Delving into the Latest Updates on CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Endocrinology and Metabolic Disease

Hemic and Lymphatic Diseases

Fusion protein

Biosimilar

Colony-stimulating factors

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

Hemic and Lymphatic Diseases	2
Endocrinology and Metabolic Disease	2
Nervous System Diseases	1

Top 5 Drug Type	Count

Biosimilar	2
Colony-stimulating factors	2
Chemical drugs	1
Synthetic peptide	1
Fusion protein	1

Top 5 Target	Count

GLP-1R(Glucagon-like peptide 1 receptor)	2
CSF-3R(Colony stimulating factor 3 receptor)	2

第一阶段（SAD）主要目的：评价SYH9017注射液单次皮下注射给药在中国超重与肥胖参与者中的安全性、耐受性次要目的：评价SYH9017注射液单次皮下注射给药在中国超重与肥胖参与者中的PK特征；评价SYH9017注射液单次给药在中国超重与肥胖参与者中的免疫原性；评价SYH9017注射液单次给药在中国超重与肥胖参与者中的PD特征第二阶段（MAD）主要目的：评价SYH9017注射液多次皮下注射给药在中国超重与肥胖参与者中的安全性、耐受性次要目的：评价SYH9017注射液多次皮下注射给药在中国超重与肥胖参与者中的PK特征；评价SYH9017注射液多次给药在中国超重与肥胖参与者中的免疫原性；评价SYH9017注射液多次给药在中国超重与肥胖参与者中PD特征；评价SYH9017注射液和司美格鲁肽注射液（诺和盈®）的PK特征、PD特征、安全性比对

[Translation]

Phase I (SAD) Primary purpose: To evaluate the safety and tolerability of a single subcutaneous injection of SYH9017 injection in Chinese overweight and obese participants Secondary purpose: To evaluate the PK characteristics of a single subcutaneous injection of SYH9017 injection in Chinese overweight and obese participants; To evaluate the immunogenicity of a single subcutaneous injection of SYH9017 injection in Chinese overweight and obese participants; To evaluate the PD characteristics of a single subcutaneous injection of SYH9017 injection in Chinese overweight and obese participants Phase II (MAD) Primary purpose: To evaluate the Safety and tolerability of SYH9017 injection after multiple subcutaneous injections in overweight and obese Chinese participants Secondary objectives: To evaluate the PK characteristics of SYH9017 injection after multiple subcutaneous injections in overweight and obese Chinese participants; To evaluate the immunogenicity of SYH9017 injection after multiple administrations in overweight and obese Chinese participants; To evaluate the PD characteristics of SYH9017 injection after multiple administrations in overweight and obese Chinese participants; To evaluate the PK characteristics, PD characteristics, and safety comparison of SYH9017 injection and semaglutide injection (Novowin®).

Start Date24 Feb 2025

Sponsor / Collaborator

CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

[+1]

NCT06604624

/ Active, not recruitingPhase 3

To Evaluate a Multicenter, Randomized, Open, Positive Parallel Controlled Phase III Clinical Trial of Semaglutide Injection (HD1916) in the Treatment of Obesity

This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.

Start Date20 Sep 2024

Sponsor / Collaborator

CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

100 Clinical Results associated with CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

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100 Deals associated with CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 31 Mar 2025

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

2

Phase 3

Approved

2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pegylated recombinant human granulocyte colony stimulating factor(CSPC Pharmaceutical Group Ltd.) ( CSF-3R )	Neutropenia More	Approved
Recombinant human granulocyte stimulating factor(CSPC Pharmaceutical Group Ltd.) ( CSF-3R )	Neutropenia More	Approved
TG103 ( GLP-1R )	Diabetes Mellitus, Type 2 More	Phase 3
Semaglutide (CSPC Zhongqi) ( GLP-1R )	Obesity More	Phase 3
Omalizumab biosimilar (CSPC) ( IgE )	Chronic Urticaria More	Pending