Delving into the Latest Updates on Beijing Deli Furui Pharmaceutical Technology Co., Ltd. with Synapse

Overview

Tags

Nervous System Diseases

Congenital Disorders

Immune System 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

Nervous System Diseases	2
Infectious Diseases	1
Immune System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

Cav2.1(calcium voltage-gated channel subunit alpha1 A)	1
COX-2(Cyclooxygenase-2)	1

主要目的：本研究采用随机开放、四序列、四周期、空腹及餐后给药设计比较空腹及餐后条件下北京德立赛纳医药科技有限公司研制、安徽四环科宝制药有限公司生产的塞来昔布片（I）（60 mg/片）2片与Pfizer Pharmaceuticals LLC生产的塞来昔布胶囊（200 mg/粒，西乐葆®）1粒在健康受试者体内暴露量的差异。并分别评价空腹/餐后条件下塞来昔布片（I）与塞来昔布胶囊的食物效应。次要目的：为观察健康志愿者单次口服试验药物和对照药物的安全性。

[Translation]

Main purpose: This study used a randomized open, four-sequence, four-period, fasting and postprandial dosing design to compare the differences in exposure of 2 tablets of celecoxib tablets (I) (60 mg/tablet) developed by Beijing Delishena Pharmaceutical Technology Co., Ltd. and produced by Anhui Sihuan Kebao Pharmaceutical Co., Ltd. and 1 tablet of celecoxib capsules (200 mg/capsule, Celebrex®) produced by Pfizer Pharmaceuticals LLC in healthy subjects under fasting and postprandial conditions. The food effects of celecoxib tablets (I) and celecoxib capsules under fasting/postprandial conditions were evaluated respectively. Secondary purpose: To observe the safety of single oral administration of test drugs and control drugs in healthy volunteers.

Start Date-

Sponsor / Collaborator

Beijing Deli Furui Pharmaceutical Technology Co., Ltd.

CTR20211309 / Not yet recruitingNot Applicable

多西他赛注射用浓缩液(自乳化型)在晚期乳腺癌或非小细胞肺癌患者的多中心、随机、开放、单剂量、两周期、双交叉的人体生物等效性试验

[Translation] A multicenter, randomized, open-label, single-dose, two-cycle, double-crossover bioequivalence study of docetaxel concentrate for injection (self-emulsifying type) in patients with advanced breast cancer or non-small cell lung cancer

主要目的以Sanofi-Aventis Deutschland GmbH公司生产的多西他赛注射液(商品名：泰索帝®)(规格：0.5mL:20mg)为参比制剂，按照生物等效性试验的有关规定，与北京德立英捷医药科技有限公司研制的多西他赛注射用浓缩液(自乳化型)(规格：1mL:20mg)为受试制剂进行体内药动学对比研究，考察多西他赛在晚期乳腺癌或非小细胞肺癌患者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的研究受试制剂多西他赛注射用浓缩液(自乳化型)和参比制剂多西他赛注射液(商品名：泰索帝®)在晚期乳腺癌或非小细胞肺癌患者中的安全性。

[Translation]

Main purpose The docetaxel injection (trade name: Taxotere®) (specification: 0.5mL: 20mg) produced by Sanofi-Aventis Deutschland GmbH was used as the reference preparation. According to the relevant provisions of the bioequivalence test, the docetaxel injection concentrate (self-emulsifying type) (specification: 1mL: 20mg) developed by Beijing Deli Yingjie Pharmaceutical Technology Co., Ltd. was used as the test preparation for in vivo pharmacokinetic comparison study to investigate the pharmacokinetic behavior of docetaxel in patients with advanced breast cancer or non-small cell lung cancer and evaluate the bioequivalence of the two preparations. Secondary purpose To study the safety of the test preparation docetaxel injection concentrate (self-emulsifying type) and the reference preparation docetaxel injection (trade name: Taxotere®) in patients with advanced breast cancer or non-small cell lung cancer.

Start Date-

Sponsor / Collaborator

Beijing Deli Yingjie Pharmaceutical Technology Co., Ltd.

CTR20232309 / RecruitingPhase 1

多西他赛注射用浓缩液（自乳化型）的人体药代动力学对比研究

[Translation] Comparative study on the pharmacokinetics of docetaxel concentrate for injection (self-emulsifying type) in humans

主要目的：以北京德立英捷医药科技有限公司研制、生产的多西他赛注射用浓缩液（自乳化型）（规格：1mL:20mg）为受试制剂，以Sanofi-Aventis Deutschland GmbH公司生产的多西他赛注射液（规格：0.5mL:20mg，泰索帝®）为参比制剂，按照生物等效性试验的有关规定进行体内药动学对比研究，考察多西他赛在诊断为恶性肿瘤且准备接受多西他赛化疗方案患者中的药代动力学行为，评价两种制剂的生物等效性。次要目的：研究受试制剂多西他赛注射用浓缩液(自乳化型)和参比制剂多西他赛注射液(商品名：泰索帝®)在诊断为恶性肿瘤且准备接受多西他赛化疗方案患者中的安全性

[Translation]

Main purpose: To use docetaxel injection concentrate (self-emulsifying type) (specification: 1mL: 20mg) developed and produced by Beijing Deli Yingjie Pharmaceutical Technology Co., Ltd. as the test preparation, and docetaxel injection (specification: 0.5mL: 20mg, Taxotere®) produced by Sanofi-Aventis Deutschland GmbH as the reference preparation, and conduct an in vivo pharmacokinetic comparison study in accordance with the relevant provisions of the bioequivalence test to investigate the pharmacokinetic behavior of docetaxel in patients diagnosed with malignant tumors and ready to receive docetaxel chemotherapy, and evaluate the bioequivalence of the two preparations. Secondary purpose: To study the safety of the test preparation docetaxel injection concentrate (self-emulsifying type) and the reference preparation docetaxel injection (trade name: Taxotere®) in patients diagnosed with malignant tumors and ready to receive docetaxel chemotherapy

Start Date28 Jul 2023

Sponsor / Collaborator

Beijing Deli Yingjie Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Beijing Deli Furui Pharmaceutical Technology Co., Ltd.

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0 Patents (Medical) associated with Beijing Deli Furui Pharmaceutical Technology Co., Ltd.

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100 Deals associated with Beijing Deli Furui Pharmaceutical Technology Co., Ltd.

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100 Translational Medicine associated with Beijing Deli Furui Pharmaceutical Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 26 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

IND Application

1

Phase 1 Clinical

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