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更新于：2026-03-28
Jiangsu Simcere Pharmaceutical Co., Ltd.
更新于：2026-03-28
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NCT07348211
An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced/Metastatic Solid Tumors
NCT07345364
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Subjects
NCT07357610
An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
100 项与 江苏先声药业有限公司 相关的临床结果
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2025-12-11SLEEP
Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial
Article
作者: Wu, Juncang ; Ma, Qinying ; Chen, Jingxu ; Liu, Yunlin ; Wang, Yuping ; Wang, Feng ; Wang, Bei ; Jiang, Yan ; Liu, Xin ; Zhang, Bin ; Xiao, Li ; Xu, Lijun ; Wang, Jian ; Li, Chenyu ; Huang, Yuansheng ; Xu, Qiaorong ; Huang, Zhaoyang ; Wang, Zan ; Wang, Hanqiao ; Yuan, Chengmei ; Cui, Hao
Abstract:
Study Objectives:
To evaluate the efficacy and safety of daridorexant in Chinese patients with insomnia disorder.
Methods:
This was a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase III clinical trial in China. Adults aged 18–75 years meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder, with a baseline Insomnia Severity Index (ISI) more than equal to 15, were randomly assigned in a 1:1 ratio to receive daridorexant 50 mg or placebo once every evening for 1 month. The primary endpoint was the change from baseline to month 1 in wake time after sleep onset (WASO) assessed by polysomnography (PSG). The secondary endpoints included the change from baseline to month 1 in self-reported total sleep time (sTST) and in latency to persistent sleep (LPS). In addition to the standardized collection of adverse events (AEs), safety data specific to insomnia treatment were assessed as follows: withdrawal symptoms, rebound insomnia, and next-day residual effects.
Results:
Two hundred and six participants were enrolled and evenly randomized to each group. Compared with the placebo group, the daridorexant group showed a significant reduction in WASO (−15.4 min, p = .0009), a significant increase in sTST (16.8 min, p = .021) and a significant reduction in LPS (geometric mean ratio to placebo 0.7, p = .001) from baseline to month 1. The proportion of participants reporting AEs during double-blind treatment was generally comparable between two groups (21.6 vs. 18.4 percent), with no notable safety signals observed. No withdrawal symptoms, rebound insomnia, and next-day residual effects were observed.
Conclusions:
Daridorexant 50 mg significantly improved both objective and self-reported sleep outcomes in Chinese patients with insomnia disorder, with a favorable safety profile.
Clinical Trial:
A Study of Daridorexant in Chinese Patients With Insomnia Disorder, https://clinicaltrials.gov/study/NCT06010693, with the number NCT06010693.Statement of Significance Daridorexant has been evaluated and approved for the treatment of insomnia in many countries worldwide, but there is no data of daridorexant in Chinese populations. This study is the first randomized controlled phase III study of daridorexant in Chinese. It verified the efficacy and safety of daridorexant in Chinese people for the first time and fully explained the characteristics of daridorexant in Chinese patients with insomnia. This study provides a basis for the approval of daridorexant for clinical use in China, as well as reference data for clinicians to use the drug in the future.
2025-12-01Chinese medical journal pulmonary and critical care medicine
Risk factors for severe and prolonged cough in influenza and COVID-19: A post hoc analysis of three randomized controlled trials
Letter
作者: Hu, Qidan ; Wang, Wei ; Wang, Yeming ; Jin, Yang ; Liu, Lian ; Xu, Jiuyang ; Li, Jingya ; Cao, Bin ; Liu, Dong ; Hu, Honglin ; Gu, Xiaoying
2025-12-01Current Computer-Aided Drug Design
Mechanisms Underlying the Protective Effects of Obeticholic Acid-activated FXR in Valproic Acid-induced Hepatotoxicity via Network Pharmacology, Molecular Docking, and Molecular Dynamics Simulations
Article
作者: Chen, Ya'nan ; Wang, Lei ; Zhou, Jingkai ; Xu, Shansen
Background::
Valproic acid (VPA)-induced hepatotoxicity is among the most common
and severe adverse drug reactions, limiting its clinical application. Recent studies have suggested
that activating the farnesoid X receptor (FXR) could be a promising therapeutic approach to alleviate
VPA-induced hepatotoxicity; however, related research remains limited.
Objective::
This study aims to comprehensively investigate the mechanisms underlying FXR activation
by obeticholic acid (OCA) for the treatment of VPA-induced hepatotoxicity.
Methods::
Network pharmacology was performed to identify potential targets and pathways underlying
the amelioration of VPA-induced hepatotoxicity by OCA. The identified pathways were validated
through GEO data analysis, and the affinities between OCA and potential key targets were
predicted using molecular docking as well as molecular dynamics simulations.
Results::
A total of 462 targets associated with VPA-induced hepatotoxicity and 288 targets of
OCA were identified, with 81 shared targets. KEGG pathway and GO enrichment analysis indicated
that the effect of OCA on VPA-induced hepatotoxicity primarily involved lipid metabolism, as
well as oxidative stress and inflammation. The results from GEO data analysis, molecular docking,
and molecular dynamics simulations revealed a close association between bile secretion, the
PPAR signaling pathway, and the treatment of VPA-induced hepatotoxicity by OCA.
Conclusion::
Our findings suggest that OCA exhibits potential therapeutic efficacy against VPAinduced
hepatotoxicity through multiple targets and pathways, thereby highlighting the therapeutic
potential of FXR as a target for treating VPA-induced hepatotoxicity.
2026-03-26
·医药代表
2026-03-26
疫苗siRNA临床申请
100 项与 江苏先声药业有限公司 相关的药物交易
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100 项与 江苏先声药业有限公司 相关的转化医学
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