South Korea Pharma-Bio Brief: Dong-A Launches Pureka; Yuhan Marks 100 Years; Celltrion, Samsung Biologics Updates Dong-A Pharm launches Pureka, a stick-pack salad with 41 fruits and vegetables Dong-A Pharm said Tuesday it has launched Pureka, a single-serve stick pack that contains 41 fruits and vegetables for convenient consumption. The company said the product targets consumers seeking to improve eating habits for health management. It is positioned around the “reverse eating” trend — eating vegetables, then protein, then carbohydrates — aimed at moderating post-meal blood sugar spikes, offering a way to consume vegetables before a meal. The brand name combines “Pure” and “Eureka,” the company said, to convey the idea of discovering a simple, “pure” daily health routine. Each stick pack is designed for easy use without washing or prep, and includes a dual blend of soluble and insoluble dietary fiber, plus probiotics and digestive enzymes, the company said. Pureka comes in two versions: “Pureka Greens Watermix,” a powder mixed with water, and “Pureka Greens Crunch,” an ultra-small tablet meant to be chewed. Yuhan marks 100th anniversary with campaign to collect company historical materials Yuhan said Tuesday it will run a campaign to collect historical materials tied to the company as it marks its 100th anniversary. The campaign aims to help restore the history of founder Dr. Yu Ilhan and Yuhan’s 100 years, the company said, by gathering a wide range of records, including items held by individuals. Eligible materials include items produced or used before 2000, such as photos and documents related to Dr. Yu and Yuhan, books, and museum-type items including products and souvenirs. The company said it will accept submissions ranging from personal daily records to materials with historical significance. Submissions will be accepted through Feb. 27 via online or text message, with a brief description and photos attached, the company said. Yuhan said it will review submissions based on archival value, preservation condition and potential use before selecting items. Selected materials will be used for Yuhan’s 100th anniversary archive, exhibitions and content production, it said. Celltrion says Omliclo gains traction in Spain, a key European market Celltrion said Tuesday that Omliclo (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, is accelerating its market expansion in Spain. Celltrion’s Spain unit was selected late last year as the top-ranked supplier in a public tender in Catalonia, a major region, the company said. It was also chosen as the top-ranked bidder in a tender to supply all public medical institutions in the Basque Country and completed a supply contract last month, it said. Omliclo is now prescribed across about 260 public and private hospitals in Spain, Celltrion said. The company said it plans to use its Spain strategy and results to expand prescriptions across Europe. Samsung Biologics signs vaccine manufacturing partnership with CEPI Samsung Biologics said Tuesday it signed a partnership agreement with the Coalition for Epidemic Preparedness Innovations, or CEPI, on Monday at the Conrad Seoul hotel in Yeouido, Seoul, to join a vaccine manufacturing facility network. Under the partnership, Samsung Biologics will be designated a “preferred” manufacturer for vaccines CEPI is supporting, the company said. In the event of a pandemic, Samsung Biologics said it will produce up to 50 million doses of vaccine and drug substance that can be converted into up to 1 billion doses of drug product vaccine, at CEPI’s request. Vaccines produced by Samsung Biologics would be supplied to South Korea first upon CEPI’s request, it said. The company said the partners will also conduct simulation exercises for rapid response, using a scenario involving an outbreak of wild-type H5 influenza. The drills are intended to verify the speed and stability of end-to-end capabilities from antigen development through manufacturing and supply, it said. Samsung Biologics said the two sides also plan to work together to strengthen chemistry, manufacturing and controls process development for recombinant protein vaccines and to expand standby production capacity.* This article has been translated by AI. 2026-02-04 17:48:00

Hanmi Pharmaceutical ramps up R&D push with homegrown drugs and global expansion plans Hanmi Pharmaceutical said it has held the top spot in South Korea’s outpatient prescription sales for seven straight years, driven by drugs developed with its own technology. The company said more than 90% of its revenue comes from in-house products, and it is accelerating efforts to find new global growth engines through research and development. Industry officials said Hanmi’s R&D spending as a share of revenue rose from 13.4% in 2022 to 15.2% as of the third quarter of last year. Analysts said the company’s steady double-digit R&D investment underpins its growth strategy. Hanmi has set a 2030 target of 1.9 trillion won in domestic sales and 1 trillion won overseas, for total revenue of 2.9 trillion won. The company expects its obesity drug program to align with industry trends and help expand its global business. Hanmi recently signed an exclusive distribution deal with Mexican drugmaker Sanfer covering its GLP-1 obesity drug candidate efpeglenatide and its diabetes combination products sold under the Daparon family name (Daparon tablets and Daparon Duo extended-release tablets). A regulatory filing said the supply contract for the Daparon products totals about 65.8 billion won and runs through Jan. 26, 2036. Efpeglenatide, a key in-house candidate, is slated for launch in the second half of this year and is under review for approval by South Korea’s Ministry of Food and Drug Safety. If approved, it would become the first domestically developed GLP-1 obesity treatment. Kwon Hae Soon, an analyst at Eugene Investment & Securities, said the obesity treatment market is expected to expand in earnest around the time of efpeglenatide’s launch, adding that a locally made product could win meaningful share given price competitiveness and supply stability. A Hanmi official said the launch price has not been set, but the company expects to secure price competitiveness because it will produce efpeglenatide at its Pyeongtaek bioplant. The official said direct control over production and supply could be a differentiator in a market where existing products rely on imports. Hanmi is also moving ahead with clinical development of next-generation obesity candidates, including HM15275, a triple-acting drug aimed at obesity and muscle loss, and HM17321, designed to increase muscle. For HM15275, the company said the U.S. Food and Drug Administration approved its Phase 2 investigational new drug application in September, and the first patient was dosed about three months later. The Phase 2 study will evaluate weight-loss effects and improvements in lean body mass in obese and severely obese patients after 36 weeks of long-term dosing. The company expects Phase 2 to end in the first half of 2027. Hanmi said oncology remains central to its new-drug pipeline. BH3120, a bispecific antibody immuno-oncology drug being co-developed with Beijing Hanmi Pharmaceutical, recently presented Phase 1 progress at the ESMO Immuno-Oncology Congress 2025. The company said BH3120 uses its Pentambody bispecific antibody platform, which allows a single antibody to bind two different targets at the same time. A Hanmi official said the company is building capabilities across multiple modalities, including targeted protein degradation, messenger RNA, cell and gene therapies, antibody-drug conjugates and single-domain antibodies, and will continue to pursue development and commercialization of innovative medicines.* This article has been translated by AI. 2026-02-03 18:27:00

Celltrion, SK Chemicals, HLB Pharma and Myung In Pharma report Europe share, sales deal, revenue and governance moves Celltrion: Remsima autoimmune drugs held 68% share in Europe last year Celltrion said Monday that its treatments for autoimmune diseases and cancer continue to hold strong market share in Europe. Citing IQVIA, the company said its Remsima product family for autoimmune diseases (IV and SC) posted a combined market share of about 68% in Europe as of the third quarter of last year. Both the intravenous and subcutaneous formulations showed steady prescribing trends. Shares were 81% in France, 84% in the U.K. and 74% in Germany, among other European markets including the five major countries known as the EU5, the company said. Celltrion said its autoimmune drug Yuflyma recorded a 24% share in Europe over the same period, keeping the top spot in prescriptions. In oncology, it said Vegzelma, used to treat metastatic colorectal cancer and breast cancer, ranked No. 1 in prescriptions with a 26% share in Europe over the same period. SK Chemicals signs co-marketing deal with Kyungnam Pharm for allergic rhinitis drug SK Chemicals said Monday it signed a joint sales agreement with Kyungnam Pharm for Nozeal soft capsules, an over-the-counter treatment for allergic rhinitis. Under the deal, Kyungnam Pharm will handle sales and marketing to pharmacies for Nozeal, which SK Chemicals had been distributing through its pharmaceutical ordering platform. The product’s active ingredient is fexofenadine and is used to relieve allergic rhinitis symptoms caused by pollen and house dust, the company said. Kyungnam Pharm said it has an 11-branch nationwide sales organization and a broad pharmacy distribution network. Park Hyun Sun, head of SK Chemicals’ pharma business, said, “Building on the strengths of both companies, we will improve accessibility at pharmacies and expand our presence in the rhinitis treatment market.” HLB Pharma says annual revenue tops 200 billion won for first time HLB Pharma said Monday that, for the first time since its founding, its consolidated annual revenue exceeded 200 billion won. In a regulatory filing on a change of 30% or more in revenue or profit structure (15% for large companies), HLB Pharma reported consolidated revenue of 205.6 billion won last year, up 50% from a year earlier. On a separate basis, revenue rose 12.7% to 154.5 billion won. The company said the result doubles its 2022 revenue, when it first surpassed 100 billion won, in just three years. It added that it achieved double-digit growth even as contract manufacturing revenue was temporarily halted after it demolished its Hyangnam plant to build a new factory. HLB Pharma said the performance was driven by the consolidation of results from Shinhwa Advance, which it acquired in April last year. It also cited a turnaround in both revenue and profit at its consumer health care division within two years of its launch. Myung In Pharm approves 1,500 won cash dividend per share, pushes professional management structure Myung In Pharm said Monday it is pursuing a shift from founder-led management to a co-CEO structure led by professional managers. The company said it held a board meeting and disclosed that it decided to nominate Lee Kwan Soon, a vice chairman at Hanmi Pharmaceutical, and Cha Bong Kwon, president in charge of sales management at Myung In Pharm, as inside director candidates. The nominations will be submitted to the company’s 38th annual general meeting of shareholders on March 26, it said. Under the plan, founder and chairman Lee Haeng Myung will step down as CEO and focus on advising the board, while professional managers take charge of operations, the company said. The company said Lee Kwan Soon earned a bachelor’s degree in chemical education from Seoul National University and completed master’s and doctoral coursework in chemistry at KAIST. He has served as vice chairman, CEO and head of the research center at Hanmi Pharmaceutical, and later led the Korea Pharmaceutical and Bio-Pharma Manufacturers Association before becoming CEO of GID Partners. Cha Bong Kwon graduated from Kyonggi University with a degree in German language and literature and rose through the company as head of the sales management division before taking his current role, the company said. * This article has been translated by AI. 2026-02-03 17:42:00

Genesis AI Healthcare VP Kang Si Cheol Named AI Technology Adviser to Seoul Medical Center Genesis AI Healthcare said Tuesday that its vice chairman, Kang Si Cheol, was appointed an artificial intelligence technology adviser to Seoul Medical Center on Monday. The company said the move is aimed at accelerating AI-driven medical innovation and helping the public hospital lead digital transformation. Kang, an AI medicine scholar and practitioner, has written books spanning theory and practice, including "AI Big History: 10 Wins Out of 22," "Artificial Intelligence Networks and Super Business," "Disruption," "An Era Comes When Even Aging Is Designed," "Hippocrates Meets Turing: The Age of AI Medicine" and "AI MBA." His recent titles, "Universal Concierge Medicine for a National Primary Doctor," "AI Translates the Human Body" and "AI Medical Management," have been described as essential reading on the present and future of AI medicine. During his two-year term, Kang is expected to provide strategic advice on digital innovation projects, including adopting Seoul Medical Center’s AI medical management solutions, building a medical AI platform, and advancing AI-based diagnosis and treatment systems. Seoul Medical Center said it plans to use the appointment to develop a model case for AI innovation in public health care and to explore ways to improve service quality and operational efficiency. Kang said, "I will do my best so that AI technology can create real value in the public health care field together with Seoul Medical Center," adding that he will "build a virtuous cycle that strengthens medical staff capabilities and improves citizens’ health."* This article has been translated by AI. 2026-02-03 17:12:00

Ilyang Pharmaceutical Cleared in Prosecutors’ Probe Over Alleged Accounting Violations Ilyang Pharmaceutical said Monday that a prosecutors’ investigation into allegations raised by financial authorities — including accounting violations and obstruction of an external audit — ended with a decision of no charges and no right to prosecute. The Suwon District Prosecutors’ Office had previously said Ilyang Pharmaceutical inflated net profit and shareholders’ equity by bringing its Chinese joint ventures, Tonghua Ilyang and Yangzhou Ilyang, into its consolidated subsidiaries, and that it submitted forged documents during the audit process. The case was referred to prosecutors along with a recommendation for severe sanctions. The company said the decision came about three months after financial authorities’ determination. Ilyang Pharmaceutical said it will continue to strictly comply with laws and accounting standards and pursue transparent, responsible management.* This article has been translated by AI. 2026-02-03 15:57:00

Celltrion, Hanmi, Dong-A ST, HLB and Jaseng report U.S. growth, deals and approvals Celltrion’s Zymfentra posts record weekly prescriptions, ramps up U.S. marketing Celltrion said Wednesday that prescriptions for its subcutaneous infliximab treatment Zymfentra rose about 27% from the same period a month earlier and about 352% from a year earlier, based on the second week of January. The company said the figure was the highest weekly total prescriptions (TRx) recorded since the drug’s U.S. launch in March 2024, according to IQVIA. Celltrion said its ongoing online and offline advertising in the United States helped drive the increase in prescriptions. It also cited the rapid buildout of a reimbursement base for patients as a key factor. Celltrion said it expects Zymfentra’s growth to accelerate starting this year and plans to step up efforts to promote the product’s competitiveness. Hanmi Pharmaceutical signs Mexico export deal with Sanfer for GLP-1 obesity drug and diabetes products Hanmi Pharmaceutical said Wednesday it signed an exclusive distribution agreement with Mexican drugmaker Sanfer covering the GLP-1 obesity drug efpeglenatide and its diabetes combination products sold under the Daparone family brand. Under the deal, Hanmi will supply finished products of efpeglenatide and the Daparone family — Daparone tablets and Daparone Duo extended-release tablets — while Sanfer will handle regulatory approval, marketing, distribution and sales in Mexico. Hanmi said Mexico has an obesity prevalence of 36.86% and a diabetes prevalence of 16.4%. The companies said they plan to expand cooperation step by step, including on efpeglenatide and broader metabolic-disease treatments. Dong-A ST wins Canadian approval for Stelara biosimilar Imuldosa Dong-A ST said Wednesday it received approval from Health Canada for Imuldosa, a biosimilar to the autoimmune disease treatment Stelara (ustekinumab). Stelara posted 2024 sales of US$21.552 billion (about 29.9357 trillion won), the company said. Imuldosa was co-developed by Dong-A Socio Holdings and Meiji Seika Pharma starting in 2013 and is used to treat inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The product has been launched in 19 countries, including the United States, Germany and the United Kingdom, and has received approvals in Middle Eastern markets including Saudi Arabia, Qatar and the United Arab Emirates. HLB says it completed FDA filing for bile duct cancer indication for lirafugratinib HLB said Wednesday that its U.S. subsidiary, Elevar Therapeutics, completed a new drug application to the Food and Drug Administration for lirafugratinib, an FGFR2 fusion/rearrangement-targeted cancer drug, as a second-line treatment for bile duct cancer. HLB said Elevar completed the filing after submitting an application on Jan. 23 for a first-line liver cancer indication, starting the FDA review process aimed at both indications. Lirafugratinib received FDA orphan-drug designation in 2022 and breakthrough therapy designation in 2023 for the bile duct cancer indication, HLB said. The company said it reached agreement with the FDA, after a formal meeting last year, to file for accelerated approval based on Phase 2 results without an additional confirmatory Phase 3 trial. HLB said the drug is likely to be considered for priority review, with the FDA to decide whether to grant it when the agency begins its full review. Jaseng Korean Medicine Hospital study finds benefits of integrative treatment for older traffic-accident patients A research team led by Shin Ju Yeon, a Korean medicine doctor at Jaseng Korean Medicine Hospital’s Spine and Joint Research Institute, said Wednesday it published results in the SCI(E)-indexed international journal Medicine on the effectiveness of integrative Korean medicine treatment for older traffic-accident patients. The team retrospectively analyzed electronic medical records of 1,788 patients ages 65 and older who were hospitalized from 2021 to 2023 at four facilities: Gangnam Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, Daejeon Jaseng Korean Medicine Hospital and Haeundae Jaseng Korean Medicine Hospital. The study assessed effectiveness and safety. During hospitalization, patients received integrative treatment including acupuncture, pharmacopuncture, herbal medicine and Chuna manual therapy. Acupuncture was administered twice a day. Treatments included Shinbaro pharmacopuncture and herbal medicines such as Anshinjitongtang and Hwanghyeoljitongtang. Average length of stay was about 10 days. The team reported significant improvements in pain and functional recovery at discharge, around 10 days after admission, across four areas: neck, lower back, shoulder and knee. The EQ-5D quality-of-life measure improved by an average of 0.12 points, with gains across all indicators.* This article has been translated by AI. 2026-01-28 17:34:19

Daewoong Pharma in talks with Saudi government to build bio, drug production ecosystem SEOUL, October 17 (AJP) - South Korea's Daewoong Pharmaceutical said Friday it has begun discussions with the Saudi Arabian government on introducing innovative drugs and developing a biotechnology ecosystem that includes research, development, and manufacturing investments. The talks reflect Saudi Arabia’s growing ambition to localize pharmaceutical production and expand its bio-manufacturing capacity as part of its broader economic diversification strategy under Vision 2030. Saudi Deputy Health Minister Khalid Alburaikan and Strategic Cooperation Director Sarah Aref recently visited Daewoong’s headquarters in Seoul, where they met with company executives to discuss collaboration opportunities. The discussions centered on drug development, clinical research, and the establishment of production facilities in the kingdom, the company said. Officials from South Korea’s Ministry of Health and Welfare and the Korea Health Industry Development Institute also attended the meeting. Saudi Arabia, the largest pharmaceutical market in the Middle East, was valued at about $13 billion last year and is projected to grow to $19 billion by 2030. The government has been accelerating efforts to strengthen pharmaceutical self-sufficiency and attract global investment into its bio sector. Daewoong, one of South Korea’s leading drugmakers, launched its botulinum toxin product Nabota in Saudi Arabia earlier this year and plans to introduce additional treatments, including Fexuclu for gastroesophageal reflux disease and Enblo, an SGLT-2 inhibitor for diabetes. The company said the recent discussions also covered cooperation on local clinical trials and regulatory approvals. Daewoong plans to participate in the Saudi Global Health Exhibition in Riyadh later this month and will host its global training program for medical professionals in Saudi Arabia by the end of the year. “We confirmed that Saudi Arabia’s vision for its pharmaceutical and bio industries aligns with Daewoong’s global cooperation goals,” said Park Sung-soo, the company’s chief executive. “We hope to contribute to the growth of Saudi Arabia’s bio industry and improve the quality of life for local consumers through long-term collaboration.” * This article, published by Aju Business Daily, was translated by AI and edited by AJP. 2025-10-17 14:13:00

Korean firm wins manufacturing contract for US shingles vaccine SEOUL, October 13 (AJP) - South Korea's GC Biopharma said Monday it has secured contract manufacturing rights for a shingles vaccine being developed by its U.S. affiliate, Curevo Vaccine. Under the agreement, GC Biopharma will produce part of the commercial supply of the vaccine, known by its project name amezosvatein (CRV-101). The product aims to challenge GlaxoSmithKline’s Shingrix, which has dominated the shingles vaccine market for years. The global market for shingles vaccines has expanded rapidly, driven by aging populations and rising awareness of preventive care. Since Shingrix’s commercial launch in 2018, annual sales have grown nearly 20 percent each year, from roughly 1 trillion won ($730 million) in 2017 to about 6 trillion won ($4.4 billion) in 2024. The GSK vaccine accounted for more than 90 percent of global market share last year, with sales exceeding 5 trillion won ($3.4 billion). Amezosvatein, like Shingrix, is a recombinant protein vaccine with an adjuvant designed to boost immune response. But Curevo’s version uses a synthetic adjuvant, which researchers say may reduce injection site pain and systemic reactions — potentially improving patient tolerability. Early Phase 2 trials have shown that amezosvatein achieved non-inferiority to existing products while demonstrating favorable safety results, according to GC Biopharma. Curevo is now conducting an expanded Phase 2 trial involving 640 adults aged 50 and older, with plans to complete the study by 2026 and advance to Phase 3 thereafter. “This agreement marks a significant milestone in securing GC Biopharma’s long-term growth drivers,” said CEO Huh Eun-chul. “We will continue to expand our presence in the global vaccine business and strengthen our role in high-value biopharmaceutical manufacturing.” * This article, published by Aju Business Daily, was translated by AI and edited by AJP. 2025-10-13 15:36:09

Discount stores crowd Korea's $5 billion health supplement market SEOUL, October 08 (AJP) - The race for South Korea’s fast-growing health and dietary supplement market is intensifying as bargain retailers and convenience stores challenge traditional drugstores for a share of a wellness-driven, aging society where eight out of 10 households regularly take preventive supplements. According to Expert Market Research, Korea’s health supplement market was valued at $5.45 billion in 2024 and is projected to expand at a compound annual growth rate of 5.2 percent, reaching $9 billion by 2034. A separate survey by the Korea Health Supplements Association found 81.2 percent of Korean households purchased health supplements in 2023. The surge in both online and offline distribution channels to meet this demand is reshaping the market structure. Daiso and convenience store chains are entering the space with low-cost, easy-access options, while the Korean Pharmaceutical Association is partnering with major drugmakers to develop pharmacy-exclusive products. ] Daiso, a popular budget franchise, has teamed up with domestic drugmakers such as Daewoong Pharmaceutical, which released 26 products priced between 3,000 and 5,000 won ($3.5) for a month’s supply. Jongkundang Health also introduced its competitively priced probiotics “Lactofit Gold” line. “We offer a variety of products like vitamins and probiotics, mostly priced at 3,000 or 5,000 won,” a Daiso official said. Convenience stores are likewise expanding their shelves. Dong-A Pharmaceutical launched its “Cellparex Baro” line exclusively through CU stores, targeting single-person households with five- to ten-day packs. “We aim to provide products that address modern health concerns with immediacy and convenience,” a Dong-A representative said. The industry is closely watching how the market evolves in the latter half of the year as low-price, convenience-driven products go head-to-head with pharmacy-exclusive, trust-based brands. In response to Daiso’s push, the Korean Pharmaceutical Association signed MOUs with Yuhan Corporation and Dong-A Pharmaceutical to co-develop affordable supplements sold exclusively through pharmacies. Eight new Yuhan-made products are due by year-end, and Dong-A’s lineup will debut in October. With online availability expanding rapidly, experts are also warning of potential misuse. “With increased accessibility, improper guidance could lead to overuse or misuse,” an industry insider said. * This article, published by Aju Business Daily, was translated by AI and edited by AJP. 2025-10-08 09:12:57

SK Biopharm's US arm posts record sales of epilepsy drug SEOUL, October 02 (AJP) - SK Life Science, the U.S. subsidiary of South Korea’s SK Biopharm, reported record sales of its epilepsy treatment cenobamate in the first half of this year, reaching 170,000 cumulative prescriptions. The company highlighted the achievement during its annual “Plan of Action” meeting in Chicago, as it looks to build momentum in one of the world’s most competitive pharmaceutical markets. More than 130 employees from SK Life Science and SK Biopharm gathered from Sept. 29 to Oct. 1 to review performance and outline next steps. Executives said the results marked the strongest sales since Xcopri, as the drug is marketed in the United States, was introduced in 2020. The Chicago meeting, now in its sixth year, also brought in senior staff from the Seoul headquarters to reinforce collaboration between the U.S. unit and its parent company. The event was designed not only to showcase achievements but also to motivate employees ahead of the next growth phase. SK Biopharm, which became the first South Korean drugmaker to build a direct sales operation in the United States, plans to leverage cenobamate’s success to expand its portfolio. “SK Biopharm stands at a crucial turning point to diversify our portfolio and target both current and future markets,” said Lee Dong-hoon, the company’s chief executive. “We expect all divisions to collaborate as one team to create greater synergy.” * This article, published by Aju Business Daily, was translated by AI and edited by AJP. 2025-10-02 14:04:06