Journalist

Lee Hyo-jeong
  • SK Biopharmaceuticals Files FDA Application for Cenobamate Oral Suspension for Epilepsy
    SK Biopharmaceuticals Files FDA Application for Cenobamate Oral Suspension for Epilepsy SK Biopharmaceuticals said April 1 it has submitted a new drug application to the U.S. Food and Drug Administration for an oral suspension formulation of its epilepsy drug cenobamate. The filing seeks approval of an additional formulation following the existing tablet version, for adults with partial-onset seizures. The company said the liquid oral suspension is expected to improve convenience for patients who have difficulty swallowing tablets and allow more flexible dosing depending on a patient’s condition and treatment setting. SK Biopharmaceuticals said it has been expanding the drug’s use in clinical practice and is also conducting pediatric clinical development of cenobamate. Based on the adult NDA and pediatric trial results, the company said it plans to gradually expand the eligible age group to include pediatric and adolescent patients. At the 2025 annual meeting of the American Epilepsy Society, the company presented poster data from a pharmacokinetic study comparing the tablet and oral suspension formulations. The two formulations showed generally similar absorption and drug exposure, indicating pharmacokinetic equivalence. Lee Dong-hoon, CEO of SK Biopharmaceuticals, said the oral suspension reflects the treatment needs of patients who struggle to take tablets. He said the company will continue to broaden patient-centered treatment options and address unmet medical needs across different patient groups to expand its prescribing base. * This article has been translated by AI. 2026-04-01 15:15:00
  • Samsung Biologics Completes Purchase of Rockville Biologics Plant From GSK
    Samsung Biologics Completes Purchase of Rockville Biologics Plant From GSK Samsung Biologics said it has completed its acquisition of a manufacturing facility in Rockville, Maryland, adding 60,000 liters of production capacity. The company said Tuesday it finalized the purchase of the biopharmaceutical plant from GlaxoSmithKline on March 31 (local time), about three months after signing the deal in December. The buyer was its U.S. subsidiary, Samsung Biologics America. The Rockville site is a 60,000-liter drug substance (DS) plant made up of two manufacturing buildings. It has infrastructure to produce antibody drugs at various scales, from clinical-stage batches to commercial production. With the acquisition, Samsung Biologics said its total production capacity increased to 845,000 liters from 785,000 liters. The company said the deal strengthens its ability to serve customers in North America and creates a two-hub manufacturing system linking Songdo, South Korea, and Rockville, offering global clients stable and flexible production options. Samsung Biologics said it will retain all of the roughly 500 local specialists at the site to ensure operational continuity. It plans to integrate the two production bases to maintain supply of existing products and step up efforts to win new orders. “This acquisition is meaningful progress in expanding our global manufacturing footprint,” CEO John Rim said. “Together with the Rockville site’s skilled workforce, we will maintain operational continuity and continue a stable supply system.”* This article has been translated by AI. 2026-04-01 11:42:26
  • Hanmi Pharmaceutical Names Hwang Sang-yeon CEO, First Outsider in 53 Years
    Hanmi Pharmaceutical Names Hwang Sang-yeon CEO, First Outsider in 53 Years Hanmi Pharmaceutical is moving to overhaul its management structure by appointing an outside chief executive for the first time in its 53-year history. At its 16th annual shareholders meeting on March 31 at its headquarters in Songpa-gu, Seoul, the company appointed Hwang Sang-yeon, head of the private equity division at HB Investment, as an inside director. Hwang was then named CEO after a board meeting held immediately following the shareholders meeting. Hwang earned bachelor’s and master’s degrees in chemistry from Seoul National University and previously served as head of the research center at Mirae Asset Securities and as CEO of Chong Kun Dang Holdings. With the appointment, CEO Park Jae-hyun, who had been selected with the backing of the owner family’s mother and daughter during a management dispute, will step down after three years in the post. Speaking to reporters after the board meeting, Hwang said he would address concerns by carrying on the late founder Lim Seong-gi’s management philosophy of “respect for people and value creation.” He also pledged to work with employees to lead the company “to the next level” as South Korea’s top drugmaker. Hanmi Pharmaceutical has long relied on internal promotions dating back to Lim’s tenure, but the decision to bring in an outsider is being viewed as a signal of a more aggressive push for organizational change. Shareholders also approved all agenda items as proposed, including the appointment of inside director Kim Na-young and outside directors Han Tae-joon and Kim Tae-yoon. At a separate shareholders meeting held the same day at Hanmi Science, shareholders approved the appointment of Kim Nam-gyu, CEO of La Défense Partners, as a new non-executive director. La Défense is part of a so-called “four-party alliance” with Shin Dong-kook, Song Young-sook, Lim Ju-hyun and La Défense. Kim, a former lawyer, is described as a strategy and legal expert with experience at Samsung Electronics’ legal office and KCGI. La Défense, which holds a 9.81% stake, is expected to exercise more direct influence over management through the board seat. The developments appear to have drawn a line under controversy over interference in Hanmi Pharmaceutical’s management. Last month, Park raised concerns that major shareholder Shin Dong-kook, chairman of Hanyang Precision, was improperly intervening in management. The dispute resurfaced after Song, chair of Hanmi Pharmaceutical Group, voiced support for a professional management system. With Park’s reappointment failing and Hwang being named CEO at this shareholders meeting, the conflict has, for now, eased. Some observers, however, say the leadership change at Hanmi Pharmaceutical and the reshaping of Hanmi Science’s board could open a new phase in competition for control. * This article has been translated by AI. 2026-03-31 14:24:00
  • Korea University Medical Center Plans 700-Bed AI-Driven Hospital in Dongtan by 2035
    Korea University Medical Center Plans 700-Bed AI-Driven Hospital in Dongtan by 2035 “Once a patient is admitted, artificial intelligence immediately matches and assigns a room and medical staff.” That is the vision Korea University Medical Center laid out for its planned “Dongtan Fourth Korea University Hospital,” which it aims to open in 2035. The center said the new facility will build on strengths of its hospitals in Anam, Guro and Ansan while moving beyond limits in integration and expansion, creating a new model: a smart, future hospital powered by autonomous AI. Yoon Eul-sik, vice president for medical affairs at Korea University and head of Korea University Medical Center, held a news briefing Monday at the Four Seasons Hotel Seoul and said the Dongtan hospital would become “a medical hub covering the southern Seoul metropolitan area and a key institution that protects the regional medical delivery system.” He said it would present “a next-generation medical model as an advanced, smart AI-based future hospital.” The hospital is planned as a 700-bed facility, with a target opening in 2035. The center said the AI-based smart hospital will concentrate future medical technologies and infrastructure, including digital pathology, an imaging center, a genetics center and cell therapy center, and a digital-twin preventive management center. It aims to build an optimized, patient-centered precision-medicine workflow and free medical staff from more than 80% of existing administrative work so they can spend more time with patients. Hospital operations are to include an “agentic AI” digital command center. The system would analyze admissions and discharges, bed and operating room utilization, and staffing in real time to allocate resources. The medical center said it expects a seamless patient experience from appointments to care, tests, admission and discharge, while sharply reducing administrative burdens on clinicians. Yoon also emphasized flexibility in design. “Given the pace of technological development, we are separating logistics and clinical routes and designing adaptable spaces that can be quickly reconfigured depending on circumstances,” he said. The Dongtan hospital is also planned as a “life-cycle medical platform” that extends beyond acute care to rehabilitation and long-term support. A convalescent rehabilitation hospital and senior welfare housing would be linked to the main hospital so patients can move from treatment to rehabilitation and return to daily life. The rehabilitation hospital is expected to combine advanced rehabilitation equipment with research, the medical center said. Yoon said the goal is to serve as the “final treatment institution” for southern Gyeonggi Province. He said the medical center aims to move away from a system in which patients with serious illnesses such as cancer and cardiovascular disease are sent to Seoul, and instead build a structure in which treatment is completed within the region. * This article has been translated by AI. 2026-03-30 18:21:09
  • Samsung Biologics Faces First-Ever Strike Threat as Union Vote Tops 95%
    Samsung Biologics Faces First-Ever Strike Threat as Union Vote Tops 95% Samsung Biologics is facing the threat of its first strike since it was founded in 2011. The company’s union said March 29 that 95.52% of eligible voters backed strike action in a completed vote. Of 3,678 eligible voters, the union said, the approval rate reached 95.52%. The union has 3,689 members, about 75% of the company’s workforce. Labor and management have held 13 rounds of wage and collective bargaining talks but have not narrowed their differences. The union is seeking an average 14% pay raise, a 30 million won incentive payment per employee, a profit-sharing bonus equal to 20% of operating profit, and allocations of company shares over three years. It also wants the company to obtain the union’s prior consent when exercising key management and personnel authority. Management has countered with a 6.2% raise, citing standards used at major group affiliates such as Samsung Electronics. Market watchers have raised concerns that a strike could disrupt Samsung Biologics’ 15 trillion won plan to expand production capacity and affect the operating schedule for its contract development and manufacturing (CDMO) plants. The union said it plans to hold informal talks after CEO John Rim returns to South Korea. Union Chairman Park Jae-seong said, “If the company brings an improved proposal during the remaining period, we are willing to talk at any time,” adding that “there is clearly room to compromise at an appropriate level” if management does so. If the two sides fail to reach an agreement, the union said it plans to begin a strike on May 1. 2026-03-29 19:54:00
  • Mideast War, Oil Spike Squeeze South Korea Pharma-Bio Supply Chains and Shipping Costs
    Mideast War, Oil Spike Squeeze South Korea Pharma-Bio Supply Chains and Shipping Costs South Korea’s pharmaceutical and biotech industry is facing a double hit from soaring oil prices tied to a prolonged Middle East war: disruptions in raw-material supplies and higher logistics costs. Major drugmakers are expanding inventories and seeking alternative suppliers amid concerns over shortages of key inputs such as naphtha, while the government is stepping up supply-chain monitoring and exploring joint measures with the industry. Industry officials said Sunday that the Middle East crisis, fueled by the war involving the United States and Israel and Iran, has heightened fears of instability in crude supplies from the region. International oil prices have topped $100 a barrel, setting new record highs. The combination of surging input prices and supply uncertainty is rippling through the sector. With domestic refiners heavily dependent on Middle Eastern crude, supply chains have come under strain and naphtha prices have jumped more than 20% this month. Naphtha is a core material used to make pharmaceutical packaging containers and IV fluid bags, raising concerns across the industry. Suppliers of basic IV solutions, including JW Jungoe Pharm and HK inno.N, are moving urgently to prepare for possible shortages of IV bags. The companies held an emergency meeting with the Ministry of Food and Drug Safety to discuss bringing in alternative materials and freezing inventories, according to industry officials. “If the situation drags on, hospitals could face supply disruptions due to a shortage of IV bags,” a pharmaceutical company official said. Major drugmakers have also taken preemptive steps to secure materials. Yuhan Corp. has stockpiled two to three months’ worth of pharmaceutical packaging materials, and Dong-A Pharmaceutical and Korea United Pharmaceutical have increased inventories through early orders. Rising logistics costs are another pressure point. With oil prices surging, sea and air freight rates have climbed 15% to 20%, pushing up the cost of importing raw materials. Smaller drugmakers said the added burden is difficult to absorb given already thin margins. The food and drug safety ministry is frequently checking the supply of pharmaceutical packaging containers. It is also reviewing regulatory support, including faster approval procedures when changes in packaging materials are needed. A pharmaceutical company official said the business environment is deteriorating rapidly as global instability drives up oil prices, exchange rates and freight costs while worsening uncertainty over raw-material supplies. The official warned that disruptions could lead to imbalances in supplies of essential medicines such as cold remedies and antibiotics, posing a potential threat to health security. Some in the industry said the turmoil should be used to reshape supply chains. A biotech industry executive noted that most domestic companies import active pharmaceutical ingredients, making broader drug production vulnerable if supply chains falter. The executive called for government incentives to raise self-sufficiency in active ingredients.* This article has been translated by AI. 2026-03-29 18:33:21
  • South Korea to Cut Generic Drug Pricing to 45% of Brand-Name Level, Industry Warns of R&D Hit
    South Korea to Cut Generic Drug Pricing to 45% of Brand-Name Level, Industry Warns of R&D Hit The government will lower the benchmark used to set prices for generic drugs to about 45% of the price of original medicines, down from 53.55%. The pharmaceutical industry says the cut, combined with supply uncertainty tied to the Middle East conflict, could curb research and development spending and worsen job insecurity. According to the industry on the 27th, the Health Insurance Policy Deliberation Committee approved the drug-pricing overhaul at a meeting the previous day. It is the first broad revamp since a across-the-board cut in 2012, and the new pricing system is set to take effect in the second half of this year. The Health Ministry said it will phase in the adjustments over 10 years through 2036 to limit the impact on the industry. For drugs already listed, the rollout will be staged based on the listing year, with the first phase covering medicines listed in 2012 and the second phase covering those listed from 2013 onward. The so-called stepwise price cut, previously applied starting with the 20th generic, will be tightened to begin with the 13th generic. The industry has pushed back since the government announced a plan in November to lower generic prices into the 40% range of original drugs. Drugmakers said they could accept a reduction to 48.2%, about 10% lower, but the government proposed lowering the level to “43% or 45%,” leaving the sides at odds. A pharmaceutical company official said concerns have grown because the decision did not settle at 48.2%, adding that the change would begin to weigh on operating profit in earnest starting next year. The official said companies could move beyond cutting costs and selling and administrative expenses to reducing labor costs, raising job insecurity. A small and midsize drugmaker official said an immediate drop in operating profit is unavoidable and that smaller firms, which have limited ability to develop new drugs in the near term, would be hit harder. With raw-material supply instability linked to the Middle East war spreading to the domestic industry, some warned that investment decisions for new-drug development could be halted. A major drugmaker official said operating profit already fell last year and that, considering the coming price cuts, decisions on investment in new-drug development would be “all stop.” The official added that companies’ moves to cut labor costs would also become reality. 2026-03-27 09:09:00
  • Samsung Biologics, Celltrion expand CDMO investment as labor and safety risks rise
    Samsung Biologics, Celltrion expand CDMO investment as labor and safety risks rise Samsung Biologics and Celltrion, after posting record results last year, are pressing ahead this year with multitrillion-won investments centered on contract development and manufacturing (CDMO) to expand capacity, industry officials said. Even with strong growth, both companies face rising internal and external risks, including labor friction, a factory safety incident and geopolitical uncertainty. Samsung Biologics reported 4.55 trillion won ($4.55 trillion won) in revenue and 2.06 trillion won in operating profit last year, reinforcing its No. 1 position in the CDMO sector, according to the industry. The company is reinvesting earnings to build Plants 5 and 6 in Songdo, Incheon, and plans to spend about 7 trillion won to develop a third bio campus. It is also moving to expand overseas production, including a $280 million investment to acquire a plant in Rockville, Maryland, as part of its strategy to widen its lead. Celltrion posted 4.16 trillion won in revenue and 1.16 trillion won in operating profit last year, and has been assessed as a global player spanning biosimilars and new drugs. It plans to invest 1.2265 trillion won to complete Plants 4 and 5 in Songdo. In the United States, it plans to invest $330 million to expand its Branchburg, New Jersey, facility to 75,000 liters. Once domestic and overseas expansions are completed, Celltrion expects to secure total production capacity of 570,000 liters, building infrastructure not only for new drugs and biosimilars but also for its contract manufacturing business. Risks have also intensified. At Samsung Biologics, labor-management tensions have deepened in recent years over disputes tied to revisions of internal rules on information security and discipline, including the introduction of a “three strikes” policy. A document was disclosed showing the human resources department separately classified and managed participants in a lawsuit over ordinary wages and union members, prompting allegations of discrimination in promotions and personnel decisions. Distrust has also lingered after negotiations over wages and working hours reductions. In this year’s wage talks, the union has demanded a 4.5-day workweek, higher starting pay and a new hazard allowance for ADC work, with talk of a possible strike. If a strike occurs, production stoppages could delay deliveries to clients and damage global confidence, given the industry’s reliance on continuous operations. It could also disrupt completion of Plants 5 and 6 and the Rockville plant, the report said. Celltrion is also under scrutiny after a subcontractor worker fell to his death at its Songdo plant, drawing criticism over industrial safety and health management. The Ministry of Employment and Labor issued a work stoppage order and launched a full investigation, including whether the case violated the Serious Accidents Punishment Act. At Celltrion’s shareholders meeting on March 24, Chairman Seo Jung-jin appeared in person for the first time in 11 years to address concerns and emphasize “responsible management,” the report said. Geopolitical uncertainty is another factor. As the war in the Middle East drags on, volatility in raw materials and fuel prices and broader supply-chain risks have increased, and there are signs global drugmakers are adjusting clinical and production budgets, the report said. “Companies are facing a new test in which they must design growth and responsibility at the same time, with good news and bad news coexisting,” an industry official said. How well they manage labor issues, major safety risks and geopolitical uncertainty “appears to be a key variable that will determine sustainable growth going forward,” the official said.* This article has been translated by AI. 2026-03-26 16:36:00
  • Chong Kun Dang CEO Kim Young-joo Pledges Profit Growth, Higher Corporate Value in 2026
    Chong Kun Dang CEO Kim Young-joo Pledges Profit Growth, Higher Corporate Value in 2026 Major drugmakers including Chong Kun Dang, Dong-A ST and Ildong Pharmaceutical held annual shareholder meetings on March 26, approving agenda items as proposed, including new director appointments and cash dividends aimed at boosting shareholder value. According to the industry, Chong Kun Dang held its 13th annual general meeting that morning at its headquarters in Chungjeong-ro. Shareholders approved a cash dividend of 500 won per share, equal to 20% of par value. In opening remarks, Chong Kun Dang CEO Kim Young-joo said the company would “deliver profit growth this year” by launching new products on schedule, strengthening product competitiveness and improving market responsiveness. He said it would also raise drug development efficiency through Achela, described as an NRDO (No Research Development Only) specialist, and “increase corporate value” by building a Baegot bio complex development cluster to secure biotech competitiveness. Chong Kun Dang Holdings also held its 71st annual general meeting on March 26. The company reported 2025 consolidated revenue of 959 billion won and operating profit of 58.3 billion won, and approved a cash dividend of 1,400 won per share, equal to 56% of par value. Dong-A ST held its 13th annual general meeting at its headquarters in Seoul’s Dongdaemun district, approving six items as proposed, including approval of financial statements, amendments to the articles of incorporation and director appointments. Shareholders approved a cash dividend of 700 won per common share and a stock dividend of 0.05 shares per share. The meeting also approved a 30 billion won reduction in capital reserves and a transfer to retained earnings to secure funding for tax-exempt dividends. CEO Jeong Jae-hoon said the company is also stepping up investment in digital health care, which he said will be central to future medical technology, and is building a foundation for growth. Dong-A Socio Holdings also held its 78th annual general meeting at its headquarters in Seoul’s Dongdaemun district. Shareholders approved five items as proposed: approval of the 78th financial statements and consolidated financial statements, partial amendments to the articles of incorporation, director appointments, appointment of an outside director who will serve on the audit committee, and approval of the cap on director compensation. They also approved a cash dividend of 1,000 won per share and a stock dividend of 0.03 shares per share. The company said the dividend is tax-exempt and not subject to dividend income tax. Ildong Pharmaceutical and Ildong Holdings each held annual shareholder meetings on March 26 at Ildong Pharmaceutical’s headquarters in Seoul’s Seocho district. Ildong Pharmaceutical CEO Yoon Woong-seop said the company will focus this year, under its management policy of “creating results with competitive advantage,” on generating sales and profit, securing new growth engines and building a sustainable business structure, while strengthening its core businesses such as pharmaceuticals and concentrating capabilities on future growth including R&D. At the meeting, all agenda items were approved as proposed, including approval of financial statements, partial amendments to the articles of incorporation, and the appointment of directors and an auditor. Ildong Holdings also approved its agenda items as proposed, including approval of financial statements reflecting its dividend plan, partial amendments to the articles of incorporation, and the appointment of directors and an auditor. Ildong Holdings CEO Park Dae-chang said the company will continue to pursue management efficiency and reform across group affiliates to strengthen its business foundation and build momentum for growth, adding that it also plans to work to enhance corporate value and increase shareholder returns.* This article has been translated by AI. 2026-03-26 15:33:00
  • SK Biopharm’s Xcopri posts record U.S. sales, lifts earnings outlook
    SK Biopharm’s Xcopri posts record U.S. sales, lifts earnings outlook SK Biopharm said its central nervous system drug cenobamate, sold in the United States as Xcopri, drove record results as the company expanded its foothold in the U.S. epilepsy market. The company said U.S. sales of cenobamate totaled 630.3 billion won last year, up 44% from a year earlier. SK Biopharm reported total revenue of 706.7 billion won and operating profit of 203.9 billion won, up 29.1% and 111.7%, respectively, from the previous year. The company said that compares with 246.2 billion won in revenue in 2022, nearly tripling over that period. The company said cenobamate is an epilepsy treatment that became the first new drug developed by a South Korean company to win U.S. Food and Drug Administration approval in 2019. It said U.S. prescriptions in the fourth quarter jumped 29.2% from a year earlier, pushing the 2025 monthly average above 47,000. Market watchers have credited a strengthened U.S. sales organization and “line of therapy” marketing for expanding early prescribing. SK Biopharm said, “As new patient inflows continue, the foundation for growth has become solid,” and raised its 2026 guidance for U.S. cenobamate sales to $580 million, about 860 billion won. Lee Dong-hoon, SK Biopharm’s CEO, attended the company’s “2026 National Sales Meeting” in Florida earlier this year and said, “Based on a shared goal, we will break down organizational boundaries and move in the same direction,” adding that the company would pursue business expansion on the back of cenobamate’s success. Lee, described by the company as an investment professional, has led the global sales expansion of cenobamate. He also serves as CEO of SK Life Science, SK Biopharm’s U.S. subsidiary, and oversaw the buildout of a direct U.S. sales system that helped lift operating profit above 200 billion won last year. The company said Choi Yoon-jung, head of the strategy division and the eldest daughter of SK Group Chairman Chey Tae-won, is overseeing investments and shaping a mid- to long-term roadmap. It said she was promoted to strategy chief in a recent reorganization and is directly managing future growth initiatives, including the launch of a radiopharmaceutical therapy, or RPT, division. SK Biopharm said it plans to use cenobamate’s momentum to increase research and development spending and accelerate pipelines that apply precision-medicine approaches, including for Parkinson’s disease. Some in the market have said expanding cenobamate’s share and moving RPT into clinical trials could speed the company’s push toward a top-tier biotech position. Analysts said cenobamate is expected to hold a favorable position because it is the only branded new drug among epilepsy treatments. Huh Hye-min, an analyst at Kiwoom Securities, said, “For now, cenobamate is the only branded new drug, so favorable market penetration is expected,” and added that because most R&D catalysts remain at early stages ahead of Phase 1 entry, the company is likely to expand R&D investment to secure growth drivers after Xcopri’s patent expiration. SK Biopharm said it traces its origins to the “P Project” launched at the Daejeon research complex in 1,993 under the late SK Group Chairman Choi Jong-hyun’s vision to build new growth engines. The company said the “P” stood for the first syllable of “pharmaceutical,” and that it began with six researchers focused on developing new drugs. It said it later built a global base by establishing a cooperation system with a pharmaceutical research center in New Jersey and is now pursuing global markets with a CNS-focused pipeline. The company said it is also expanding beyond cenobamate into next-generation modalities such as RPT and targeted protein degradation, or TPD, as it seeks to demonstrate SK Group’s “30-year commitment” to biotech.* This article has been translated by AI. 2026-03-25 18:27:00