Delving into the Latest Updates on Shanghai Shyndec Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Infectious Diseases

Other Diseases

Nervous System Diseases

Small molecule drug

Herbal medicine

Synthetic peptide

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	9
Nervous System Diseases	7
Endocrinology and Metabolic Disease	6
Immune System Diseases	3
Neoplasms	2

Top 5 Drug Type	Count

Small molecule drug	17
Herbal medicine	6
Synthetic peptide	1
Contrast agent	1
Chemical drugs	1

Top 5 Target	Count

MR(Mineralocorticoid receptor)	1
PBPs(Bacterial penicillin-binding protein)	1
PARP1(Poly (ADP-Ribose) polymerase 1)	1
adrenergic receptor(Adrenergic receptors)	1
fungal CYP51A1	1

主要目的：本试验旨在研究空腹及餐后口服上海现代制药股份有限公司生产的阿戈美拉汀片（25mg）的药代动力学特征，并以Les Laboratoires Servier持证的阿戈美拉汀片（Valdoxan®，25mg）作为参比制剂，比较两制剂的药动学参数，评价两制剂的人体生物等效性。次要目的：观察健康受试者口服受试制剂和参比制剂的安全性。

[Translation]

Primary objective: This study aims to study the pharmacokinetic characteristics of agomelatine tablets (25 mg) produced by Shanghai Modern Pharmaceutical Co., Ltd. after oral administration on an empty stomach and after meals, and to compare the pharmacokinetic parameters of agomelatine tablets (Valdoxan®, 25 mg) certified by Les Laboratoires Servier as the reference preparation, and to evaluate the bioequivalence of the two preparations in humans. Secondary objective: To observe the safety of the test preparation and the reference preparation when taken orally in healthy subjects.

Start Date19 Sep 2024

Sponsor / Collaborator

Shanghai Shyndec Pharmaceutical Co., Ltd.

CTR20242986 / CompletedNot Applicable

美阿沙坦钾片在健康受试者中的生物等效性研究

[Translation] Bioequivalence study of Asartan potassium tablets in healthy subjects

本试验旨在研究单剂量空腹和餐后口服拟以国药集团容生制药有限公司持证的美阿沙坦钾片（80 mg）的药代动力学特征，并以Takeda Pharma A/S持证的美阿沙坦钾片（易达比®，80mg）作为参比制剂，比较两制剂的药动学参数，评价两制剂的人体生物等效性，并观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

This study aims to study the pharmacokinetic characteristics of a single-dose oral fasting and postprandial dose of Asartan Potassium Tablets (80 mg) licensed by Sinopharm Rongsheng Pharmaceutical Co., Ltd., and Asartan Potassium Tablets (Edabib®, 80 mg) licensed by Takeda Pharma A/S as the reference preparation, compare the pharmacokinetic parameters of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date11 Sep 2024

Sponsor / Collaborator

Guoyao Group Rongsheng Pharmaceutical Co. Ltd.

CTR20242418 / CompletedNot Applicable

达格列净片在健康受试者中的生物等效性研究

[Translation] Bioequivalence study of dapagliflozin tablets in healthy subjects

本试验旨在研究单剂量空腹和餐后口服上海现代制药股份有限公司研制、生产的达格列净片（10mg/片）的药代动力学特征，并以AstraZeneca Pharmaceuticals LP生产的达格列净片（Farxiga®，安达唐®，10mg/片）作为参比制剂，比较两制剂的药动学参数，评价两制剂的人体生物等效性，并观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

This study aims to study the pharmacokinetic characteristics of a single-dose fasting and postprandial oral administration of dapagliflozin tablets (10 mg/tablet) developed and produced by Shanghai Modern Pharmaceutical Co., Ltd., and to use dapagliflozin tablets (Farxiga®, Andatang®, 10 mg/tablet) produced by AstraZeneca Pharmaceuticals LP as the reference preparation, to compare the pharmacokinetic parameters of the two preparations, to evaluate the human bioequivalence of the two preparations, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date19 Aug 2024

Sponsor / Collaborator

Shanghai Shyndec Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shanghai Shyndec Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Shanghai Shyndec Pharmaceutical Co., Ltd.

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52

Literatures (Medical) associated with Shanghai Shyndec Pharmaceutical Co., Ltd.

01 Sep 2022·Preparative Biochemistry & BiotechnologyQ4 · ENGINEERING & TECHNOLOGY

Effect of temperature on synthesis of clavulanic acid and impurity substance G during fermentation by Streptomyces clavuligerus

Q4 · ENGINEERING & TECHNOLOGY

Article

Author: Zhuang, Ying-Ping ; Chu, Ju ; Feng, Tao ; Bai, Yan-Feng ; Zhao, Jie ; Wang, Yong-Hong

Effect of temperature on synthesis of Clavulanic acid (CA) and impurity substance G during fermentation by Streptomyces clavuligerus were investigated. Results show that fermentation at 24 °C is the most favorable for CA synthesis though the fermentation duration was 20-30 hours longer than fermentation at 26 and 28 °C. Meanwhile, the impurity substance G was only 110 mg/L in the end broth of fermentation at 24 °C, which was significantly lower than 148 and 180 mg/L of fermentation at 26 and 28 °C, respectively. Correlation of specific growth rate and CA synthesis was statistically analyzed based on data of 10 batches of industrial fermentation. Two temperature-shift strategies were investigated in 50 L fermenter. Fermentation with 26-24 °C temperature strategy achieved 5097 mg/L CA titer, meanwhile the fermentation duration was shortened 24 hours comparing with fermentation at constant 24 °C. Fermentation with 26-24 °C control strategy was validated in a 60 m³ industrial fermenter, in which 4960 mg/L of CA was achieved while impurity G substance was decreased to titer 65 mg/L from 200 to 300 mg/L of normal production.

01 Dec 2021·Applied Biochemistry and BiotechnologyQ3 · ENGINEERING & TECHNOLOGY

Statistical Optimizing of Medium for Clavulanic Acid Production by Streptomyces clavuligerus Using Response Surface Methodology

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Wang, Yong-Hong ; Feng, Tao ; Zhao, Jie ; Chu, Ju ; Zhuang, Ying-Ping

Clavulanic acid (CA) is a naturally occurring antibiotic produced by Streptomyces clavuligerus. Statistical optimization of the fermentation medium for CA production by Streptomyces clavuligerus was carried out. Multiple carbon sources, glycerol, dextrin, and triolein, were considered simultaneously. A two-level fractional factorial design experiment was conducted to identify the significant components of medium on CA production. Statistical analysis of the results showed that soybean meal, dextrin, and triolein were the most significant medium ingredients on CA production. The optimal level of these screened components was obtained by RSM based on the result of a Box-Behnken design, in which the values of dextrin, soybean meal, and triolein in CA fermentation medium were 12.37 g/L, 39.75 g/L, and 26.98 ml/L, respectively. Using the proposed optimized medium, the model predicted 938 mg/L of CA level and via experimental rechecking the model, 946 mg/L of CA level was attained in shake flask fermentation, significantly high than 630 mg/L of original medium. The optimized medium was further verified in 50-L stirred fermenter, and compared with performance of original medium in parallel, CA titer was increased from 889 to 1310 mg/L; a 47% increase was achieved through medium optimization by statistical approaches.

01 Dec 2020·BMC Geriatrics

Correction to: Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study

Author: Lv, Linsheng ; Chen, Miaoxia ; Liu, Xun ; Yan, Lei

An amendment to this paper has been published and can be accessed via the original article.

100 Deals associated with Shanghai Shyndec Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Shanghai Shyndec Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 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

Discovery

1

4

Phase 1 Clinical

Approved

20

9

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ethiodized Oil	Contrast agents More	Approved
Mannatide	Immune Deficiency Disease More	Approved
Ibuprofen/Codeine Phosphate ( COX x Opioid receptors )	-	Approved
Terconazole ( fungal CYP51A1 )	Candidiasis, Vulvovaginal More	Approved
Milnacipran Hydrochloride ( NET x SERT )	Depressive Disorder More	Approved