to begin mass shipments of the the sixth generation high bandwidth memory chips dubbed HBM4 later this month, according to industry sources Sunday. The chips will be rolled out from the third week of February after the Lunar New Year holiday break, thrusting the HBM laggard into the front tier as HMB4 is expected to become the standard from next-generation AI chips. The shipment schedule has been finalized to align with the production of Nvidia's next-generation AI accelerator, known as Vera Rubin. Samsung has reportedly completed quality verification and received purchase orders, with the latest order including a significant increase in sample volumes for final module testing. Kim Jae-jun, vice president of Samsung's memory business, confirmed the production timeline during a fourth-quarter earnings call last month. He stated that mass production of HBM4 chips with speeds of 11.7Gbps was already underway for scheduled delivery in February. Nvidia is expected to officially unveil the Vera Rubin platform featuring Samsung's HBM4 at the GTC 2026 conference next month. The HBM4 chips feature specifications that exceed current industry standards. While the JEDEC standard is set at 8Gbps, Samsung's product achieves transfer speeds of 11.7Gbps, a 22 percent improvement over the previous HBM3E generation. The memory bandwidth per single stack has increased to 3 terabytes per second, while a 12-stack configuration provides a 36GB capacity. The company plans to expand this to 48GB using 16-stack technology in the future. To achieve these performance gains, Samsung integrated its 10-nanometer-class sixth-generation DRAM with its 4-nanometer foundry process. The company is promoting a one-stop solution that combines logic, memory, foundry, and packaging to streamline production and improve energy efficiency, which is expected to lower power consumption and cooling costs in data centers. The move comes as competition for the AI memory market intensifies. Samsung expects its HBM shipment volume to more than triple this year compared to last year and is currently building a new production line at its Pyeongtaek Campus. Its local peer and HBM leader, SK hynix, is ramping up its HBM4 capacity to meet potential additional demand from Nvidia. With Micron currently trailing in the supply chain competition, analysts expect Samsung and SK hynix to split the majority of HBM orders for the Vera Rubin chips. 2026-02-08 15:40:45