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市場調查報告書

亞太地區的頭頸癌治療藥市場:2023年

Head and Neck Cancer Therapeutics in Asia-Pacific Markets to 2023 - Launch of Premium Immunotherapies and Increasing Prevalence to Drive the Market

出版商 GBI Research 商品編碼 630780
出版日期 內容資訊 英文 155 Pages
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亞太地區的頭頸癌治療藥市場:2023年 Head and Neck Cancer Therapeutics in Asia-Pacific Markets to 2023 - Launch of Premium Immunotherapies and Increasing Prevalence to Drive the Market
出版日期: 2017年12月27日 內容資訊: 英文 155 Pages
簡介

本報告提供亞太地區的頭頸癌治療藥市場相關調查,疾病概要,上市產品、開發中產品分析,臨床實驗分析,市場成長的推動要素與阻礙因素,及主要市場預測等彙整資料。

第1章 目錄

第2章 簡介

  • 疾病的簡介
  • 流行病學
  • 症狀
  • 病因、病理學
  • 診斷
  • 分期
  • 預後
  • 治療指南、選擇

第3章 上市產品

  • 概要
  • 化學治療藥
  • 表皮成長因素受體 (EGFR) 標靶治療藥
  • PD-1/PD-L1免疫查核點抑制劑
  • 上市產品的效果、安全性比較

第4章 開發平台分析

  • 概要
  • 開發平台:各開發階段、分子類型、給藥途徑、計劃類型
  • 開發平台:各分子標的
  • 有前途的開發平台候補藥
  • 開發中產品的效果、安全性比較
  • 產品競爭力的組成架構

第5章 臨床實驗分析

  • 失敗率
  • 臨床實驗規模
  • 臨床實驗期間
  • 臨床實驗標準的摘要

第6章 多方案預測

  • 概要
  • 亞太地區市場
  • 印度
  • 中國
  • 澳洲
  • 韓國
  • 日本

第7章 促進要素、障礙

  • 促進要素
  • 障礙

第8章 契約、策略性整合

  • 授權契約
  • 共同開發契約

第9章 附錄

目錄
Product Code: GBIHC465MR

Abstrac

  • Head and Neck Cancer Therapeutics in Asia-Pacific Markets to 2023 - Launch of Premium Immunotherapies and Increasing Prevalence to Drive the Market

Summary

  • Head and neck squamous cell carcinoma is the sixth most common cancer, and its incidence is growing. The term head and neck cancer (HNC) refers to a number of malignancies that usually begin in the squamous cells (90% of HNCs) that line the moist, mucosal surfaces inside the head and neck. These cancers develop inside the mouth, the nose and the throat.
  • HNCs can also initially develop in the salivary glands; however, these are relatively uncommon. Salivary glands contain many different types of cells that can become cancerous, so there are many different types of salivary gland cancers. Relatively rare HNC malignancies include acinic cell adenocarcinoma of the parotid gland (a form of salivary gland cancer), eye cancer (retinoblastoma), and ear cancer.
  • The annual incidence of HNCs worldwide is more than 0.5 million cases, with around 0.3 million related deaths occurring each year. In terms of the initial site of development, around 44% of HNCs involve the oral cavity, more than 30% the larynx, and around 25% the pharynx. The incidence of tobacco-related HNC is decreasing, but the incidence of cancer due to the human papillomavirus (HPV) continues to increase at a rate of 2-4% per year. HNC is most common in the middle aged, with a peak incidence rate between the ages of 55 and 64, and a median age of diagnosis of 62.
  • The HNC market is characterized by a small selection of marketed drug options, consisting of chemotherapies, targeted therapies (anti-EGFR), and immunotherapies (PD1/PD-L1 inhibitor). Historically, cytotoxic chemotherapies have made up the bulk of the HNC market. Little competition currently exists in the HNC market, leaving an area of considerable opportunity for interested newcomers. Currently, four targeted therapies are available in the APAC HNC market, which are Erbitux, BIOMAb EGFR, Opdivo and Keytruda. The remainder of this market is composed of generics. Recent additions to the market have highlighted that the treatment landscape is diversifying and becoming less reliant on chemotherapy options.
  • With the approval of Keytruda in Australia, and Opdivo in Australia, South Korea and Japan, there has been an increase in targeted therapy options. Additionally avelumab (a PD-L1 inhibitor) is likely to be approved in APAC countries at the end of the forecast period, as it is currently undergoing Phase III trials in Japan, Australia and South Korea. A number of mAbs are in development in HNC for the inhibition of various different pathways and signaling systems. Many companies are following a strategy of developing products with similar mechanisms of action to those of existing products already approved in either HNC or other oncology indications. EGFR and PD-1/PD-L1 are the most commonly addressed targets in the current pipeline.
  • However, there are also many innovative products in the HNC pipeline, which reflects a deepening scientific understanding of the underlying pathophysiology of HNC and the growing list of molecules that have been implicated in the initiation and progression of the disease.
  • The report "Head and Neck Cancer Therapeutics in Asia-Pacific Markets to 2023 - Launch of Premium Immunotherapies and Increasing Prevalence to Drive the Market" helps you to -
  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
  • Visualize the composition of the HNC market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
  • Analyze the HNC pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
  • Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
  • Predict HNC market growth in the five assessed Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
  • Identify commercial opportunities in the HNC deals landscape by analyzing trends in licensing and co-development deals.

Scope

  • The HNC Asia-Pacific market will be valued at $424.5m in 2023, growing from $265.9m in 2016 at a CAGR of 6.9%.
  • How will immune checkpoint inhibitors such as Opdivo, Keytruda and Imfinzi contribute to growth?
  • What effect will patent expirations of branded therapies have on market value?
  • The HNC pipeline is large and diverse, with an strong presence of mAbs and targeted therapies.
  • What are the common targets and mechanisms of action of pipeline therapies?
  • Will the pipeline address unmet needs such as the lack of targeted therapies available for locally advanced HNC patients?
  • What implications will the increased focus on targeted therapies have on the future of HNC treatment?
  • Numerous late-stage pipeline therapies with a strong clinical record have the potential to enter the market over the forecast period.
  • How have the late-stage therapies performed in clinical trials?
  • How would the approval of Keytruda, Opdivo and Bavencio to treat locally advanced HNC patients affect the competitive landscape, with no immunotherapy currently available to address this patient subset?
  • The market forecasts indicate that Japan will contribute the most to the Asia-Pacific market value due to the emergence of novel therapies.
  • How will the annual cost of therapy and market size vary between the five assessed Asia-Pacific markets?
  • How could changes in risk factors such as population age, tobacco use (both smoked and smokeless) and alcohol consumption influence the market?
  • Licensing deals are the most common form of strategic alliance in HNC, with total deal values ranging from under $10m to over $1 billion.
  • How do deal frequency and value compare between target families and molecule types?
  • What were the terms and conditions of key licensing deals?

Reasons to buy

  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
  • Visualize the composition of the HNC market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
  • Analyze the HNC pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
  • Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
  • Predict HNC market growth in the five assessed Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
  • Identify commercial opportunities in the HNC deals landscape by analyzing trends in licensing and co-development deals.

1 Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 8
  • 1.2 List of Figures 8

2 Introduction 10

  • 2.1 Disease Introduction 10
  • 2.2 Epidemiology 10
  • 2.3 Symptoms 13
  • 2.4 Etiology and Pathophysiology 13
    • 2.4.1 Etiology 13
    • 2.4.2 Pathophysiology 16
    • 2.4.3 Biomarkers/Targets of Interest 20
  • 2.5 Diagnosis 21
  • 2.6 Disease Stages 22
  • 2.7 Prognosis 29
  • 2.8 Treatment Guidelines and Options 31
    • 2.8.1 Surgery and Radiation Therapy 33
    • 2.8.2 Chemotherapy 34
    • 2.8.3 Targeted Therapies 35

3 Marketed Products 37

  • 3.1 Overview 37
  • 3.2 Chemotherapies 38
    • 3.2.1 TS-1 (tegafur plus gimeracil plus oteracil) - Taiho Pharma 38
    • 3.2.2 Cisplatin 40
    • 3.2.3 Docetaxel 41
    • 3.2.4 Fluorouracil (5-FU) 42
    • 3.2.5 Methotrexate 42
  • 3.3 Epidermal Growth Factor Receptor Targeted Therapies 43
    • 3.3.1 Erbitux (cetuximab) - Eli Lilly/Merck KGaA 43
    • 3.3.2 BIOMAb EGFR (nimotuzumab) - Biocon/Biotech Pharmaceutical Co. 45
  • 3.4 Programmed Cell Death Protein 1/Programmed Death Ligand 1 Immune Checkpoint Inhibitors 47
    • 3.4.1 Opdivo (nivolumab) - Bristol-Myers Squibb 47
    • 3.4.2 Keytruda (pembrolizumab) - Merck & Co. 50
  • 3.5 Comparative Efficacy and Safety of Marketed Products 53

4 Pipeline Analysis 56

  • 4.1 Overview 56
  • 4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 57
  • 4.3 Pipeline by Molecular Target 60
  • 4.4 Promising Pipeline Candidates 62
    • 4.4.1 Imfinzi (durvalumab) - MedImmune 62
    • 4.4.2 Gilotrif/Giotrif/Xovoltib (afatinib) - Boehringer Ingelheim 66
    • 4.4.3 Bavencio (avelumab) - Merck KgaA/Pfizer 68
  • 4.5 Comparative Efficacy and Safety of Pipeline Products 70
  • 4.6 Product Competitiveness Framework 71

5 Clinical Trial Analysis 73

  • 5.1 Failure Rate 73
    • 5.1.1 Overall Failure Rate 73
    • 5.1.2 Failure Rate by Phase and Molecule Type 75
    • 5.1.3 Failure Rate by Phase and Molecular Target 76
  • 5.2 Clinical Trial Size 77
    • 5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 77
    • 5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 78
    • 5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 79
    • 5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 80
  • 5.3 Clinical Trial Duration 81
    • 5.3.1 Trial Duration by Molecule Type and Stage of Development 81
    • 5.3.2 Trial Duration by Molecular Target and Stage of Development 82
  • 5.4 Summary of Clinical Trial Metrics 83

6 Multi-scenario Forecast 84

  • 6.1 Overview 84
  • 6.2 Asia-Pacific Market 85
  • 6.3 India 87
    • 6.3.1 Treatment Usage Patterns 87
    • 6.3.2 Annual Cost of Therapy 88
    • 6.3.3 Market Size 89
  • 6.4 China 90
    • 6.4.1 Treatment Usage Patterns 90
    • 6.4.2 Annual Cost of Therapy 91
    • 6.4.3 Market Size 92
  • 6.5 Australia 94
    • 6.5.1 Treatment Usage Patterns 94
    • 6.5.2 Annual Cost of Therapy 95
    • 6.5.3 Market Size 95
  • 6.6 South Korea 97
    • 6.6.1 Treatment Usage Patterns 97
    • 6.6.2 Annual Cost of Therapy 98
    • 6.6.3 Market Size 99
  • 6.7 Japan 100
    • 6.7.1 Treatment Usage Patterns 100
    • 6.7.2 Annual Cost of Therapy 101
    • 6.7.3 Market Size 102

7 Drivers and Barriers 104

  • 7.1 Drivers 104
    • 7.1.1 Increasing Incidence of HNC 104
    • 7.1.2 Adoption of Immuno-oncology Therapies in the HNC Treatment Algorithm 104
    • 7.1.3 Launch of Premium Priced Pipeline Products 104
    • 7.1.4 Increasing Usage of High Premium Priced Combination Therapies 105
    • 7.1.5 Diversified Healthcare Reform and Insurance System to Boost Market Growth 105
  • 7.2 Barriers 106
    • 7.2.1 Usage of Surgical Therapies at Early Stage Reduces Drug Treatment Rate 106
    • 7.2.2 Patent Expiration of Branded Therapies to Affect HNC Market Growth 106
    • 7.2.3 Lack of Development of Pipeline Products for Locally Advanced HNC 106
    • 7.2.4 High Prices of Therapeutics, Lack of Reimbursement and Penetration of Generics to Slow Down Market Growth in China and India 106
    • 7.2.5 Drug Pricing Reforms 107

8 Deals and Strategic Consolidations 108

  • 8.1 Licensing Deals 108
    • 8.1.1 Deals by Region and Value 108
    • 8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 110
    • 8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 111
    • 8.1.4 Key Licensing Deals 113
  • 8.2 Co-development Deals 115
    • 8.2.1 Deals by Region and Value 115
    • 8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 116
    • 8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 117
    • 8.2.4 Key Co-development Deals 119

9 Appendix 121

  • 9.1 All Pipeline Drugs by Stage of Development 121
    • 9.1.1 Discovery 121
    • 9.1.2 Preclinical 122
    • 9.1.3 IND/CTA-filed 125
    • 9.1.4 Phase I 126
    • 9.1.5 Phase II 130
    • 9.1.6 Phase III 133
  • 9.2 Market Forecasts to 2023 134
    • 9.2.1 Asia-Pacific 134
    • 9.2.2 India 134
    • 9.2.3 China 134
    • 9.2.4 Australia 135
    • 9.2.5 South Korea 135
    • 9.2.6 Japan 136
  • 9.3 Bibliography 136
  • 9.4 Abbreviations 148
  • 9.5 Research Methodology 150
    • 9.5.1 Secondary Research 151
    • 9.5.2 Marketed Product Profiles 151
    • 9.5.3 Late-Stage Pipeline Candidates 152
    • 9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 152
    • 9.5.5 Product Competitiveness Framework 152
    • 9.5.6 Pipeline Analysis 152
    • 9.5.7 Forecasting Model 153
    • 9.5.8 Deals Data Analysis 154
  • 9.6 Contact Us 154
  • 9.7 Disclaimer 155

1.1 List of Tables

  • Table 1: Symptoms of HNC, 2017 13
  • Table 2: Symptoms of HNC Metastasis, 2017 13
  • Table 3: Common Mutations in HNC Metastasis, 2017 19
  • Table 4: TNM Classification of Lip, Oral Cavity, and Oropharyngeal Cancers, 2017 23
  • Table 5: TNM Classification of the Larynx, 2017 24
  • Table 6: TNM Classification of the Hypopharynx, 2017 26
  • Table 7: TNM Classification of Salivary Gland Cancers, 2017 27
  • Table 8: TNM Classification of Nasopharyngeal Cancers, 2017 28
  • Table 9: Stage Grouping for HNC (Excluding Nasopharyngeal and Thyroid Cancer), 2017 29
  • Table 10: Stage Grouping for Nasopharyngeal Cancer, 2017 29
  • Table 11: HNC Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006-2017 114
  • Table 12: HNC Therapeutics Market, Global, Co-development Deals Valued Above $10m, 2006-2017 120
  • Table 13: HNC Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 121
  • Table 14: HNC Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 122
  • Table 15: HNC Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2017 125
  • Table 16: HNC Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 126
  • Table 17: HNC Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 130
  • Table 18: HNC Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 133
  • Table 19: HNC Therapeutics Market, APAC, Market Forecast, 2016-2023 134
  • Table 20: HNC Therapeutics Market, India, Market Forecast, 2016-2023 134
  • Table 21: HNC Therapeutics Market, China, Market Forecast, 2016-2023 134
  • Table 22: HNC Therapeutics Market, Australia, Market Forecast, 2016-2023 135
  • Table 23: HNC Therapeutics Market, South Korea, Market Forecast, 2016-2023 135
  • Table 24: HNC Therapeutics Market, Japan, Market Forecast, 2016-2023 136

1.2 List of Figures

  • Figure 1: HNC Therapeutics Market, Australia, Estimated Age-Specific Incidence and Mortality Rates for HNC, by Sex, 2017 12
  • Figure 2: HNC Therapeutics Market, Australia, Five-Year Relative Survival from HNC by Sex, 1984-2013 12
  • Figure 3: HNC Therapeutics Market, Treatment Algorithm for HNC (Excluding Nasopharyngeal and Thyroid Cancer) 32
  • Figure 4: HNC Therapeutics Market, Treatment Algorithm for Nasopharyngeal Cancer and Thyroid Cancer 33
  • Figure 5: HNC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products 53
  • Figure 6: HNC Therapeutics Market, Global, Pipeline, 2017 59
  • Figure 7: HNC Therapeutics Market, Global, Pipeline by Molecular Target, 2017 61
  • Figure 8: HNC Therapeutics Market, Pipeline by Molecular Target and Stage of Development, 2017 62
  • Figure 9: HNC Therapeutics Market, APAC, Imfinzi Forecast ($m), 2019-2023 65
  • Figure 10: HNC Therapeutics Market, APAC, Durvalumab plus Tremelimumab Forecast ($m), 2019-2023 66
  • Figure 11: HNC Therapeutics Market, APAC, Gilotrif/Giotrif/Xovoltib Forecast ($m), 2020-2023 68
  • Figure 12: HNC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products 71
  • Figure 13: HNC Therapeutics Market, Competitor Matrix for HNC Marketed and Pipeline Products, 2017 72
  • Figure 14: HNC Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 74
  • Figure 15: HNC Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 75
  • Figure 16: HNC Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 76
  • Figure 17: HNC Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 77
  • Figure 18: HNC Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016 78
  • Figure 19: HNC Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016 79
  • Figure 20: HNC Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016 80
  • Figure 21: HNC Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016 81
  • Figure 22: HNC Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016 82
  • Figure 23: HNC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 83
  • Figure 24: HNC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 83
  • Figure 25: HNC Therapeutics Market, APAC, Treatment Patterns ('000), 2016-2023 86
  • Figure 26: HNC Therapeutics Market, APAC, Market Size ($m), 2016-2023 87
  • Figure 27: HNC Therapeutics Market, India, Treatment Patterns ('000), 2016-2023 88
  • Figure 28: HNC Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023 89
  • Figure 29: HNC Therapeutics Market, India, Market Size ($m), 2016-2023 90
  • Figure 30: HNC Therapeutics Market, China, Treatment Patterns ('000), 2016-2023 91
  • Figure 31: HNC Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023 92
  • Figure 32: HNC Therapeutics Market, China, Market Size ($m), 2016-2023 93
  • Figure 33: HNC Therapeutics Market, Australia, Treatment Patterns ('000), 2016-2023 94
  • Figure 34: HNC Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023 95
  • Figure 35: HNC Therapeutics Market, Australia, Market Size ($m), 2016-2023 96
  • Figure 36: HNC Therapeutics Market, South Korea, Treatment Patterns ('000), 2016-2023 98
  • Figure 37: HNC Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 99
  • Figure 38: HNC Therapeutics Market, South Korea, Market Size ($m), 2016-2023 100
  • Figure 39: HNC Therapeutics Market, Japan, Treatment Patterns ('000), 2016-2023 101
  • Figure 40: HNC Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023 102
  • Figure 41: HNC Therapeutics Market, Japan, Market Size ($m), 2016-2023 103
  • Figure 42: HNC Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2017 109
  • Figure 43: HNC Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2017 110
  • Figure 44: HNC Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2017 111
  • Figure 45: HNC Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2017 112
  • Figure 46: HNC Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2017 113
  • Figure 47: HNC Therapeutics Market, Global, Co-development Deals by Region, 2006-2017 115
  • Figure 48: HNC Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2017 116
  • Figure 49: HNC Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2017 117
  • Figure 50: HNC Therapeutics Market, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2017 118
  • Figure 51: HNC Therapeutics Market, Global, Co-development Deals by by Molecular Target and Aggregate Deal Value ($m), 2006-2017 119
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