Yong Zhou Shi

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

This is a phase I/II, multicenter, open-label, first-in-human study of FWD1802 in patients with locally advanced or metastatic breast cancer that is estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative (Phase II: restricted to patients with ESR1-mutated). It consists of three parts: the FWD1802 dose-escalation phase (Phase I Part A), the FWD1802 dose-expansion phase (Phase I Part B), and the dose-expansion study of FWD1802 in patients with ESR1 mutations (Phase II study). Each study phase includes a screening period (up to 4 weeks), a treatment period (maximum treatment duration of 2 years; continuation beyond 2 years is permitted if the investigator judges the subject is still benefiting, with agreement from both the investigator and sponsor), and a follow-up period. The Phase II study includes a pre-screening period; patients with unknown mutation status may undergo testing that includes ESR1 mutation status prior to the screening period. Phase I Part A is the FWD1802 dose-escalation study: A dose-escalation trial using a combination of an "accelerated titration" design and a "3+3" design is planned, with a maximum of 27 subjects to be enrolled. The Safety Monitoring Committee (SMC) will evaluate pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety data to guide the determination of potentially effective doses for Part B and the Phase II study. Phase I Part B is the FWD1802 dose-expansion study: Based on safety, PK, PD, and other data obtained from Part A, 2 to 4 dose cohorts will be selected for further exploration of FWD1802's PK profile and the recommended phase 2 dose (RP2D). Each dose cohort will be expanded to include up to 10 subjects (including subjects from the corresponding dose cohort in Part A). The SMC will decide which dose cohorts to expand and the timing of expansion based on information obtained from Part A. Dose expansion may proceed concurrently with the dose-escalation phase, within dose ranges already confirmed as safe by the SMC. The Phase II study is cohort expansion study targeting the population with ESR1 mutations: Enrolled subjects will have ER-positive, HER2-negative breast cancer with ESR1 mutations. One to two dose levels will be selected for exploration, with each dose level enrolling no more than 30 subjects, for a maximum total enrollment of 60 subjects.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine called Hansenulapolymorpha in Chinese women aged 18 to 45 years. This Phase III randomized, blinded, placebo-controlled trial involves 13,500 women divided into three age groups: 18-26, 27-35, and 35-45 years. The study aims to assess the incidence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with various HPV types after vaccination. Participants receive either the 11-valent HPV vaccine or a placebo through intramuscular injections in the upper arm deltoid muscle. The vaccination schedule includes three doses given at 0, 2, and 6 months. The trial compares the vaccine's effects against placebo across the different age groups, following strict immunization timing. During the study, women attend follow-up visits and provide information through diary cards and contact forms. Researchers monitor safety, immune responses, and HPV-related cervical changes, including CIN2+ occurrences one month after the third dose. The trial also includes pregnancy testing before vaccination and requires effective contraception during the study. Total participation includes vaccination and follow-up over approximately six years to evaluate long-term outcomes.

Researchers are evaluating the effectiveness and safety of PM8002, a bispecific antibody targeting PD-L1 and VEGF, combined with FOLFIRI chemotherapy as a second-line treatment for patients with neuroendocrine neoplasm (NEC and Ki-6755% G3 NET) who did not respond to first-line platinum-based chemotherapy. This phase II, single-arm study focuses on patients with advanced disease that cannot be surgically removed. Participants will receive PM8002 and FOLFIRI through intravenous infusion as the treatment regimen. The study will monitor the response to this combination therapy and assess treatment-related side effects. Treatment will continue under the study protocol as the second-line therapy after prior chemotherapy failure. During the study, participants will undergo regular evaluations including tumor measurements according to RECIST v1.1 criteria, assessments of organ function, and monitoring for any adverse events related to treatment. The main outcomes measured are the objective response rate over approximately two years and treatment-related adverse events up to 30 days after the last treatment. The study requires participants to have an expected survival of at least 12 weeks and a good performance status to ensure safety and ability to participate.

This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.

Researchers are conducting a randomized, open-label Phase Ib/IIa study to assess the effectiveness and safety of SPH4336 alone or combined with Cadonilimab in patients with advanced solid tumors, including advanced well differentiated/dedifferentiated liposarcoma. This study targets patients whose tumors cannot be treated by surgery or other local treatments and aims to measure progression-free survival over approximately two years. Participants will receive SPH4336 tablets orally at a dose of 400 mg once daily in 28-day cycles, either by itself or together with Cadonilimab given by intravenous infusion at 6 mg/kg every 28 days. The study includes a dose expansion phase requiring at least one measurable tumor lesion according to RECIST v1.1 criteria. Treatment will continue with monitoring of safety and response. During the study, participants will undergo laboratory tests to ensure organ function adequacy and be monitored for side effects, including previous treatment toxicities. Researchers will track progression-free survival and observe adverse events. Participants must agree to use effective contraception during the study. The expected survival for participants is at least three months, and the total study duration includes regular treatment cycles and follow-up assessments.

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 effectiveness and safety of orelabrutinib in adults with chronic primary immune thrombocytopenia (ITP) who have had the condition for at least 12 months. This phase III study compares orelabrutinib with a placebo in patients who have not responded well to or cannot tolerate standard first-line treatments like glucocorticoids or intravenous immunoglobulin. Participants will receive either orelabrutinib or a placebo once daily. The study is randomized, double-blind, and placebo-controlled to ensure unbiased results. The treatment period includes monitoring for response durability over an average of six months. During the study, participants will be regularly assessed for treatment response and safety. Researchers will measure the durable response rate, which reflects sustained improvement over the study period. Monitoring includes clinical evaluations and laboratory tests to ensure participant safety and to track the drug's effects.

Researchers are evaluating the effectiveness and safety of a chemotherapy drug called JSKN003 compared to other chemotherapy treatments chosen by doctors for adults with HER2-low, unresectable, or metastatic breast cancer. This study focuses on patients whose cancer has returned or spread and who have already tried one or two previous chemotherapy treatments without success. It is a phase III, open-label, randomized study conducted at multiple centers. Participants will be randomly assigned to one of two groups: one group will receive JSKN003 given through an intravenous infusion according to the study plan, while the other group will receive one of several chemotherapy drugs selected by their doctor before joining the study. These options include capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. Treatment is given as a single drug in both groups. During the study, participants will be monitored for up to about three years to see how long they live without their cancer worsening. Researchers will conduct imaging scans, lab tests, and other evaluations to track disease progression and overall health. Safety and side effects will be carefully observed, and participants' tumor samples will be analyzed to confirm HER2 status. The study aims to enroll 408 subjects and includes follow-up assessments to ensure continued monitoring of treatment outcomes.

Researchers are evaluating the safety and effectiveness of a combination treatment of camrelizumab, apatinib, and eribulin compared to physician's choice chemotherapy in women with advanced triple-negative breast cancer (TNBC). The study focuses on whether this combination improves progression-free survival (PFS) and overall survival (OS). Additional goals include comparing response rates, disease control, clinical benefits, duration and timing of response, two-year survival rates, biomarker analysis, quality of life, and safety by monitoring adverse events. Participants receive either the combination of camrelizumab (200 mg IV on Day 1), apatinib (250 mg orally once daily), and eribulin (1.4 mg/m² IV on Days 1 and 8) in 21-day cycles, or physician's choice chemotherapy. The study compares these two treatment approaches as later-line options for advanced TNBC. Treatments continue according to the study plan to assess differences in outcomes between groups. During the trial, participants undergo evaluations including scans and laboratory tests to measure tumor response and general health. Researchers track progression-free survival up to 60 months and overall survival up to 120 months. Quality of life and biomarker data are also collected. Safety is closely monitored by recording the incidence and severity of adverse events. The study involves ongoing assessments to gather comprehensive data on treatment effects and participant well-being.