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Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Pipeline Review, H2 2017

Published By :

Global Markets Direct

Published Date : Nov 2017

Category :

Pharmaceutical

No. of Pages : 112 Pages

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Pipeline Review, H2 2017

Summary

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) pipeline Target constitutes close to 23 molecules. Out of which approximately 21 molecules are developed by companies and remaining by the universities/institutes. The latest report Cyclin Dependent Kinase 4 - Pipeline Review, H2 2017, outlays comprehensive information on the Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type.

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Cyclin-dependent kinase 4 is an enzyme encoded by the CDK4 gene. Ser/Thr-kinase component of cyclin D-CDK4 (DC) complexes phosphorylate and inhibit members of the retinoblastoma (RB) protein family including RB1 and regulate the cell-cycle during G1/S transition. Activation of the cyclin-D-CDK4 complex appears to require other factors such as recruitment of the substrate via a substrate recruitment motif, and/or formation of the CDKN1B ternary complex. The molecules developed by companies in Pre-Registration, Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical and Discovery stages are 1, 2, 3, 1, 1, 12 and 1 respectively. Similarly, the universities portfolio in Preclinical and Discovery stages comprises 1 and 1 molecules, respectively. Report covers products from therapy areas Oncology, Immunology, Infectious Disease, Genito Urinary System And Sex Hormones and Toxicology which include indications Breast Cancer, Mantle Cell Lymphoma, Metastatic Breast Cancer, Lymphoma, Non-Small Cell Lung Cancer, Colon Cancer, Colorectal Cancer, Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer, Liposarcoma, Metastatic Hepatocellular Carcinoma (HCC), Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer, Metastatic Melanoma, Oligodendroglioma, Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Recurrent Glioblastoma Multiforme (GBM), Solid Tumor, Thymic Carcinoma, Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia), Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia), Acute Renal Failure (ARF) (Acute Kidney Injury), Anaplastic Oligoastrocytoma, Astrocytoma, Bacterial Infections, Brain Tumor, Chemotherapy Induced Myelosuppression, Dedifferentiated Liposarcoma, Diffuse Large B-Cell Lymphoma, Duodenal Cancer, Endometrial Cancer, Ependymoma, Epithelial Ovarian Cancer, Epstein-Barr Virus (HHV-4) Infections, Fallopian Tube Cancer, Gastric Cancer, Germ Cell Tumors, Glioblastoma Multiforme (GBM), Glioma, Head And Neck Cancer, Head And Neck Cancer Squamous Cell Carcinoma, Hematological Tumor, Hepatocellular Carcinoma, Leukemias, Melanoma, Meningioma, Metastatic Adenocarcinoma of The Pancreas, Metastatic Brain Tumor, Metastatic Colorectal Cancer, Metastatic Ovarian Cancer, Metastatic Transitional (Urothelial) Tract Cancer, Multiple Myeloma (Kahler Disease), Myelosuppression, Neuroblastoma, Neuroendocrine Tumors, Peritoneal Cancer, Primary CNS Lymphoma, Prostate Cancer, Rheumatoid Arthritis, Small-Cell Lung Cancer and Squamous Non-Small Cell Lung Cancer.

Furthermore, this report also reviews key players involved in Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics development with respective active and dormant or discontinued projects. Driven by data and information sourced from proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources.

Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data.

Scope

- The report provides a snapshot of the global therapeutic landscape for Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22)
- The report reviews Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources
- The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages
- The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities
- The report reviews key players involved in Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics and enlists all their major and minor projects
- The report assesses Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type
- The report summarizes all the dormant and discontinued pipeline projects
- The report reviews latest news and deals related to Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics

Reasons to buy

- Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand the targeted therapy areas and indications for Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22)
- Identify the use of drugs for target identification and drug repurposing
- Identify potential new clients or partners in the target demographic
- Develop strategic initiatives by understanding the focus areas of leading companies
- Plan mergers and acquisitions effectively by identifying key players and its most promising pipeline therapeutics
- Devise corrective measures for pipeline projects by understanding Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) development landscape
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope
Table of Contents
Table of Contents 2
List of Tables 6
List of Figures 6
Introduction 7
Global Markets Direct Report Coverage 7
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Overview 8
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Therapeutics Development 9
Products under Development by Stage of Development 9
Products under Development by Therapy Area 10
Products under Development by Indication 11
Products under Development by Companies 15
Products under Development by Universities/Institutes 21
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Therapeutics Assessment 23
Assessment by Mechanism of Action 23
Assessment by Route of Administration 24
Assessment by Molecule Type 26
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Companies Involved in Therapeutics Development 27
Beta Pharma Inc 27
Eli Lilly and Co 27
G1 Therapeutics Inc 28
Jiangsu Hengrui Medicine Co Ltd 29
MEI Pharma Inc 30
Novartis AG 30
Onconova Therapeutics Inc 31
Pfizer Inc 32
Sihuan Pharmaceutical Holdings Group Ltd 33
Teijin Pharma Ltd 34
Tiziana Life Sciences Plc 34
ViroStatics srl 34
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Drug Profiles 36
abemaciclib - Drug Profile 36
Product Description 36
Mechanism Of Action 36
R&D Progress 36
BPI-1178 - Drug Profile 45
Product Description 45
Mechanism Of Action 45
R&D Progress 45
C-1748 - Drug Profile 46
Product Description 46
Mechanism Of Action 46
R&D Progress 46
G-1T100182 - Drug Profile 48
Product Description 48
Mechanism Of Action 48
R&D Progress 48
G-1T100183 - Drug Profile 49
Product Description 49
Mechanism Of Action 49
R&D Progress 49
G-1T101551 - Drug Profile 50
Product Description 50
Mechanism Of Action 50
R&D Progress 50
G-1T38 - Drug Profile 51
Product Description 51
Mechanism Of Action 51
R&D Progress 51
GZ-381 - Drug Profile 53
Product Description 53
Mechanism Of Action 53
R&D Progress 53
HEC-80797 - Drug Profile 54
Product Description 54
Mechanism Of Action 54
R&D Progress 54
milciclib - Drug Profile 55
Product Description 55
Mechanism Of Action 55
R&D Progress 55
ON-123300 - Drug Profile 57
Product Description 57
Mechanism Of Action 57
R&D Progress 57
palbociclib - Drug Profile 59
Product Description 59
Mechanism Of Action 59
R&D Progress 59
ribociclib succinate - Drug Profile 72
Product Description 72
Mechanism Of Action 72
R&D Progress 72
SHR-6390 - Drug Profile 80
Product Description 80
Mechanism Of Action 80
R&D Progress 80
Small Molecule to Inhibit CDK 4 and 6 for Rheumatoid Arthritis - Drug Profile 81
Product Description 81
Mechanism Of Action 81
R&D Progress 81
Small Molecule to Inhibit CDK4 and CDK6 for Oncology - Drug Profile 82
Product Description 82
Mechanism Of Action 82
R&D Progress 82
Small Molecule to Inhibit CDK4, CDK6 and CDK9 for EBV Infections - Drug Profile 83
Product Description 83
Mechanism Of Action 83
R&D Progress 83
Small Molecule to Target Cdk2, Cdk4, Cdk6, Cyclin D1, Cyclin B1, Cdc2, p53 and p16 for Bacterial Infections and Oncology - Drug Profile 84
Product Description 84
Mechanism Of Action 84
R&D Progress 84
SRX-3177 - Drug Profile 85
Product Description 85
Mechanism Of Action 85
R&D Progress 85
trilaciclib - Drug Profile 86
Product Description 86
Mechanism Of Action 86
R&D Progress 86
voruciclib - Drug Profile 90
Product Description 90
Mechanism Of Action 90
R&D Progress 90
VS-2370 - Drug Profile 93
Product Description 93
Mechanism Of Action 93
R&D Progress 93
XZP-3287 - Drug Profile 94
Product Description 94
Mechanism Of Action 94
R&D Progress 94
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Dormant Products 95
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Discontinued Products 97
Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) - Product Development Milestones 98
Featured News & Press Releases 98
Oct 16, 2017: Onco360 Selected for VERZENIO Limited Distribution Pharmacy Network 98
Oct 12, 2017: FDA Grants Priority Review for Potential New Indication for Lilly's Verzenio (abemaciclib) as Initial Treatment of Advanced Breast Cancer 98
Oct 10, 2017: Diplomat Selected to Dispense VERZENIO for Breast Cancer 98
Oct 10, 2017: Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer 99
Oct 10, 2017: VERZENIO (abemaciclib) Approved for Treatment of Metastatic Breast Cancer, Available for Order at Biologics 99
Oct 06, 2017: Lilly MONARCH 3 Study Published In Journal Of Clinical Oncology Demonstrates Benefit Of Verzenio (Abemaciclib) Plus NSAI In Advanced Breast Cancer 100
Oct 04, 2017: Lilly Receives U.S. FDA Approval Of Verzenio (Abemaciclib) 101
Sep 28, 2017: FDA approves new treatment for certain advanced or metastatic breast cancers 103
Aug 30, 2017: CFDA Granted Approval of Phase I-III Clinical Trials for Birociclib, an Internally Developed Innovative Patented New Drug 104
Aug 29, 2017: New Phase 3 Data for Abemaciclib Presented at ESMO 2017 Congress 105
Aug 24, 2017: Novartis Kisqali (ribociclib) receives EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor 106
Aug 22, 2017: Alliance Foundation Trials Opens Global Trial Investigating First-In-Class Palbociclib In HR+, HER2 Metastatic Breast Cancer 107
Aug 14, 2017: Potential Treatment for Brain Cancer as Drug Shrinks Tumors 108
Jul 19, 2017: Tiziana Life Sciences Announces Initiation of a Phase IIa Clinical Trial with Milciclib in Patients with Hepatocellular Carcinoma 109
Jul 12, 2017: CFDA Granted Approval of Phase I-III Clinical Trials for Birociclib, an Internally Developed Innovative Patented New Drug 110
Appendix 111
Methodology 111
Coverage 111
Secondary Research 111
Primary Research 111
Expert Panel Validation 111
Contact Us 111
Disclaimer 112

List of Tables
Number of Products under Development by Stage of Development, H2 2017 9
Number of Products under Development by Therapy Areas, H2 2017 10
Number of Products under Development by Indications, H2 2017 11
Number of Products under Development by Indications, H2 2017 (Contd..1), H2 2017 13
Number of Products under Development by Indications, H2 2017 (Contd..2), H2 2017 14
Number of Products under Development by Companies, H2 2017 15
Products under Development by Companies, H2 2017 16
Products under Development by Companies, H2 2017 (Contd..1), H2 2017 17
Products under Development by Companies, H2 2017 (Contd..2), H2 2017 18
Products under Development by Companies, H2 2017 (Contd..3), H2 2017 19
Products under Development by Companies, H2 2017 (Contd..4), H2 2017 20
Number of Products under Investigation by Universities/Institutes, H2 2017 21
Products under Investigation by Universities/Institutes, H2 2017 22
Number of Products by Stage and Mechanism of Actions, H2 2017 23
Number of Products by Stage and Route of Administration, H2 2017 25
Number of Products by Stage and Molecule Type, H2 2017 26
Pipeline by Beta Pharma Inc, H2 2017 27
Pipeline by Eli Lilly and Co, H2 2017 28
Pipeline by G1 Therapeutics Inc, H2 2017 29
Pipeline by Jiangsu Hengrui Medicine Co Ltd, H2 2017 29
Pipeline by MEI Pharma Inc, H2 2017 30
Pipeline by Novartis AG, H2 2017 31
Pipeline by Onconova Therapeutics Inc, H2 2017 32
Pipeline by Pfizer Inc, H2 2017 33
Pipeline by Sihuan Pharmaceutical Holdings Group Ltd, H2 2017 33
Pipeline by Teijin Pharma Ltd, H2 2017 34
Pipeline by Tiziana Life Sciences Plc, H2 2017 34
Pipeline by ViroStatics srl, H2 2017 35
Dormant Products, H2 2017 95
Dormant Products, H2 2017 (Contd..1), H2 2017 96
Discontinued Products, H2 2017 97

List of Figures
Number of Products under Development by Stage of Development, H2 2017 9
Number of Products under Development by Therapy Areas, H2 2017 10
Number of Products under Development by Top 10 Indications, H2 2017 11
Number of Products by Stage and Mechanism of Actions, H2 2017 23
Number of Products by Routes of Administration, H2 2017 24
Number of Products by Stage and Routes of Administration, H2 2017 24
Number of Products by Stage and Molecule Type, H2 2017 26

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