Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) – Pipeline Review, H2 2016’, provides in depth analysis on Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) targeted pipeline therapeutics.

The report provides comprehensive information on the Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1), targeted therapeutics, 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 Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) targeted therapeutics development and features dormant and discontinued projects.

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 Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1)

The report reviews Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) 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 Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) targeted therapeutics and enlists all their major and minor projects

The report assesses Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) 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 Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) 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 Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1)

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 Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC 2.7.10.1) 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

Aslan Pharmaceuticals Pte Ltd

Boehringer Ingelheim GmbH

GamaMabs Pharma S.A.

Hanmi Pharmaceuticals, Co. Ltd.

HEC Pharm Co., Ltd.

Jiangsu Kanion Pharmaceutical Co., Ltd.

Minerva Neurosciences, Inc.

Pfizer Inc.

Puma Biotechnology, Inc.

Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

XuanZhu Pharma Co., Ltd.

Zensun (Shanghai) Sci & Tech Co., Ltd.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) Overview 8

Therapeutics Development 9

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Products under Development by Stage of Development 9

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Products under Development by Therapy Area 10

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Products under Development by Indication 11

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Pipeline Products Glance 13

Late Stage Products 13

Early Stage Products 14

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Products under Development by Companies 15

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Products under Development by Universities/Institutes 20

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Therapeutics Assessment 22

Assessment by Monotherapy/Combination Products 22

Assessment by Mechanism of Action 23

Assessment by Route of Administration 25

Assessment by Molecule Type 27

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Companies Involved in Therapeutics Development 29

Aslan Pharmaceuticals Pte Ltd 29

Boehringer Ingelheim GmbH 30

GamaMabs Pharma S.A. 31

Hanmi Pharmaceuticals, Co. Ltd. 32

HEC Pharm Co., Ltd. 33

Jiangsu Kanion Pharmaceutical Co., Ltd. 34

Minerva Neurosciences, Inc. 35

Pfizer Inc. 36

Puma Biotechnology, Inc. 37

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. 38

XuanZhu Pharma Co., Ltd. 39

Zensun (Shanghai) Sci & Tech Co., Ltd. 40

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Drug Profiles 41

afatinib dimaleate - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

dacomitinib - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

FCN-411 - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

MIN-301 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

Monoclonal Antibodies to Antagonize HER4 for Oncology - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

neratinib - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

Neucardin - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

NRG-4 - Drug Profile 80

Product Description 80

Mechanism Of Action 80

R&D Progress 80

NT-113 - Drug Profile 82

Product Description 82

Mechanism Of Action 82

R&D Progress 82

PB-357 - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

pirotinib - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

poziotinib - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

sirotinib - Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

SKLB-1206 - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

varlitinib - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

yinlitinib - Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

Z-650 - Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Dormant Projects 95

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Discontinued Products 97

Receptor Tyrosine Protein Kinase ERBB 4 (Tyrosine Kinase Type Cell Surface Receptor HER4 or Proto Oncogene Like Protein c ErbB 4 or p180erbB4 or HER4 or ERBB4 or EC

2.7.10.1) - Featured News & Press Releases 98

Oct 09, 2016: Overall survival data from LUX-Lung 7 head-to-head trial of afatinib versus gefitinib presented at ESMO 2016 98

Oct 05, 2016: VeriStrat Test Identifies Patients with Squamous Cell Carcinoma of the Lung Who Are More Likely to Have Improved Survival on Afatinib Therapy 99

Sep 20, 2016: Puma Biotechnology Announces U.S. FDA Acceptance of New Drug Application for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer 100

Sep 08, 2016: New analysis showed dose adjustment of Gilotrif (afatinib) improved tolerability without an apparent impact on efficacy in patients with EGFR mutation-positive non-small cell lung cancer 101

Aug 26, 2016: CFDA Granted Approval of Phase I-III Clinical Trials for Sirotinib (XZP - 5491) 102

Aug 22, 2016: Puma Biotechnology Announces European Medicines Agency Validation of Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe 102

Jul 25, 2016: Boehringer Ingelheim stops LUX-Head & Neck 2 and 4 trials following pre-planned analysis from independent Data Monitoring Committee 103

Jul 21, 2016: Puma Biotechnology Announces Interim 5-Year Disease Free Survival Data from Phase III Trial of PB272 (Neratinib) in Extended Adjuvant HER2-Positive Early Stage Breast Cancer (ExteNET Trial) 104

Jul 21, 2016: Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer 105

Jul 08, 2016: Loyola Oncologist Co-authors Neratinib Study That Used New, Targeted Model to Test Breast Cancer Treatment 105

Jul 07, 2016: Puma Biotechnology Announces I-SPY 2 Phase II Study of Neratinib Published in The New England Journal of Medicine 107

Jun 27, 2016: Puma Biotechnology Submits Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe 108

Jun 13, 2016: New first-line treatment for lung cancer now funded by Quebec public drug plan (RAMQ) 109

Jun 05, 2016: Puma Biotechnology Presents Positive Phase II Data at the 2016 ASCO Annual Meeting 110

May 18, 2016: Puma Biotechnology Announces Publication of Neratinib Abstract for the 2016 ASCO Annual Meeting 111

Appendix 112

Methodology 112

Coverage 112

Secondary Research 112

Primary Research 112

Expert Panel Validation 112

Contact Us 112

Disclaimer 113

List of Tables

List of Tables

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Number of Products under Development by Companies, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Development by Companies, H2 2016 (Contd..1) 17

Products under Development by Companies, H2 2016 (Contd..2) 18

Products under Development by Companies, H2 2016 (Contd..3) 19

Number of Products under Investigation by Universities/Institutes, H2 2016 20

Products under Investigation by Universities/Institutes, H2 2016 21

Assessment by Monotherapy/Combination Products, H2 2016 22

Number of Products by Stage and Mechanism of Action, H2 2016 24

Number of Products by Stage and Route of Administration, H2 2016 26

Number of Products by Stage and Molecule Type, H2 2016 28

Pipeline by Aslan Pharmaceuticals Pte Ltd, H2 2016 29

Pipeline by Boehringer Ingelheim GmbH, H2 2016 30

Pipeline by GamaMabs Pharma S.A., H2 2016 31

Pipeline by Hanmi Pharmaceuticals, Co. Ltd., H2 2016 32

Pipeline by HEC Pharm Co., Ltd., H2 2016 33

Pipeline by Jiangsu Kanion Pharmaceutical Co., Ltd., H2 2016 34

Pipeline by Minerva Neurosciences, Inc., H2 2016 35

Pipeline by Pfizer Inc., H2 2016 36

Pipeline by Puma Biotechnology, Inc., H2 2016 37

Pipeline by Shanghai Fosun Pharmaceutical (Group) Co., Ltd., H2 2016 38

Pipeline by XuanZhu Pharma Co., Ltd., H2 2016 39

Pipeline by Zensun (Shanghai) Sci & Tech Co., Ltd., H2 2016 40

Dormant Projects, H2 2016 95

Dormant Projects (Contd..1), H2 2016 96

Discontinued Products, H2 2016 97

List of Figures

List of Figures

Number of Products under Development for, H2 2016 9

Number of Products under Development by Therapy Area, H2 2016 10

Number of Products under Development by Top 10 Indication, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Early Stage Products, H2 2016 14

Assessment by Monotherapy/Combination Products, H2 2016 22

Number of Products by Mechanism of Actions, H2 2016 23

Number of Products by Stage and Molecule Type, H2 2016 23

Number of Products by Routes of Administration, H2 2016 25

Number of Products by Stage and Routes of Administration, H2 2016 25

Number of Products by Molecule Types, H2 2016 27

Number of Products by Stage and Molecule Type, H2 2016 27

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