Delving into the Latest Updates on Suzhou First Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Skin and Musculoskeletal Diseases

Endocrinology and Metabolic Disease

Urogenital Diseases

Small molecule drug

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	3
Neoplasms	2
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	5

Top 5 Target	Count

ER(Estrogen receptors)	2
DAT(Dopamine transporter)	1

主要目的：考察中国健康受试者在空腹/餐后条件下单剂量口服苏州第壹制药有限公司生产的达格列净片（规格：10mg）与 AstraZeneca Pharmaceuticals LP 的达格列净片（规格：10mg）的体内药代动力学特征，评价其生物等效性。次要目的：评价单剂量口服达格列净片（规格：10mg）受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of dapagliflozin tablets (specification: 10 mg) produced by Suzhou No. 1 Pharmaceutical Co., Ltd. and dapagliflozin tablets (specification: 10 mg) produced by AstraZeneca Pharmaceuticals LP in healthy Chinese subjects after single oral administration under fasting/postprandial conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of the test and reference formulations of single oral dapagliflozin tablets (specification: 10 mg) in healthy Chinese subjects.

Start Date-

Sponsor / Collaborator

Suzhou First Pharmaceutical Co., Ltd.

CTR20180743 / Completed

富马酸喹硫平片100mg健康受试者中随机、开放、两制剂、单次给药、四周期重复交叉空腹餐后状态下生物等效性研究

[Translation] A randomized, open-label, two-dose, single-dose, four-period repeated crossover bioequivalence study of quetiapine fumarate tablets 100 mg in healthy subjects under fasting and fed conditions

以苏州第壹制药有限公司生产的富马酸喹硫平片为受试制剂，阿斯利康（AstraZeneca）公司生产的富马酸喹硫平片（商品名：思緖康）为参比制剂，研究两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。

[Translation]

Quetiapine fumarate tablets produced by Suzhou First Pharmaceutical Co., Ltd. were used as the test preparation, and quetiapine fumarate tablets (trade name: Siokan) produced by AstraZeneca Company were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations in single administration under fasting and postprandial conditions were evaluated to evaluate whether the two preparations are bioequivalent.

Start Date-

Sponsor / Collaborator

Suzhou First Pharmaceutical Co., Ltd.

CTR20240029 / CompletedNot Applicable

富马酸伏诺拉生片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of vonoprazan fumarate tablets in healthy subjects after single oral administration on an empty stomach or after a meal

主要目的：考察中国健康受试者在空腹/餐后条件下单剂量口服江苏利泰尔药业有限公司（持有人：苏州第壹制药有限公司）生产的富马酸伏诺拉生片与 Takeda Pharmaceutical Company Limited, Hikari Plant 生产的（持证商：Takeda Pharmaceutical Company Limited）富马酸伏诺拉生片后的体内药代动力学特征，评价两制剂的生物等效性；次要目的：研究单剂量口服富马酸伏诺拉生片（规格：20mg）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of vonoprazan fumarate tablets produced by Jiangsu Litaier Pharmaceutical Co., Ltd. (Owner: Suzhou No. 1 Pharmaceutical Co., Ltd.) and vonoprazan fumarate tablets produced by Takeda Pharmaceutical Company Limited, Hikari Plant (Certificate Holder: Takeda Pharmaceutical Company Limited) in healthy Chinese subjects after single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations; Secondary objective: To study the safety of single oral dose vonoprazan fumarate tablets (specification: 20 mg) in healthy Chinese subjects.

Start Date02 Jan 2024

Sponsor / Collaborator

Suzhou First Pharmaceutical Co., Ltd.

100 Clinical Results associated with Suzhou First Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Suzhou First Pharmaceutical Co., Ltd.

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100 Deals associated with Suzhou First Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Suzhou First 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

5

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Levoleucovorin	Colorectal Cancer More	Approved
Chlorotrianisene ( ER )	Prostatic Hyperplasia More	Approved
Methylphenidate Hydrochloride ( DAT )	Narcolepsy More	Approved
Cholecalciferol Chloesterol	Osteoporosis More	Approved
Tamoxifen Citrate ( ER )	Breast Cancer More	Approved