预约演示
更新于：2026-06-18
China State Institute of Pharmaceutical Industry
更新于：2026-06-18
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其他疾病
内分泌与代谢疾病
肿瘤
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CTR20261332
培哚普利氨氯地平片（Ⅲ）在健康参与者中的生物等效性试验（餐后试验）
CTR20261328
培哚普利氨氯地平片（Ⅲ）在健康参与者中的生物等效性试验（空腹试验）
CTR20261777
马昔腾坦片在健康参与者中餐后条件下的生物等效性试验
100 项与 中国医药工业研究总院有限公司 相关的临床结果
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2026-06-01BIOORGANIC & MEDICINAL CHEMISTRY
Design, synthesis and evaluation of trofinetide prodrug based on diketopiperazine strategy
Article
作者: Bian, Jing ; Feng, Jun ; Lu, Jianguang ; Guo, Chen ; Xu, Zhiru ; Dong, Yuanzhen ; Feng, Xue ; Luo, Tao ; Peng, Wenjing
Trofinetide is the only drug approved worldwide for the treatment of Rett syndrome, a rare pediatric disease. However, its extremely short half-life, large oral dose, high incidence of gastrointestinal adverse reactions, and consequently high treatment costs pose formidable clinical and economic challenges. To address these issues, we employed a diketopiperazine strategy to design a novel class of trofinetide prodrugs, aiming to alter the administration route and optimize its pharmacokinetic properties. Through the determination of solubility and in vitro conversion half-life, and based on the established screening criteria, TFD 10 was selected from the series of qualified compounds as a representative for pharmacokinetic evaluation. TFD 10 exhibited efficient conversion to trofinetide both in vitro and in vivo. Compared to oral administration of trofinetide, subcutaneous injection of TFD 10 markedly prolonged the half-life (6-fold) and substantially increased systemic exposure (40-fold), successfully achieving the design objectives. This study validates the feasibility of this strategy, and TFD 10, as a proof-of-concept lead compound, demonstrates significant potential for further development.
2026-05-01Redox Biology
ACOD1-itaconate in macrophage attenuates oxidative stress and inflammation in benign airway stenosis by upregulating and transferring FTH1
Article
作者: Xu, ZhiRu ; Shi, Yue ; Xu, ChengFei ; Zhang, YiFei ; Yang, ChengCheng ; Shi, DongChen ; Zong, Zhe ; Luo, Tao ; Wang, XiaoMin ; Shi, Hui ; Huang, HaiDong ; Bai, Chong ; Dong, YuChao ; Guo, XinYi ; Han, ChaoFeng ; Chen, YiLin
The oxidative stress of macrophage plays pivotal roles of acute and chronic inflammation and chronic fibrotic phases, in which the metabolic mechanism needs to be further explored. In our research, multi-omics analyses of human and murine during Benign airway stenosis (BAS) biopsy identified ACOD1 as a hallmark of immunometabolic regulation during acute inflammation stage. ACOD1 knockout aggravated both acute and chronic inflammation, which increased the granulation tissue formation. The ACOD1-itaconate axis, along with its derivative, 4-octyl itaconate (4-OI), orchestrated acute and chronic inflammation, which attenuated the fibrosis of BAS. 4-OI upregulated FTH1 expression in macrophages by activating NRF2, which effectively suppressed oxidative stress and acute inflammation. Furthermore, 4-OI promoted the packaging of FTH1 into macrophage-derived exosomes, which were transferred to fibroblasts in a SCARA5-dependent manner, inducing fibroblast ferroptosis and alleviating chronic fibrosis. In sum, this study illustrates that the ACOD1-itaconate metabolic axis decreases oxidative stress and inflammation in macrophage, which attenuates fibrosis by inducing FTH1 transfer, offering a therapeutic target for fibrotic airway diseases.
2026-04-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
Development of online monitoring strategy for continuous coating process of transdermal patches based on near-infrared spectroscopy
Article
作者: Wang, Yidian ; Luo, Huafei ; Wang, Shujie
Transdermal patches are increasingly important for non-invasive drug delivery. To address the challenges of quality control in continuous manufacturing, we developed a comprehensive near-infrared (NIR) spectroscopy-based monitoring strategy using rivastigmine patches as a model. A custom sample holder was designed to eliminate bubbles and solvent evaporation artefacts in high-viscosity adhesives, enabling stable spectral acquisition. Combined with optimised preprocessing and variable selection (CARS and biPLS), robust partial least squares (PLS) models were established for drug content, solid content, and dry adhesive weight. Adhesive solution models exhibited excellent performance (R2 > 0.984, RPD > 7), while offline patch models achieved near-reference accuracy (R2 > 0.995). When integrated into a continuous coating line, online models delivered highly accurate dry adhesive weight prediction (R2 = 0.998, RPD = 12.29) and reliable drug content monitoring (R2 = 0.948, RPD = 3.10) despite process variations in web speed and coating thickness. To the best of our knowledge, this work demonstrates the first integrated real-time NIR monitoring approach throughout the coating process, providing a practical PAT solution that significantly enhances process understanding and quality assurance in continuous production.
100 项与 中国医药工业研究总院有限公司 相关的药物交易
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100 项与 中国医药工业研究总院有限公司 相关的转化医学
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2026年06月21日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
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