Journalist

Park Boram
  • Yuhan, Huino Begin Commercial Rollout of AI Telemetry System MemoCue
    Yuhan, Huino Begin Commercial Rollout of AI Telemetry System MemoCue Yuhan Corp. said Tuesday it has begun commercializing an artificial intelligence telemetry solution, MemoCue, with digital health care company Huino. The system will be supplied to H Plus Yangji Hospital and applied to about 100 beds in key departments where cardiac monitoring is essential, the company said. MemoCue analyzes hospitalized patients’ electrocardiogram data in real time to detect abnormal signs early and support clinicians’ decisions. It is designed to extend monitoring beyond intensive care units to general wards. Yuhan said the system can use a hospital’s existing communications infrastructure without installing a separate network gateway, reducing the burden of adoption. The solution includes a wearable ECG device, the Memo Patch M, designed with patient convenience and safety in mind. It uses a defibrillation protection circuit that delivers more than 99% of treatment energy to the patient and can resume measurement within five seconds after a shock, the company said. The product received U.S. Food and Drug Administration 510(k) clearance last year and earned the top electrical safety rating under the international medical device safety standard IEC 60601-1, known as “Type CF Defib-proof.” A Yuhan official said the company expects the system to help hospitalized patients recover by enabling accurate alerts and rapid response. 2026-04-21 11:12:19
  • Hyundai Bioscience Wins South Korea Approval for Prostate Cancer Trial Change; Other Pharma-Bio Updates
    Hyundai Bioscience Wins South Korea Approval for Prostate Cancer Trial Change; Other Pharma-Bio Updates Hyundai Bioscience wins MFDS approval for prostate cancer trial change Hyundai Bioscience said April 20 that South Korea’s Ministry of Food and Drug Safety has given final approval to a revised investigational new drug plan for a combination-therapy clinical trial in prostate cancer using its broad-based “environment normalization” agent, Penetrium. The company said it will submit related documents on April 21 to the Institutional Review Board at Seoul National University Hospital, then hold a site initiation visit in mid-May before starting patient enrollment and dosing. The trial is examining whether reduced drug response can stem not only from cancer-cell mutations but also from a physical barrier in the tumor microenvironment that can create what it calls “pseudo-resistance,” in which drugs fail to reach the tumor and the lack of response is mistaken for tumor evolution. The newly approved change adds an AR-V7 genetic-variant test at the patient screening stage. Patients with “true resistance” (AR-V7 positive), in which the receptor itself is altered and the drug does not work, will be excluded. The study will instead select patients with “pseudo-resistance” (AR-V7 negative) and treat them with a combination of enzalutamide and Penetrium. The company said that if the trial produces successful interim results, prostate cancer patients could potentially continue benefiting from existing targeted therapies without moving to chemotherapy that can involve severe side effects. Huons Group joins Gyeonggi Community Chest of Korea’s major-donor program Huons Group said April 20 it held a donation ceremony after joining the Gyeonggi branch of the Community Chest of Korea’s “Sharing Prestigious Company” program. Attendees included Song Soo-young, CEO of Huons Global and Huons; Kang Min-jong, CEO of Humedix; and Kwon In-wook, chairman of the Gyeonggi Community Chest of Korea, the company said. The program is a network of corporate donors that have contributed at least 100 million won. Huons Group said three of its companies decided to join together to continue donations, following ongoing community support, medical volunteer work and scholarship programs. The donations will be used through the Gyeonggi Community Chest of Korea to support living and medical expenses for low-income households and to improve educational environments, the company said. GC Green Cross MS wins EU CE-IVDR certification for GGP-100 glucose meter GC Green Cross MS said April 20 that its new blood glucose monitoring system, the GC Fit (model GGP-100), has received certification under the European Union’s In Vitro Diagnostic Medical Devices Regulation, known as CE-IVDR. CE-IVDR tightens performance and safety requirements compared with the previous CE-IVDD framework and is required for entry into the EU market, the company said. GC Green Cross MS said the GGP-100 met the strengthened standards despite being classified as a high-risk Class C product, demonstrating safety and performance. The company said the certification also secures EU-level performance and safety coverage for its full lineup of blood glucose meters, including existing products. The company said the approval enables EU market entry about two months earlier than planned. It also said it plans to expand exports by obtaining CE-IVDR certification for an optical hemoglobin measurement product. Jaseng Korean Medicine Hospital backs Bucheon FC 1995 youth teams with training gear Jaseng Medical Foundation said April 20 it held a handover ceremony to provide soccer equipment for Bucheon FC 1995 youth teams. The foundation said the support is intended to help create a stable training environment for young players aspiring to become national team members. About 100 players will receive uniforms, soccer cleats and balls, among other items, worth about 5 million won. Jaseng Healthcare also sponsored health functional foods, it said. The foundation said it plans to continue support under the aim of encouraging the youth teams’ efforts, while monitoring training conditions and considering additional measures such as medical support. Bucheon Jaseng Korean Medicine Hospital has provided medical support to Bucheon FC 1995 under a partnership spanning 17 years, and has participated as the club’s main sponsor since last year.* This article has been translated by AI. 2026-04-20 17:45:00
  • Dongkook Life Science Wins EU CEP for Iopamidol API, Expands Contrast-Agent Supply Chain
    Dongkook Life Science Wins EU CEP for Iopamidol API, Expands Contrast-Agent Supply Chain Dongkook Life Science said April 20 it has obtained a Certificate of Suitability, or CEP, for its iopamidol active pharmaceutical ingredient. A CEP is a quality certification for APIs issued by the European Directorate for the Quality of Medicines & HealthCare, or EDQM, and is a key requirement for entering the European pharmaceutical market. Iopamidol is a nonionic iodine-based contrast agent used in CT scans. The company said demand for diagnostic imaging is rising, and that securing quality at the API stage is closely tied to the competitiveness of finished drugs. Dongkook Life Science previously obtained approval from China’s National Medical Products Administration, or NMPA, for its gadobutrol API, an MRI contrast agent. In Japan, a manufacturer of a finished drug using the company’s gadobutrol API has cleared the Pharmaceuticals and Medical Devices Agency, or PMDA, approval process, securing a supply base. The company said this links Europe, China and Japan into a global supply chain for contrast agents. “We plan to increase the share of overseas sales by advancing quality and strengthening production capabilities,” a company official said. * This article has been translated by AI. 2026-04-20 14:00:46
  • HK inno.N, NextGen Bioscience to Co-Develop Idiopathic Pulmonary Fibrosis Drug Candidate NXC680
    HK inno.N, NextGen Bioscience to Co-Develop Idiopathic Pulmonary Fibrosis Drug Candidate NXC680 HK inno.N said on the 20th that it has signed a joint research and development agreement with NextGen Bioscience to co-develop NXC680, a drug candidate for idiopathic pulmonary fibrosis, or IPF. The companies said the deal is aimed at combining HK inno.N’s R&D capabilities with NextGen’s work on the candidate to move it into clinical development and explore global commercialization potential. Under the agreement, HK inno.N will handle optimization of the finished-drug formulation and run clinical trials, while NextGen will supply the active pharmaceutical ingredient and provide research data. The two companies plan to jointly conduct a Phase 1 clinical trial. NXC680 has shown potential to treat pulmonary fibrosis in nonclinical studies and has received orphan drug designation from the U.S. Food and Drug Administration. In South Korea, it has obtained approval for a Phase 1 investigational new drug application. Song Geun-seok, a vice president at HK inno.N, said the company will work to increase the value of competitive candidates in areas with high unmet medical needs and, over the mid to long term, strengthen its new-drug portfolio for the global market.* This article has been translated by AI. 2026-04-20 13:57:25
  • Korea’s Skin Booster Market Shifts as ECM Products Expand, Raising Regulatory Questions
    Korea’s Skin Booster Market Shifts as ECM Products Expand, Raising Regulatory Questions Competition in South Korea’s skin booster market is shifting quickly as more pharmaceutical and biotech companies enter the field and products based on human tissue spread. Skin boosters refer to injectable procedures that deliver substances such as hyaluronic acid and collagen into the dermis to help moisturize, improve elasticity and support skin regeneration. The market, long led by products such as PharmaResearch’s Rejuran and Juvlook, is increasingly seeing late challengers promote ECM (extracellular matrix) offerings. According to Grand View Research, the domestic skin booster market totaled $87.7 million (about 128.7 billion won) in 2024 and is projected to grow 16% annually through 2030. Rejuran has dominated the sector, and PharmaResearch’s revenue topped 500 billion won last year on growth in its aesthetics business centered on the product. But as the market expands and new products multiply, its once-dominant position is weakening, with ECM skin boosters at the center of the change. L&C Bio’s “Ellavie Rituo,” launched in late 2024, is made by leaving only the collagen structure from donated deceased skin tissue, turning it into powder and injecting it. The company now has about 2,000 hospital and clinic accounts. L&C Bio is also reviewing an additional production-facility expansion, targeting October. If carried out, output is expected to rise from 30,000 units to as many as more than 150,000 units a month by the end of this year. Lee Seung-eun, an analyst at Yuanta Securities, forecast that Rituo revenue could expand to 50 billion won this year from about 6 billion won a year earlier. Other drug and biotech companies are also moving in. CGBio’s affiliate CGBiomeditech, which is expanding its ECM business based on its parent company’s human-tissue processing capabilities, recently acquired CGBio’s Seongnam human-tissue processing tissue bank to secure a production base. GC Wellbeing has launched “GCell Rebonne” and is accelerating its push into medical aesthetics. MS Bio handles tissue processing, while GC Wellbeing has built a system to manage and supply raw materials through a distribution tissue bank at its Eumseong plant in North Chungcheong Province. Hugel has also joined the market by signing a domestic distribution contract for Hans Biomed’s “CellrDM.” Differences in oversight are also fueling the spread of ECM products. Rituo is classified as human tissue, meaning it is subject to procedures different from medical devices such as Rejuran and Juvlook. Medical devices must go through the Ministry of Food and Drug Safety’s process for each product, including intended use and indications. Human tissue, by contrast, can be supplied to hospitals and clinics without separate approval for each product, creating a relatively lower barrier to entry. Lee Jun-seok, an analyst at Hanyang Securities, said, “The ECM skin booster business depends on stable procurement of raw materials,” adding that success will hinge on “how reliably companies can secure human tissue that meets regulatory requirements.” At the same time, debate is intensifying over the use of human tissue for cosmetic purposes. Critics have raised ethical concerns because donated tissue is used in commercial procedures. Kwon Dong-ju, an attorney at law firm Yulchon, said at the K-Bio Health Forum on April 16, hosted by Democratic Party lawmaker Seo Dong-seok under the theme “Reasonable regulatory measures for the proper use of donated human tissue,” that it is not reasonable for products with the same purpose and method of administration as other injectable skin boosters already approved as medical devices to be regulated entirely differently. He argued that the Human Tissue Act should explicitly ban cosmetic use. * This article has been translated by AI. 2026-04-20 06:03:18
  • Samsung Bioepis Presents Follow-Up Phase 3 Data on Osteoporosis Drug Ovodens in Europe
    Samsung Bioepis Presents Follow-Up Phase 3 Data on Osteoporosis Drug Ovodens in Europe Samsung Bioepis said Sunday it presented follow-up results from a Phase 3 study of its Prolia biosimilar, Ovodens (project name SB16), at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) in Prague, Czech Republic. The analysis was an exploratory subgroup review of the global Phase 3 SB16 trial. It examined 456 postmenopausal women with osteoporosis to assess whether disease characteristics such as age, body mass index and history of vertebral fractures affected the drug’s efficacy. Samsung Bioepis analyzed the percent change from baseline in bone mineral density of the lumbar spine, total hip and femoral neck at 12 months in patients included in the subgroup analysis for SB16 and the reference product. The company said the SB16 and reference-product subgroups showed consistent treatment effects, reaffirming biological similarity between the two products. Shin Dong-hoon, head of the Clinical Medicine Division at Samsung Bioepis, said the company confirmed Ovodens’ consistent treatment effect across diverse patient groups and would strengthen its capabilities to expand evidence-based prescribing of biologic medicines.* This article has been translated by AI. 2026-04-19 10:54:00
  • Korean Drugmakers Gain FDA Orphan Drug Designations, Boosting Global Push
    Korean Drugmakers Gain FDA Orphan Drug Designations, Boosting Global Push South Korean pharmaceutical and biotech companies are increasingly securing orphan drug designations from the U.S. Food and Drug Administration, a step they see as helping open doors to global markets. The designation does not guarantee a successful drug, but it can cut time and costs in the approval process and is widely viewed as a strategic pathway. Industry officials said April 16 that candidates being developed by ABL Bio, Yuhan Corp. and Onconic Therapeutics have recently received FDA orphan drug designation. The FDA program targets rare diseases with small patient populations and few or no alternative treatments. The designation comes with regulatory incentives. The FDA offers benefits such as waiving application fees and providing expedited review, and it supports a 25% tax credit for clinical trial costs. After a product is approved for sale, it also grants seven years of market exclusivity in the United States. ABL Bio said its bile duct cancer candidate tovecimig, a bispecific antibody it licensed out to Compass Therapeutics, was designated an orphan drug. The drug is designed to block both the DLL4 and VEGF-A pathways, which play key roles in new blood vessel growth and tumor vascular formation. It is being developed for bile duct cancer, where treatment options are limited. Yuhan said its Gaucher disease candidate YH35995 also received orphan drug designation. Gaucher disease is a hereditary rare disorder in which a specific enzyme deficiency disrupts metabolism, leaving significant unmet medical needs. The company said only about 100 patients are registered in South Korea, but the market is shaped around high-priced therapies, making it potentially profitable. Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, said its synthetic lethality-based dual-target anticancer drug nesuparib was recently designated an orphan drug for small cell lung cancer. Nesuparib had previously received orphan drug designation for pancreatic and gastric cancers, and the latest decision again points to broader development potential, the company said. The rare-disease drug market is growing as diagnostic tools improve and aging populations contribute to rising patient numbers, expanding demand for treatments. Evaluate, a pharmaceutical data analytics firm, said rare-disease therapies accounted for about 17% of the global prescription drug market as of last year and are projected to reach about 20% of the total prescription market by 2030. Still, orphan drug designation does not necessarily translate into commercial success. Because the designation is granted at an early stage, candidates must still prove themselves through clinical trials, regulatory review and market entry. "Even candidates with orphan drug designation are often discontinued because they fail to prove efficacy or run into safety issues," a pharmaceutical industry official said. "Even if they clear clinical trials, there can be variables at the commercialization stage, such as failing to meet production cost targets." Even so, a track record of orphan drug designation is often taken as a signal that a candidate has cleared a certain level of screening and that regulators recognize unmet needs in the disease area. That can be a positive factor in global partnerships, industry officials said. "Rare diseases have limited market size, but institutional support can reduce the burden," another industry official said. "Building approval experience can help earn trust in the global market."* This article has been translated by AI. 2026-04-16 18:18:51
  • Korea Medical Tourism Expands Beyond Beauty to Cancer and Fertility Care
    Korea Medical Tourism Expands Beyond Beauty to Cancer and Fertility Care As South Korea enters the era of 1 million foreign patients, its medical tourism industry is rapidly moving beyond skin care and cosmetic procedures into specialized treatment such as cancer care and infertility services. With demand rising for longer courses of care that run from diagnosis and surgery through recovery, hospitals say overall patient management — including language support, logistics and follow-up — is becoming a key measure of competitiveness. The government had set a goal of attracting 700,000 foreign patients by 2027, but the total already topped 1 million last year. Industry officials said on the 16th that Korea’s medical tourism has long been driven by K-beauty, but more patients are now traveling to Korea for complex treatment, including cancer and infertility care. Asan Medical Center said more than 19,000 foreign patients visited in 2024. Patients from the United States as well as the United Arab Emirates and Mongolia often request consultations in advance by email or messaging apps and send medical opinions from local doctors along with CT and MRI materials to prepare for care, a hospital official said. The hospital’s International Healthcare Center has built an integrated online platform that links registration, uploading test materials, pre-consultations and telemedicine, allowing management to begin before patients arrive. “More patients with serious illnesses are coming to Korea after setting treatment plans through remote care before entering the country,” an Asan Medical Center official said. Over the past five years, the hospital conducted more than 800 remote consultations for patients from 57 countries, many involving severe cases such as liver and pancreatic cancer, the official said. Analysts say the shift toward serious disease treatment also reflects conditions overseas. In the United States, treatment costs are high, and many procedures are known to cost about 50% to 90% more than in Korea. In the United Kingdom, patients can wait months to see specialists. By contrast, Korea is viewed as combining relatively lower costs with strong outcomes. In 2023, Korea’s treatable mortality rate — early deaths that could be avoided with timely, effective care — was 45 per 100,000 people, well below the OECD average of 77. Satisfaction with medical technology and facilities is also reflected in repeat demand: A Korea Health Industry Development Institute survey found 59.8% of foreign patients said they were willing to return. Hospitals are also strengthening tailored services to attract overseas patients. With about 70% of foreign patients coming from nearby countries such as Japan, China and Taiwan, Magok CHA Hospital’s fertility center is cited as an example of improving convenience by leveraging its location near Gimpo Airport. For infertility patients who must return repeatedly to match treatment schedules, the “10-minute drive from the airport” is described as a key advantage. The center has also set up a separate treatment area, Building B, for foreign patients, separating their routes from those of Korean patients. The hospital said it redesigned the care environment to reflect longer interpretation and consultation times. “We chose the location with accessibility in mind, and we operate specialized interpreters and a one-on-one consultation system,” a fertility center official said. Seoul, where 85% of foreign patients are concentrated, is expanding policy support. The city plans to increase its pool of interpreter coordinators from 100 to 1,000 this year, broadening coverage beyond English, Chinese and Japanese to include less common languages such as Russian and Arabic. “Not only medical care but also interpretation and guidance can shape the patient experience,” a Seoul Tourism Organization official said, adding that trust built through those services can influence perceptions of Korea’s health care overall. Seoul is also pushing to introduce “medical-friendly accommodations.” A city official said medical tourism is currently centered on hospitals and clinics, with related services such as patient recruitment agencies, travel firms and transportation operating alongside them. The city is reviewing support systems tailored to long-stay patients, the official said.* This article has been translated by AI. 2026-04-16 18:18:00
  • Korea Pharmaceutical and Bio-Pharma Association Welcomes Launch of National Bio Innovation Committee
    Korea Pharmaceutical and Bio-Pharma Association Welcomes Launch of National Bio Innovation Committee The Korea Pharmaceutical and Bio-Pharma Association welcomed the launch of the National Bio Innovation Committee, saying it expects governance of the pharmaceutical and biotech sector to be unified. In a statement issued on the 16th, the association said coordination among ministries and the government’s ability to execute policy would be strengthened, adding that it hopes policy goals and implementation plans will be pursued in a systematic way. Earlier that day, the government held a launch ceremony for the committee at the Government Complex Sejong, chaired by Prime Minister Kim Min-seok. The committee was formed by integrating the separately run National Bio Committee and the Bio Health Innovation Committee, with the aim of overseeing and coordinating bio policy across the government. The association said intensifying global technology competition has brought a shift across areas including new drug development, convergence with artificial intelligence and advanced manufacturing, underscoring the need for the committee. It also said plans to expand open innovation based on cooperation among industry, academia, research institutes, hospitals and government, and to strengthen full-cycle support from research and development to commercialization, would help drive both expansion of the industry and qualitative growth. The association also gave a positive assessment of measures such as AI-based support for R&D, building a national bio cluster and pursuing regulatory rationalization. It said it hopes the committee will serve as a policy control tower and a focal point for strengthening national competitiveness, adding that it will actively cooperate for successful operations.* This article has been translated by AI. 2026-04-16 18:06:21
  • Osstem Implant Wins EU Certification for Dental Unit Chairs; SK Chemicals Launches Low-Dose Triple Hypertension Pill
    Osstem Implant Wins EU Certification for Dental Unit Chairs; SK Chemicals Launches Low-Dose Triple Hypertension Pill Osstem Implant’s dental unit chairs meet EU medical device rules Osstem Implant said Thursday it has obtained European Union Medical Device Regulation certification, known as CE MDR, for its dental unit chairs, following certification for its implant products. The certified models are the K3 and K5, the company said. It described them as flagship products with cumulative global sales of 60,000 units. A dental unit chair is used to seat or recline patients during treatment and combines multiple small devices and precision parts, requiring advanced development and manufacturing capabilities, the company said. Osstem Implant launched its first unit chair, the K3, in 2013 under the concept of a “back-to-basics chair.” The company said it designed the height adjustment range and table movement structure for flexibility, aiming for stable usability across different clinical settings. SK Chemicals launches low-dose triple-combination hypertension drug Telamclo SK Chemicals said Thursday it has launched Telamclo, a low-dose, triple-combination drug for hypertension. Telamclo combines telmisartan 20 milligrams, amlodipine 2.5 milligrams and chlorthalidone 6.25 milligrams. SK Chemicals said each ingredient is set at about half the standard dose used in single-ingredient products. The drug was developed in cooperation with Yuhan Corp., which previously marketed Truset tablets with the same ingredients and doses, the company said. SK Chemicals said the launch reflects a treatment trend toward using drugs with different mechanisms from the early stages of care. It said hypertension involves multiple mechanisms, and single-drug therapy can have limits in controlling blood pressure, driving broader use of combination products. The company said telmisartan works to inhibit blood vessel constriction, amlodipine helps relax blood vessels, and chlorthalidone regulates the excretion of sodium and water, addressing multiple causes at once. SK Chemicals said it plans to strengthen its market push by building on synergy with its existing hypertension lineup, including Cosca tablets, and by offering a portfolio spanning single-ingredient and combination therapies.* This article has been translated by AI. 2026-04-16 16:48:00