Delving into the Latest Updates on Servier Tianjin Pharmaceutical Co. Ltd. with Synapse

Overview

Basic Info

Introduction

Servier (Tianjin) Pharmaceutical Co Ltd is one of the sixteen production bases that Servier Group has set up globally. It is the only production base in Asia that supplies original research drugs to China and certain Asian countries, while also supporting local clinical research. Servier (Tianjin) Pharmaceutical Co Ltd has rich experience in the consistency evaluation of generic drugs and the development of innovative drugs. Not only does it localize the production of original research drugs of Servier, meeting the needs of a large number of Chinese patients in cardiovascular metabolism, venous health, and tumor fields, but it also provides long-term drug processing services for other Asian countries such as South Korea. Servier (Tianjin) Pharmaceutical Co Ltd possesses a sound and mature quality management system and industry-leading introduced equipment. It is committed to continuously optimizing environmental protection measures and improving production efficiency, professional service quality, and management efficiency. Furthermore, the Tianjin Production Base offers pharmaceutical production outsourcing (CMO) services, aiding clients in rapidly promoting project implementation.

Tags

Cardiovascular Diseases

Nervous System Diseases

Endocrinology and Metabolic Disease

Small molecule drug

Herbal medicine

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

Endocrinology and Metabolic Disease	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2
Herbal medicine	1

Top 5 Target	Count

ACE(Angiotensin-converting enzyme)	1
ACAA2(acetyl-CoA acyltransferase 2)	1

空腹状态下单次口服曲美他嗪缓释胶囊80 mg （每日1次）与餐后状态下（高脂、高热量早餐）单次口服曲美他嗪缓释胶囊80 mg （每日1次）的药代动力学对比研究。一项在中国健康受试者中开展的开放、随机、两周期、双向交叉、单中心、I期研究。

[Translation] A comparative study of the pharmacokinetics of a single oral dose of trimetazidine extended-release capsules 80 mg (once daily) in the fasting state and a single oral dose of trimetazidine extended-release capsules 80 mg (once daily) in the fed state (high-fat, high-calorie breakfast). An open-label, randomized, two-period, two-way crossover, single-center, phase I study conducted in healthy Chinese subjects.

主要目的：主要目的是在中国健康受试者中比较空腹状态下单次口服曲美他嗪缓释胶囊80 mg （每日1次）与餐后状态下（高脂、高热量早餐）单次口服曲美他嗪缓释胶囊80 mg （每日1次）的药代动力学。次要目的：次要目的是在中国健康受试者中收集曲美他嗪缓释胶囊80 mg（每日1次）的一般安全性和耐受性信息。

[Translation]

Primary objective: The primary objective is to compare the pharmacokinetics of a single oral dose of trimetazidine extended-release capsules 80 mg (once daily) in the fasting state with a single oral dose of trimetazidine extended-release capsules 80 mg (once daily) in the fed state (high-fat, high-calorie breakfast) in healthy Chinese subjects. Secondary objective: The secondary objective is to collect general safety and tolerability information of trimetazidine extended-release capsules 80 mg (once daily) in healthy Chinese subjects.

Start Date24 Feb 2021

Sponsor / Collaborator

Servier Tianjin Pharmaceutical Co. Ltd.

CTR20190562 / CompletedPhase 1

观察固定复方制剂培哚普利吲达帕胺氨氯地平中固定复方培哚普利吲达帕胺与氨氯地平之间药代动力学相互作用

[Translation] Observation of the pharmacokinetic interaction between the fixed combination of perindopril, indapamide and amlodipine in the fixed combination preparation of perindopril, indapamide and amlodipine

在中国健康男性受试者中，确定在空腹状态单次给药后，固定复方制剂S 06593（培哚普利精氨酸5 mg/吲达帕胺1.25 mg/氨氯地平5 mg）中固定复方制剂（培哚普利叔丁胺盐4 mg/吲达帕胺1.25 mg）与氨氯地平5 mg 之间是否存在药物代谢动力学相互作用。

[Translation]

To determine whether there is a pharmacokinetic interaction between the fixed combination (perindopril tert-butylamine salt 4 mg/indapamide 1.25 mg) and amlodipine 5 mg in the fixed combination S 06593 (perindopril arginine 5 mg/indapamide 1.25 mg/amlodipine 5 mg) in healthy Chinese male subjects after a single dose in the fasting state.

Start Date17 Jun 2019

Sponsor / Collaborator

Servier Tianjin Pharmaceutical Co. Ltd.

[+2]

CTR20181901 / CompletedPhase 3

在经过为期1个月的培哚普利4 mg/吲达帕胺1.25 mg双药治疗后血压未得到控制的原发性高血压患者中，评价固定复方制剂培哚普利5 mg/吲达帕胺1.25 mg/氨氯地平5 mg与自由联合治疗培哚普利4 mg/吲达帕胺1.25 mg+氨氯地平5 mg相比2个月治疗后的临床疗效和安全性，研究过程中会基于患者血压控制情况调整研究药物剂量。一项中国境内、多中心、随机、双盲、为期7个月的研究。

[Translation] In patients with essential hypertension whose blood pressure was not controlled after 1 month of dual therapy with perindopril 4 mg/indapamide 1.25 mg, the clinical efficacy and safety of the fixed combination of perindopril 5 mg/indapamide 1.25 mg/amlodipine 5 mg were evaluated compared with the free combination therapy of perindopril 4 mg/indapamide 1.25 mg + amlodipine 5 mg after 2 months of treatment. The study drug dose was adjusted based on the patient's blood pressure control during the study. A multicenter, randomized, double-blind, 7-month study in China.

在经过培哚普利/吲达帕胺双药治疗后血压未得到控制的高血压患者中，评估培哚普利/吲达帕胺/氨氯地平的疗效和安全性。

[Translation]

To evaluate the efficacy and safety of perindopril/indapamide/amlodipine in hypertensive patients whose blood pressure is not controlled after perindopril/indapamide dual therapy.

Start Date06 May 2019

Sponsor / Collaborator

Servier Tianjin Pharmaceutical Co. Ltd.

[+2]

100 Clinical Results associated with Servier Tianjin Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Servier Tianjin Pharmaceutical Co. Ltd.

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1

Literatures (Medical) associated with Servier Tianjin Pharmaceutical Co. Ltd.

01 Apr 2024·ESC Heart Failure

Effectiveness and safety of ivabradine in Chinese patients with chronic heart failure: an observational study

Article

Author: Sun, Yuemin ; Su, Guohai ; Feng, Lei ; Ding, Wenhui ; Xu, Yamei ; Han, Huiyuan ; Liu, Xiaohui ; Kong, Xiangqing ; Shen, Yuansheng ; Zhang, Yuhui ; Zhang, Ping ; Guo, Xiaomei ; Zhang, Shuyang ; Yang, Jiefu ; Dong, Yugang ; Zhou, Jingmin ; Tang, Baopeng ; Liu, Fan ; Shi, Bei ; Ge, Junbo ; Zhang, Hong ; Fu, Guosheng ; Zhang, Qing ; Zheng, Zhaofen ; Qian, Caizhen ; Ge, Zhiming

AbstractAimsA therapeutic strategy for chronic heart failure (HF) is to lower resting heart rate (HR). Ivabradine is a well‐known HR‐lowering agent, but limited prospective data exist regarding its use in Chinese patients. This study aimed to evaluate the effectiveness and safety of ivabradine in Chinese patients with chronic HF.Methods and resultsThis multicentre, single‐arm, prospective, observational study enrolled Chinese patients with chronic HF. The primary outcome was change from baseline in HR at 1 and 6 months, measured by pulse counting. Effectiveness was also evaluated using laboratory tests, the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (CSS) and overall summary score (OSS), and New York Heart Association (NYHA) class. Treatment‐emergent adverse events (TEAEs) were assessed. A post hoc analysis examined the effectiveness and safety of ivabradine combined with an angiotensin receptor–neprilysin inhibitor (ARNI) or beta‐blocker. A total of 1003 patients were enrolled [mean age 54.4 ± 15.0 years, 773 male (77.1%), mean baseline HR 88.5 ± 11.3 b.p.m., mean blood pressure 115.7/74.4 ± 17.2/12.3 mmHg, mean left ventricular ejection fraction 30.9 ± 7.6%, NYHA Classes III and IV in 48.8% and 22.0% of patients, respectively]. HR decreased by a mean of 12.9 and 16.1 b.p.m. after 1 and 6 months, respectively (both P < 0.001). At Month 6, improvements in the KCCQ CSS and OSS of ≥5 points were observed in 72.1% and 74.1% of patients, respectively (both P < 0.001). Left ventricular ejection fraction increased by 12.1 ± 11.6 (P < 0.001), and 66.7% of patients showed improvement in NYHA class (P < 0.001). At Month 6, the overall proportion of patients in NYHA Classes III and IV was reduced to 13.5% and 2.1%, respectively. Serum brain natriuretic peptide (BNP) and N‐terminal pro‐BNP changed by −331.9 ng/L (−1238.6, −134.0) and −1113.8 ng/L (−2202.0, −297.2), respectively (P < 0.001). HR reductions and improvements in NYHA and KCCQ scores with ivabradine were similar with and without use of ARNIs or beta‐blockers. Of 498 TEAEs in 296 patients (29.5%), 73 TEAEs in 55 patients (5.5%) were considered related to ivabradine [most frequent sinus bradycardia (n = 7) and photopsia (n = 7)]. TEAEs were reported in a similar number of patients in ARNI and beta‐blocker subgroups (21.9–35.6%).ConclusionsIvabradine treatment reduced HR and improved cardiac function and health‐related quality of life in Chinese patients with chronic HF. Benefits were seen irrespective of whether or not patients were also taking ARNIs or beta‐blockers. Treatment was well tolerated with a similar profile to previous ivabradine studies.

100 Deals associated with Servier Tianjin Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Servier Tianjin 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

Approved

3

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Trimetazidine Hydrochloride ( ACAA2 )	Angina Pectoris More	Approved
Orange Extract	Hemorrhoids More	Approved
Perindopril/Indapamide ( ACE )	Hypertension More	Approved
Gliclazide ( SUR )	Diabetes Mellitus, Type 2 More	Pending