Top 5 Target	Count

β2-adrenergic receptor(Beta-2 adrenergic receptor)	1
GnRHR(Gonadotropin-releasing hormone receptor)	1
GABAB receptor(Gamma-Aminobutyric Acid B Receptor)	1
ER(Estrogen receptors)	1

Drugs associated with Ningbo Team Pharm Co. Ltd.

Elagolix Sodium

Target

GnRHR

Mechanism

GnRHR antagonists

Active Org.

AbbVie, Inc. [+4]

Originator Org.

Neurocrine Biosciences, Inc.

Active Indication

Pain [+7]

Inactive Indication

Menopausal symptoms [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date23 Jul 2018

Formoterol Fumarate

Target

β2-adrenergic receptor

Mechanism

β2-adrenergic receptor agonists

Active Org.

AstraZeneca UK Ltd. [+3]

Originator Org.

Novartis AG

Active Indication

Asthma [+3]

Inactive Indication

airway disease [+4]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date16 Feb 2001

Toremifene Citrate

Target

Mechanism

ERs modulators

Active Org.

Orion Oyj [+2]

Originator Org.

Orion Co., Ltd.

Active Indication

Estrogen receptor-negative breast cancer [+2]

Inactive Indication

Fractures, Bone [+6]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date31 Mar 1995

Clinical Trials associated with Ningbo Team Pharm Co. Ltd.

CTR20240628 / CompletedNot Applicable

盐酸曲唑酮片在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of trazodone hydrochloride tablets in humans under fasting and fed conditions

本研究考察健康受试者在空腹及餐后条件下，单次口服由福安药业集团宁波天衡制药有限公司生产的盐酸曲唑酮片（受试制剂，规格：100mg）或由Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.P.A持证的盐酸曲唑酮片（参比制剂，规格：100mg）的药动学特征，评价两制剂的生物等效性及安全性。

[Translation]

This study investigated the pharmacokinetic characteristics of trazodone hydrochloride tablets (test preparation, strength: 100 mg) produced by Ningbo Tianheng Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group or trazodone hydrochloride tablets (reference preparation, strength: 100 mg) certified by Aziende Chimiche Riunite Angelini Francesco-A.C.R.A.F.S.P.A. in healthy subjects under fasting and postprandial conditions, and evaluated the bioequivalence and safety of the two preparations.

Start Date07 Mar 2024

Sponsor / Collaborator

Ningbo Team Pharm Co. Ltd.

CTR20234308 / CompletedNot Applicable

卡维地洛片（10mg）健康人体生物等效性研究

[Translation] Bioequivalence study of carvedilol tablets (10 mg) in healthy volunteers

主要目的：本研究以福安药业集团宁波天衡制药有限公司生产的卡维地洛片（规格：10mg）为受试制剂，按生物等效性研究的有关规定，以原研厂家Daiichi Sankyo Co., Ltd.生产的卡维地洛片（规格：10mg，商品名：ARTIST®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察受试制剂卡维地洛片和参比制剂卡维地洛片（ARTIST®）在健康受试者中的安全性。

[Translation]

Primary objective: This study used carvedilol tablets (specification: 10 mg) produced by Ningbo Tianheng Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group as the test preparation. According to the relevant regulations of bioequivalence studies, carvedilol tablets (specification: 10 mg, trade name: ARTIST®) produced by the original manufacturer Daiichi Sankyo Co., Ltd. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary objective: To observe the safety of the test preparation carvedilol tablets and the reference preparation carvedilol tablets (ARTIST®) in healthy subjects.

Start Date22 Jan 2024

Sponsor / Collaborator

Ningbo Team Pharm Co. Ltd.

CTR20240006 / CompletedNot Applicable

多索茶碱片（0.4 g）在餐后状态下健康人体生物等效性研究

[Translation] Study on the bioequivalence of doxofylline tablets (0.4 g) in healthy volunteers in the fed state

主要目的：本研究以福安药业集团宁波天衡制药有限公司研发的多索茶碱片（规格：0.4 g）为受试制剂，按生物等效性研究的有关规定，以原研厂家ABC FARMACEUTICI S.P.A.持有的多索茶碱片（规格：400 mg，商品名：ANSIMAR®）为参比制剂，评估受试制剂和参比制剂在餐后状态下给药后的生物等效性。次要目的：观察受试制剂多索茶碱片和参比制剂多索茶碱片（ANSIMAR®）在健康受试者中的安全性。

[Translation]

Main purpose: This study used the doxofylline tablets (specification: 0.4 g) developed by Ningbo Tianheng Pharmaceutical Co., Ltd. of Fu'an Pharmaceutical Group as the test preparation. According to the relevant regulations of bioequivalence studies, the doxofylline tablets (specification: 400 mg, trade name: ANSIMAR®) held by the original manufacturer ABC FARMACEUTICI S.P.A. were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration in the postprandial state. Secondary purpose: Observe the safety of the test preparation doxofylline tablets and the reference preparation doxofylline tablets (ANSIMAR®) in healthy subjects.

Start Date08 Jan 2024

Sponsor / Collaborator

Ningbo Team Pharm Co. Ltd.

100 Clinical Results associated with Ningbo Team Pharm Co. Ltd.

0 Patents (Medical) associated with Ningbo Team Pharm Co. Ltd.

Literatures (Medical) associated with Ningbo Team Pharm Co. Ltd.

01 Sep 2023·Pakistan journal of pharmaceutical sciences

A validated method for the determination of quetiapine fumarate tablets in human plasma by UPLC-MS/MS and its application to a pharmacokinetic study in healthy Chinese subjects.

Article

Author: Luo, Kaiwei ; Huang, Lihong ; Lin, Jie ; Sun, Pingping ; Lu, Weiyong ; Zhao, Haiming ; Zhang, Huina ; Yang, Wenjuan ; Cheng, Qunan ; Lou, Tingting

A rapid, highly specific and sensitive UPLC-MS/MS method was developed for the determination of Quetiapine Fumarate, a therapeutic drug for various psychiatric disorders, in human plasma. The samples were pretreated using a protein precipitation method, followed by chromatographic separation using a column (Kinetex C18, 2.6µm 50*2.1mm) equipped with an ESI source and MRM mode mass spectrometer. In the validation results of the method, the analyte quetiapine showed a peak at approximately 1.0 minute and exhibited good linearity within the concentration from 2.5 to 2000ng/mL. The intra- and inter-batch precision CV% were within the range of -1.3% to 7.7% and precision of intra- and inter-batch were below 15.0%. Furthermore, this method demonstrated low matrix effects and high recovery rates. The quetiapine plasma sample solution remained stable at room temperature for 25 hours and following 4 freeze-thaw cycles. The prepared samples remained stable in the autosampler (The temperature control of the autosampler was 5^oC) for 185 hours and after four freeze-thaw cycles at -20^oC and -70^oC for 40 days. The present work effectively employed this approach to investigate the pharmacokinetics of orally administered quetiapine fumarate tablets in a cohort of healthy Chinese individuals, both in a fasting state and after a meal.

01 Jul 2023·Pakistan journal of pharmaceutical sciences

Determination of rebamipide in human plasma by a validated liquid chromatography-tandem mass spectrometry: Application in pharmacokinetics research.

Article

Author: Zhao, Hangyu ; Dai, Xiaoyan ; Cheng, Jiangmin ; Chen, Xuefen ; Liu, Zebei ; Zhao, Haiming ; Zhang, Huina ; Qin, Benkai ; Huang, Lihong

A new method for the determination of rebamipide in human heparin sodium plasma by LC-MS was established and its methodology was validated. In this method, protein precipitation method was used to pretreat the samples and the rebamipide-d4 isotope of rebamipide was used as the internal standard. In the multi reaction monitoring mode, the electrospray ion source was used as the ionization technolog and LC-MS was used for detection and analysis. The liquid chromatographic conditions were: 00B-4605-AN (Kinetex® XB-C18 100A 50mm × 2.1mm, 5μm); mobile phase A: 0.1% FA and 1 mM NH₄FA aqueous solution, mobile phase B: 0.1% FA and 1mM NH₄FA 90% ACN solution, flow rate: 0.300mL/min, injection volume: 10uL, column temperature: 30oC, collection time: 3 min, injector temperature control: 5^oC. The retention time of rebamipide and rebamipide-d4 were 1.32min and 1.31min, respectively. The lower limit of quantification was 1ng/mL and the calibration map of rebamipide in the concentration range of 1 to 800ng/mL was linear (R² >0.990, n=11). The CV% values of the inter and intra batch precision of the method were both less than 15.0%. This method has been successfully applied to pharmacokinetic studies to evaluate the main pharmacokinetic parameters of rebamipide.

01 Jul 2023·Pakistan journal of pharmaceutical sciences

Development and evaluation of sustained release matrix tablets of pregabalin: A case study based on quality by design to analyze the impact of variables.

Article

Author: Yonghua Yu, - ; Huina Zhang, - ; Benkai Qin, - ; Penghe Xu, - ; Tingting Lou, -

The current research work describes systematic development of sustained release matrix tablets of a hydrophilic drug, pregabalin, using employing rational blend of hydrophilic polymers such as polyoxyethylene and carbomer as the release controlling polymers. As per the QbD-based approach, the patient-centric quality target product profile was defined and critical quality attributes were earmarked. Preliminary studies were conducted for screening the formulation and process variables. Systematic optimization of the highly critical and influential formulation variables were optimized with the help of an orthogonal experimental design. The impact of independent factors such as the amount of polyvinyl pyrrolidone, polyethylene oxide and carbomer 971P was optimized on in vitro drug release parameters at different time points as the dependent factors. The optimized tablet formulation was subjected to film coating with opadry color concentrate with the help of standard pan coating process. Further, the process optimization was performed for evaluating the impact of key process parameters on the quality attributes of the drug product. Overall, the study indicated successful development of the sustained release tablet formulation of pregabalin using hydrophilic polymers, where experimental design use provides significantly benefit in the product and process understanding.

100 Deals associated with Ningbo Team Pharm Co. Ltd.

100 Translational Medicine associated with Ningbo Team Pharm Co. Ltd.

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Pipeline

Pipeline Snapshot as of 05 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

Phase 1 Clinical

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Baclofen ( GABAB receptor )	Muscle Spasticity More	Approved
Toremifene Citrate ( ER )	Breast Cancer More	Approved
Formoterol Fumarate ( β2-adrenergic receptor )	Bronchitis More	Approved
Elagolix Sodium ( GnRHR )	Moderate pain More	Phase 1

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