Delving into the Latest Updates on CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. with Synapse

Overview

Tags

Infectious Diseases

Otorhinolaryngologic Diseases

Nervous 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

Infectious Diseases	2
Endocrinology and Metabolic Disease	1
Hemic and Lymphatic Diseases	1
Immune System Diseases	1
Nervous System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

PBPs(Bacterial penicillin-binding protein)	1
Top II(Topoisomerase II)	1

To evaluate the bioequivalence of the test preparation (daunorubicin cytarabine liposome for injection) produced by Shijiazhuang Sinopharm Pharmaceutical Co., Ltd. and the reference preparation (daunorubicin cytarabine liposome for injection, trade name: Vyxeos) produced by Jazz Pharmaceuticals Co., Ltd.

Start Date07 Aug 2023

Sponsor / Collaborator

CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

CTR20230112 / RecruitingPhase 3

比较盐酸米托蒽醌脂质体注射液联合卡培他滨与卡培他滨单药用于含铂治疗失败的复发转移性鼻咽癌受试者的随机、开放、阳性对照、多中心Ш期临床研究

[Translation] A randomized, open, positive-controlled, multicenter phase 2 clinical study comparing mitoxantrone hydrochloride liposome injection combined with capecitabine and capecitabine alone in subjects with recurrent metastatic nasopharyngeal carcinoma who have failed platinum-based treatment

主要研究目的：评价盐酸米托蒽醌脂质体注射液联合卡培他滨对比卡培他滨单药治疗在复发转移性鼻咽癌受试者中的有效性。次要研究目的：评价盐酸米托蒽醌脂质体注射液联合卡培他滨对比卡培他滨单药治疗在复发转移性鼻咽癌受试者中的有效性和安全性；评价盐酸米托蒽醌脂质体注射液的药代动力学（PK）特征。

[Translation]

Main study objectives: To evaluate the efficacy of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in subjects with recurrent metastatic nasopharyngeal carcinoma. Secondary study objectives: To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with capecitabine versus capecitabine monotherapy in subjects with recurrent metastatic nasopharyngeal carcinoma; To evaluate the pharmacokinetic (PK) characteristics of mitoxantrone hydrochloride liposome injection.

Start Date15 Feb 2023

Sponsor / Collaborator

CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

CTR20222282 / CompletedNot Applicable

丁酸氯维地平注射用乳剂随机、开放、两周期、两交叉健康受试者生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of clevidipine butyrate emulsion for injection in healthy subjects

主要目的：研究静脉输注受试制剂丁酸氯维地平注射用乳剂（石药集团中诺药业（石家庄）有限公司生产）与参比制剂丁酸氯维地平注射用乳剂（Cleviprex®，Fresenius Kabi Austria GmbH（奥地利）公司生产）在健康受试者体内的药代动力学，评价静脉输注两种制剂的生物等效性。次要目的：研究静脉输注受试制剂丁酸氯维地平注射用乳剂和参比制剂Cleviprex® 在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of the test preparation clevidipine butyrate injection emulsion (produced by Shijiazhuang Zhongnuo Pharmaceutical Co., Ltd., China Pharmaceutical Group) and the reference preparation clevidipine butyrate injection emulsion (Cleviprex®, produced by Fresenius Kabi Austria GmbH (Austria)) in healthy subjects after intravenous infusion, and to evaluate the bioequivalence of the two preparations after intravenous infusion. Secondary objective: To study the safety of the test preparation clevidipine butyrate injection emulsion and the reference preparation Cleviprex® in healthy subjects after intravenous infusion.

Start Date15 Sep 2022

Sponsor / Collaborator

CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

100 Clinical Results associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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0 Patents (Medical) associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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100 Deals associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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100 Translational Medicine associated with CSPC Hebei Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 25 Dec 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 3 Clinical

1

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Carbenicillin Disodium ( PBPs )	Pseudomonas Infections More	Approved
Mitoxantrone liposomal(CSPC Pharmaceutical Group Ltd.) ( Top II )	Nasopharyngeal Carcinoma More	Phase 3