Sacheon

This prospective, open-label, multicenter, single-arm, non-interventional, observational surveillance is designed to assess the safety and effectiveness of Atectura inhalation capsule for up to 24 weeks under routine clinical practice. Three different doses of Atectura inhalation capsule will be prescribed via Breezhaler according to the approved label information in Korea. No additional diagnostic or monitoring procedures will be conducted specifically for this study.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the safety and effectiveness of Asciminib in Korean patients with Chronic Myeloid Leukemia CML in a prospective, open-label, multi-center observational study. The study focuses on understanding how Asciminib works in real-world clinical settings following its market approval, enrolling patients treated under usual clinical practice. Participants prescribed Asciminib by their physicians according to the locally approved label will be included in this study. The dosage and duration of Asciminib treatment will be decided by the investigators based on prescribing information. The study plans to enroll all patients prescribed Asciminib for two years after its market launch. During the study, researchers will monitor participants for adverse events and various molecular response rates at 12 and 24 weeks. Data on safety, including serious and unexpected adverse reactions, will be collected. Participants will be followed during their usual care, and no study drug will be dispensed by the sponsor. The total participation duration depends on clinical practice and monitoring schedules.

Researchers are observing adults with primary hypercholesterolemia or mixed dyslipidemia who are prescribed Leqvio Pre-filled Syringe inclisiran sodium to assess its safety and effectiveness in routine clinical practice. This is a non-interventional post-marketing surveillance study required by Korean health authorities to monitor patients already receiving this treatment. Participants are adults 18 years or older who have been prescribed Leqvio according to approved guidelines, including those who have not reached LDL-C targets with statins or cannot tolerate statins. There is no treatment allocation or placebo the study enrolls patients who have already started Leqvio treatment. The study will track patients over a period of up to 15 months. Throughout the study, researchers will monitor adverse events and adverse drug reactions and measure changes in LDL cholesterol levels and lipid profiles at baseline, 3, 9, and 15 months. The study will also analyze how patients baseline characteristics and medication use affect outcomes. Participants will provide informed consent, and their safety and treatment responses will be regularly assessed during routine clinical visits.

This research aims to gather safety and effectiveness information for patients with neovascular age-related macular degeneration nAMD who are prescribed brolucizumab. It is an open-label, multicenter, single-arm, observational post-marketing surveillance study conducted by Novartis Pharmaceuticals to monitor patients receiving this treatment in real-world settings. Participants prescribed brolucizumab according to approved local guidelines will be enrolled. The study observes patients over 12 weeks initially, with additional data collected at 24 weeks and optionally at 36 weeks. There is no randomization or placebo group, as this is an observational study focusing on those already receiving brolucizumab. During the study, researchers will collect safety information, including adverse events up to 12 weeks and beyond. They will also evaluate vision-related outcomes such as changes in visual acuity and retinal thickness at baseline and follow-up visits. Other data include treatment history, injection numbers, and disease activity. Participants will be monitored through clinical assessments over the study period, which may last up to 36 weeks.