Zi Bo Shi

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are evaluating the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) injection for treating upper limb spasticity in adults with unilateral hemiplegia caused by stroke. This randomized, double-blind, multi-center phase II/III study focuses on adults aged 18 to 75 years who have experienced at least 3 months since stroke onset and exhibit functional impairments in hygiene, dressing, limb position, or pain due to spasticity. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A (YY001) at doses between 200 to 400 units, BOTOX® at 200 units, or a placebo prepared with 0.9% Sodium Chloride. The study monitors effects at 4 weeks after treatment, comparing the changes in muscle tone using the Modified Ashworth Scale among the groups. During the study, participants' disability levels, treatment adherence, and any side effects will be assessed. Oral antispasticity medication and physical or occupational therapy, if ongoing, must be stable before enrollment. Safety monitoring includes exclusion of individuals with allergies to study drugs, recent botulinum toxin use, fixed limb contractures, or other medical conditions that increase risk. The study spans screening, treatment, and follow-up to ensure thorough evaluation of outcomes and safety.

Researchers are conducting a Phase Ib/II clinical trial to assess the safety, effectiveness, and how the body processes TQB3909 tablets combined with azacitidine in adults with myeloid malignancies, which include diseases like acute myeloid leukemia and myelodysplastic syndromes. The study aims to evaluate how well patients tolerate this combination and its impact on their condition. Participants will receive TQB3909, a protein inhibitor, along with azacitidine, a cytidine nucleoside analogue. The treatment is administered as tablets, and the study is open-label and multi-center. The trial focuses on monitoring adverse events for up to 24 weeks and measuring remission rates within 4 weeks after starting treatment. During the study, participants will undergo various evaluations to track safety and treatment response, including monitoring for side effects and laboratory tests. Researchers will record the incidence and severity of any adverse events and assess the rate of complete remission or remission with partial blood recovery. Participants must be adults aged 18 years or older and will be followed closely for up to 24 weeks to ensure safety and effectiveness of the treatment combination.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are evaluating the efficacy, safety, and tolerability of two dosing regimens of itepekimab compared to placebo as an add-on treatment to intranasal corticosteroids in adult men and women with chronic rhinosinusitis with nasal polyps (CRSwNP). This multinational, randomized, double-blind, placebo-controlled Phase 3 study includes participants aged 18 years and older who have inadequately controlled CRSwNP. The study aims to better understand how these treatments impact nasal polyp symptoms and disease control over a one-year period. Participants will be randomly assigned to receive one of two dosing regimens of itepekimab or a placebo, all administered by subcutaneous injection. All participants will continue using mometasone furoate nasal spray as standard intranasal corticosteroid therapy. Treatment will last up to 52 weeks, followed by a 20-week safety follow-up period. The study includes a total of 9 site visits and 20 phone or home visits during the participant's involvement. Participants will be involved in regular assessments including endoscopic nasal polyp scoring and nasal congestion symptom evaluations at baseline and throughout the 24 weeks, among other time points. Researchers will monitor changes in nasal polyp scores and nasal congestion scores to measure the treatment effects. Safety and tolerability will be closely followed during the treatment and safety follow-up periods, with total participation lasting up to 76 weeks for most participants, or 56 weeks for those transitioning to an extension study.

Researchers are evaluating the safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Bladder cancer, primarily bladder uroepithelial cancer, is a common genitourinary tumor with a high recurrence rate, especially for non-muscle-invasive bladder cancer (NMIBC), which accounts for about 75% of cases. This research evaluates how drug sensitivity testing using patient-derived bladder cancer organoids can guide individualized bladder perfusion chemotherapy to improve treatment selection and reduce recurrence. The study is designed as a multicenter cohort study and aims to compare recurrence-free survival rates among patients receiving organoid-sensitive chemotherapy, organoid-non-sensitive chemotherapy, and BCG therapy. Patients undergo organoid culture from tumor tissue collected during surgery to test sensitivity to several chemotherapeutic agents including gemcitabine, piroxicam, epirubicin, mitomycin, and doxorubicin. Based on organoid drug sensitivity results, patients are assigned to either an organoid-sensitive drug perfusion group or an organoid-non-sensitive drug perfusion group. Chemotherapy regimens include induction perfusion weekly for 4 weeks starting 4 to 8 weeks post-surgery, followed by maintenance perfusion monthly for 11 months. The BCG group receives a series of infusions over one year including induction, booster, and maintenance doses. Participants are closely followed with regular cystoscopy based on their risk level to monitor tumor recurrence and progression over one and three years. Assessments include clinical efficacy evaluations using established criteria and survival analysis to compare recurrence rates. Safety and adverse events are recorded, and data management and quality control measures are applied. The study duration includes treatment, follow-up, and outcome measurement periods up to three years to explore the value of organoid-guided therapy in precision bladder cancer treatment.

Researchers are evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study. Participants who fulfill the inclusion and exclusion criteria will be enrolled at up to 35 study sites in mainland China. All eligible participants will be randomized in a 2:1 ratio to HST101 or placebo dosed subcutaneously (Q4W \[≤31 days\]) in the initial 12-week randomized double-blind treatment period. After 12-week treatment, all the participants will enter to the 36-week open-label treatment period where those who are on HST101 will continue to receive HST101 in the same dosing regimen as dosed in the randomized period, and those who are on placebo will be switched to HST101 300 mg (Q4W \[≤31 days\]) administered subcutaneously. The total study duration will be up to 55 weeks which includes a up to 3-week Screening Period, 12-week randomized, double-blind, placebo-controlled treatment period, 36-week open-label treatment period, followed by a 4-week follow-up period.