Three infectious disease diagnostic products certified under the European Union's In Vitro Diagnostic Medical Devices Regulation (CE IVDR) by HLB PANAGENE./Courtesy of HLB PANAGENE

■ HLB PANAGENE said on the 4th that three molecular diagnostic reagents for infectious diseases have obtained certification under the European Union (EU) In Vitro Diagnostic Medical Devices Regulation (CE IVDR). The company said it expects that, with this CE IVDR certification, its independently developed PNA-based molecular diagnostic technology will be internationally recognized and that its credibility in the global market will rise. The company plans to expand its business scope into global markets that have adopted IVDR standards, including European countries, and strengthen its foothold in the global market.

■ GC Cell said on the 4th that the interim results of its phase 1a trial of CD5 CAR-NK cell therapy "GCC2005" have been selected for an oral presentation at the 67th American Society of Hematology Annual Meeting (ASH 2025). GCC2005 is an allogeneic umbilical cord blood-derived CAR-NK cell therapy targeting CD5. It covers interim results from the first domestic phase 1a study in patients with relapsed or refractory NK/T-cell lymphoma. In the initial safety assessment of seven patients, no dose-limiting toxicities, serious adverse events, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease—fatal adverse effects associated with cell therapies—were reported.

■ Medytox said on the 4th that it took part in ICLAS, an international conference hosted by the Korean Society for Laser, Dermatology and Trichology, held from the 1st to the 3rd. On the 1st, it held the "Medytox Night" global networking event, drawing about 200 medical experts and partner representatives from more than 20 countries including Japan, Thailand and Brazil. Actor Park Hyung-sik, global ambassador for the hyaluronic acid filler "Neuramis," and actor Hong Hwa-yeon, ambassador for the neuroderma cosmetic brand "Neuraderm," attended and delivered messages of support for Medytox as it makes a global leap. The company set up a large exhibition booth and promoted its product lineup.

■ Daewoong Pharmaceutical said on the 4th that it will increase the number of sessions of the "Nabota Master Class (NMC)," a global medical education program, from twice a year to four times a year, and will invite medical professionals from each region, including Asia, Latin America and the Middle East, to run tailored academic programs. This year, Nabota signed the largest export contracts in the regions, including 73.8 billion won in Thailand and 180 billion won in Brazil, and was launched successively in Saudi Arabia and Qatar, key countries in the Middle East. In line with this, the company is developing NMC into an education platform that enhances brand trust through capacity building and academic exchange among medical professionals, going beyond simple procedure training.

■ STCube released on the 4th that it will present the first clinical data for its anti-BTN1A1 immune checkpoint inhibitor "Nelmastobart" in metastatic colorectal cancer at the Society for Immunotherapy of Cancer (SITC 2025) to be held Nov. 7–9 in Maryland. The presentation includes early results from phase 1b/2 of the combination of Nelmastobart with TAS-102 (trifluridine/tipiracil) and bevacizumab, and an interim analysis of an investigator-initiated study of Nelmastobart plus capecitabine. BTN1A1 is a target that suppresses CD8 T-cell activation in the tumor microenvironment and is drawing attention as a next-generation immuno-oncology target that can complement the limitations of PD-1/PD-L1. Both studies selected for this SITC involve patients with metastatic colorectal cancer in third-line or later treatment, and the Nelmastobart-based combinations showed favorable tolerability and early anticancer activity.

■ WOOJUNG BIO said on the 4th that it will take part in the "1st Research Equipment Experts' Day Opening Science and Technology Innovation," to be held Nov. 13–14 on the Ulsan National Institute of Science and Technology (UNIST) campus, and present a vision for advanced equipment for bio research. Invited as an expert in Korean bio research equipment, the company will disclose for the first time its in-house research data on the advanced equipment "DVC" (Digital Ventilated Cage), which it supplies exclusively in Korea.

■ Korea University Guro Hospital said on the 4th that obstetrics and gynecology professor Lee Jae-gwan has been elected the new chair of the Korean Society of Obstetrics and Gynecology. At its regular general assembly of delegates held on Oct. 31, the Korean Society of Obstetrics and Gynecology elected Professor Lee as the 27th chair. The term is two years, from 2025 to 2027. Lee is a leading authority in gynecologic oncology and has served as president of the Korean Society of Gynecologic Oncology, the Korean Society of Obstetrics and Gynecologic Endoscopy, and the Korean Translational Research Society for Gynecologic Cancer, contributing to advances in women's cancer care and research.

■ Korea University Ansan Hospital said on the 4th that it has reached a cumulative 4,000 robot-assisted surgeries. In 2015, when robotic surgery had yet to become active in the region, the hospital's Robotic Surgery Center introduced the "da Vinci S" model, laying the foundation for advanced medicine in the southwestern Gyeonggi area. It then introduced the fourth-generation "da Vinci Xi" in 2018 and, in 2021, additionally secured the single-port robotic system "da Vinci SP," the first in Gyeonggi Province. It currently operates both the "da Vinci SP" and "da Vinci Xi" in parallel, performing patient-tailored robotic surgeries across various departments by disease. Recently, the cumulative number of robotic surgeries rose from 3,000 in Nov. 2024 to 4,000 in one year.

■ Roche Diagnostics Korea said on the 4th that "VENTANA Kappa Lambda," a new technology for hematopathology diagnostics, was recently listed for insurance reimbursement. VENTANA Kappa Lambda is a dual-staining-based hematopathology product that uses ultra-sensitive ISH technology to analyze kappa and lambda light chains simultaneously on a single slide. It enables highly sensitive clonality analysis in patients with B-cell lymphoma or those suspected of the disease. This can complement the limitations of existing diagnostic methods and improve the accuracy and efficiency of lymphoma diagnosis. The company noted that the reimbursement decision is significant in that coverage was applied quickly by referencing the existing SISH technology.

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