Qingyuan

Researchers are evaluating TQB2102, a new antibody-drug conjugate designed to target tumor cells in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study focuses on assessing the safety and effectiveness of TQB2102, which combines a humanized antibody against HER2 with a powerful drug payload to kill cancer cells more specifically and potently than traditional treatments. The study includes patients who have not responded successfully to previous platinum-based chemotherapy. Participants will receive TQB2102 injections, which is a HER2 dual-antibody-drug conjugate. The treatment is given to women with measurable lesions confirmed by RECIST 1.1 criteria, and who have varying levels of HER2 expression in their tumor tissue. Women of childbearing potential must have a negative pregnancy test before starting and agree to use highly effective contraception throughout the study. The treatment period and dosing schedules are designed to monitor the drug's impact carefully. Throughout the study, participants will be closely monitored for overall response rate up to 12 months. Assessments include regular evaluations of tumor response, safety checks, and compliance with treatment. The study excludes patients with certain health conditions, recent surgeries, or other treatments that might interfere. The total duration and detailed follow-up procedures ensure thorough observation of TQB2102's effects and participant safety.

Researchers are evaluating the safety and effects of fosmanogepix, a study medicine, for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida species. This Phase 3 clinical trial compares fosmanogepix to the standard treatment of caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard therapy by a margin of 15%. The study includes adult patients diagnosed with these infections. Participants will receive either fosmanogepix or caspofungin as an intravenous infusion daily at the study clinic. After the initial infusion phase, patients may switch to oral tablets of fosmanogepix or fluconazole capsules, which can be taken at the clinic or at home if discharged. Treatment duration varies by individual, lasting up to six weeks depending on infection clearance and symptom improvement. A follow-up visit will take place six weeks after stopping treatment. During the study, patients will undergo multiple visits to monitor their health and treatment response. Researchers will assess outcomes such as the proportion of patients alive at 30 days and the overall treatment success at the end of study treatment, up to day 42. Safety will be closely monitored throughout the study and during follow-up, ensuring comprehensive evaluation of the treatments over the entire participation period.

Chronic kidney disease (CKD) includes various conditions that cause damage to the kidneys or reduce their function. CKD affects about 10.8% of the population in China, making it a major health concern due to its high prevalence and associated risks, including progression to kidney failure and increased cardiovascular problems. This study aims to better understand CKD in China by investigating its occurrence, progression, treatment, and related risk factors using real-world patient data from multiple centers. The research is a multi-center, prospective, observational study involving a large and diverse group of participants from mainland China. It uses a standardized data network for efficient collection and analysis of patient information. The study includes people diagnosed with CKD, those at risk due to conditions like hypertension or diabetes, and healthy individuals, allowing for broad and detailed analysis. The study does not involve specific treatments but focuses on observing patients over time. Participants will be followed for up to 5 years to monitor the development or progression of CKD and related health outcomes. Researchers will collect and analyze clinical data and track kidney function and disease status over this period. This long-term observation aims to provide valuable insights into CKD prevention and management, helping to reduce the disease burden in China.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity of BBT002 in healthy volunteers and patients with Chronic Obstructive Pulmonary Disease (COPD). This randomized, double-blind, placebo-controlled study is conducted in two parts: Part A involves single ascending doses in healthy volunteers, and Part B involves multiple ascending doses in COPD patients. The study is designed as a Phase 1 trial to gather early information on the effects of BBT002 in these populations. Participants will receive either BBT002 or a placebo. In Part A, healthy volunteers receive a single dose of BBT002 in sequential ascending dose cohorts. In Part B, patients with COPD receive two repeated doses of BBT002. The study carefully monitors dosing and responses during these periods to evaluate various safety and biological activity aspects of the drug. Throughout the study, participants undergo multiple assessments including monitoring for adverse events, laboratory tests, vital signs, physical examinations, and electrocardiograms (ECGs). These evaluations occur up to Day 141 for Part A and Day 169 for Part B after the first dose. The researchers aim to track changes in these measures to determine the safety and effects of BBT002 over time.

Researchers are evaluating vedolizumab as a treatment for adults in China with moderately to severely active Crohn's Disease. This Phase 3 study aims to assess both the safety and effectiveness of vedolizumab given by intravenous infusion. Approximately 408 participants will be enrolled and randomly assigned to receive either vedolizumab or a placebo during the initial phase. Participants will receive vedolizumab 300 mg through an IV infusion at weeks 0, 2, and 6. After week 14, all participants continue in an open-label extension phase where they receive 300 mg vedolizumab every 8 weeks for up to 58 weeks. Starting at week 18, those who do not respond or whose disease worsens may have their treatment frequency increased to every 4 weeks. There can be up to 20 study visits over the 58-week period. During the study, participants will undergo various assessments including clinical evaluations, endoscopic examinations, and patient-reported outcomes. Safety will be closely monitored with a final safety visit 18 weeks after the last dose. After completing or discontinuing the study, participants will be contacted by telephone for a long-term safety follow-up six months after their last dose. The primary outcome measured is the percentage of participants achieving a clinical response by week 14.

Researchers are evaluating the safety and effectiveness of 9MW1911 in people with Chronic Obstructive Pulmonary Disease (COPD) through a Phase II, multicenter, double-blind, randomized, placebo-controlled clinical trial. The study focuses on patients aged 40 to 75 years who have a history of moderate to severe COPD exacerbations and moderate-to-severe COPD lung function impairment. This trial aims to compare 9MW1911 to a placebo to better understand its impact on COPD symptoms and exacerbations. Participants will be assigned to receive either intravenous 9MW1911 or a placebo every 28 days. The treatment period lasts 52 weeks, during which the study drug is administered monthly. The trial includes careful monitoring and evaluation of the participants' lung function and health status throughout this time to assess the effects of the treatment. During the study, participants will undergo various assessments including lung function tests and monitoring for COPD flare-ups or exacerbations. The primary outcome measured is the annual rate of moderate to severe acute COPD exacerbations over 52 weeks. Safety evaluations and regular health checks will also be conducted to ensure participant well-being. The total duration of participation in the trial is one year, providing comprehensive data on treatment effects and safety.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Researchers are evaluating depemokimab as a potential add-on treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who also have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab in improving health outcomes for people whose COPD is not well controlled despite standard inhaler therapy. Participants must have a history of elevated blood eosinophil levels and confirmed lung function measurements consistent with COPD. Participants will be randomly assigned to receive either depemokimab, given as a sterile liquid, or a placebo solution containing sodium chloride. Both treatments will be administered as part of a double-blind, placebo-controlled trial across multiple centers. The study includes patients who have been on optimized inhaler treatments including inhaled corticosteroids combined with long-acting bronchodilators for at least six months before the study begins. During the study, participants will be monitored over a period extending up to 104 weeks to measure the annualized rate of moderate to severe COPD exacerbations. Researchers will conduct regular assessments including lung function tests, symptom questionnaires, and safety evaluations. The study will also track participants' adherence to treatment and record any side effects or health changes to better understand the long-term impact of depemokimab.