考察中国健康受试者在空腹及餐后条件下单剂量口服山东丹红制药有限公司提供的来那度胺胶囊（受试制剂，T，25mg）与持证商Bristol-Myers Squibb Pharma EEIG的来那度胺胶囊（参比制剂，R，25mg）后的体内药代动力学特征，并进行生物等效性评价。同时评价单剂量口服来那度胺胶囊受试制剂（规格：25mg）及参比制剂（规格：25mg）在中国健康受试者中的安全性。

[Translation]

The in vivo pharmacokinetic characteristics of lenalidomide capsules (test preparation, T, 25 mg) provided by Shandong Danhong Pharmaceutical Co., Ltd. and lenalidomide capsules (reference preparation, R, 25 mg) from licensee Bristol-Myers Squibb Pharma EEIG were investigated in healthy Chinese subjects after a single oral dose under fasting and postprandial conditions, and bioequivalence evaluation was performed. At the same time, the safety of the test preparation (specification: 25 mg) and reference preparation (specification: 25 mg) of lenalidomide capsules taken orally in a single dose in healthy Chinese subjects was evaluated.

Start Date19 Sep 2024

Sponsor / Collaborator

Shandong Danhong Pharmaceutical Co., Ltd.

CTR20242245 / RecruitingPhase 1

一项评价 BC0305 胶囊在健康受试者中安全性、耐受性、药代动力学和药效学特征的随机、双盲、安慰剂对照、单剂量递增 I 期临床试验

[Translation] A randomized, double-blind, placebo-controlled, single-ascending dose phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of BC0305 capsules in healthy subjects

主要目的：评价健康受试者单剂量口服 BC0305 胶囊的安全性和耐受性，为该药多剂量临床试验方案的制定提供参考依据。次要目的：评价健康受试者单剂量口服 BC0305 胶囊的药代动力学和药效学特征。评价 BC0305 胶囊给药在体内的代谢产物，及主要代谢产物的 PK 特征（如适用）。

[Translation]

Primary objective: To evaluate the safety and tolerability of a single oral dose of BC0305 capsules in healthy subjects, and to provide a reference for the formulation of a multi-dose clinical trial protocol for the drug. Secondary objective: To evaluate the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of BC0305 capsules in healthy subjects. To evaluate the metabolites of BC0305 capsules in vivo, and the PK characteristics of the main metabolites (if applicable).

Start Date18 Jul 2024

Sponsor / Collaborator

Shandong Danhong Pharmaceutical Co., Ltd.

CTR20241972 / RecruitingPhase 1

评价在中国健康受试者体内给予BC0306的单中心、随机、双盲、安慰剂对照、单次递增给药的安全性、耐受性、药代动力学及药效学特性的I 期临床研究

[Translation] A single-center, randomized, double-blind, placebo-controlled, single-ascending dosing study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BC0306 in healthy Chinese subjects

主要目的：评估健康成人空腹条件下单次服用BC0306后的安全性和耐受性；次要目的：评估健康成人空腹条件下单次服用BC0306后的药代/药效动力学特征；探索BC0306胶囊口服特定剂量后可能的代谢产物。

[Translation]

The primary objective is to evaluate the safety and tolerability of BC0306 after a single dose in healthy adults on an empty stomach. The secondary objective is to evaluate the pharmacokinetic/pharmacodynamic characteristics of BC0306 after a single dose in healthy adults on an empty stomach. The secondary objective is to explore the possible metabolites of BC0306 capsules after oral administration of a specific dose.

Start Date11 Jul 2024

Sponsor / Collaborator

Shandong Danhong Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shandong Danhong Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shandong Danhong Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Shandong Danhong Pharmaceutical Co., Ltd.

01 Dec 2021·Journal of Translational MedicineQ2 · MEDICINE

Prediction of hepatocellular carcinoma risk in patients with chronic liver disease from dynamic modular networks

Q2 · MEDICINE

ArticleOA

Author: Chen, Qilong ; Yang, Wei ; Liu, Qiong ; Chen, Yinying ; Li, Dongfeng ; Nan, Jingyi ; Liu, Jun ; Su, Shibing ; Peng, Yehui ; Li, Xiaodong ; Zhang, Yingying ; Wang, Jie ; Wu, Huikun ; Xiang, Xinghua ; Wang, Zhong ; Li, Bing

AbstractBackgroundDiscovering potential predictive risks in the super precarcinomatous phase of hepatocellular carcinoma (HCC) without any clinical manifestations is impossible under normal paradigm but critical to control this complex disease.MethodsIn this study, we utilized a proposed sequential allosteric modules (AMs)-based approach and quantitatively calculated the topological structural variations of these AMs.ResultsWe found the total of 13 oncogenic allosteric modules (OAMs) among chronic hepatitis B (CHB), cirrhosis and HCC network used SimiNEF. We obtained the 11 highly correlated gene pairs involving 15 genes (r > 0.8, P < 0.001) from the 12 OAMs (the out-of-bag (OOB) classification error rate < 0.5) partial consistent with those in independent clinical microarray data, then a three-gene set (cyp1a2-cyp2c19-il6) was optimized to distinguish HCC from non-tumor liver tissues using random forests with an average area under the curve (AUC) of 0.973. Furthermore, we found significant inhibitory effect on the tumor growth of Bel-7402, Hep 3B and Huh7 cell lines in zebrafish treated with the compounds affected those three genes.ConclusionsThese findings indicated that the sequential AMs-based approach could detect HCC risk in the patients with chronic liver disease and might be applied to any time-dependent risk of cancer.

03 May 2020·Phosphorus, Sulfur, and Silicon and the Related Elements

Synthesis of 2-phenoxyl-2-oxo-1,4,2-oxazaphosphinanes from a three component reaction

Author: Ding, Xiling ; Zhao, Yufen ; Bi, Wenzhu ; Chen, Xiaolan ; Zhang, Wenjie ; Li, Zijie

A 1-pot synthetic strategy was developed for the synthesis of heterocyclic 1,4,2-oxazaphosphinanes via a three component Kabachnik-Fields reaction of 2-aminophenol, di-Ph H-phosphonate and carbonyl compoundsThrough this newly developed method, 12 organophosphorus heterocycles and 2 related chrysin derivatives were synthesized with high yields.The target compounds were characterized by ¹H, ³¹P and 13C NMR and MS.

01 Dec 2019·Chinese MedicineQ3 · MEDICINE

Metabolome and transcriptome analyses reveal quality change in the orange-rooted Salvia miltiorrhiza (Danshen) from cultivated field

Q3 · MEDICINE

ArticleOA

Author: Huang, Luqi ; Cui, Guanghong ; Kang, Liping ; Guo, Juan ; Tang, Jinfu ; Fang, Wentao ; Wang, Yanan ; Zhan, Zhilai ; Chen, Tong ; Ma, Ying ; Wang, Ling ; Zhao, Yujun ; Ren, Zhenli ; Nan, Tiegui ; Shen, Ye ; Lai, Changjiangsheng ; Ma, Xiaohui ; Lin, Huixin ; Zhang, Yan ; Zeng, Wen

AbstractBackgroundThe dry root and rhizome of Salvia miltiorrhiza Bunge, or Danshen, is a well-known, traditional Chinese medicine. Tanshinones are active compounds that accumulate in the periderm, resulting in red-colored roots. However, lines with orange roots have been observed in cultivated fields. Here, we performed metabolome and transcriptome analyses to investigate the changes of orange-rooted Danshen.MethodsMetabolome analysis was performed by ultra-high-performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC/Q-Tof–MS) to investigate the metabolites variation between orange Danshen and normal Danshen. RNA sequencing and KEGG enrichment analysis were performed to analyzing the differentially expressed genes between orange-rooted and normal Danshen.ResultsIn total, 40 lipophilic components were detected in metabolome analysis, and seven compounds were significantly decreased in the orange Danshen, including the most abundant active compounds, tanshinone IIA and tanshinone I in normal Danshen. Systematic analysis of transcriptome profiles revealed that the down-regulated genes related to catalytic dehydrogenation was not detected. However, two genes related to stress resistance, and four genes related to endoplasmic reticulum (ER)-associated degradation of proteins were up-regulated in orange Danshen.ConclusionsDecreases in the content of dehydrogenated furan ring tanshinones such as tanshinone IIA resulted in phenotypic changes and quality degradation of Danshen. Transcriptome analysis indicated that incorrect folding and ER-associated degradation of corresponding enzymes, which could catalyze C15-C16 dehydrogenase, might be contributed to the decrease in dehydrogenated furan ring tanshinones, rather than lower expression of the relative genes. This limited dehydrogenation of cryptotanshinone and dihydrotanshinone I into tanshinones IIA and I products, respectively, led to a reduced quality of Danshen in cultivated fields.

100 Deals associated with Shandong Danhong Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Shandong Danhong Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

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

Preclinical

Phase 1 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Yangzheng Compound Mixture	Frailty Syndrome More	Approved
Adalimumab biosimilar(Shandong Danhong Pharmaceutical Co., Ltd.) ( TNF-α )	Ankylosing Spondylitis More	Phase 3
Recombinant human brain natriuretic peptide(Shandong Danhong Pharmaceutical) ( NPRA )	Acute decompensated heart failure More	Phase 1
BC0306	Nonalcoholic Steatohepatitis More	Phase 1
WXSH-0024 ( AT2R )	Neuralgia More	Phase 1

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