Familial Hypercholesterolemia – Pipeline Insight, 2020
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DelveInsight’s, “Familial Hypercholesterolemia – Pipeline Insight, 2020,” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Familial Hypercholesterolemia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Geography Covered
Familial Hypercholesterolemia: Overview
Familial hypercholesterolemia is an inherited condition characterized by very high levels of cholesterol in the blood. Cholesterol is a waxy, fat-like substance that is produced in the body and obtained from foods that come from animals (particularly egg yolks, meat, poultry, fish, and dairy products). The body needs this substance to build cell membranes, make certain hormones, and produce compounds that aid in fat digestion. In people with familial hypercholesterolemia, the body is unable to get rid of extra cholesterol, and it builds up in the blood. Too much cholesterol increases a person's risk of developing heart disease.
People with familial hypercholesterolemia have a high risk of developing a form of heart disease called coronary artery disease at a young age. This condition occurs when excess cholesterol in the bloodstream is deposited on the inner walls of blood vessels, particularly the arteries that supply blood to the heart (coronary arteries).
Symptoms
The major symptoms and signs of familial hypercholesterolemia are:
Diagnosis of familial hypercholesterolemia is based on physical examination and laboratory testing. Physical examination may find xanthomas and xanthelasmas (skin lesions caused by cholesterol rich lipoprotein deposits), and cholesterol deposits in the eye called corneal arcus.
Laboratory testing includes blood testing of cholesterol levels, studies of heart function, and genetic testing. Blood testing of cholesterol levels may show: increased total cholesterol usually above 300 mg/dl (total cholesterol of more than 250 mg/dl in children) and LDL levels usually above 200 mg/dl. Studies of heart function, such as a stress test, may be abnormal.
Genetic testing may show an alteration (mutation) in the LDL receptor gene.
Treatment
This segment of the Familial Hypercholesterolemia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Familial Hypercholesterolemia Emerging Drugs
Further product details are provided in the report
Familial Hypercholesterolemia: Therapeutic Assessment
This segment of the report provides insights about the different Familial Hypercholesterolemia drugs segregated based on following parameters that define the scope of the report, such as:
Phases
DelveInsight’s report covers around 10+ products under different phases of clinical development like
Familial Hypercholesterolemia: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Familial Hypercholesterolemia therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Familial Hypercholesterolemia drugs.
Report Highlights
Current Treatment Scenario and Emerging Therapies:
DelveInsight’s, “Familial Hypercholesterolemia – Pipeline Insight, 2020,” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Familial Hypercholesterolemia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Geography Covered
- Global coverage
Familial Hypercholesterolemia: Overview
Familial hypercholesterolemia is an inherited condition characterized by very high levels of cholesterol in the blood. Cholesterol is a waxy, fat-like substance that is produced in the body and obtained from foods that come from animals (particularly egg yolks, meat, poultry, fish, and dairy products). The body needs this substance to build cell membranes, make certain hormones, and produce compounds that aid in fat digestion. In people with familial hypercholesterolemia, the body is unable to get rid of extra cholesterol, and it builds up in the blood. Too much cholesterol increases a person's risk of developing heart disease.
People with familial hypercholesterolemia have a high risk of developing a form of heart disease called coronary artery disease at a young age. This condition occurs when excess cholesterol in the bloodstream is deposited on the inner walls of blood vessels, particularly the arteries that supply blood to the heart (coronary arteries).
Symptoms
The major symptoms and signs of familial hypercholesterolemia are:
- High levels of total cholesterol and LDL cholesterol.
- A strong family history of high levels of total and LDL cholesterol and/or early heart attack.
- Elevated and therapy-resistant levels of LDL in either or both parents.
- Xanthomas (waxy deposits of cholesterol in the skin or tendons).
- Xanthelasmas (cholesterol deposits in the eyelids).
- Corneal arcus (cholesterol deposit around the cornea of the eye).
- If angina (chest pain) is present, it may be sign that heart disease is present.
Diagnosis of familial hypercholesterolemia is based on physical examination and laboratory testing. Physical examination may find xanthomas and xanthelasmas (skin lesions caused by cholesterol rich lipoprotein deposits), and cholesterol deposits in the eye called corneal arcus.
Laboratory testing includes blood testing of cholesterol levels, studies of heart function, and genetic testing. Blood testing of cholesterol levels may show: increased total cholesterol usually above 300 mg/dl (total cholesterol of more than 250 mg/dl in children) and LDL levels usually above 200 mg/dl. Studies of heart function, such as a stress test, may be abnormal.
Genetic testing may show an alteration (mutation) in the LDL receptor gene.
Treatment
- The overall goal of treatment is to lower the risk for atherosclerotic heart disease by lowering the LDL cholesterol levels in the blood stream. Atherosclerosis is a condition in which fatty material collects along the walls of arteries. This fatty material thickens, hardens, and may eventually block the arteries.
- The first step in treatment for an individual who has heterozygous familial hypercholesterolemia is changing the diet to reduce the total amount of fat eaten to 30 percent of the total daily calories.
- Exercise, especially to lose weight, may also help in lowering cholesterol levels.
- Drug therapy is usually necessary in combination with diet, weight loss, and exercise, as these interventions may not be able to lower cholesterol levels alone.
This segment of the Familial Hypercholesterolemia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Familial Hypercholesterolemia Emerging Drugs
- LIB 003: LIB Therapeutics
- Tafolecimab: Innovent Biologics
Further product details are provided in the report
Familial Hypercholesterolemia: Therapeutic Assessment
This segment of the report provides insights about the different Familial Hypercholesterolemia drugs segregated based on following parameters that define the scope of the report, such as:
- Major Players in Familial Hypercholesterolemia
Phases
DelveInsight’s report covers around 10+ products under different phases of clinical development like
- Mid-stage products (Phase II and Phase I/II)
- Early-stage products (Phase I/II and Phase I) along with the details of
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
- Route of Administration
- Subcutaneous
- Intravenous
- Oral
- Intramuscular
- Molecule Type
- Small molecules
- Recombinant fusion proteins
- Monoclonal antibodies
- Immunoglobulins
- Immunoproteins
- Serum globulins
- Product Type
Familial Hypercholesterolemia: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Familial Hypercholesterolemia therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Familial Hypercholesterolemia drugs.
Report Highlights
- The companies and academics are working to assess challenges and seek opportunities that could influence Familial Hypercholesterolemia R&D. The therapies under development are focused on novel approaches to treat/improve Familial Hypercholesterolemia.
- August 2020: Innovent announces the results of the phase 1/2 clinical study of PCSK9 antibody tafolecimab at the European Society of Cardiology Annual Conference
- The accepted results were from CIBI306A101 and CIBI306B101, which demonstrated satisfactory safety and efficacy profiles of Tafolecimab.
- Specially, compared with the marketed PCSK9 inhibitors, Tafolecimab preliminarily demonstrated longer dosing interval, which is 6 or even up to 8 weeks.
- Familial Hypercholesterolemia Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Familial Hypercholesterolemia drugs?
- How many Familial Hypercholesterolemia drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Familial Hypercholesterolemia?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Familial Hypercholesterolemia therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Familial Hypercholesterolemia and their status?
- What are the key designations that have been granted to the emerging drugs?
- Jiangsu HengRui Medicine Co., Ltd.
- Amgen
- Innovent Biologics (Suzhou) Co. Ltd.
- Regeneron Pharmaceuticals
- Akeso
- The Medicines Company
- Regenxbio Inc.
- LIB Therapeutics LLC
- SHR-1209
- Evolocumab
- IBI306
- Evinacumab
- AK102
- AAV directed hLDLR gene therapy
Introduction
Executive Summary
Familial Hypercholesterolemia: Overview
Causes
Mechanism of Action
Signs and Symptoms
Diagnosis
Disease Management
Pipeline Therapeutics
Comparative Analysis
Therapeutic Assessment
Assessment by Product Type
Assessment by Stage and Product Type
Assessment by Route of Administration
Assessment by Stage and Route of Administration
Assessment by Molecule Type
Assessment by Stage and Molecule Type
Familial Hypercholesterolemia – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
Familial Hypercholesterolemia companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Familial Hypercholesterolemia Collaboration Deals
Company-Company Collaborations (Licensing / Partnering) Analysis
Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
Comparative Analysis
LIB 003: LIB Therapeutics
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
Comparative Analysis
SHR-1209: Jiangsu HengRui Medicine Co., Ltd.
Product Description
Research and Development
Product Development Activities
AK102: Akeso
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Pre-clinical and Discovery Stage Products
Comparative Analysis
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
Comparative Analysis
Familial Hypercholesterolemia Key Companies
Familial Hypercholesterolemia Key Products
Familial Hypercholesterolemia- Unmet Needs
Familial Hypercholesterolemia- Market Drivers and Barriers
Familial Hypercholesterolemia- Future Perspectives and Conclusion
Familial Hypercholesterolemia Analyst Views
Familial Hypercholesterolemia Key Companies
Appendix
Executive Summary
Familial Hypercholesterolemia: Overview
Causes
Mechanism of Action
Signs and Symptoms
Diagnosis
Disease Management
Pipeline Therapeutics
Comparative Analysis
Therapeutic Assessment
Assessment by Product Type
Assessment by Stage and Product Type
Assessment by Route of Administration
Assessment by Stage and Route of Administration
Assessment by Molecule Type
Assessment by Stage and Molecule Type
Familial Hypercholesterolemia – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
Familial Hypercholesterolemia companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Familial Hypercholesterolemia Collaboration Deals
Company-Company Collaborations (Licensing / Partnering) Analysis
Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
Comparative Analysis
LIB 003: LIB Therapeutics
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
Comparative Analysis
SHR-1209: Jiangsu HengRui Medicine Co., Ltd.
Product Description
Research and Development
Product Development Activities
AK102: Akeso
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Pre-clinical and Discovery Stage Products
Comparative Analysis
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
Comparative Analysis
Familial Hypercholesterolemia Key Companies
Familial Hypercholesterolemia Key Products
Familial Hypercholesterolemia- Unmet Needs
Familial Hypercholesterolemia- Market Drivers and Barriers
Familial Hypercholesterolemia- Future Perspectives and Conclusion
Familial Hypercholesterolemia Analyst Views
Familial Hypercholesterolemia Key Companies
Appendix
LIST OF TABLES
Table 1 Total Products for Familial Hypercholesterolemia
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
Table 1 Total Products for Familial Hypercholesterolemia
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
LIST OF FIGURES
Figure 1 Total Products for Familial Hypercholesterolemia
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
Figure 1 Total Products for Familial Hypercholesterolemia
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products