▲ JW Pharmaceutical said on the 20th that hemophilia A treatment Hemlibra (ingredient name emicizumab) has been newly added to the World Health Organization (WHO) Model List of Essential Medicines and Model List of Essential Medicines for Children in the 2025 revision. Hemlibra is a bispecific antibody therapy designed to mimic the function of coagulation factor VIII and is the only prophylactic treatment that can be used by both patients with hemophilia A who have antibodies that confer resistance to factor VIII products and those without antibodies. In addition, with a single subcutaneous injection as infrequently as once every four weeks, the preventive effect against bleeding persists, greatly improving dosing convenience compared with existing intravenous injections.
▲ Celltrion said on the 20th that autoimmune disease treatment Yuflyma (ingredient name adalimumab) has received an additional approval from the U.S. Food and Drug Administration (FDA) for pediatric use. The newly added indications are two: pediatric uveitis and hidradenitis suppurativa. Celltrion obtained approval in line with the expiration of exclusivity for the original drug for the relevant pediatric indications. Pediatric patients, whose treatment options had been limited, will now enjoy equivalent therapeutic benefits to the original drug at a more reasonable price, the company said.
■ Medytox affiliate Numeco said on the 20th that it has obtained marketing authorization from the Moldovan health authorities for the botulinum toxin product Neulux. Moldova's medical tourism market is growing rapidly, backed by strong medical infrastructure and price competitiveness. Medytox said that by launching its botulinum toxin product Meditoxin (export name Neuronox) and its hyaluronic acid filler Neuramis in the Moldovan market and establishing its presence, it achieved a record high in local sales last year.
■ Yuhan Corporation said on the 20th that it has launched Yuhan Minox Pen Gel, an over-the-counter hair loss treatment in a pen type containing 5% minoxidil. Yuhan Minox Pen Gel features a roll-on pen-type structure that allows consumers to apply it precisely to the desired area without getting it on their hands. Pump out the gel-type solution and lightly roll it over the hair loss area to use. The gel formulation allows focused application to localized areas such as the crown, M-shape, and hairline without running or smudging.
▲ Ipsen Korea said on the 20th that Bylvay, a treatment for progressive familial intrahepatic cholestasis (PFIC), has been launched in Korea. It is also covered by national health insurance. Bylvay is the world's first oral therapy for treating PFIC symptoms, providing a noninvasive option for patients who previously had no choices other than high-risk treatments such as liver transplantation. Since its first approval in the United States and Europe in 2021, it has received authorization in major countries, and in Korea it was selected in 2023 as the first drug in the Ministry of Health and Welfare's pilot program for simultaneous approval, assessment, and negotiation, with reimbursement applied in October this year.
▲ Ybrain said on the 20th that it presented clinical results on the efficacy and safety of its depression electroceutical Mindsteam for the treatment of perinatal depression at the 2025 fall meeting of the Korean Neuropsychiatric Association held in Gyeongju on the 17th. The presentation was jointly conducted by Cho Hee-young, an obstetrics and gynecology professor at Seoul National University Hospital who is leading the clinical trial of Mindsteam in patients with perinatal depression, and Kim Min-kyoung, a psychiatry professor at CHA Ilsan Medical Center. The company said that after using Mindsteam for four weeks in patients with perinatal depression, participants' depression scores (K-BDI-II, K-EPDS) decreased by 6.5 points and 5.3 points, respectively, showing a marked improvement in depression.
▲ GC Biopharma's diagnostics and medical device subsidiary GC MS said on the 20th that it recently obtained authorization from the Ministry of Food and Drug Safety for the new personal blood glucose meter GC Fit Glucometer (GGP-100) and has officially launched it in the Korean market. It is a personal glucometer that uses capillary blood from the fingertip, meets the international standard ISO 15197 based on a simple design, and features a hematocrit correction function to enhance measurement accuracy. It also improves the xylose interference issue that can occur with the glucose dehydrogenase (GDH-FAD)–based measurement method, providing results with higher reliability.
▲ Lunit said on the 20th that it will present two research abstracts using its AI biomarker platform Lunit SCOPE at the Society for Immunotherapy of Cancer (SITC) 2025, to be held in Maryland, United States, from Nov. 5 to 9. In a poster presentation, Lunit plans to unveil research conducted in collaboration with global contract research organization (CRO) CellCarta on identifying immune phenotypes in non-small cell lung cancer and colorectal and urothelial cancers through AI-based tumor microenvironment analysis, and research on elucidating the spatial correlation between tumor-associated antigens and lymphocytes through AI-based quantitative immunohistochemistry (IHC) analysis.
▲ FutureChem said on the 20th that it presented a poster at the European Society for Medical Oncology (ESMO) on dosimetry data from a domestic phase 2 clinical trial of prostate cancer treatment FC705. The core of the presentation was an analysis of changes in organ-specific radiation absorption according to the number of administrations. At the first administration, the highest absorbed doses were observed in the salivary glands and kidneys, but with repeated administrations, the dose to the salivary glands decreased significantly. In contrast, doses to the kidneys, liver, and red bone marrow showed a slight increasing trend, and all cumulative organ doses were confirmed to be well below safety thresholds.
▲ Prestige Biopharma said on the 20th that it presented key research achievements in the development of a pancreatic cancer treatment at the European Society for Medical Oncology (ESMO) 2025. It introduced the mechanism of action of PAUF and the importance of its inhibition in pancreatic cancer, as well as the latest clinical development results for Ulenistamab (PBP1510), the world's first anti-PAUF monoclonal antibody, which drew strong interest from attendees, the company said.
▲ AI-based digital pathology corporations Deep Bio said on the 20th that a study by pathology professor Kim Jeong-yeol's team at Korea University Guro Hospital, co-developed with the company, demonstrating that an AI model can predict the risk of breast cancer recurrence using only H&E-stained pathology slides without genetic testing, has been published in Nature Scientific Reports. An analysis of pathology slides from 125 patients with early breast cancer was used to build a deep learning model that classifies recurrence risk as low, intermediate, or high; it recorded an 87.75% concordance rate with gene expression tests at the patch level, a 91.2% prediction accuracy in the high-risk group, and a high correlation with histological grade with a correlation coefficient of 0.61.
▲ Medical imaging AI corporations Phantommix said on the 20th that it has signed a strategic academia-industry cooperation memorandum of understanding (MOU) with Yonsei University's Department of Digital Healthcare. The agreement focuses on joint technology development to advance AI technology for diagnosing heart disease and expand its clinical application. Phantommix is a corporations that developed Myomics and Angiomics, automatic analysis solutions for cardiac MRI and CT images, which shorten analysis time from more than 30 minutes to within five minutes and provide diagnostic accuracy at the level of a biopsy.