[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of Zhenzhu Drop Pills in the treatment of recurrent oral ulcers with heart and spleen heat accumulation syndrome

以靶溃疡愈合时间为主要疗效指标，确证珍珠滴丸治疗复发性口腔溃疡（心脾积热证）的有效性和安全性，为本品注册审查提供依据。

[Translation]

Taking target ulcer healing time as the main efficacy indicator, the effectiveness and safety of Pearl Drops in the treatment of recurrent oral ulcers (heart and spleen heat accumulation syndrome) were confirmed, providing a basis for the registration review of this product.

Start Date16 Apr 2019

Sponsor / Collaborator

Guiyang Medical College

[+1]

CTR20180356

/ RecruitingPhase 2

洛铂联合紫杉醇治疗铂敏感型复发卵巢上皮癌的剂量探索性研究

[Translation] A dose-finding study of lobaplatin combined with paclitaxel in the treatment of platinum-sensitive recurrent epithelial ovarian cancer

通过剂量递增（剂量爬坡）试验，探索洛铂联合紫杉醇方案（TL）中洛铂的最佳剂量，为后续的多中心Ⅱ/Ⅲ期临床研究中洛铂用药剂量提供依据，并初步观察洛铂联合紫杉醇方案治疗铂敏感型复发卵巢上皮癌的有效性和安全性。

[Translation]

Through a dose escalation (dose escalation) trial, the optimal dose of lobaplatin in the lobaplatin combined with paclitaxel regimen (TL) was explored to provide a basis for the dosage of lobaplatin in subsequent multicenter phase II/III clinical studies, and to preliminarily observe the efficacy and safety of the lobaplatin combined with paclitaxel regimen in the treatment of platinum-sensitive recurrent ovarian epithelial cancer.

Start Date30 May 2018

Sponsor / Collaborator

Hainan Chang'an International Pharmaceutical Co. Ltd.

100 Clinical Results associated with Guizhou Yibai Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Guizhou Yibai Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Guizhou Yibai Pharmaceutical Co., Ltd.

01 Jun 2025·Phytomedicine

Restorative mechanisms of Shugan Yiyang capsule on male infertility through ‘pharmaco-metabo-net’ tripartite correlation analysis

Article

Author: Wu, Xiangli ; Tao, Ling ; Fan, Jian ; Shen, Ying ; Li, Chunmei ; Wu, Fuli ; Shen, Xiangchun ; Yang, Qingbo

BACKGROUNDShugan Yiyang capsule (SGYY), a commonly used traditional Chinese medicine formulation, is primarily indicated for the treatment of erectile dysfunction, yet existing studies on the therapeutic effects on male infertility (MI) are insufficient and the specific mechanisms remain poorly understood. Given the close relationship between MI, sperm quality, and erectile function, this study aims to investigate the role of SGYY in the restoration of MI and explore the underlying mechanisms.METHODSThe efficacy of SGYY is comprehensively evaluated through pharmacodynamic, metabolomic, and network pharmacology. Sperm parameters, reproductive hormones, sexual behavior, neural enzymes, oxidative stress markers, pro-inflammatory cytokines, and testicular histopathology are measured to reveal the restorative effects of MI. Furthermore, urine and serum metabolomics, along with network pharmacology and surface plasmon resonance, are employed to explore the molecular mechanisms and predict core targets.RESULTSSGYY significantly improved overall health parameters, including body weight, water intake, urine output, food consumption, and spontaneous activity. Specifically, SGYY prominently recovered sexual behavior, ameliorated sperm quality, increased mitochondrial membrane potential, normalized reproductive hormones, upregulated endothelial nitric oxide synthase, attenuated oxidative stress markers, and pro-inflammatory cytokines, and repaired testicular pathological damage. Metabolomic analysis identified 47 candidate biomarkers, among which SGYY significantly modulated 39 potential biomarkers, encompassing 8 main metabolic pathways such as histidine metabolism, cysteine and methionine metabolism, propanoate metabolism, and taurine and hypotaurine metabolism. Additionally, network pharmacology predicted 8 core targets, comprising HSP90AA1, ESR1, MAPK1, CASP3, IL6, TNF, BCL2, and MAPK8.CONCLUSIONSGYY improves sperm quality and erectile function by regulating oxidative stress, energy metabolism, and neurological function, thereby exerting a restorative effect on MI, as evidenced by the modulation of 8 main metabolic pathways, 39 potential biomarkers, and 8 core targets. Pharmacodynamic provides foundational validation, metabolomic uncovers intrinsic metabolic changes, and network pharmacology predicts therapeutic targets, with findings from the 'Pharmaco-Metabo-Net' tripartite correlation analysis providing a solid theoretical strategy and scientific evidence to support the clinical application of SGYY in restoring MI.

02 Apr 2025·Journal of Agricultural and Food Chemistry

Black Raspberry Polyphenols Shape Metabolic Dysregulation and Perturbation in Gut Microbiota to Promote Lipid Metabolism and Liver Regeneration

Article

Author: Shen, Xiangchun ; Guo, Zhenghong ; Zhang, Yiquan ; Dai, Weiyan ; Xiao, Ting ; Tao, Ling ; Yang, Bo ; Cheng, Xingyan ; Huang, Feilong ; Duan, Jinchang

Black raspberry as a functional food is a potential modulator of human metabolic disease. However, the role of black raspberry polyphenols (HSM) in shaping metabolic dysregulation and perturbation in gut microbiota (GM) to promote lipid metabolism and liver regeneration is unclear. In this work, the effects of HSM in mitigating metabolic disturbances and hepatic damage induced by a high-fat diet (HFD) and antibiotics (Abs) in mice were measured. HSM significantly alleviated HFD-induced obesity, insulin resistance, lipid and glucose metabolic dysregulation, as well as hepatic damage by activating the PI3K/AKT pathway and pregnane X receptor (PXR)-farnesoid X receptor (FXR) axis with improved GM, which was evidenced by short-chain fatty acids, 16S, and nontarget metabolism analysis. Excellent results were also evident in mice treated with Abs. Besides, HSM markedly inhibited key digestive enzymes associated with metabolic syndrome and also significantly enhanced antioxidant capacity after metabolized by GM. The discoveries underscored the potential of dietary HSM to manage lipid metabolism and liver regeneration within GM homeostasis.

01 Mar 2025·Cancer Biomarkers

Evaluating the efficacy of PARP inhibitor in ARID1A-deficient colorectal cancer: A ex vivo study

Article

Author: Kang, MingWei ; Zhou, Ping ; Xu, Shan ; Zhang, Yuping ; Qin, Shaojie ; Zong, Rui ; Li, Jie

ARID1A mutations are a common occurrence in colorectal cancer (CRC) cells, but clinical therapeutic options targeting this anomaly remain unavailable. The loss of ARID1A functionality compromises DNA damage repair processes, potentially causing cancer cells to rely more heavily on PARP-dependent DNA repair pathways to preserve genomic integrity, thereby making them susceptible to PARP inhibitor (PARPi) therapy. To evaluate the suitability of PARPi treatment for CRC patients with ARID1A sufficiency (ARID1A+) and ARID1A deficiency (ARID1A-), our study enrolled 80 patients who had undergone surgical treatment for primary CRC. Surgical specimens underwent immunohistochemical examination to assess ARID1A protein expression. The study explored correlations between ARID1A expression loss and clinicopathological characteristics. Moreover, primary CRC cells were isolated through enzymatic digestion and validated using the colorectal carcinoma marker CK20. Subsequently, PARPi sensitivity was investigated in untreated ARID1A+ and ARID1A- CRC patients using an ATP-tumor chemosensitivity assay (ATP-TCA). Additionally, we confirmed the efficacy of PARPi in these primary CRC cells through clone formation and assessed its impact on cell cycle dynamics, apoptosis, and DNA damage repair signaling pathways using immunofluorescence and flow cytometry. The results demonstrated that the ARID1A- group displayed greater sensitivity to PARPi compared to the ARID1A+ group. PARPi treatment led to increased tumor cell death in the ARID1A- group. Mechanistically, ARID1A deficiency resulted in cell cycle abnormalities, particularly G2/M phase arrest, which was further exacerbated by PARPi treatment. Furthermore, PARPi treatment significantly increased the number of RAD51 foci in ARID1A- cell lines. In conclusion, our study highlights the potential of PARPi as an effective therapeutic option for ARID1A- CRC patients.

100 Deals associated with Guizhou Yibai Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Guizhou Yibai Pharmaceutical Co., Ltd.

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Pipeline Snapshot as of 10 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Lobaplatin ( DNA )	Small Cell Lung Cancer More	Approved
Aidi Injection	Lymphoma More	Approved
AiDi	Liver Cancer More	Approved
Jinlian Qingre Effervescent Tablets	Common Cold More	Approved
Reteplase biosimilar(Guizhou Yibai Pharma) ( PLG )	Myocardial Infarction More	Approved

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