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

Global Markets Direct’s, ‘Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) – Pipeline Review, H2 2017’, provides in depth analysis on Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted pipeline therapeutics. The report provides comprehensive information complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of 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 and features dormant and discontinued projects. The report analyses the pipeline products from therapy areas Oncology, Immunology, Infectious Disease, Genito Urinary System And Sex Hormones and Toxicology under development targeting Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22).

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s 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. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data.

*Updated report will be delivered in 48 hours of order confirmation.

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 it’s 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

Companies mentioned

Beta Pharma Inc

Eli Lilly and Co

G1 Therapeutics Inc

Jiangsu Hengrui Medicine Co Ltd

MEI Pharma Inc

Novartis AG

Onconova Therapeutics Inc

Pfizer Inc

Sihuan Pharmaceutical Holdings Group Ltd

Teijin Pharma Ltd

Tiziana Life Sciences Plc

ViroStatics srl

Table of Contents

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

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

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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