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

Skin and Musculoskeletal Diseases

Other Diseases

Monoclonal antibody

Biosimilar

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

Neoplasms	17
Hemic and Lymphatic Diseases	11
Immune System Diseases	11
Endocrinology and Metabolic Disease	4
Infectious Diseases	3
Nervous System Diseases	1

Top 5 Drug Type	Count

Monoclonal antibody	11
Biosimilar	7
Small molecule drug	6
Recombinant polypeptide	2
Antibody drug conjugate (ADC)	2

Top 5 Target	Count

HER2(Receptor tyrosine-protein kinase erbB-2)	4
Bcl-2(Apoptosis regulator Bcl-2)	1
AR(Androgen Receptor)	1
GLP-1R x INSR	1
TSLP(Thymic stromal lymphopoietin)	1

主要研究目的: 评价TQ05105片在不同级别肾功能受试者中单次给药后的药代动力学（PK）特征。次要研究目的：（1）评价TQ05105片在不同级别肾功能受试者中单次给药后的尿液中药物排泄情况。（2）评价TQ05105片在不同级别肾功能受试者中单次给药后的安全性。

[Translation]

Main study objectives: To evaluate the pharmacokinetic (PK) characteristics of TQ05105 tablets after a single dose in subjects with different levels of renal function. Secondary study objectives: (1) To evaluate the drug excretion in urine of TQ05105 tablets after a single dose in subjects with different levels of renal function. (2) To evaluate the safety of TQ05105 tablets after a single dose in subjects with different levels of renal function.

Start Date12 Oct 2024

Sponsor / Collaborator

Centaurus Biopharma Co Ltd

[+2]

CTR20242940 / RecruitingPhase 3

评价TQH2722注射液治疗中重度特应性皮炎受试者的有效性和安全性的多中心、随机、双盲、安慰剂对照III期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of TQH2722 injection in the treatment of moderate to severe atopic dermatitis

主要目的：1.评价TQH2722注射液在成人中重度AD受试者中的有效性。次要目的：1.评价TQH2722注射液在成人中重度AD受试者中的安全性； 2.评价TQH2722注射液对成人中重度AD受试者患者报告结局（PROs）的改善； 3.评价TQH2722注射液在成人中重度AD受试者中的药代动力学特征； 4.评价TQH2722注射液在成人中重度AD受试者中的免疫原性。

[Translation]

Primary objectives: 1. To evaluate the efficacy of TQH2722 injection in adult subjects with moderate to severe AD. Secondary objectives: 1. To evaluate the safety of TQH2722 injection in adult subjects with moderate to severe AD; 2. To evaluate the improvement of patient-reported outcomes (PROs) of TQH2722 injection in adult subjects with moderate to severe AD; 3. To evaluate the pharmacokinetic characteristics of TQH2722 injection in adult subjects with moderate to severe AD; 4. To evaluate the immunogenicity of TQH2722 injection in adult subjects with moderate to severe AD.

Start Date27 Sep 2024

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

CTR20242868 / RecruitingPhase 3

评价注射用TQB2102对比研究者选择的化疗在HER2低表达复发/转移性乳腺癌中有效性和安全性的随机、开放、平行对照的III期临床试验

[Translation] A randomized, open-label, parallel-controlled phase III clinical trial to evaluate the efficacy and safety of TQB2102 for injection versus chemotherapy of investigator's choice in recurrent/metastatic breast cancer with low HER2 expression

评价在HR阳性、HER2低表达复发/转移性乳腺癌受试者中，注射用TQB2102对比研究者选择的化疗能显著延长受试者的无进展生存期(PFS）。评价TQB2102对比研究者选择的化疗在HER2低表达复发/转移性乳腺癌受试者中的无进展生存期（PFS）等。

[Translation]

To evaluate whether injectable TQB2102 can significantly prolong the progression-free survival (PFS) of subjects with HR-positive, HER2-low-expressing recurrent/metastatic breast cancer compared with the investigator's choice of chemotherapy. To evaluate the progression-free survival (PFS) of TQB2102 compared with the investigator's choice of chemotherapy in subjects with recurrent/metastatic breast cancer with low HER2 expression.

Start Date24 Sep 2024

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

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 16 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

IND Application

3

8

IND Approval

Phase 1 Clinical

6

4

Phase 2 Clinical

Phase 3 Clinical

4

3

NDA/BLA

Approved

5

2

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Rituximab biosimilar (Chia-tai Tianqing) ( CD20 )	Chronic Lymphocytic Leukemia More	Approved
Bevacizumab biosimilar (Chia-tai Tianqing) ( VEGF-A )	Non-squamous non-small cell lung cancer More	Approved
Benmelstobart ( PDL1 )	Extensive stage Small Cell Lung Cancer More	Approved
Trastuzumab biosimilar (Chia-tai Tianqing) ( HER2 )	HER2 Positive Breast Cancer More	Approved
Recombinant coagulation factor VIII(Chia Tai-Tianqing) ( F10 )	Hemophilia A More	Approved