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 2017

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 2017’, 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 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. The report analyses the pipeline products from therapy areas Oncology, Cardiovascular, Central Nervous System and Gastrointestinal under development targeting 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).

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 SA

Hanmi Pharmaceuticals 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

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 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 22

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 24

Assessment by Mechanism of Action 24

Assessment by Route of Administration 26

Assessment by Molecule Type 28

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 30

Aslan Pharmaceuticals Pte Ltd 30

Boehringer Ingelheim GmbH 30

GamaMabs Pharma SA 32

Hanmi Pharmaceuticals Co Ltd 32

Jiangsu Kanion Pharmaceutical Co Ltd 33

Minerva Neurosciences Inc 33

Pfizer Inc 34

Puma Biotechnology Inc 35

Shanghai Fosun Pharmaceutical (Group) Co Ltd 36

XuanZhu Pharma Co Ltd 36

Zensun (Shanghai) Sci & Tech Co Ltd 37

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 38

afatinib dimaleate - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

dacomitinib - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

FCN-411 - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

MIN-301 - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

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 82

Product Description 82

Mechanism Of Action 82

R&D Progress 82

NRG-4 - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

NT-113 - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

PB-357 - Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

pirotinib - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

poziotinib - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

sirotinib - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

SKLB-1206 - Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

varlitinib - Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

yinlitinib - Drug Profile 98

Product Description 98

Mechanism Of Action 98

R&D Progress 98

Z-650 - Drug Profile 99

Product Description 99

Mechanism Of Action 99

R&D Progress 99

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 Products 100

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 102

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) - Product Development Milestones 103

Featured News & Press Releases 103

Jul 21, 2017: NERLYNX (neratinib) Tablets Approved for HER2+ Breast Cancer in the Extended Adjuvant Setting 103

Jul 20, 2017: NERLYNX tablets for HER2+ Breast Cancer in the Extended Adjuvant Setting 103

Jul 19, 2017: Onco360 Chosen For NERLYNX Limited Distribution Pharmacy Network 104

Jul 17, 2017: U.S. Food and Drug Administration Approves Puma's NERLYNX (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer 104

Jul 10, 2017: Lung Cancer: VeriStrat Test Identifies Patients with Squamous Cell Carcinoma of the Lung Who Are More Likely to Have Improved Survival on Afatinib Therapy 105

Jul 06, 2017: Puma Biotechnology Completes Targeted Enrollment in Neratinib Phase III Metastatic Breast Cancer Trial 105

Jun 29, 2017: Aslan Pharmaceuticals Announces First Patient Enrolled In Global Pivotal Treetopp Study For Varlitinib In Biliary Tract Cancer 106

Jun 12, 2017: Aslan Pharmaceuticals Announces MTD For Varlitinib In Combination With Chemotherapies Commonly Used In First Line Gastric Cancer 106

Jun 05, 2017: Research suggests possible new treatment for EGFR-positive lung cancer 107

Jun 03, 2017: Puma Biotechnology Announces Positive PB272 Phase II Data from TBCRC 022 Trial in Patients with HER2-Positive Metastatic Breast Cancer with Brain Metastases at the 2017 ASCO Annual Meeting 108

Jun 02, 2017: Aslan Pharmaceuticals Announces Publication of New Varlitinib Data in Metastatic Solid Tumors at ASCO 109

Jun 01, 2017: Aslan Pharmaceuticals Receives Clinical Trial Authorisation To Initiate Pivotal Study Of Varlitinib In Gastric Cancer 110

May 30, 2017: NICE Terminates Technology Appraisal for Afatinib in Advanced Squamous NSCLC After Platinum-based Chemotherapy 110

May 22, 2017: Puma Biotechnology Announces Posting of FDA Oncologic Drugs Advisory Committee Briefing Documents for Neratinib Meeting 111

May 18, 2017: New Data On Varlitinib Published At 2017 Annual Meeting Of American Society Of Cancer Oncology 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 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 12

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

Products under Development by Companies, H2 2017 (Contd..5), H2 2017 21

Number of Products under Investigation by Universities/Institutes, H2 2017 22

Products under Investigation by Universities/Institutes, H2 2017 23

Number of Products by Stage and Mechanism of Actions, H2 2017 25

Number of Products by Stage and Route of Administration, H2 2017 27

Number of Products by Stage and Molecule Type, H2 2017 29

Pipeline by Aslan Pharmaceuticals Pte Ltd, H2 2017 30

Pipeline by Boehringer Ingelheim GmbH, H2 2017 31

Pipeline by GamaMabs Pharma SA, H2 2017 32

Pipeline by Hanmi Pharmaceuticals Co Ltd, H2 2017 32

Pipeline by Jiangsu Kanion Pharmaceutical Co Ltd, H2 2017 33

Pipeline by Minerva Neurosciences Inc, H2 2017 33

Pipeline by Pfizer Inc, H2 2017 34

Pipeline by Puma Biotechnology Inc, H2 2017 35

Pipeline by Shanghai Fosun Pharmaceutical (Group) Co Ltd, H2 2017 36

Pipeline by XuanZhu Pharma Co Ltd, H2 2017 36

Pipeline by Zensun (Shanghai) Sci & Tech Co Ltd, H2 2017 37

Dormant Products, H2 2017 100

Dormant Products, H2 2017 (Contd..1), H2 2017 101

Discontinued Products, H2 2017 102

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 Mechanism of Actions, H2 2017 24

Number of Products by Stage and Mechanism of Actions, H2 2017 24

Number of Products by Routes of Administration, H2 2017 26

Number of Products by Stage and Routes of Administration, H2 2017 26

Number of Products by Molecule Types, H2 2017 28

Number of Products by Stage and Molecule Types, H2 2017 28

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