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更新于：2025-06-15
Suzhou Ribo Life Science Co., Ltd.
更新于：2025-06-15
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消化系统疾病
内分泌与代谢疾病
心血管疾病
siRNA
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CTIS2023-510369-92-00
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients with Mixed Dyslipidemia - RC02T001
NCT06797401
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia
CTR20244751
评价不同剂量QLC7401在接受优化降脂治疗控制不佳的低密度脂蛋白胆固醇（LDL-C）升高的原发性高胆固醇血症或混合型高脂血症患者中有效性和安全性的多中心、随机、双盲、安慰剂对照II期临床研究
100 项与 苏州瑞博生物技术股份有限公司 相关的临床结果
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2025-06-02ORAL DISEASES
Chinese Expert Consensus on Management of Betel-Chewing-Related Oral Squamous Cell Carcinoma.
Review
作者: Liu, Binjie ; Tang, Zhangui ; Xu, Pu ; Peng, Xin ; Ren, Guoxin ; Meng, Jian ; Xing, Lu ; Bu, Rongfa ; Li, Longjiang ; Guo, Wei ; Gao, Shan ; Sun, Moyi ; Hu, Yanjia ; Shang, Wei ; Bin, Xin ; Li, Bo
OBJECTIVE:
Betel-chewing-related oral squamous cell carcinoma (BCR-OSCC) has become a global health issue with increasing incidence year by year around the world. Active prevention of the occurrence of BCR-OSCC, monitoring the population exposed to Betel Nuts, and early diagnosis and treatment are very important to maintain and improve the quality of life of patients. However, there is currently no consensus or guideline that provides targeted guidance on the management of BCR-OSCC.
SUBJECTS AND METHODS:
A consensus panel consisting of 15 leading Chinese experts from multidisciplinary fields was convened, and a roundtable meeting was held to discuss the topics of BCR-OSCC.
RESULTS:
Based on existing research reports and the experts' clinical experiences, a consensus on staging, diagnosis, and treatment for BCR-OSCC was formed through extensive discussion.
CONCLUSION:
This manuscript presents consensus recommendations and a summary of evidence supporting each recommendation. This consensus may improve clinical practices about BCR-OSCC in China and propel more clinical trials to provide high-level evidence for BCR-OSCC management.
2025-06-01CLINICAL PHARMACOKINETICS
Prediction of Interspecies Translation for Targeting Delivery Coefficients of GalNAc-siRNA Silencing Apolipoprotein C-III Using a Mechanistic Minimal Physiologically Based Pharmacokinetic/Pharmacodynamic Model
Article
作者: Yang, Zhenzhen ; Gao, Shan ; Tian, Zhiteng ; Chu, Yantao ; Liu, Yanhong ; Luo, Hui ; Song, Ling ; Liu, Dongyang
BACKGROUND AND OBJECTIVE:
The emerging N-acetylgalactosamine-small interfering RNA (GalNAc-siRNA) conjugates lead the way for liver-targeting delivery to exert gene-silencing therapeutic effects. To facilitate the drug development of GalNAc-siRNA, further detailed understanding of the key modality-specific mechanisms underlying the temporal discordance between pharmacokinetics and pharmacodynamics and how these processes can be extrapolated from animals to humans is needed.
METHODS:
A mechanistic minimal physiologically based pharmacokinetic/pharmacodynamic (mPBPK-PD) model for an investigational new apolipoprotein C-III (APOC3)-silencing GalNAc-siRNA (RBD5044) was developed using available pharmacokinetic/pharmacodynamic (PK/PD) data. The aim was to explore hepatic-targeting delivery processes, the PK/PD relationship, and interspecies translation.
RESULTS:
First, multiple PK/PD datasets from mice were satisfactorily fitted using the mPBPK-PD model. Second, we translated the mice model to the monkey model, validated it, and then extrapolated from mice and monkeys to humans to simulate the PK/PD characteristics. We then mechanistically summarized and proposed the essential in vivo delivery processes of GalNAc-siRNA after subcutaneous administration (termed "ADUEB": Absorption [into system circulation], Disposition [distribution to liver target and elimination], Uptake [into hepatocytes], Escape [from endosome and lysosome compartments], and Binding [with argonaute2 to form RNA-induced silencing complex]). The targeting delivery coefficients of these processes achieved with the model using RBD5044 and the published data of another GalNAc-siRNA (fitusiran) quantitatively reflected the delivery efficiency and rate-limiting factors in targeted hepatocytes.
CONCLUSION:
This study successfully constructed the mPBPK-PD model and conducted interspecies extrapolation for a GalNAc-siRNA targeting APOC3. Promising quantitative insights into a hepatic-targeted GalNAc-siRNA delivery system are provided to characterize the unique temporal disconnection of PK/PD properties and evaluate the key in vivo delivery processes. It will promote model-informed strategies and quantitative mechanistic understanding to support efficient drug development, evaluation, and clinical application of this modality in the future.
2024-01-01Bioanalysis
Metabolite Identification and Quantitation of RBD1016 siRNA: A Direct Comparison of Hybridization-Based LC-FD and LC-HRAM Assays
Article
作者: Chu, Yantao ; Wang, Laixin ; Guo, Zhaoxu ; Yu, Hong ; Yan, Min ; Ji, Yuhuan ; Meng, Min ; Chu, Limin
Aim: RBD1016 is an N-acetylgalactosamine-conjugated siRNA drug currently in a phase II trial for treatment of chronic hepatitis B virus. To evaluate its absorption, distribution, metabolism and excretion (ADME) and pharmacokinetic/pharmacodynamic (PK/PD) properties, two LC-based bioanalytical methods, LC–high-resolution/accuracy MS and LC–fluorescence detection, were developed and qualified. Materials & methods: The LC–high-resolution/accuracy MS method was used for metabolite identification and simultaneous quantitation of the antisense and sense strands as well as their respective metabolites. The LC–fluorescence detection assay was primarily used for analyzing the antisense strand and its metabolites in low-concentration plasma samples. The two methods were successfully bridged by analyzing the same sets of study samples. Results & conclusion: Both methods were found to have excellent accuracy/precision, specificity and reproducibility to support ADME and PK/PD studies of RBD1016 siRNA.
100 项与 苏州瑞博生物技术股份有限公司 相关的药物交易
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100 项与 苏州瑞博生物技术股份有限公司 相关的转化医学
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