Report Detail

Medical Devices & Consumables Shuwen Biotech Co Ltd - Product Pipeline Analysis, 2018 Update

  • RnM2733823
  • |
  • 07 January, 2019
  • |
  • Global
  • |
  • 39 Pages
  • |
  • GlobalData
  • |
  • Medical Devices & Consumables

Summary

Shuwen Biotech Co Ltd (Shuwen Biotech) is a medical equipment company. The company develops diagnostic products and services for disease prevention, diagnosis and personalized medicine. It offers in-vitro diagnostic (IVD) kits for oncology and pregnancy-related conditions. Shuwen Biotech develops tests for predisposition, screening, diagnosis, classification, prognosis, theranostics and therapeutic monitoring. The company’s kits are used for the diagnosis of breast cancer, lung cancer, colorectal cancer, urology, autoimmune diseases, neurological diseases and infectious diseases. It also provides laboratory developed test (LDT) and clinical testing services such as mammatyper breast cancer molecular subtyping, epidermal growth factor receptor (EGFR) mutation analysis, KRAS mutation analysis, BRAF mutation analysis, EML4-ALK fusion analysis, and PIK3CA mutation analysis. The company provides clinical services such as PD-L1 IHC testing, esoteric clinical chemistry tests, esoteric immunological tests, MTFHR genotyping for folic acid supplementation, and N9 nutrigenetic testing. Shuwen Biotech is headquartered in Huzhou, China.

This report is a source for data, analysis, and actionable intelligence on the company’s portfolio of pipeline products. The report provides key information about the company, its major products and brands.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.

Scope:

- The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments
- The report analyzes all pipeline products in development for the company Shuwen Biotech Co Ltd
- The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status)
- The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date
- The report provides detailed description of products in development, technical specification and functions
- The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date.

Reasons to Buy:

- Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape
- Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio
- To formulate effective Research & Development strategies
- Develop market-entry and market expansion strategies
- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Develop competition strategies by identifying the status and likely launch of the competitors’ pipeline products through review of the clinical trials, stage and of development, etc
- Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio

Note: Some sections may be missing if data is unavailable for the company


Table of Contents

    Table of Contents 2

      List of Tables 4

        List of Figures 4

          Shuwen Biotech Co Ltd Company Overview 5

            Shuwen Biotech Co Ltd Company Snapshot 5

              Shuwen Biotech Co Ltd Pipeline Products and Ongoing Clinical Trials Overview 5

                Shuwen Biotech Co Ltd – Pipeline Analysis Overview 8

                  Shuwen Biotech Co Ltd - Key Facts 8

                    Shuwen Biotech Co Ltd - Major Products and Services 9

                      Shuwen Biotech Co Ltd Pipeline Products by Development Stage 10

                        Shuwen Biotech Co Ltd Pipeline Products Overview 12

                          CapCord Preeclampsia Detection Kit 12

                            CapCord Preeclampsia Detection Kit Product Overview 12

                              Colorectal Cancer Theranostic Test 13

                                Colorectal Cancer Theranostic Test Product Overview 13

                                  Companion Diagnostic (CDx) Kit 14

                                    Companion Diagnostic (CDx) Kit Product Overview 14

                                      Companion Diagnostic Assay - Cancer 15

                                        Companion Diagnostic Assay - Cancer Product Overview 15

                                          Diagnostic Test - Infectious Diseases 16

                                            Diagnostic Test - Infectious Diseases Product Overview 16

                                              Diagnostic Test - Neurological Diseases 17

                                                Diagnostic Test - Neurological Diseases Product Overview 17

                                                  Diagnostic Test - Autoimmune Diseases 18

                                                    Diagnostic Test - Autoimmune Diseases Product Overview 18

                                                      Diagnostic Test - Urological Disorders 19

                                                        Diagnostic Test - Urological Disorders Product Overview 19

                                                          FGFR1 FISH Gene Amplification Detection Kit - Lung Cancer 20

                                                            FGFR1 FISH Gene Amplification Detection Kit - Lung Cancer Product Overview 20

                                                              FGFR1 Gene Amplification Detection FISH Kit - Breast Cancer 21

                                                                FGFR1 Gene Amplification Detection FISH Kit - Breast Cancer Product Overview 21

                                                                  FGFR1 Gene Amplification Detection QPCR Kit - Breast Cancer 22

                                                                    FGFR1 Gene Amplification Detection QPCR Kit - Breast Cancer Product Overview 22

                                                                      FGFR1 QPCR Gene Amplification Detection Kit - Lung Cancer 23

                                                                        FGFR1 QPCR Gene Amplification Detection Kit - Lung Cancer Product Overview 23

                                                                          Microsatellite Instability (MSI) Assay Kit - Colorectal Cancer 24

                                                                            Microsatellite Instability (MSI) Assay Kit - Colorectal Cancer Product Overview 24

                                                                              PIK3CA Mutation Analysis Kit - Colorectal Cancer 25

                                                                                PIK3CA Mutation Analysis Kit - Colorectal Cancer Product Overview 25

                                                                                  PIK3CA Mutation Analysis Kit - Lung Cancer 26

                                                                                    PIK3CA Mutation Analysis Kit - Lung Cancer Product Overview 26

                                                                                      PIK3CA Mutation Analysis Real-Time PCR Kit - Breast Cancer 27

                                                                                        PIK3CA Mutation Analysis Real-Time PCR Kit - Breast Cancer Product Overview 27

                                                                                          RPS Gene Expression Signature Kit - Breast Cancer 28

                                                                                            RPS Gene Expression Signature Kit - Breast Cancer Product Overview 28

                                                                                              Shuwen Biotech Co Ltd - Key Competitors 29

                                                                                                Shuwen Biotech Co Ltd - Key Employees 30

                                                                                                  Shuwen Biotech Co Ltd - Locations And Subsidiaries 31

                                                                                                    Head Office 31

                                                                                                      Recent Developments 32

                                                                                                        Shuwen Biotech Co Ltd, Recent Developments 32

                                                                                                          Jul 19, 2018: Shuwen Biotech’s clinical lab successfully passes Biyearly College of American Pathologists audit 32

                                                                                                            May 16, 2018: Shuwen Debuts it’s CODAR-ARMS PCR Liquid Biopsy Technology at ASCO 2018 32

                                                                                                              Apr 26, 2018: Abcam and Shuwen Biotech sign strategic MoU to establish global alliance for companion diagnostic (CDx) kit development 32

                                                                                                                Sep 18, 2017: Shuwen Biotech Receives CE Mark for EGFR Mutation PCR Kit for Lung Cancer 33

                                                                                                                  Jan 13, 2017: Shuwen Biotech Receives EN ISO 13485 Certification 33

                                                                                                                    Jun 30, 2015: Shuwen Biotech Appoints Recognized Leader in Urologic Pathology to Advisory Board 33

                                                                                                                      Feb 25, 2015: Diagnostic Industry Veteran Gregory C. Critchfield Joins Shuwen Biotech’s Advisory Board 33

                                                                                                                        Dec 11, 2014: Shuwen Biotech Receives License to Operate New Diagnostic Reference Lab in China and Forms New Subsidiary for the Lab 34

                                                                                                                          Oct 05, 2014: Shuwen Biotech Enters into Collaboration and Clinical Trial Agreement with Shanghai First Maternity and Infant Hospital 34

                                                                                                                            Jul 05, 2014: Shuwen Biotech Appoints Saaras Hu as Laboratory Director 35

                                                                                                                              Appendix 36

                                                                                                                                Methodology 36

                                                                                                                                  About GlobalData 39

                                                                                                                                    Contact Us 39

                                                                                                                                      Disclaimer 39

                                                                                                                                      Summary:
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