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Otorhinolaryngologic Diseases

Nervous System Diseases

Cardiovascular Diseases

Enzyme

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Enzyme	1

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主要目的：比较中国健康受试者单次静脉滴注巴曲酶注射液受试制剂和参比制剂后的药代动力学特征及生物等效性评价。次要目的：（1）评价中国健康受试者单次静脉滴注巴曲酶注射液受试制剂和参比制剂后的药效学特征；（2）评价中国健康受试者单次静脉滴注巴曲酶注射液受试制剂和参比制剂后的安全性和耐受性。

[Translation]

Primary objective: To compare the pharmacokinetic characteristics and bioequivalence evaluation of the test and reference formulations of batroxobin injection in healthy Chinese subjects after a single intravenous infusion. Secondary objectives: (1) To evaluate the pharmacodynamic characteristics of the test and reference formulations of batroxobin injection in healthy Chinese subjects after a single intravenous infusion; (2) To evaluate the safety and tolerability of the test and reference formulations of batroxobin injection in healthy Chinese subjects after a single intravenous infusion.

Start Date17 Jun 2024

Sponsor / Collaborator

Simcere Pharmaceutical (Hainan) Co. Ltd.

[+1]

CTR20201610 / CompletedNot Applicable

健康受试者空腹状态下单次皮下注射依诺肝素钠注射液的生物等效性试验

[Translation] Bioequivalence study of a single subcutaneous injection of enoxaparin sodium injection in healthy subjects under fasting condition

健康受试者单次皮下注射依诺肝素钠注射液（受试制剂，东营天东制药有限公司研制）与原研药—依诺肝素钠注射液（商品名：克赛®，参比制剂）后，评价受试制剂与参比制剂是否具有生物等效性。

[Translation]

After a single subcutaneous injection of enoxaparin sodium injection (test preparation, developed by Dongying Tiandong Pharmaceutical Co., Ltd.) and the original drug - enoxaparin sodium injection (trade name: Kesai®, reference preparation) were given to healthy subjects, the bioequivalence of the test preparation and the reference preparation was evaluated.

Start Date04 Sep 2020

Sponsor / Collaborator

Dongying Tiandong Pharmaceutical Co. Ltd.

100 Clinical Results associated with Dongying Tiandong Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Dongying Tiandong Pharmaceutical Co. Ltd.

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2

Literatures (Medical) associated with Dongying Tiandong Pharmaceutical Co. Ltd.

Nature CommunicationsQ1 · CROSS-FIELD

Discovery of exolytic heparinases and their catalytic mechanism and potential application

Q1 · CROSS-FIELD

ArticleOA

Author: Zhang, Qingdong ; Cao, Hai-Yan ; Wei, Lin ; Chen, Xiu-Lan ; Zhang, Yu-Zhong ; Chi, Lianli ; Chen, Xiangxue ; Yuan, Min ; Wang, Peng ; Shi, Deling ; Lu, Danrong ; Li, Fuchuan ; Du, Min

AbstractHeparinases (Hepases) are critical tools for the studies of highly heterogeneous heparin (HP)/heparan sulfate (HS). However, exolytic heparinases urgently needed for the sequencing of HP/HS chains remain undiscovered. Herein, a type of exolytic heparinases (exoHepases) is identified from the genomes of different bacteria. These exoHepases share almost no homology with known Hepases and prefer to digest HP rather than HS chains by sequentially releasing unsaturated disaccharides from their reducing ends. The structural study of an exoHepase (BIexoHep) shows that an N-terminal conserved DUF4962 superfamily domain is essential to the enzyme activities of these exoHepases, which is involved in the formation of a unique L-shaped catalytic cavity controlling the sequential digestion of substrates through electrostatic interactions. Further, several HP octasaccharides have been preliminarily sequenced by using BIexoHep. Overall, this study fills the research gap of exoHepases and provides urgently needed tools for the structural and functional studies of HP/HS chains.

Frontiers in MicrobiologyQ2 · BIOLOGY

Identification and Signature Sequences of Bacterial Δ4,5Hexuronate-2-O-Sulfatases

Q2 · BIOLOGY

ArticleOA

Author: Wang, Shumin ; Chen, Xiangxue ; Guan, Jingwen ; Zhang, Qingdong ; Li, Fuchuan

Glycosaminoglycan (GAG) sulfatases, which catalyze the hydrolysis of sulfate esters from GAGs, belong to a large and conserved sulfatase family. Bacterial GAG sulfatases are essential in the process of sulfur cycling and are useful for the structural analysis of GAGs. Only a few GAG-specific sulfatases have been studied in detail and reported to date. Herein, the GAG-degrading Photobacterium sp. FC615 was isolated from marine sediment, and a novel Δ^4,5hexuronate-2-O-sulfatase (PB2SF) was identified from this bacterium. PB2SF specifically removed 2-O-sulfate from the unsaturated hexuronate residue located at the non-reducing end of GAG oligosaccharides produced by GAG lyases. A structural model of PB2SF was constructed through a homology-modeling method. Six conserved amino acids around the active site were chosen for further analysis using site-directed mutagenesis. N113A, K141A, K141H, H143A, H143K, H205A, and H205K mutants exhibited only feeble activity, while the H310A, H310K, and D52A mutants were totally inactive, indicating that these conserved residues, particularly Asp52 and His310, were essential in the catalytic mechanism. Furthermore, bioinformatic analysis revealed that GAG sulfatases with specific degradative properties clustered together in the neighbor-joining phylogenetic tree. Based on this finding, 60 Δ^4,5hexuronate-2-O-sulfatases were predicted in the NCBI protein database, and one with relatively low identity to PB2SF was characterized to confirm our prediction. Moreover, the signature sequences of bacterial Δ^4,5hexuronate-2-O-sulfatases were identified. With the reported signature motifs, the sulfatase sequence of the Δ^4,5hexuronate-2-O-sulfatase family could be simply identified before cloning. Taken together, the results of this study should aid in the identification and further application of novel GAG sulfatases.

100 Deals associated with Dongying Tiandong Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Dongying Tiandong 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

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