Journalist

Cho Hyeon-mi
  • SK Bioscience Wins EU Flu Vaccine Project; VioL Rebrands; HLB Pharma Honored
    SK Bioscience Wins EU Flu Vaccine Project; VioL Rebrands; HLB Pharma Honored SK Bioscience wins European flu vaccine project SK Bioscience said Feb. 26 it was selected, with its German unit IDT, for a first-phase assignment under a next-generation vaccine development initiative run by the European Commission’s Health and Digital Executive Agency, or HaDEA, under a mandate from the European Health Emergency Preparedness and Response Authority, or HERA. The companies will join Australian vaccine platform firm Vaxxas in a three-party consortium to develop patch-based vaccines for seasonal influenza for older adults and pandemic influenza (avian influenza) for all age groups. It is the first time SK Bioscience has won a project from European health authorities, the company said. HaDEA will provide a total of 12.9 million euros (about 22.2 billion won) for first-phase research, including a Phase 1 clinical trial. Depending on technology validation and clinical results, support could later expand to as much as 225 million euros (about 383.6 billion won), SK Bioscience said. Chief Executive Ahn Jae-yong called it “the first case” in which the combined global network and technical capabilities of SK Bioscience and IDT, following the IDT acquisition, have led to business results. He said the company will continue seeking opportunities to enter Europe with vaccines it develops and strengthen competitiveness through innovative platforms. VioL changes name to ‘VioL Medical’ to sharpen medical-device identity VioL, a maker of energy-based medical devices, said Feb. 26 it has changed its corporate name to VioL Medical. The company said adding “Medical” preserves existing brand assets while making its identity as a specialized medical-device company clearer and signaling its aim to meet global standards. It said it plans to raise market share in key markets in North America, Europe and Asia and strengthen local distribution networks. It also plans to continue expanding investment to advance next-generation energy-based devices and research and development. Founded in 2009, VioL Medical offers microneedle radio-frequency-based medical devices. The company said it has been strengthening its business foundation step by step since being acquired last year by VIG Partners. CEO Lee Eun-cheon said the name change reflects a commitment to create practical value in clinical settings and deliver sustainable growth for partners, customers and investors. He said the company will set a new standard in the global medical market based on differentiated technology and clinical competitiveness. HLB Pharma named one of Korea’s 100 Best Companies to Work For for third straight year HLB Pharma said Feb. 26 it was named to the “2026 Korea’s 100 Best Companies to Work For,” marking its third consecutive year on the list. The awards were presented the previous day at the “2026 24th Korea’s Best Companies to Work For” ceremony. The company said CEO Park Jae-hyung was also named “Most Respected CEO in Korea,” winning for a third straight year. Vice President Kim Man-gyu received the “GPTW Pioneer Award,” and Director Lee Yong-woo, who oversees HR and general affairs, received the “GPTW Innovation Leader Award.” HLB Pharma said it runs a communication program that allows the CEO and new employees to exchange views informally. It also cited a monthly allowance paid to employees’ parents and an early-departure work culture aimed at improving efficiency, as part of efforts to build a workplace that respects family and personal life. Park said the company has steadily pursued workplace-culture innovation based on the belief that sustained growth comes from people. He said HLB Pharma will further strengthen competitiveness by building an environment where employees can take pride in their work and stay engaged.* This article has been translated by AI. 2026-02-26 16:24:18
  • Celltrion ramps up US manufacturing to buffer against tariffs
    Celltrion ramps up US manufacturing to buffer against tariffs SEOUL, February 26 (AJP) - Biopharmaceutical company Celltrion said Thursday that it has taken steps to ensure its U.S. operations remain uninterrupted amid growing uncertainty over tariffs following a Supreme Court ruling last week. In a statement, Celltrion said it is ready to respond regardless of how tariff-related issues are resolved after the U.S. Supreme Court found U.S. President Donald Trump's sweeping global tariffs policy unlawful. Celltrion, which acquired U.S. drugmaker Eli Lilly's biopharmaceutical manufacturing facility in Branchburg, New Jersey, late last year, said it completed a full inspection and preparations for full operations by the end of January and began manufacturing this month. The company said it has also begun procedures to manufacture its own products locally and plans to build a system linking production with its direct sales network to supply them across the U.S. as soon as possible. Under its phased plans, Celltrion said it will hedge against tariff uncertainty by supplying the U.S. market with products manufactured at its Branchburg plant. 2026-02-26 13:58:08
  • Celltrion Says U.S. Plant Begins Operations, Aiming to Reduce Tariff Risk
    Celltrion Says U.S. Plant Begins Operations, Aiming to Reduce Tariff Risk Celltrion said Feb. 26 it has completed all steps needed to ensure its business operations will not be disrupted regardless of how U.S. tariffs are ultimately settled. In a statement posted on its website titled “Status of U.S. operations and the company’s position on tariff risk,” Celltrion outlined the start-up of its U.S. manufacturing base and its plans to respond to tariff uncertainty. The company acquired U.S. drugmaker Eli Lilly’s plant in Branchburg, New Jersey, late last year. Celltrion said it finished a full facility inspection and preparations for full-scale operations by the end of January, and began contract manufacturing of Lilly products this month. It added that it has also begun validation procedures to produce Celltrion’s own products, and plans to build a system that links local production with its direct sales network to supply U.S.-made products to the U.S. market as soon as possible. The company also disclosed short- and medium- to long-term measures on tariffs. In the near term, it said it will rely on a second-year supply volume already in the U.S. to hedge against tariff uncertainty. After that, it plans to supply the U.S. market with products made at the Branchburg plant to move beyond tariff issues. Celltrion said that while the Trump administration’s tariff policy could change following a U.S. Supreme Court ruling invalidating reciprocal tariffs, it has completed a structural response system to tariff risk by establishing local production and supply capabilities. 2026-02-26 10:27:00
  • Korean Biopharma Ramps Up U.S. Production as Trump Tariff Uncertainty Grows
    Korean Biopharma Ramps Up U.S. Production as Trump Tariff Uncertainty Grows Uncertainty over tariff policy under the Trump administration is rising again, putting industries on edge. Concerns are growing in South Korea’s biotech sector as the possibility emerges of steep U.S. tariffs on Korean-made pharmaceuticals that have been exported duty-free. Companies say they plan to limit exposure by building inventory and starting production in the United States. According to industry officials on the 23rd, the Trump administration has intensified trade pressure on partners worldwide after the U.S. Supreme Court ruled that reciprocal tariffs imposed under the International Emergency Economic Powers Act, or IEEPA, were illegal. President Donald Trump said on Feb. 20 (local time), shortly after the ruling, that he would use Section 122 of U.S. trade law to impose a 10% tariff on imports from all countries. The next day, he raised it to 15%, the maximum allowed under that provision. The administration has also signaled it could impose tariffs under Section 301 of the Trade Act and Section 232 of the Trade Expansion Act, which would be tougher than the earlier reciprocal tariffs. The court decision invalidated only the IEEPA-based reciprocal tariffs and does not affect tariffs grounded in other statutes. After the ruling, the Office of the U.S. Trade Representative began unfair-trade investigations of major partners under Section 232. In South Korea, it has been investigating whether trade is unfair in nine categories, including pharmaceuticals, since last year. The Korea International Trade Association’s trade research unit said additional tariffs on at least seven categories could materialize by September due to Section 232. With tariff risks resurfacing, South Korean biotech companies are moving faster. Celltrion will begin producing biologic drugs this month at its Branchburg, New Jersey, facility, which it acquired from Eli Lilly. The plant has capacity of 66,000 liters for drug substance production, and Celltrion plans to expand it to 132,000 liters by 2030 through additional investment. The company previously secured two years’ worth of supply for the U.S. market. A Celltrion official said the company has prepared both preemptive inventory and longer-term measures, including operating a U.S. plant, and will respond so that any tariff policy does not affect the company. Samsung Biologics is accelerating work to complete an acquisition. It plans to finish the takeover process by next month for a biologics plant in Rockville, Maryland, which it bought in December, and to start local production immediately after completion. The plant currently has capacity of 60,000 liters, and Samsung Biologics is considering an expansion of 20,000 to 40,000 liters. Lee Seung-gyu, vice chairman of the Korea Bio Association, said biotech companies are minimizing tariff impacts by securing production facilities in the United States, and he urged the government to seek needed support while listening to industry views.* This article has been translated by AI. 2026-02-23 15:18:00
  • Report: Nearly 80% of Biologics Losing EU Patents by 2032 Have No Biosimilar in Development
    Report: Nearly 80% of Biologics Losing EU Patents by 2032 Have No Biosimilar in Development Europe is expected to see patents expire on about 100 biologic drugs over the next six years, but 79% of them have no biosimilar versions currently in development, a report found. The Korea Bio Medicine Association said in a report released on the 22nd, citing IQVIA and other sources, that exclusive rights for about 100 biologics in Europe will end by 2032. Even so, 79% have no biosimilars in development. Biosimilar pipelines slated for Europe accounted for just 10%, while 11% had unclear prospects for local launch. The report said limited development for lower-revenue products and rare-disease treatments has created a structural “biosimilar development gap.” That gap could translate into an estimated $143 billion (about 207 trillion won) in missed opportunities in Europe, the report said — equal to 55% of total sales for biologics nearing patent expiration. It added that even high-selling biologics do not have enough biosimilar development underway. The report urged South Korean companies to keep focusing on blockbuster products with annual sales in the trillions of won while also moving early to secure biosimilar markets in new therapeutic areas such as ophthalmology and dermatology. It also recommended improving development efficiency through differentiated formulations and by taking advantage of simplified global regulations. As of 2024, South Korean companies including Celltrion, Samsung Bioepis and Prestige Biopharma accounted for 12 of the 28 biosimilars that received a recommendation for approval from the European Medicines Agency, the report said, the most of any country. Of the 41 products recommended last year, one was from Celltrion. “Building a preemptive response system through cooperation among industry, academia, research institutes and government in areas where development gaps are expected will contribute to the sustainability of the domestic biosimilar industry and strengthen global competitiveness,” the report said.* This article has been translated by AI. 2026-02-22 15:33:00
  • 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
  • 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
  • Celltrion tops 4 trillion won in annual sales, posts record operating profit
    Celltrion tops 4 trillion won in annual sales, posts record operating profit Celltrion said it surpassed 4 trillion won in annual revenue and 1 trillion won in operating profit for the first time. In a regulatory filing on Wednesday, the company said 2025 revenue rose 17% from a year earlier to 4.1625 trillion won, while operating profit surged 137.5% to 1.1685 trillion won on a consolidated basis. Operating margin climbed 14.3 percentage points to 28.1%. Celltrion attributed the results to steady growth in established products and rapid expansion of higher-margin newer drugs. Global biopharmaceutical sales rose 24% to 3.8638 trillion won as products including Remsima SC, Yuflyma, Vegzelma, Zymfentra, Stekima, Omliclo and Stoboclo-Osenvelt gained traction alongside Remsima, Truxima and Herzuma. New products accounted for 54% of sales. Remsima held a 59% market share in Europe and 30% in the United States, the company said. Truxima posted market shares in the 30% range in the U.S. and Europe. Herzuma ranked No. 1 in Europe and had a 75% share in Japan. Yuflyma and Vegzelma also ranked No. 1 in Europe. Five products — Stekima, Stoboclo-Osenvelt, Omliclo, Aptozma and Idencelt — were launched in the second half of last year but still generated more than 300 billion won in annual sales, Celltrion said. For 2026, Celltrion set a revenue target of 5.3 trillion won. It said it will pursue a “selection and concentration” strategy by reducing the share of high-cost products and focusing bids on newer, higher-net-profit products, aiming to lift the new-product sales share to about 70%. The company also said its Branchburg, New Jersey, manufacturing facility, whose acquisition was completed at the end of last year, will begin generating contract manufacturing (CMO) revenue this year. Celltrion said it signed a deal with Eli Lilly to supply biopharmaceutical products worth 678.7 billion won over three years through 2029. A Celltrion official said the company expects strong growth to continue this year as structural cost improvements take hold and the impact of new product launches becomes more pronounced. The official said Celltrion will work to expand its biosimilar pipeline and secure new growth engines, including new drugs and CMO, to become a global big pharma company.* This article has been translated by AI. 2026-02-05 10:03:00
  • PharmaResearch Annual Sales Top 500 Billion Won for First Time
    PharmaResearch Annual Sales Top 500 Billion Won for First Time PharmaResearch said its annual sales topped 500 billion won for the first time in 2025, driven by growth in its medical device and cosmetics businesses. In a regulatory filing on Tuesday, the company said 2025 revenue rose 53% from a year earlier to 535.7 billion won on a consolidated basis. Operating profit increased 70% to 214.2 billion won. The company said it posted broad-based growth across all business segments, with medical devices and cosmetics leading results. “An increase in domestic demand tied to an inflow of foreign tourists and rising exports centered on medical devices and cosmetics worked together,” the company said. Medical device sales grew 62% from a year earlier, and cosmetics sales surged 69%, led by major overseas markets including the United States and Japan, the company said. PharmaResearch said it plans to accelerate its mid- to long-term global expansion. It will begin European sales of “Rejuran,” which drew attention at the world’s largest aesthetic plastic surgery conference, IMCAS, held last month in Paris. The company also plans to enter the Middle East and South America to diversify markets. It said it will start with Chile, Peru, Argentina and Mexico, and will seek approval in Brazil, the region’s largest market, to expand further in Latin America. The company said it will continue investing in research and development to diversify its portfolio, including expanding its product lineup to cancer treatments and beginning clinical trials aimed at securing approval in Japan, in addition to its pharmaceuticals, medical devices, cosmetics and health functional foods. A PharmaResearch official said 2025 was “a year in which we laid the foundation for a global leap through meaningful growth,” adding that the company maintained steady growth even before results from Europe were fully reflected in earnings. The official said the company plans to invest in facilities to stabilize its global supply chain and strengthen R&D to speed entry into countries where it has not yet received approvals, while reinforcing leadership in the skin booster market.* This article has been translated by AI. 2026-02-04 18:09:00
  • SK Bioscience Sales Jump 143% on Strong Results From German Unit IDT
    SK Bioscience Sales Jump 143% on Strong Results From German Unit IDT SK Bioscience said strong results from its German subsidiary, acquired two years ago, helped more than double its annual revenue last year. In a regulatory filing on Monday, the company said 2025 revenue on a consolidated basis rose 143.5% from a year earlier to 651.4 billion won. Its operating loss narrowed to 123.5 billion won from 138.4 billion won in 2024. The improvement was driven largely by IDT, a Germany-based contract development and manufacturing organization acquired in 2024. IDT posted 465.7 billion won in 2025 revenue, up about 17% year over year, and recorded an operating profit of 9.9 billion won, marking a turnaround. The company attributed the gains to stronger partnerships with existing customers and higher productivity from process-efficiency efforts. SK Bioscience said growth in its core vaccine lineup also supported results. Influenza vaccine SkyCellflu maintained steady growth as export volumes to Central and South America and Southeast Asia increased, despite a price decline tied to a switch to a trivalent formulation. Chickenpox vaccine SkyVaricella increased its share of global exports on the back of stable supply through the Pan American Health Organization. Shingles vaccine SkyZoster raised its market share as more South Korean local governments expanded vaccination programs. Sales of Sanofi products distributed in South Korea also more than tripled from a year earlier, the company said. Beyfortus, an RSV preventive antibody injection launched last year, posted near sellout-level performance during the fall and winter RSV season. Hexaxim, the country’s first six-in-one vaccine covering diphtheria, tetanus, pertussis, polio, Hib and hepatitis B, and Tdap vaccine Adacel also supported higher sales on steady demand. SK Bioscience said it plans to sustain growth centered on its subsidiaries and its Songdo R&PD center. The company completed the relocation of its headquarters and research institute to Songdo, Incheon, last month and said it is accelerating efforts to secure key pipelines under an integrated system spanning R&D through commercialization preparation. A 21-valent pneumococcal protein conjugate vaccine being co-developed with Sanofi is in global Phase 3 trials in the United States, Europe and South Korea, the company said. Its L House production facility in Andong, North Gyeongsang Province, is being expanded while it pursues global approvals and prepares for commercial production. The company also highlighted RSM01, an RSV monoclonal antibody brought in from Gates MRI under the Gates Foundation, and an Ebola vaccine being developed with MSD. It said RSM01, backed by exclusive global supply rights, is expected to be a new growth driver targeting a related market valued at 6 trillion won. The Ebola vaccine is expected to move faster with support from the Coalition for Epidemic Preparedness Innovations. The company said it also expects clinical trials this year for a universal COVID-19 vaccine, a next-generation pneumococcal vaccine and an avian influenza vaccine. A company official said, “This year, we will further advance global CDMO growth centered on IDT, while accelerating development of core pipelines with the Songdo R&PD center as a hub to secure mid- to long-term growth engines.”* This article has been translated by AI. 2026-02-03 17:51:00