A Prospective, Multicenter, Randomized, Single-Blind, Exploratory Clinical Trial to Validate the Efficacy and Safety and Predict Treatment Response of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression

This study will evaluate the efficacy and safety of a theta burst stimulation (TBS) protocol of repetitive transcranial magnetic stimulation (rTMS) in adults with treatment-resistant depression. Participants will be randomized to either antidepressant treatment plus active rTMS TBS or antidepressant treatment plus sham stimulation for the first 10 sessions followed by active rTMS TBS for the next 10 sessions. The main objective is to compare the change in Hamilton Depression Rating Scale (HAM-D) total score after 10 treatment sessions between groups and to explore predictors of treatment response.

开始日期2026-05-01

申办/合作机构

Asan Medical Center

[+3]

NCT06637943

/ Not yet recruitingN/AIIT

Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies: Point-of-care Viscoelastic Tests vs Standard Central Laboratory Tests

The present study is a prospective, multi-center observational trial comparing the times taken to diagnose coagulopathies using point-of-care (POC) viscoelastic tests or standard central laboratory tests (SCL tests) in patients with intraoperative bleeding.

开始日期2026-02-01

申办/合作机构

Konkuk University Medical Center

[+4]

NCT07395752

/ RecruitingN/AIIT

Development and Biological Efficacy Validation of Youth Suicide and Self-Harm Intervention Program

The goal of this clinical trial is to develop and evaluate youth-focused intervention programs for suicide and self-harm that are tailored to the psychological, developmental, and cultural characteristics of Korean adolescents and young adults. The study examines whether two structured, mindfulness-based intervention programs-one for middle and high school students and one for young adults-reduce suicidal ideation, self-harm behaviors, depressive symptoms, and emotion-regulation difficulties.
The study also aims to determine whether these clinical improvements are associated with biological changes, including alterations in resting-state functional brain activity (e.g., ALFF, ReHo, and functional connectivity) and social rhythm patterns.
The main questions this study seeks to answer are:
* Does the youth suicide and self-harm intervention program reduce suicidal ideation and self-injurious thoughts/behaviors?
* Does the program improve mood, sleep, hopelessness, and emotion regulation?
* Are improvements in clinical outcomes accompanied by changes in biological markers of suicide risk?
* Researchers will compare the intervention program to usual care provided in hospitals, schools, and community mental health settings.
Participants will:
* Participate in the structured suicide/self-harm intervention program or receive usual care.
* Complete standardized assessments of mood, sleep, emotion regulation and suicide/self-harm risk.
* Undergo biological assessments, including resting-state fMRI and rhythm-related measures, at baseline and follow-up.
* Be followed for up to 12 weeks.

开始日期2025-07-30

申办/合作机构

Ajou University

[+2]

100 项与 Korea Health Industry Development Institute 相关的临床结果

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0 项与 Korea Health Industry Development Institute 相关的专利（医药）

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项与 Korea Health Industry Development Institute 相关的文献（医药）

2026-01-01·Drug information journal

Sales Erosion of Originator Drugs Following Generic Entry: Quantitative Analysis and Predictive Modeling

Article

作者: Lee, Sang-Won ; Jung, Soon Kyu

INTRODUCTION:

Generic drug entry into the pharmaceutical market typically leads to a substantial decline in originator sales. Understanding the extent and trajectory of this erosion is essential for effective lifecycle management and strategic planning. This study quantified sales erosion after generic entry for originator drugs approved in the United States between 2010 and 2019 and developed a model to predict year-specific sales retention based on key product- and market-level characteristics.

METHODS:

A total of 140 originator drugs were analyzed using FDA approval records and sales data from Evaluate Pharma. Five-year retention patterns were modeled using a three-parameter exponential decay function. Subgroup analyses were conducted by year of generic entry, therapeutic class, and product-specific features. A polynomial regression model using 700 product-year observations incorporated three binary market indicators and linear and quadratic time terms.

RESULTS:

Sales retention declined from 73.1% in the first year after generic entry to 31.7% by year five. The exponential decay model demonstrated a strong goodness-of-fit (root mean squared error [RMSE] = 0.006), capturing the initial steep decline and subsequent stabilization. Subgroup analyses showed faster erosion for blockbuster drugs and in markets with multiple first-generation generics. The regression model explained 96.4% of annual variation in retention (RMSE = 0.033), accounting for product and market heterogeneity.

CONCLUSION:

Sales decline after generic entry follows a predictable yet heterogeneous trajectory shaped by product and market factors. Exponential decay and polynomial regression models together offer a robust framework for forecasting sales retention and guiding strategic decisions in the pharmaceutical industry.

2025-12-31·Women's health nursing (Seoul, Korea)

Maternal depression over 7 years postpartum: trajectories and multidimensional predictors in a longitudinal cohort study

Article

作者: Yang, Jae Eun ; Kim, Ah Rim

Purpose: Maternal depression can persist beyond the immediate postpartum period and can adversely affect maternal functioning and child development. However, evidence describing long-term trajectories and multidimensional predictors remains limited. This study investigated the 7-year trajectory of maternal depressive symptoms from childbirth to when the child reached 6 years of age and identified significant predictors across child, maternal, and family domains.Methods: In total, 1,030 mothers from the Panel Study on Korean Children were included. Depressive symptoms were assessed at postpartum years 1, 3, 5, and 7 using the Kessler Depression Scale. Latent growth modeling was used to examine symptom trajectories, and logistic regression analyses were conducted to identify predictors of depressive-symptom risk.Results: Overall, 55.6% of mothers experienced at least one episode of mild-to-moderate or severe depressive symptoms. Among at-risk mothers, depressive symptoms demonstrated a slight upward trajectory with significant individual variability (linear model fit: χ²=12.65, root mean square error of approximation=.052, comparative fit index=.961). Significant predictors included preterm or low-birth-weight delivery (odds ratio [OR]=2.29), prenatal depression (OR=2.61), postpartum depression at 1 month (OR=3.41), high parenting stress (OR=1.63), low self-esteem (OR=2.33), and marital conflict (OR=2.02). Higher educational attainment emerged as a protective factor (OR=0.59).Conclusion: These findings demonstrate the persistence of maternal depressive symptoms and highlight key predictors for promptly identifying mothers at elevated risk. Integrating routine longitudinal screening with interventions targeting maternal stress, self-esteem, and family functioning may be critical for mitigating long-term depressive trajectories. Family-centered approaches, including partner involvement and conflict-management strategies, appear essential for improving maternal mental health and promoting healthier developmental environments for children.

2025-12-01·Materials Today Bio

Y-shaped trivalent aptamer for targeted visualization and tracking of reprogrammed astrocytes

Article

作者: Kim, Young-Pil ; Park, Chang-Hwan ; Lee, Eun-Hye ; Lee, Yeonju ; Oh, Bohyun ; Lee, Hong-Gyun ; Lee, Jin-Sam ; Lee, Eun-Song ; Jeong, Hyobin ; Kim, Kyung-Min

Despite extensive research into the diverse transformations and functions of astrocytes, conventional fluorescence immunohistochemistry for their distinct identification remains challenging and time-consuming, primarily due to the lack of cell surface binders specific to these glial cells. To address this limitation, we developed a specific and straightforward imaging strategy for primary astrocytes using cell surface-targeting aptamers. We identified a novel anti-astrocyte DNA aptamer (designated Ast17-30) through a 17-round cell-SELEX process incorporating magnetic-activated cell sorting, designed to bypass the technical hurdles of SELEX when applied to short-lived cells. To enhance binding affinity, we further engineered this aptamer into a Y-shaped trimer (Tri-ΔAst17-30), enabling clear discrimination between astrocytes and neurons. Consequently, the engineered trivalent aptamer facilitated rapid astrocyte-specific endocytosis within minutes due to its increased binding avidity. This capability enabled longitudinal monitoring of astrocyte conversion into induced neural precursor cells, observing moderate pro-inflammatory gene expression in their transcriptomic profiles. Furthermore, Tri-ΔAst17-30 bound strongly to astrocytic glioblastoma cells (U87MG), with minimal binding to glial glioblastoma cells (C6), confirming specificity for astrocytic tumor cells. Given the current absence of reliable live-astrocyte-specific imaging techniques, we propose that this trivalent anti-astrocyte DNA aptamer has potential for investigating developmental pathways and targeted therapy of these crucial glial cells.

项与 Korea Health Industry Development Institute 相关的新闻（医药）

2026-05-19

·易贸生物精选

KHIDI、KIMCO、KPBMA…韩国官方制药机构都来支持BIOCHINA@Korea，中国企业可以对接到哪些资源？

易贸医疗会议团队编辑 2025-2026年，甘李药业与JW Pharmaceutical达成创新药区域授权，潜在交易总额8110万美元；驯鹿生物与GC Cell达成CAR-T细胞疗法授权合作；复宏汉霖向Lotus授予药物韩国独家商业化权益，整体潜在合作金额超1.12亿美元…… 跨境授权与管线合作不断落地，中韩产业合作持续升温，在这一趋势下，KPBMA（韩国制药生物协会）、KHIDI（韩国健康产业开发院）、KIMCO（韩国创新药品联盟）等官方组织充分发挥国家级产业平台的桥梁作用，通过政策协调、企业匹配与商务对接等多元举措，系统性地推动两国药企在前沿创新领域的深度链接。今年3月，KPBMA、KHIDI带团21家韩国公司亮相苏州BIOCHINA2026，联合超40家韩国企业高层参与Korea Night，并深度参与大会展览、论坛等场景。 7月9-10日，KPBMA、KHIDI、KIMCO三所韩国官方制药机构将携手BIOCHINA，以全球合作伙伴的身份加入BIOCHINA Global Forum @ Korea 2026，大会将以论坛、约见、路演、活动四大体系打造中韩合作交流平台，共建更高密度、更高效率的中韩生物医药合作生态。 KPBMA是韩国医药与生物医药产业的最大代表性组织。拥有超70年历史，始终致力于推动韩国医药产业可持续发展、提升国民健康水平，会员覆盖韩国本土药企、创新生物科技企业及跨国药企在韩机构。 KHIDI是韩国政府下属的健康产业开发院，主要职责是推动韩国健康产业的发展、支持医疗技术创新及行业政策实施与全球化发展。 KIMCO是2020年由韩国保健福祉部、KPBMA及59家本土药企共同发起的非营利平台，致力于通过共同投资、公私合作及技术改良新药开发，推动韩国生物医药产业的开放创新与协同发展。韩国生物医药产业市场体量庞大、增长稳健，依托KPBMA、KHIDI、KIMCo等韩国官方制药机构的产业网络及BIOCHINA Global Forum @ Korea 2026这一中韩药企交流平台，中国企业可直通韩国头部药企、生物公司及科研机构，聚焦创新药授权与BD合作、前沿技术对接、供应链配套合作三大方向，高效拓展海外市场—— 中韩双方文化相近、沟通成本低，企业互信基础扎实，中国企业可在此基础上开展创新药区域授权与跨境BD合作，通过license-in/out、商业化权益合作等方式，快速打开韩国市场。韩国在创新药研发与临床转化上具备成熟体系，前沿创新赛道资源集中，中国药企可围绕ADC、CGT、双抗、mRNA等赛道，与韩国Biotech开展联合研发等前沿技术对接。韩国医药产业上游高度依赖欧美供应商，价格偏高、交期较长，而中国设备、耗材、原料已具备成熟合规资质与品质保障。中国企业可凭借高性价比、交付高效与地缘邻近优势，精准填补韩国市场替代缺口，有效助力韩企降本增效，切入本地供应体系，成为稳定的上游合作伙伴。 BlOCHINA Global Forum @ Korea BlOCHINA Global Forum @ Korea 2026年7月9-10日韩国首尔会议规模 500+参会者，300+家中韩企业参会人群中韩来自抗体、ADC、细胞与基因治疗、小分子药物等Pharma & Biotech C-level高层、研发&BD负责人和生命科学服务商企业高层会议亮点中韩生物医药产业交流合作平台加速技术创新合作，探索BD合作机会快人一步扫码报名添加小易咨询详情 2025BIOCHINA首尔精彩回顾 BIOCHINA全球计划

2026-05-13

·17Talk易企说

KHIDI、KIMCO、KPBMA…韩国官方制药协会都来支持BIOCHINA@Korea，中国企业可以对接到哪些资源？

易贸医疗会议团队编辑 2025-2026年，甘李药业与JW Pharmaceutical达成创新药区域授权，潜在交易总额8110万美元；驯鹿生物与GC Cell达成CAR-T细胞疗法授权合作；复宏汉霖向Lotus授予药物韩国独家商业化权益，整体潜在合作金额超1.12亿美元…… 跨境授权与管线合作不断落地，中韩产业合作持续升温，在这一趋势下，KPBMA（韩国制药生物协会）、KHIDI（韩国健康产业开发院）、KIMCO（韩国创新药品联盟）等官方组织充分发挥国家级产业平台的桥梁作用，通过政策协调、企业匹配与商务对接等多元举措，系统性地推动两国药企在前沿创新领域的深度链接。今年3月，KPBMA、KHIDI带团21家韩国公司亮相苏州BIOCHINA2026，联合超40家韩国企业高层参与Korea Night，并深度参与大会展览、论坛等场景。 7月9-10日，KPBMA、KHIDI、KIMCO三所韩国官方制药机构将携手BIOCHINA，以全球合作伙伴的身份加入BIOCHINA Global Forum @ Korea 2026，大会将以论坛、约见、路演、活动四大体系打造中韩合作交流平台，共建更高密度、更高效率的中韩生物医药合作生态。 KPBMA是韩国医药与生物医药产业的最大代表性组织。拥有超70年历史，始终致力于推动韩国医药产业可持续发展、提升国民健康水平，会员覆盖韩国本土药企、创新生物科技企业及跨国药企在韩机构。 KHIDI是韩国政府下属的健康产业开发院，主要职责是推动韩国健康产业的发展、支持医疗技术创新及行业政策实施与全球化发展。 KIMCO是2020年由韩国保健福祉部、KPBMA及59家本土药企共同发起的非营利平台，致力于通过共同投资、公私合作及技术改良新药开发，推动韩国生物医药产业的开放创新与协同发展。韩国生物医药产业市场体量增长稳健，依托KPBMA、KHIDI、KIMCO等韩国官方制药机构的产业网络及BIOCHINA Global Forum @ Korea 2026这一中韩药企交流平台，中国企业可直通韩国头部药企、生物公司及科研机构，聚焦创新药授权与BD合作、前沿技术对接、供应链配套合作三大方向，高效拓展海外市场—— 中韩双方文化相近、沟通成本低，企业互信基础扎实，中国企业可在此基础上开展创新药区域授权与跨境BD合作，通过license-in/out、商业化权益合作等方式，快速打开韩国市场。韩国在创新药研发与临床转化上具备成熟体系，前沿创新赛道资源集中，中国药企可围绕ADC、CGT、双抗、mRNA等赛道，与韩国Biotech开展联合研发等前沿技术对接。韩国医药产业上游高度依赖欧美供应商，价格偏高、交期较长，而中国设备、耗材、原料已具备成熟合规资质与品质保障。中国企业可凭借高性价比、交付高效与地缘邻近优势，精准填补韩国市场替代缺口，有效助力韩企降本增效，切入本地供应体系，成为稳定的上游合作伙伴。 BlOCHINA Global Forum @ Korea BlOCHINA Global Forum @ Korea 2026年7月9-10日韩国首尔会议规模 500+参会者，300+家中韩企业参会人群中韩来自抗体、ADC、细胞与基因治疗、小分子药物等Pharma & Biotech C-level高层、研发&BD负责人和生命科学服务商企业高层会议亮点中韩生物医药产业交流合作平台加速技术创新合作，探索BD合作机会上下游出海供应链合作窗口快人一步扫码报名添加小易咨询详情 2025BIOCHINA首尔精彩回顾 BIOCHINA全球计划

2026-05-11

·PRNewswire

HoneyNaps Selected for Korea's 2026 Global ICT Unicorn Program

First SleepTech company selected for Korea's ICT Unicorn Program FDA-cleared AI sleep diagnostic solution strengthens global expansion strategy Simultaneous selection for ICT Unicorn Program and K-VIP boosts U.S. market expansion BOSTON, May 11, 2026 /PRNewswire/ -- HoneyNaps, an AI-powered sleep healthcare company, announced that it has been selected for the "2026 Global ICT Unicorn Program (ICT GROWTH)" organized by Korea's Ministry of Science and ICT and the National IT Industry Promotion Agency (NIPA). HoneyNaps is the first SleepTech company ever selected for the government-led scale-up initiative. Continue Reading HoneyNaps Selected for Korea’s 2026 Global ICT Unicorn Program The Global ICT Unicorn Program is a strategic government initiative designed to identify and support high-growth technology companies with strong global expansion potential. The program provides comprehensive support including overseas market expansion, investment connections, policy financing, and global networking opportunities. This year, 15 companies across advanced ICT sectors—including artificial intelligence, healthcare, and data solutions—were selected. Through this achievement, HoneyNaps has been recognized for both its technological competitiveness and business potential, further strengthening its foundation for global growth. HoneyNaps continues to advance its FDA-cleared AI sleep disorder diagnostic solution, SOMNUM, while expanding its integrated AI sleep healthcare ecosystem through: SOMNUM Pro, an on-premise AI automated scoring software optimized for hospitals and sleep clinics; SOMNUM Cloud, a web-based platform for large-scale sleep data analysis and interpretation; and SOMNUM Clinical Service, a clinical trial analysis and operational support service for pharmaceutical companies and research organizations. Together, these solutions support high-quality sleep analysis and operational efficiency across healthcare institutions. The company was also recently selected for the "2026 Korea BioHealth Value-up Innovation Program (K-VIP)" organized by the Korea Health Industry Development Institute (KHIDI), through which HoneyNaps expanded its U.S. presence by establishing a local base at the Cambridge Innovation Center (CIC) in Kendall Square, Boston. HoneyNaps plans to gradually expand collaborations with leading U.S. hospitals and sleep centers while actively pursuing joint research and clinical partnerships with global pharmaceutical and medical device companies. In parallel, the company is advancing development of a Korean sleep foundation model (SleepFM) leveraging multimodal polysomnography (PSG) data to expand AI applications beyond sleep disorders into cardiovascular and neurological disease analysis and clinical decision support. Sean Ha (Taekyoung Ha), President of HoneyNaps USA, stated, "Selection for the Global ICT Unicorn Program, combined with our expansion into Kendall Square, creates strong momentum for our global business growth. By combining our FDA-cleared technology, U.S. clinical network, and government-backed scale-up support, we aim to become a leading AI sleep healthcare company representing Korea in the global market." About HoneyNaps HoneyNaps is a South Korea-based digital health company specializing in AI-driven sleep diagnostics, sleep disorder analytics, and next-generation sleep healthcare solutions. The company develops technologies that improve access, efficiency, and clinical accuracy in sleep medicine through artificial intelligence and scalable healthcare platforms. For further information, please contact: HoneyNaps USA, Inc. Christine Kwon / Managing Director Email: [email protected] Address: 14th Floor, One Broadway, Cambridge, MA 02142 Website: SOURCE HoneyNaps 21% more press release views with Request a Demo

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