[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of dapagliflozin tablets in healthy subjects under the fed state

主要目的：中国健康受试者餐后状态下，口服单剂量达格列净片（Dapagliflozin Tablets，受试制剂T，北京赛而生物药业有限公司生产，规格：10mg/片）与达格列净片（Dapagliflozin Tablets，参比制剂R，AstraZeneca AB持有，AstraZeneca Pharmaceuticals LP生产，商品名：安达唐®/FORXIGA®，规格：10mg/片）进行生物等效研究，研究受试制剂与参比制剂在人体内的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂达格列净片和参比制剂达格列净片（安达唐®/FORXIGA®）在健康受试者中的安全性。

[Translation]

Primary objective: To conduct a bioequivalence study on a single oral dose of dapagliflozin tablets (test preparation T, produced by Beijing Saier Biopharmaceutical Co., Ltd., specification: 10 mg/tablet) and dapagliflozin tablets (dapagliflozin tablets, reference preparation R, owned by AstraZeneca AB and produced by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®, specification: 10 mg/tablet) in healthy Chinese subjects in the postprandial state, to study the absorption rate and extent of the test preparation and the reference preparation in the human body, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation dapagliflozin tablets and the reference preparation dapagliflozin tablets (Andatang®/FORXIGA®) in healthy subjects.

Start Date-

Sponsor / Collaborator

Beijing Saier Biological Pharmaceutical Co., Ltd.

CTR20243094 / Not yet recruitingNot Applicable

达格列净片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹状态下的生物等效性试验

[Translation] A randomized, open, single-dose, two-formulation, two-sequence, two-cycle crossover bioequivalence study of dapagliflozin tablets in healthy subjects under fasting conditions

主要目的：中国健康受试者空腹状态下，口服单剂量达格列净片（Dapagliflozin Tablets，受试制剂T，北京赛而生物药业有限公司生产，规格：10mg/片）与达格列净片（Dapagliflozin Tablets，参比制剂R，AstraZeneca AB持有，AstraZeneca Pharmaceuticals LP生产，商品名：安达唐®/FORXIGA®，规格：10mg/片）进行生物等效研究，研究受试制剂与参比制剂在人体内的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂达格列净片和参比制剂达格列净片（安达唐®/FORXIGA®）在健康受试者中的安全性。

[Translation]

Primary objective: To conduct a bioequivalence study on a single oral dose of dapagliflozin tablets (test preparation T, produced by Beijing Saier Biopharmaceutical Co., Ltd., specification: 10 mg/tablet) and dapagliflozin tablets (dapagliflozin tablets, reference preparation R, owned by AstraZeneca AB, produced by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®, specification: 10 mg/tablet) in healthy Chinese subjects under fasting state, to study the absorption rate and extent of the test preparation and the reference preparation in the human body, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation dapagliflozin tablets and the reference preparation dapagliflozin tablets (Andatang®/FORXIGA®) in healthy subjects.

Start Date-

Sponsor / Collaborator

Beijing Saier Biological Pharmaceutical Co., Ltd.

CTR20201746 / CompletedPhase 4

单唾液酸四己糖神经节苷脂钠注射液(GM1)治疗急性缺血性脑卒中的有效性及安全性的随机、双盲、安慰剂平行对照、多中心临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial on the efficacy and safety of monosialotetrahexosylganglioside sodium injection (GM1) in the treatment of acute ischemic stroke

评价单唾液酸四己糖神经节苷脂钠注射液治疗急性缺血性脑卒中的有效性及安全性

[Translation]

To evaluate the efficacy and safety of monosialotetrahexosylganglioside sodium injection in the treatment of acute ischemic stroke

Start Date11 Sep 2020

Sponsor / Collaborator

Beijing Science Sun Pharmaceutical Co., Ltd.

100 Clinical Results associated with Beijing Science Sun Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Beijing Science Sun Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Beijing Science Sun Pharmaceutical Co., Ltd.

25 Aug 2023·Nutrients

Auricularia auricula Peptides Nutritional Supplementation Delays H₂O₂-Induced Senescence of HepG2 Cells by Modulation of MAPK/NF-κB Signaling Pathways.

Article

Author: Li, Haiyan ; Gao, Ji'an ; Zhao, Fen ; Liu, Xinqi ; Han, Qianwen ; Ma, Biao

Auricularia auricula is a traditional medicinal and edible mushroom with anti-aging effects. Many studies focused on polysaccharides and melanin. However, the anti-aging effects and mechanism of the nutritional supplementation of Auricularia auricula peptides (AAPs) were not elucidated. In this study, AAPs were prepared by enzymolysis of flavor protease and the protective effects on H₂O₂-induced senescence of HepG2 cells were explored for the first time. The potential mechanism was also investigated. AAPs were mostly composed of low molecular weights with less than 1000 Da accounting for about 79.17%, and contained comprehensive amino acids nutritionally, including seven essential amino acids, aromatic, acidic, and basic amino acids. AAPs nutritional supplementation could significantly decrease the levels of intracellular reactive oxygen species (ROS) and malondialdehyde (MDA), and increase the activities of antioxidant enzymes (SOD, CAT, and GSH-Px). In addition, the senescence-associated-β-galactosidase (SA-β-gal) activity was restrained, and the expression levels of senescence-associated secretory phenotype (SASP) (IL-6, IL-8, IL-1β, and CXCL2) were also decreased. Ribonucleic acid sequencing (RNA-Seq) was carried out to screen the differentially expressed genes (DEGs) between different groups. GO and KEGG enrichment analysis showed that the mechanism was related to the MAPK/NF-κB signaling pathways. Quantitative real-time PCR (qRT-PCR) analysis and Western blot were carried out to verify the key genes and proteins in the pathways, respectively. AAPs nutritional supplementation resulted a significant down-regulation in key the genes c-fos and c-jun and up-regulation in DUSP1 of the MAPK signaling pathway, and down-regulation in the key genes CXCL2 and IL-8 of the NF-κB signaling pathway. The results of Western blot demonstrate that AAPs nutritional supplementation could inhibit MAPK/NF-κB pathways by reducing the expression levels of IKK, IκB, P65, and phosphorylation of ERK, thus decreasing the inflammatory reaction and delaying cell senescence. It is the first time that AAPs nutritional supplementation was proved to have protective effects on H₂O₂-induced oxidative damage in HepG2 cells. These results implicate that dietary AAPs could be used as nutrients to reduce the development or severity of aging.

Foods

Bioactive Peptides from Edible Mushrooms—The Preparation, Mechanisms, Structure—Activity Relationships and Prospects

Review

Author: Zhao, Fen ; Li, Haiyan ; Gao, Ji'an ; Ma, Biao ; Liu, Xinqi

Mushroom bioactive peptides (MBPs) are bioactive peptides extracted directly or indirectly from edible mushrooms. MBPs are known to have antioxidant, anti-aging, antibacterial, anti-inflammatory and anti-hypertensive properties, and facilitate memory and cognitive improvement, antitumour and anti-diabetes activities, and cholesterol reduction. MBPs exert antioxidant and anti-inflammatory effects by regulating the MAPK, Keap1-Nrf2-ARE, NF-κB and TNF pathways. In addition, MBPs exert antibacterial, anti-tumour and anti-inflammatory effects by stimulating the proliferation of macrophages. The bioactivities of MBPs are closely related to their molecular weights, charge, amino acid compositions and amino acid sequences. Compared with animal-derived peptides, MBPs are ideal raw materials for healthy and functional products with the advantages of their abundance of resources, safety, low price, and easy-to-achieve large-scale production of valuable nutrients for health maintenance and disease prevention. In this review, the preparation, bioactivities, mechanisms and structure–activity relationships of MBPs were described. The main challenges and prospects of their application in functional products were also discussed. This review aimed to provide a comprehensive perspective of MBPs.

Shipin Yu Yaopin

Determination of Sodium Ions in Nadroparin Calcium by Flame Absorption Spectrometry

Author: Lyu Xiao-li ; Kong Shuang-quan ; Song Meng-wei ; Ren Li-xin

Objective To establish a quant. determination method for sodium ions in nadroparin calcium.Methods Sodium ions were determined at 589.0 nm using caesium chloride as masking agent by flame at. absorption spectrometry.Results Under the optimized conditions, the calibration curve of sodium ion showed good linearity(r=0.9998).The linear range of sodium ion was 0.2 to 1.5 μg/mL, and the limit of detection(LOD) and the limit of quantitation(LOQ) were 0.006 and 0.020 μg/mL, resp.The average recovery was 100.72 %, with RSD of 1.24 %.Conclusion The method is simple, rapid, high sensitive and reproducible, which can meet requirements for the determination of sodium ions in nadroparin calcium.

100 Deals associated with Beijing Science Sun Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Beijing Science Sun Pharmaceutical Co., Ltd.

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Pipeline Snapshot as of 24 Dec 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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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Plasmin ( Fibrinogen x Plasminogen activators )	Thrombotic cerebral infarction More	Approved
Bevacizumab(Beijing Science Sun) ( VEGF-A )	Metastatic Colorectal Carcinoma More	IND Approval
Anti-angiogenesis Peptide(Beijing Cancer Hospital)	Lung Cancer More	Preclinical
JTYM (Beijing Science Sun Pharmaceutical Co., Ltd.)	Cardiovascular Diseases More	Discontinued
YJM (Beijing Science Sun Pharmaceutical Co., Ltd.)	Cerebrovascular Disorders More	Discontinued

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