Delving into the Latest Updates on Nanjing Shunxin Pharmaceutical Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Established in 2001 by Thailand's Charoen Pokphand Group and Jiangsu Province Agricultural Reclamation Group, Nanjing Shunxin Pharmaceutical Co., Ltd. is now a leading Chinese pharmaceutical company. It specializes in areas including cardiovascular, tumor, imaging, perioperative, digestive, and urological therapies. Guided by the notion that imitation stimulates innovation, the company invests heavily in its R&D team, fostering innovative products that rank among the top in China's generic drug consistency evaluations. The company is currently researching a lots of products including innovative drugs, biopharmaceuticals, sustained-release formulations, and specialized generic drugs.

Tags

Neoplasms

Other Diseases

Skin and Musculoskeletal Diseases

Monoclonal antibody

Small molecule drug

Biosimilar

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

Neoplasms	20
Immune System Diseases	11
Hemic and Lymphatic Diseases	10
Endocrinology and Metabolic Disease	5
Infectious Diseases	3
Nervous System Diseases	1

Top 5 Drug Type	Count

Monoclonal antibody	11
Small molecule drug	8
Biosimilar	5
Bispecific antibody	4
Fusion protein	3

Top 5 Target	Count

HER2(Receptor tyrosine-protein kinase erbB-2)	4
PD-1 x TGF-β(Programmed cell death protein 1 x Transforming growth factor beta)	1
IL-33R(Interleukin-1 receptor-like 1)	1
CD40(Tumor necrosis factor receptor superfamily member 5)	1
F10(Coagulation factor X)	1

主要目的 1.定量分析健康受试者口服[14C]TQ05105后排泄物中的总放射性，获得人体放射性排泄率数据和主要排泄途径； 2.定量分析健康受试者单次口服[14C]TQ05105后全血和血浆中的总放射性，获得血浆中总放射性的药代动力学参数，并考察全血和血浆中总放射性的分配情况； 3.考察健康受试者口服[14C]TQ05105后人血浆、尿液和粪便的放射性物谱，鉴定主要代谢产物，确定主要生物转化途径及消除途径；次要目的 1.采用已验证的LC-MS/MS方法定量分析血浆中TQ05105及其代谢产物（TQ12550、TQ12581或更多）的浓度，获得血浆中TQ05105及其代谢产物（TQ12550、TQ12581或更多）的药代动力学参数； 2.观察[14C] TQ05105单次用药后健康受试者的安全性。

[Translation]

main purpose 1. Quantitatively analyze the total radioactivity in the excretion of healthy subjects after oral administration of [14C]TQ05105, and obtain data on human radioactivity excretion rate and main excretion pathways; 2. Quantitatively analyze the total radioactivity in the whole blood and plasma of healthy subjects after a single oral administration of [14C]TQ05105, obtain the pharmacokinetic parameters of the total radioactivity in the plasma, and examine the distribution of the total radioactivity in the whole blood and plasma; 3. Examine the radioactive spectrum of human plasma, urine and feces after oral administration of [14C]TQ05105 to healthy subjects, identify the main metabolites, and determine the main biotransformation pathways and elimination pathways; secondary purpose 1. Use a validated LC-MS/MS method to quantitatively analyze the concentration of TQ05105 and its metabolites (TQ12550, TQ12581 or more) in plasma, and obtain the drug concentration of TQ05105 and its metabolites (TQ12550, TQ12581 or more) in plasma. kinetic parameters; 2. Observe the safety of healthy subjects after a single dose of [14C] TQ05105.

Start Date12 Mar 2024

Sponsor / Collaborator

Centaurus Biopharma Co., Ltd.

[+2]

CTR20240527 / RecruitingPhase 2

TQB2868注射液联合安罗替尼胶囊与化疗一线治疗转移性胰腺癌的单臂、开放、Ⅱ期临床研究

[Translation] Single-arm, open-label, phase II clinical study of TQB2868 injection combined with anlotinib capsules and chemotherapy as first-line treatment of metastatic pancreatic cancer

主要目的：评估TQB2868注射液联合安罗替尼胶囊与化疗一线治疗转移性胰腺癌的初步疗效；次要目的：评估TQB2868注射液联合安罗替尼胶囊与化疗一线治疗转移性胰腺癌的安全性；探索目的： TQB2868注射液治疗相关的生物标志物与疗效的关系； TQB2868注射液在转移性胰腺癌受试者中的免疫原性。

[Translation]

main purpose: To evaluate the preliminary efficacy of TQB2868 injection combined with anlotinib capsules and chemotherapy in the first-line treatment of metastatic pancreatic cancer; Secondary purpose: Evaluate the safety of TQB2868 injection combined with anlotinib capsules and chemotherapy in the first-line treatment of metastatic pancreatic cancer; Exploration purpose: The relationship between biomarkers related to TQB2868 injection treatment and efficacy; Immunogenicity of TQB2868 injection in subjects with metastatic pancreatic cancer.

Start Date08 Mar 2024

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

CTR20233746 / RecruitingPhase 1

[14C]TQB3616在中国健康受试者中的物质平衡临床研究

[Translation] Clinical Study on Material Balance of [14C]TQB3616 in Chinese Healthy Subjects

定量分析健康受试者单次口服[14C]TQB3616后排泄物中的总放射性，获得人体放射性排泄率数据和主要排泄途径；定量分析健康受试者单次口服[14C]TQB3616后全血和血浆中总放射性，获得血浆总放射性的药代动力学参数，并考察全血和血浆中总放射性的分配情况；获得健康受试者口服[14C]TQB3616后血浆、尿液和粪便的放射性代谢物谱，鉴定主要代谢产物，确定代谢途径及消除途径。采用已验证的LC-MS/MS方法定量分析血浆中TQB3616及其代谢产物的浓度，获得血浆中TQB3616及其代谢产物（如适用）的药代动力学参数；观察[14C]TQB3616单次用药后健康受试者的安全性

[Translation]

Quantitatively analyze the total radioactivity in the excretion of healthy subjects after a single oral administration of [14C]TQB3616, and obtain data on human radioactivity excretion rate and main excretion pathways; Quantitatively analyze the total radioactivity in whole blood and plasma of healthy subjects after a single oral administration of [14C]TQB3616, obtain the pharmacokinetic parameters of total plasma radioactivity, and examine the distribution of total radioactivity in whole blood and plasma; Radioactive metabolite profiles in plasma, urine and feces of healthy subjects after oral administration of [14C]TQB3616 were obtained, the main metabolites were identified, and the metabolic pathways and elimination pathways were determined. Use a validated LC-MS/MS method to quantitatively analyze the concentration of TQB3616 and its metabolites in plasma, and obtain the pharmacokinetic parameters of TQB3616 and its metabolites (if applicable) in plasma; Observe the safety of healthy subjects after a single dose of [14C]TQB3616

Start Date06 Feb 2024

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

[+1]

100 Clinical Results associated with Nanjing Shunxin Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Nanjing Shunxin Pharmaceutical Co., Ltd.

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100 Deals associated with Nanjing Shunxin Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Nanjing Shunxin Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 01 Jul 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

3

4

IND Approval

Phase 1 Clinical

13

5

Phase 2 Clinical

NDA/BLA

6

3

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Trastuzumab biosimilar (Chia-tai Tianqing) ( HER2 )	HER2 Positive Breast Cancer More	Approved
Rituximab biosimilar (Chia-tai Tianqing) ( CD20 )	Chronic Lymphocytic Leukemia More	Approved
Recombinant coagulation factor VIII(Chia Tai-Tianqing) ( F10 )	Hemophilia A More	Approved
Envonalkib ( ALK )	Non-Small Cell Lung Cancer More	NDA/BLA
Recombinant human coagulation factor VIIa(Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.) ( F10 x factor IX )	Hemophilia A More	NDA/BLA